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

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. 

Upadacitinib was proven to provide sustained and clinically meaningful improvements in patient-reported outcomes (PROs) for patