Read the most up-to-date information about the latest developments in psoriatic arthritis

Clinical Updates in Psoriatic Arthritis

The impact of psoriatic arthritis on patients’ quality of life and importance of an early, accurate diagnosis.

Expert Perspective on the Management of Psoriatic Arthritis

Rheumatoid Arthritis Quiz

Learn more about the latest developments in rheumatoid arthritis

Focus on Rheumatoid Arthritis

Ingrid Torjesen is a UK-based freelance health journalist with more than 30 years of experience in health and medical communications. She works for numerous publications including Rheumatology Network, the BMJ and the Economist’s Intelligence Unit. Before her freelance career, her staff jobs included news editor of both Pulse and GP (the two leading UK weekly titles for primary care doctors), and opinion and features editor of the Health Service Journal (the UK’s leading health policy title). She also spent a few years working in Australia, including on Australian Doctor.

Glucocorticoids should only be used as bridging therapy

Earlier addition of a biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD) to methotrexate in patients who continue to experience moderate to severe disease activity despite conventional synthetic DMARDs

Methotrexate is recommended over hydroxychloroquine or sulfasalazine for DMARD-naive patients with moderate-to-high disease activity

Methotrexate is recommended over leflunomide for DMARD-naive patients with moderate-to-high disease activity

Methotrexate monotherapy is recommended over biologic DMARD or targeted synthetic DMARD monotherapy for DMARD-naive patients with moderate-to-high disease activity

Methotrexate monotherapy is recommended over dual or triple conventional synthetic DMARD therapy for DMARD-naive patients with moderate-to-high disease activity

Methotrexate monotherapy is recommended over methotrexate plus a tumor necrosis factor (TNF) inhibitor for DMARD-naive patients with moderate-to-high disease activity

Methotrexate monotherapy is recommended over methotrexate plus a non–TNF inhibitor biologic DMARD or targeted synthetic DMARD for DMARD-naive patients with moderate-to-high disease activity

Articles

The American College of Rheumatology (ACR) published its long-awaited update to the 2015 Guidelines on the Management of Rheumatoid Arthritis last week. Have you read the 2021 update yet? Test your knowledge of the most important points with our quiz.

Rheumatoid Arthritis Quiz: Key Changes to ACR Rheumatoid Arthritis Guidelines (2021 Update)

Lana Dykes is the Editor of Rheumatology Network. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. She enjoys cooking, yoga, and drawing. 

Rheumatology Network spoke with Alexis Ogdie, MD, to discuss her study, “Real-World Patient Experience and Treatment Preferences in Patients With Psoriatic Arthritis,” which was recently presented at the EULAR 2021 Virtual Congress. Ogdie is a medical advisor for CreakyJoints, as well as Associate Professor of Medicine and Epidemiology and rheumatologist at the University of Pennsylvania. She explains the importance of understanding the patient perspective, the survey they employed to evaluate symptoms and disease impact, and the ultimate results of the study.

To begin, why is it important for rheumatologists to understand a patient's experience of living with psoriatic arthritis and their treatment preferences?

Well, 1 of the things is, as a rheumatologist, we're often focused on the number of joints that are swollen, whether or not there's dactylitis, or axial disease. So, thinking very much about the physical aspects of the disease. And what I think some of the studies about preferences show us is that it's more about the impact than the number of swollen joints, for example. And so that kind of helps us come up with a well-rounded treatment plan if we've thought through all the potential ways in which the patient is being impacted by the disease.

Why do patients with psoriatic arthritis frequently experience inadequate or intolerance to therapies?

So, first of all, I don't know that they always frequently have intolerance, I think, actually, most therapies are pretty well tolerated. In particular, our biologic therapies, for example, are very well tolerated medications overall. Now, unfortunately, there is in inadequate response to many of our therapies, so we still at best get about 30 to 40% of our patients to remission with an individual therapy. And that's kind of at best, like I said, so we have a long way to go into getting better therapies that really treat the patient to a level of disease activity that they want. I think the main thing is people end up switching therapies because 1 isn't really good enough. And sometimes you have to go through a couple to find the one that's right for that particular patient.

Can you tell me a little bit about the methods you and your team use to create the study design and survey?

ArthritisPower is a patient-powered research network, so patients can go on and contribute their data. And so, we utilized that network to deliver a survey to patients with psoriatic arthritis, and they responded about their treatment preferences. Before we sent the survey, we asked some individual patients about their experiences to help us come up with a list of different items to include on the survey so that we were covering the full range when we sent the items out to the patients.

And what were some of the symptoms and disease impacts that the study evaluated?

It evaluated the importance of a variety of physical features like joints, dactylitis, enthesitis, psoriasis, and then it also evaluated the relative importance to patients of the individual impact. So, whether that be fatigue, diminished physical activity, and being able to socialize. Those kinds of things. So, we asked patients to rank among those.

 We found that patients in this particular study had mainly mild psoriasis. And so they've actually rated the psoriasis as not as important to them. And I think that would be different if you had a group of patients who had more moderate to severe psoriasis. They may right rate that more highly. We also found some of the same impacts that we've seen in other studies that pain is important to patients, but physical function and fatigue are also important symptoms for patients who are managing this disease.

No, we actually weren't surprised by the results. We've seen this with other studies as well. But this was nice confirmatory test to make sure that this other population of patients is feeling the same way as previous study patients as well.

What do you believe patients preferred omitting methotrexate from their treatment plan?

Patients often report to us that they have nausea or fatigue after methotrexate. In rheumatoid arthritis we hear the same thing, but in rheumatoid arthritis, it also works pretty well. And so, patients will take that tradeoff for having improved disease activity. On the other hand, in psoriatic arthritis, there may not be the same level of efficacy. And so, in some patients who aren't doing better, the tradeoff for the risk benefit ratio isn't worth it to them; they get these side effects without significant improvement. So, I think that's 1 of the reasons that patients were in favor in general of dropping methotrexate. Additionally, many of these patients had been through that drug already. If you ask the individual patient sitting in front of you on methotrexate, they may or may not feel that way. But most of these patients had already been through methotrexate.

Why do you believe patients prefer oral medications once a day and injection once a month over other treatment methods?

Well, in this particular study, patients were interested in being able to travel and not having to worry about bringing their injectable medication with them. And so that was 1 of the reasons they preferred oral. And I'd say on average, patients in this particular study preferred oral over subcutaneous, but, you know, it varies by patient for their individual lifestyle. So, a once daily medication is generally pretty easy to take and monthly injections are easy to take as well. Some of my patients even prefer the weekly injections simply because then they remember it too. I think it's just varied by patient population, but on average patients prefer the once daily oral drug.

Why is the mode of administration an important factor in starting a new therapy?

Well, I think it comes back to patient's lifestyle. So, you have to really assess: what are they doing on a day-to-day basis? Are they traveling much? What are their needs? And how are they going to best remember the medication? So, each patient has something that might be unique for them.

Was the study strengthened or limited by any factors that you'd like to discuss?

The patient population was a group of, in general, educated patients who had mild psoriasis. So, I think we just have to kind of take that with a grain of salt. Many of these people are in the patient-powered research network because they're very interested and kind of active patients. So that would just be 1 consideration that we always think about when we're talking about a survey to a specific patient population.

Does your team plan on doing any further research on the topic?

We've done a few other studies. My own group has also looked at patient preferences in a similar but slightly different way, and basically found very similar things as well. One of the things we've thought about is: can we better identify treatment paradigms or ways of thinking about treatment that directs to what the patient wants? And if we had a standardized way of assessing patient preferences, and then a standardized way of kind of helping formulate a treatment plan that takes into account all the impacts that the patient is experiencing, that might be helpful to the clinician when you're kind of coming up with a treatment plan in a relatively short visit.

Is there anything else you'd like our audience to know about ArthritisPower, CreakyJoints, or psoriatic arthritis?

One thing is CreakyJoints is a great reference for your patients. I give that to my patients all the time. It's nice because it's reviewed by physicians. So, there's some good content there. There are also patient guideline booklets that have a lot of detailed information for the patient who wants a lot of detailed information. And then ArthritisPower is great because there's an app and they can track their outcome measures. So, if you have that patient that's really interested in improving their fatigue, or you want to do an intervention or something, they can track their own symptoms on that app and then show you their symptoms. I find it not only a good way to contribute to the research community, but actually its a very practical way of tracking outcome measures. That's something that I recommended to my patients.

Well, thank you so much for speaking with me today. I really appreciate it.

Videos

In partnership with CreakyJoints, Alexis Ogdie, MD discusses her study, “Real-World Patient Experience and Treatment Preferences in Patients With Psoriatic Arthritis,” which was recently presented at the EULAR 2021 Virtual Congress. 

Alexis Ogdie, MD: Importance of Patient Experience in Psoriatic Arthritis Treatment

Rheumatology Network's Top 5: June 11, 2021

Take 5 minutes to catch up on Rheumatology Network's highlights from the week ending June 11, 2021.


Rheumatology Network interviewed Liana Fraenkel, MD, MPH to discuss the recent updates to the American College of Rheumatology 

 for the Treatment of Rheumatoid Arthritis. Fraenkel served as part of the Core Leadership Team and is a rheumatologist at Berkshire Medical Center and Director of Patient Centered Population Health Research. She explains the differences between the 2015 and 2021 guidelines, the key takeaways, and the clinical significance of these changes.

To view our coverage of the guidelines, click 

The American College of Rheumatology updates its clinical practice guidelines at the minimum of every 5 years to ensure that rheumatologists have the most up-to-date information available to them. These guidelines include specific recommendations for rheumatoid arthritis which is our most common chronic inflammatory arthritis.

What are the main differences between the 2015 and 2021 guidelines?

The main differences between the 2015 and 2021 guidelines are that we now conditionally recommend against using low-dose prednisone as bridge therapy. Another difference is that we now recommend adding a biologic over adding sulfasalazine and hydroxychloroquine (which would equate to triple therapy) for patients who are not doing well enough on methotrexate.

What do rheumatologists need to know about the 2021 guidelines?

The main points emphasized the guidelines are to maximize the use of methotrexate before advancing to a biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD). We also include recommendations for how to manage side effects associated with methotrexate in order to increase the number of patients who can remain on methotrexate monotherapy. As mentioned above, the recommendation is now to escalate the methotrexate with addition of a biologic over advancing her triple therapy. Another key take away is to try to avoid glucocorticoids whenever possible, including low-dose glucocorticoids.Treated target continues to be strongly recommended for patients with not been previously treated with biologic DMARDs or targeted synthetic DMARDs, but the recommendation is conditional for those with previous experience on these medications. Further, there are several additional recommendations for specific patient populations including patients with subcutaneous nodules and pulmonary liver disease. For the first time the guidelines also address patients with nontuberculous mycobacterial lung disease.

We hope that these guidelines help support best practices across rheumatologist in the right states. The guidelines also revealed several gaps in the literature for which further research is required to answer key clinical questions including at what dose methotrexate should be started, what are the best mechanisms to try to decrease side effects to the methotrexate, further data to compare the effectiveness and safety between DMARDs, and how best to treat patients with prevalent comorbidities.

Were there any sticking points (for both the voting panel and patient panel)?

There were several sticking points, ie more difficult decisions at the panel deliberated on. One was regarding the need for bridge therapy with low-dose prednisone. It is recognized that many patients will require prednisone to help manage her symptoms until DMARDs kick in. However, because of the toxicity associated with even low doses of prednisone, and the common finding that patients remain on low-dose prednisone much longer than originally planned when using as bridge therapy, the panel’s recommendation was now to recommend against the use of low-dose prednisone even as bridge therapy. This is not meant to eliminate this oxygen for patients who needed, it is meant to ensure that rheumatologists do not default to using bridge therapy but that rather this is only used when absolutely necessary. The other major sticking point was on whether patients that were not doing well enough on methotrexate should escalate to triple therapy or to adding a biologic or targeted synthetic DMARD. Again, this recommendation required significant deliberation. In the end, the patient's preference for earlier onset of treatment persuaded the panel to recommend a biologic or targeted synthetic DMARD over triple therapy. Studies also showing that it is difficult for some patients to remain on triple therapy, most probably due to sulfasalazine, was also taken into consideration. There were also 2 areas where patients and the remaining of the voting panel disagreed. One was on the initial use of combination conventional synthetic DMARDs over methotrexate monotherapy. Patient's preferred initial treatment with combination because of its incremental benefits, whereas clinicians do not feel that this incremental benefit warranted the additional burden of toxicity associated with combination therapy. This difference was also noted in 2015 guidelines. In addition, patients were also strongly for discontinuing DMARDs when tapering over dose reduction, whereas the clinicians preferred the latter.

Were there any items that still need to be decided?

The guidelines cited several areas where there was insufficient evidence to permit any recommendations. We actually published a table including over 10 important areas where data are needed to make important clinical decisions in everyday practice. These include issues surrounding methotrexate administration, how best to implement treat to target strategies, comparative effectiveness and safety data between her different agents, as well as how best to treat patients with important comorbidities.

What are the priorities for the next guidelines?

Originally these guidelines were meant to address other areas which are very important for patient care including nonpharmacologic therapy and vaccine administration. Both of these issues will be undertaken in efforts by other panels.

Liana Fraenkel, MD, MPH, discusses the recent updates to the American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis, for which she served as part of the Core Leadership Team. 

Liana Fraenkel, MD, MPH: ACR 2021 Treatment Guidelines for Rheumatoid Arthritis 

Risankizumab (RZB) showed significantly greater improvements in symptoms of psoriatic arthritis (PsA) when compared with a placebo, according to a study presented at the EULAR Virtual Congress 2021, entitled, 

“Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Includintg Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trail.”

 RZB was also well tolerated in patients who were intolerant to biologics (Bio-IR) and conventional synthetic disease-modifying antirheumatic drugs (csDMARDs-IR).

RZB is an immunoglobulin G1 monoclonal antibody that binds to the p19 subunit of interleukin 23 (IL-23) and works by selectively inhibiting this cytokine. The KEEPsAKE 2 trail compared RZB with a placebo in patients with active PsA who have a history of inadequate response and/or intolerance to biologics and DMARD therapies.

Patients were randomized and received subcutaneous RZB 150 mg at week 0, 4 and 16 or a placebo. The primary endpoint was achieving an American College of Rheumatology score of ≥ 20% improvement (ACR20) at the end of week 24. Safety was also a top priority.

Eligible patients were aged ≥ 18 years and had active psoriatic arthritis (PsA) as defined by having symptom onset for ≥ 6 months, ≥ 5 tender and swollen joints, active plaque psoriasis, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) standards. Additionally, participants demonstrated inadequate response or intolerance to 1 or 2 eligible biologic agents or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), including methotrexate, apremilast, and sulfasalazine.

Of the 443 patients, 224 were selected for the RZB cohort and 219 received the placebo. Participants had similar demographics and baseline characteristics in both RZB and placebo cohorts. The majority were female (55.4% and 54.8%, respectively) and of comparable age (53 years and 52 years, respectively). The mean swollen joint count was 13.3, tender joint count was 22.6, and the mean duration of PsA was 8.2 years. A total of 206 patients had inadequate response to biologic therapies.

Significantly more patients in the RZB cohort achieved the primary endpoint when compared with the placebo group (51.3% vs 26.5%, respectively; P < .001), including disease activity in joints and skin for patients who were Bio-IR and csDMARD-IR. Serious adverse events were reported for 4.0% of participants in the RZB group, compared with 5.5% in the placebo group. Apart from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue; P < .009), RZB-treated patients showed improvement in all secondary endpoints as well.

The RZB group did not exhibit any specific safety issues and had similar adverse effects when compared to the placebo group. There were no deaths reported in either arms.

“When we look at the ranked and non-ranked secondary endpoints, all of these were met with a statistically significant superiority of RZB over placebo, including patient-reported outcomes (PROs) as well as enthesitis and dactylitis scores,” stated Andrew Östör, MD, MA, MB, FRACP, FRCP.

Risankizumab showed significantly greater improvements in symptoms of psoriatic arthritis when compared with a placebo and was well tolerated in patients who were intolerant to biologics and conventional synthetic disease-modifying antirheumatic drugs.

Risankizumab Significantly More Effective Than Placebo in Treating Psoriatic Arthritis 

Rheumatology Network sat down with Eugen Feist, MD, to discuss the recent olokizumab data presented at the EULAR 2021 Virtual Congress as a promising therapy for rheumatoid arthritis. Feist is the Medical Director at Helios Department for Rheumatology in Germany. He explains the therapeutic prospects for olokizumab, its unique biologic mode of action, and the clinical significance of the phase III studies.

While currently only available in Russia, olokizumab, a direct interleukin 6 (IL-6) inhibitor, is close to approval in a variety of other countries and may soon be available as an additional medication for the treatment of rheumatoid arthritis. The addition may improve disease management for this patient population. Besides affecting patients with rheumatoid arthritis, IL-6 plays a role in the pathogenesis for other diseases as well, such as systemic sclerosis.

“We need real world evidence. We hope for future development, maybe even other indications outside of rheumatoid arthritis because there may also be an option to use the drug in other rheumatic diseases for which we don't have a good treatment approach so far, but a high medical need,” stated Feist. “It is of interest to explore the full treatment benefits that this new drug can offer us.”

Feist was not surprised by the results of the study, as IL-6 inhibitors have been proven to be an effective approach to treating rheumatoid arthritis and boast a solid safety profile. Investigators did not find any new safety signals and olokizumab appears to be similar to other biologic drugs.

“I think we have really seen a bright development in rheumatology. Although some of us may have believed that the problem with rheumatoid arthritis was already solved, I think we all have learned in the past years that this is not the case,” Feist concluded. “There is indeed still a lot of work to do... At the end of the day, new developments are on the way. We can all look forward to these new treatment options.”

Stay up to date on the latest news in rheumatology. Sign up for Rheumatology Network's eNewsletter 

Rheumatology Network sat down with Eugen Feist, MD, to discuss the recent olokizumab data including the therapeutic prospects for olokizumab, its unique biologic mode of action, and the clinical significance of the phase III studies.









Eugen Feist, MD: Olokizumab Emerges as Promising Therapy for Rheumatoid Arthritis

The American College of Rheumatology has updated its treatment 

 for rheumatoid arthritis. The guideline includes 44 treatment recommendations, 7 of which are now strongly recommended. They address administration of methotrexate, treat-to-target for patients naïve to biologic disease modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic DMARDS (tsDMARDs), and prophylactic antiviral therapy for patients initiating rituximab who are hepatitis B core antibody positive.

In this slideshow, we highlight the 7 strongest recommendations.

The 2021 Treatment Guidelines for Rheumatoid Arthritis

Be sure to check out Rheumatology Network's 

Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis [published online ahead of print, 2021 Jun 8]. Arthritis Care Res (Hoboken). 2021;10.1002/acr.24596. doi:10.1002/acr.24596

The American College of Rheumatology has updated its treatment guidelines for rheumatoid arthritis. The guideline includes 44 treatment recommendations, 7 of which are now strongly recommended. 

Rheumatology Network spoke with Jessica Walsh, MD, to discuss her study, “

Patient perspectives of biologic treatments for axial spondyloarthritis: satisfaction, wear-off between doses, and use of supplemental medications

,” which was presented at the EULAR 2021 Virtual Congress. Walsh is a medical advisor for CreakyJoints and is affiliated with the University Utah School of Medicine and George E. Wahlen Veteran Affairs Medical Center. She gives a brief summary of the study design and results, explains why most patients experience wear-off between biologic doses, and the importance of understanding a patient’s experience of their treatment.

Hi, Dr Walsh, thank you for joining me today.

To begin, why is understanding a patient's experience of biologic disease-modifying antirheumatic drug (DMARD) therapy is so critical for rheumatologists treating this patient population?

Patients experience their diseases a little bit more globally, I think, sometimes than providers think about and so understanding how patients perceive their therapy and what their goals are is important. And understanding where the gaps are between what the providers and the patients want is very helpful. For example, I think a lot of times providers think in terms of specific disease features. Their tendon disease is active or inactive, or their joints are active or inactive, whereas the patient kind of takes it all together and may think about it more in terms of “I'm in pain, or I'm not in pain” more so than what specific features might be involved.

Can you tell me a bit about the study design?

Yes. So, this is a survey study, a cross sectional survey. So, patients were invited to participate via CreakyJoints, a platform where patients are invited to give information and also learn about their diseases. And they self-report what their disease state is in there. There are questions about who their rheumatologist is and what their symptoms are to help us better understand their disease. And then they answer a lot of survey questions. And then we look at those and report on the outcomes.

So, for this study, we were looking at biologics and patient satisfaction, disease activity, particularly in regards to the medication wear-off between doses or waning efficacy between doses. So, we wanted to know how frequently this was occurring and whether wear-off was associated with satisfaction and disease activity. And we also looked at what other medications patients use when they were reporting wear-off of their medications and their biologic medications.

Oh, not particularly. Well, actually, let me take that back. The frequency of patients reporting wear-off was pretty high. Over 60% of patients said that they experienced waning efficacy between their doses. And, I think, clinically we hear patients talk about that a lot. But I was still somewhat surprised that it was as high or as frequent as we've learned in the study.

Why do you believe that most of the patients with axial spondyloarthritis experience wear-off between doses causing them to reach for other medication options in the interim?

That's a great question. It’s a little bit inconsistent with what we know or what we think we've learned from clinical trials and from pharmacokinetic information. Patients apparently frequently say, though, in the last day to 3 days, 4 days before the dose that their symptoms get worse. And I don't know that I understand clinically why that is happening. But you know, it's a consistently reported issue that's affecting patients’ disease activity and quality of life.

In your opinion, is there any way to mitigate treatment dissatisfaction and the use of supplementary treatments for these patients?

I think this can be approached from multiple angles. Obviously, it would be great if there was an answer to why these medications are wearing off. Is it as simple as we need to change the dosing schedules? So, if it's an every 2-week medication, maybe it should be every 12 days or every 7 days. We would obviously need more data to better understand if that's the right approach. From a from another standpoint, is it appropriate and recommended to reach for supplemental pain management, medications and/or non-pharmacological treatment? I think the answer to that is obviously, yes. For some people experiencing the disease that might be exercise or therapy. Sometimes people may use meditation more. But you know, a lot of patients in this study are using medications and non-steroidal anti inflammatories were very commonly reported to be used, particularly when patients were experienced the wear-off. Muscle relaxants were commonly used. Interestingly, about 37/38% reached for opioids to help cope with the wear-off experience, glucocorticoids were used in about 20%, cannabinoids were used in about 20%. So, there's a lot going on that the patients are associating with this wear-off or using to cope with it. And I think we need to better understand what is occurring before we can know how to appropriately improve wear-off and support patients in their management of the wear-off.

Were there any strengths or limitations of the study that you'd like to address?

The population of the study is a little bit interesting. One of the strengths is that it's predominantly female. Historically, axial spondyloarthritis has been studied much more frequently in males. It's exciting to have a more female predominant population. It's also patient reported diagnosis, so we need to keep that in mind. This might not be the most representative export population since the demographics are different than what we're used to seeing in other studies. But I do think it's exciting. Of course, it's cross sectional and there's always issues with not understanding what's going on in the longer term, recall bias, and all sorts of issues when we're looking at cross sectional patient reported surveys. But overall, I think it's a fairly unique study that's helping us understand, or getting starting to understand, a frequently encountered problem that we see in clinical care.

Does your team plan on doing any further research on this topic?

Yes, I think so. I don't think all the plans are completely laid out yet, but I there's a lot of interest from both the provider and research side, and also from the patient side. So, I do think we'll dig a little deeper.

Is there anything else that you'd like to add about this study or axial spondyloarthritis before we wrap up?

I think in general, I'm very pleased and honored to be involved in more patient-centered research and learning about perspectives that are a little bit different than provider perspectives and what we see in clinical care. I think we need to do a lot more work with this. And I am happy that this particular topic is getting some traction, because it's just something that I talk about so much in clinic with patients on a day-to-day basis.

Dr Walsh, thank you so much for speaking with me today.

Rheumatology Network spoke with Jessica Walsh, MD, to discuss her study, “Patient perspectives of biologic treatments for axial spondyloarthritis: satisfaction, wear-off between doses, and use of supplemental medications."

Jessica Walsh, MD: Patient Perspectives of Biologic Treatments for Axial Spondyloarthritis

Rheumatology Network sat down with Alyssa Johnsen, MD, PhD, to discuss findings presented at the recent European Congress of Rheumatology on phase 3b Psoriatic Arthritis (PsA) data that showed guselkumab (TREMFYA®) achieved robust joint symptom improvement and skin clearance in patients with inadequate response to tumor necrosis factor inhibition. Johnsen is the Vice President and Rheumatology Disease Area Leader at Janssen Research & Development. As a part of the EULAR 2021 Virtual Congress, the company presented 34 scientific abstracts, many of which were centered around the efficacy of guselkumab for psoriatic arthritis. We talk about the challenges of delivering safe and effective treatments in this patient population, the clinical significance of these results, and how guselkumab can help improve physical, social, and work activity for these patients.

Why is delivering treatments that are safe and effective so challenging in this patient population?

Well, first of all, psoriatic arthritis is a chronic, arthritic condition that can lead to long term joint damage and even disability. But one of the unique things about psoriatic arthritis when you compare it to other inflammatory arthritities, like rheumatoid arthritis, PsA is unique in that it has multiple domains involved. So, patients also can get skin psoriasis, they can get inflammation of the soft tissues around the joints, they can have both peripheral as well as axial symptoms. So, it really is a multi-domain disease. And we need therapeutic options that treat all of the multiple domains of psoriatic arthritis.

Can you tell me a little bit about the methods your team used in creating the COSMOS study?

The purpose of the COSMOS was to get additional information even beyond the seminal trials that form the basis of our global regulatory submissions, which have led to multiple global approvals. So, there were 2 seminal trials, the DISCOVER 1 and the DISCOVER 2. And they studied in 1 of the trials, patients who are naive to advance therapies such as biologics, and the other was a mixed population, but most of the patients were naive to biologic therapies and some that had experienced drugs like tumor necrosis factor (TNF) inhibitors. And so, we saw from those studies that guselkumab versus placebo showed efficacy in multiple domains of the disease, including in those TNF experienced patients. What the COSMOS study was designed to do was to study in a dedicated study, that population of patients who had had an inadequate response to TNF inhibitors; so had either inadequate efficacy or a small percentage, less than 20%, had experienced safety issues that caused them to no longer be able to take a TNF inhibitor. So it's really a dedicated study to look at that population, which has historically been more difficult to treat.

The results that were that in that population, compared to placebo, guselkumab showed significant a significant difference in arthritis as measured by the American College of Rheumatology (ACR) 20 as well as improved skin clearance measured by Psoriasis Area and Severity Index (PASI) scores, including the PASI 100, which is 100% clearance of skin. So, it showed versus placebo in this more difficult to treat population, guselkumab is a robustly effective therapy.

Can you elaborate on the rapid and durable joint symptom improvement and skin clearance shown in the DISCOVER 1 and 2 studies?

Sure, I can. So, those are some of the other exciting data that are being presented at EULAR. Now having passed to the primary endpoints for these studies, we're able to look at longer term outcomes for these patients and continue to track these patients as they go past 1 year and 2 years even. And we see that there is a maintenance of response to guselkumab even up to 2 years across the domains tested; so arthritis, tissue, inflammation, skin, as well as imitate inhibition of radiographic progression, which is really fantastic to see. It's incredibly important to physicians and to patients that if they start a therapy and they get an initial good response, they want to see a maintenance of that therapy. So really excited to see that as well. There's data now being presented that as early as 4 weeks you could see decrease in symptoms as measured by the ACR20 so that you can start to see a separation from placebo. So again, you can see an effect relatively rapidly and that effect is maintained up to 2 years.

What is the current safety profile of guselkumab?

The safety profile has been established, based on the DISCOVER program, as well as in COSMOS, where we see a consistent safety profile. We also have data from psoriasis and there's a relatively consistent safety profile in psoriatic arthritis as well as psoriasis.

How has guselkumab impacted physical, social, and work activity for patients with psoriatic arthritis?

Psoriatic arthritis is a multi-domain disease, but it also impacts people's social interactions, their ability to work, as well as, you know, diseases like psoriatic arthritis and psoriasis can be associated with symptoms of depression and fatigue. So, in fact, guselkumab has been shown to improve some of these patient reported outcomes that give us an idea of depression and fatigue. We're presenting data on work productivity, and that psoriatic arthritis is associated with decreased work productivity measures, but that guselkumab can improve that and help restore some of that functioning for patients with psoriatic arthritis.

Were there any strengths or limitations of the studies that you'd like to expand upon?

Well, I mean, I think the strength is that the more data we get on guselkumab and psoriatic arthritis, the better position a physician is really in to make appropriate treatment choices for their patients. And so I’m really excited to have presented in the past the primary endpoint data from DISCOVER 1 and DISCOVER 2. And now we're seeing the long-term data, which can give physicians even more information about the behavior of guselkumab over time, as well as showing in this dedicated TNF inadequate response patient population, significantly different responses, again, showing efficacy. So, I think that's really the strength is that the additional data continues to give us confidence in the efficacy and safety profile of guselkumab.

Yes. We continue to be very dedicated to bringing new therapies to patients with psoriatic arthritis. And as part of that continue to study guselkumab in this population to better understand the full efficacy and safety profile. We’re dedicated to continue to learn about guselkumab in this patient population.

Is there anything else that you'd like our audience to know before we wrap up?

I think the one other thing is really what a remarkable innovation inhibition of the interleukin 23 (IL-23) pathway is. Guselkumab is an inhibitor of the IL-23 pathway. One of the things IL-23 does is it's a driver of th17 cells, which are known to be pathogenic in diseases like psoriatic arthritis and psoriasis. So, we're also very committed to the under fully understanding that pathway and all the ways that that inhibiting that pathway may be of benefit to patients with immune mediated diseases. At Janssen, we're very committed to this pathway-focused approach where we address diseases with significant unmet need. And we sort of match them up with driving pathways and also think about all the ways that a particular pathway can benefit patients. So, I think a really important and interesting part of the story as well is that there's still more to come even outside of psoriatic arthritis for guselkumab.

Well, Dr Johnson, thank you so much for speaking with me today. I really appreciate it.

Thank you very much, I appreciate as well. Thank you so much for your time.

Alyssa Johnsen, MD, PhD, spoke with Rheumatology Network about the efficacy of guselkumab for psoriatic arthritis, the challenges of delivering safe and effective treatments in this patient population, and how guselkumab can help improve physical, social, and work activity for these patients.

Alyssa Johnsen, MD, PhD: Guselkumab Improves Joint Symptoms and Skin Clearance in Psoriatic Arthritis

Rheumatology Network sat down for an interview with Benjamin Nowell, PhD, in partnership with CreakyJoints, to discuss his study entitled, “A Mindfulness Program Dosing Study to Evaluate Improvement in Emotional Distress Among People With Rheumatic Disease,” which was presented at the EULAR 2021 Virtual Congress. Nowell is the Director of Patient-Centered Research at CreakyJoints, part of the Global Healthy Living Foundation. He explains the Healthy Mind Healthy You study, which assessed 2 mindfulness programs of varying lengths and compared the results. We also talk about how mindfulness can improve emotional distress in this patient population and why he believes these patients may require additional support to remain engaged throughout a mindfulness program.

Hi, Dr Nowell. Thanks for joining me today.

 for the invitation to talk about this study.

Absolutely. What first interested you in researching mindfulness programs in this specific patient population?

Well, personally, mindfulness meditation is something that I've been aware of for a long time. I used to live in San Francisco and used to attend classes there. And then, as I was finishing my social work program, I also took a weekend intensive mindfulness meditation course. And so, for my own personal uses, I've been very interested in mindfulness as a way of dealing with anxiety and living more in the present moment. And there's some evidence from other studies that mindfulness really can be really helpful to improve wellbeing among patients with other conditions. But 1 thing that we wanted to look at in particular in this study was the impact for people living with rheumatic diseases. And the focus of our study in this case, was really to be able to compare 2 different lengths of mindfulness meditation training, because it's a reasonable hypothesis that the more training you get, like an 8-week versus a 3-week training, it's reasonable to assume that you might get more of a benefit from doing a longer training. So, in our study, we wanted to examine that question,

Why have programs increased in popularity for patients with rheumatic disease?

Well, I think in general, as we live in an increasingly distracting world with our devices, with the pings and getting notifications from our email, from texts, from social media, things move very fast. And there's evidence from prior studies that mindfulness meditation is an effective way to allow us to just take time out, be present in in the moment that we're in right now, and to develop this sort of intense awareness and focus on the present moment without judgment. And especially for people with living with rheumatic disease, it can be an important way to help take notice of things that we might be feeling so anxiety, pain, you know, bad feelings, and to be able to better cope with them. So, I think that for the purposes of this study, that was one of the things that was important to us, to examine why that's so important for people living with rheumatic disease. And to see if people can get a benefit from a shorter programmer, can you to do more to derive more benefit?

Can you tell me a bit of background on the Healthy Mind Healthy You study and the 2 programs (both full length and brief) that were compared?

Absolutely. I should say to that for people living with inflammatory joint conditions, that there's evidence that mindfulness can be useful in complementing existing treatments. So not as a replacement for but to augment the existing therapies that they're working with their rheumatologist on because there's evidence that it can help with psychological distress, to help with self-efficacy, pain and pain symptoms, to help with emotional processing, even to help with fatigue and an overall wellbeing. So, in this study, we were part of a larger study that was funded by the Patient Centered Outcomes Research Institute (PCORI). So, this was adult US participants who are part of the Arthritis Power registry, which is what we lead here at Global Healthy Living Foundation. But there were a number of other patient-powered research networks, for other conditions, for cancer, for cardiovascular health, and so on, that were also part of this study. And the idea was to compare the effectiveness of these 2 online mindfulness training programs. And the name of this bigger initiative was called Healthy Mind Healthy You (the bigger, PCORI funded study). So, what we did was we compared this mindfulness-based cognitive therapy session, or MBCT. That is an 8-week program with 1 30 to 45 minutes session per week. And then compare that against a 3-week program of also 1 30 to 45 minutes session per week. And the programs are actually quite similar. They cover a lot of the same topics, they both define what mindfulness is, some address some common myths about mindfulness. People engage in body breath, exercise, getting practices and familiarity with that, understanding how to use the body breath in daily life. So, going a little deeper into that is something that they would cover on the 8-week course, but not in the 3-week course. And so, there's some good overlap of the main topics covered in the 2 programs. But for the longer course, there's some repetition and going a little bit deeper in some of the topics.

So what we did was, over the course of the programs themselves, the 3-week or the 8-week, and then the follow up weeks that followed, we collected a number of outcome measures. The 4 that we looked at in this study were the World Health Organization 5 wellbeing index, or the HU 5, something called the perceived stress scale, or PSS, and then to PROMIS, patient reported outcome measures, the short form for anxiety and the short form for depression. And what we found is that when we looked at the comparison between our 2 groups that baseline, the demographic characteristics of the participants in the 3-week versus the 8-week, where there was no significant difference between those 2. And also, their outcome scores at baseline were similar. So, the randomization seemed to have worked, which is great. Then when we looked at 8 weeks out, so a few weeks after the 3-week course finished, and then right at the end of the 8-week course, that there wasn't no significant difference between outcome measures between the 2 different lengths of the course, which in some ways, is great. So, it's the hypothesis that a longer course might provide more benefit didn't seem to hold water. So, it looks like people can actually get a benefit from even a 3-week abbreviated or brief course for mindfulness. The other thing that we found that really interesting is that, in particular, the PROMIS anxiety scores improved by 3, which is enough to be a minimally important difference. So, it's a meaningful change in anxiety scores. So, this study lends some additional credence to the idea that even brief meditation training can be helpful for people living with rheumatic disease that it actually, in particular for anxiety, wellbeing makes a difference and helps people feel a little bit better.

Were you and your team surprised by the results?

I think it was somewhat surprising to find that there was no significant difference between the longer course and the shorter course. And I think that's frankly, good news. Because sometimes it's a big commitment for any of us to take on an 8-week course and just stick with that. One thing that is important about mindfulness is that it's a practice. It's an ongoing practice. But people can learn how to do it in a in a relatively short amount of time. So, it's a practice that can be easily picked up once you know the basics. So, I think it's not necessarily surprising. But it's great news. I think it's good confirmation that we can you can get some benefit out of a shorter course versus a longer course. I think what also may not be surprising, but it's just good news in general, is that this stuff works. You know, there's prior research that indicates that mindfulness meditation is effective at improving wellbeing, decreasing anxiety, and just general coping. And so, I think this, this study supports those prior studies as well. And specifically, with a group of people who are living with different rheumatic diseases.

Why do you believe that these patients seem to require additional support to remain engaged throughout the program?

Yeah, so we had a lot of attrition in the study. So, for example, of the 324 participants who completed assessments at baseline, who basically joined the study at the beginning, only 70 patients, 35 in each of the arms, completed the assessments at week 8. So that's more than a 70% attrition rate. It's like 3/4 of our participants are dropping for this particular study. So that leads us to believe that we really think people need a little more support for an online course like this. Some of the things that I would recommend we provide in a future study like this, or for other folks that are doing similar studies, is to do a bit more in terms of following up with patients. There were automated emails and reminders that went out to them, but there was not additional support, like technical support. And since all of these trainings, all of the sessions were online, or web-based, if someone wasn't as familiar with that, that platform or using that kind of modality, they may get frustrated, they may drop out at that point. The other thing that we found in other studies as well is it can be really helpful to have a case manager, a study coordinator, someone who follows up with text messages with a phone call, or a personal email that says, “Hey, just a reminder, your next session is due this week, or your assessments are due,” so that we can get better adherence in a study like this. For this study, we did not use our Arthritis Power app, the platform that we typically use for studies. We did recruit from the registry, but people were participating in the study on another network’s platform. And so we didn't have as much control over managing the participant support in this particular study. But I think to ensure it we wanted to make sure that people can benefit from, from a training like this for mindfulness in general. And also, so that we can get more evidence about the effectiveness of these kinds of trainings, it'd be great to have higher adherence. So that's why a study like this, it would be, it'd be helpful, I think, to add some of those additional mechanisms for support to help people be more adherent.

Were there any strengths or limitations of the study that you'd like to discuss?

So, the participants were primarily female and white, the mean age of just 58 years old. And we also had a number of different conditions that were participating, rheumatoid arthritis, fibro osteoporosis. I think what would be helpful is to get to be able to drill down and look at more, more specifically, at condition by condition what we're seeing in the results. But we didn't have a high enough sample size to do that. It's 1 limitation. I think another limitation is what I was just talking about: that there was a pretty high rate of attrition in this study, and that participants volunteered to join the study. So, people were already inclined to be someone who was looking for study opportunities like this, even if they didn't all complete them. So, another improvement we would make is to be able to potentially recruit all patients from rheumatology clinics. So, you get a wider swath, a more representative and inclusive cohort of participants who can be part of this study. And then, as I mentioned before, I think in terms of just helping adherence to provide more support, in particular tech support, would be something that we would do for future studies.

This is reported in the abstract for this for you, or for this conference, but in a longer paper that we're writing up. We did use imputation methods to flesh out and get a bigger kind of synthetic database that we can do some additional analyses on. And of course, there's always the sort of inherent limitation of using imputation methods for to generate a database for mixed effects model analysis.

How does mindfulness help to improve emotional distress in patients with rheumatic disease?

We know anecdotally from patients that it's a big part of what we've seen in other studies that we've conducted: mental health is a major concern. And just the challenges of coping with having a chronic condition that that has some unexpected components of it. So, for example, people with rheumatoid arthritis may have flares somewhat unexpectedly, they don't always know whether a medication is going to work for them, or work in the long term. And so, it's important to be able to have strategies that can complement the medical care with something that helps them cope with the sort of emotional challenges of dealing with a chronic disease. And so that's why mindfulness I think, is so such a can be such a powerful tool for a lot of people to try to use in terms of dealing with the anxiety, to sort of unanticipated challenges of living with and treating rheumatic disease.

I think just a reminder that this mindfulness meditation has been around a long time, it evolved from Buddhism, from Buddhist practice, and has become, as you know, increasingly popular over the last couple of decades. And just a reminder that mindfulness is something that can benefit everyone. And it's becoming particularly helpful for us in the modern world as we get pulled into stuff that keeps us constantly distracted, constantly working at a shallow level. Mindful mindfulness can help us dig deeper and do more deep work and also be more able to cope with the sort of slings and arrows of daily life and especially the challenges of living with chronic condition.

Well, Dr Nowell, thank you so much for speaking with me today. I really appreciate it.

You My pleasure. Thank you for the interest in the study. We're excited to get the message out about this and hope to be able to offer more types of wellness programs like this through Global Healthy Living Foundation, CreakyJoints and Arthritis Power. So, thanks again for inviting me.

Rheumatology Network sat down for an interview with Benjamin Nowell, PhD, in partnership with CreakyJoints, to discuss the Healthy Mind Healthy You study, which assessed 2 mindfulness programs of varying lengths, designed for people with rheumatic disease, and compared the results. 

Benjamin Nowell, PhD: Mindfulness Program for Patients With Rheumatic Disease

Katie Robinson is a medical writer. She covers various health and medical topics for a professional audience.

In psoriatic arthritis (PsA), while swollen joint count remains a key assessment when defining oligoarticular and moderate disease, joint location and functional impairment are also considered when describing the disease as moderate, according to a study published in the

, corresponding author Dafna D. Gladman, MD, FRCPC, a professor of Medicine at the University of Toronto, said that “the reason for doing this study was the requirement for at least 5 swollen joints for approval for advanced therapy in patients with PsA.” Dr Gladman added that “rheumatologists consider the site and functional limitation of the affected joints more than the actual number of joints involved. Therefore, the requirement by many providers for a minimum of 5 swollen joints is likely inappropriate.”

Clinical trials generally focus on polyarticular PsA and an unmet need exists for an effective treatment for patients with oligoarticular disease. Patients with articular symptoms are usually treated with non-steroidal anti-inflammatory drugs, corticosteroid injections, and disease-modifying anti-rheumatic drugs, with biologic options recommended for those with polyarticular or severe PsA.

Dr. Gladman and colleagues used an online survey to determine rheumatologists’ perspectives on the definition and treatment of oligoarticular and moderate PsA. A total of 64 rheumatologists responded from 6 Canadian provinces. Nearly half of respondents were in practice for more than 20 years.

A majority of surveyed rheumatologists reported swollen joint count as the measure they have used when defining moderate PsA, along with tender joint count, enthesitis, dactylitis, work productivity, patient perception, and HAQ score. Of the rheumatologists, 86.4% and 96.7% using swollen joint count to describe moderate PsA and oligoarticular PsA, respectively, while also considering location of inflammation in PsA assessments.

When specifying the lower and upper swollen joint count cutoff scores for defining moderate PsA, the rheumatologists reported a wide range of scores, which the authors said suggests a lack of an agreed-upon definition for moderate PsA.

“Moderate PsA is defined not only by swollen joint count, but also encompasses other manifestations of PsA, their relative severity, and impact on patients. Oligoarticular PsA is defined primarily by joint count with reduced emphasis on severity of other manifestations,” stated investigators. “This discrepancy suggests a need to decouple treatment access from joint count and instead focus on the impact on individual patients, which includes assessing for all features of PsA, as well as patient-reported outcome measures.”

Further, 68% of rheumatologists identified access to treatment as the greatest challenge with oligoarticular PsA, more so than comorbidities, patient acceptance, treatment choices, diagnosis, when to initiate treatment, and lack of treatment.

Gladman, DD, Starr, M, Cividino, A, et al. Canadian Rheumatologists' Perspectives on Moderate Psoriatic Arthritis and Oligoarticular Psoriatic Arthritis. [published online ahead of print, 2021 May 15]. 

. 2021;jrheum.201195. doi:10.3899/jrheum.201195

In addition to swollen joint count, joint location and functional impairment should also be considered when describing psoriatic arthritis as moderate.

Swollen Joint Count Questioned in Moderate, Oligoarticular Psoriatic Arthritis 

Rheumatology Network sat down with Pedro Machado, MD, PhD, to discuss his EULAR 2021 presentation entitled, “COVID-19 vaccine safety in patients with rheumatic and musculoskeletal disease.” Dr. Machado is an Associate Professor at the University College London, in the UK. He explains to us the key findings of the study, common concerns for patients and physicians regarding the COVID-19 vaccine, and the clinical significance of these results.

To begin, what first motivated you to investigate COVID-19 safety for this specific patient population?

So with the introduction of the COVID-19 vaccination programs, there were specific concerns raised by the population with rheumatic diseases because they have either an underlying immune dysfunction or sometimes they're taking drugs that affect the immune system. And therefore, there were concerns because of the specificities that there could be certain type of adverse events that would be more common or more worrying among patients with immune mediated disease in general. So that was the motivation to create a registry specific for patients with rheumatic diseases.

What are some of the common concerns for patients and physicians in regard to the COVID-19 vaccine?

One of the concerns was that the vaccines could potentially lead to flares of the inflammatory rheumatic disease, or to certain that there could be certain side effects, especially the ones that are immune mediated that could be more common among patients with rheumatic diseases. There is a second concern that is not addressed by this registry, because this is a registry looking at the safety of the vaccines. But there is also a concern with regards to the efficacy of the vaccines, because potentially some of the drugs that are being used could decrease the immunological response to the vaccine, but that is being addressed by other types of studies because it requires the collection of biologic material and the assessment of the antibody production and also T cell responses in our patients. This registry is only about the safety of the vaccines. 

What were the key findings of your study?

I guess the key message of the of the results that we'll be presenting, the key takeaway message is that the COVID-19 vaccines are safe in patients with rheumatic diseases. Most of the observed adverse events were the same as in the general population. And they were non-serious symptoms involving short term, local or systemic reactions. So, things like pain in the sight of injection, fatigue, headaches, flu-like symptoms. So, the same type of thing that is observed in the general population, and in fact, the same type of thing that is observed with many other vaccines. The other thing is that the overwhelming majority of our patients, they tolerate the vaccination very well, with rare reports of inflammatory, rheumatic disease flare, and very rare reports of severe adverse events. Therefore, I think that these initial findings should provide reassurance to rheumatologists and to vaccine recipients, and they should promote confidence in COVID-19 vaccine safety in our patient population. You know, vaccines are one of the greatest medical advances of modern times. They prevent millions of deaths yearly, and many, many more million deaths will be prevented with COVID-19 vaccines and this includes patients with rheumatic diseases.

Were you surprised by the results of your study?

I wouldn't say surprised, no. I think it's important to monitor what is happening our patient population and in the general population in general because there can always be surprises; there can always be unexpected reactions. And so therefore it is really important to monitor the vaccination problems and the side effects that are being reported. I will say that I wasn’t surprised because I was quite confident about the safety of these vaccines in our patient population and the data from the registry is just corroborating that expectation.

What is the clinical significance of these results?

I think the clinical significance is that healthcare professionals in rheumatology should be confident when advising dear patients about the safety of the vaccines and they should encourage all patients to be vaccinated with any type of COVID-19 vaccine.

Were there any strengths or limitations of the study that you would like to highlight?

I think the one of the strengths is that the population that has been reported to the registry is highly representative of the of the type of population that we see now in our clinics. So more than 90% of the patients, whether inflammatory rheumatic disease such as rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, systemic lupus, was also quite a diverse population. And the obvious limitation is that it is still a small number of patients. We are reporting around 1500 subjects, we now have close to 3000 reported to the registry. But it's still a small sample size for this type of study. But data collection is ongoing. And we'll be looking at the results periodically and updating the scientific community as the study proceeds.

Well, just 1 last message: get vaccinated and get vaccinated with any of the vaccines that are offered to you.

Thank you so much for speaking with me today. I really appreciate it.

Rheumatology Network sat down with Pedro Machado, MD, PhD, to discuss his EULAR 2021 presentation entitled, “COVID-19 vaccine safety in patients with rheumatic and musculoskeletal disease.” 

Pedro Machado, MD, PhD: COVID-19 Vaccine Safety in Patients With Rheumatic and Musculoskeletal Disease

Rheumatology Network's Top 5: June 4, 2021

Take 5 minutes to catch up on Rheumatology Network's highlights from the week ending June 4, 2021.


This week, Rheumatology Network sat down with Roy Fleischmann, MD, to discuss his presentations for EULAR 2021, which include topics about the side effects of JAK inhibitors, analysis of disease activity measures of methotrexate withdrawal among patients with rheumatoid arthritis, and the long-term safety and efficacy of upadacitinib or adalimumab in patients with rheumatoid arthritis. Fleischmann is Clinical Professor of Medicine at the University of Texas Southwestern Medical Center at Dallas and co-Medical Director of the Metroplex Clinical Research Center in Dallas.

Fleischmann delves into the well-known side effects the JAK inhibitors, including serious infections, opportunist infections, such as herpes zoster, changes in hemoglobin, and the increase in lipids. He begins by explaining that a recent report stated that tofacitinib (5 and 10 milligrams) was not as safe as TNF inhibitors, citing higher rates of malignancies and a higher hazard ratio. However, he focuses on the fact that the incident rates for both of these treatments are actually quite low and relatively comparable.

The second study compared the performance of disease activity measures for patients receiving tofacitinib after methotrexate withdrawal and those who continued with both tofacitinib and methotrexate. Investigators discovered that regardless of the disease activity state, most participants receiving tofacitinib maintained achievement of disease activity at the end of the study, regardless of methotrexate therapy. While the study was limited by the nature of being a post hoc analysis, Fleischmann believes that the results are still fairly accurate.

In his third study, Fleischmann compared 15 milligrams daily of upadacitinib plus methotrexate with adalimumab plus methotrexate. Results indicated that over 3 years, end points were in favor of upadacitinib over TNF inhibitors as far as clinical responses and patient reported outcome responses. While it was a small study in terms of safety, investigators noted a clear increased incidence of herpes zoster, liver function test abnormalities, and an increased rate of lipids with upadacitinib compared with adalimumab. However, the rates of venous thrombotic episodes were more prevalent in the adalimumab cohort.

“The companies and the FDA and the American Medical Association (AMA) are certainly very interested in this topic. And I expect that there will be many, many more analyses done on this. There is a study that is being run [that] should give us better information about the real risk. But I think that what the important point is, you don't want to minimize the risks the risks can occur,” stated Fleischmann. “This whole area is one where we still don't know what the true effects of the drugs are.”

Roy Fleischmann, MD, discusses his presentations for EULAR 2021, which include topics about the side effects of JAK inhibitors, disease activity measures of methotrexate withdrawal among patients with rheumatoid arthritis, and the long-term safety and efficacy of upadacitinib or adalimumab in patients with rheumatoid arthritis. 

Roy Fleischmann, MD: Efficacy of Upadacitinib and Adalimumab for Rheumatoid Arthritis

Rheumatology Network sat down with Neil Solomons, MD, to discuss his latest 

Neil Solomons, MD, sits down to discuss his latest study, entitled “Aurinia Announces Publication of AURORA 1 Phase 3 Study Results with LUPKYNIS™ (voclosporin) in The Lancet,” which will be presented at EULAR 2021.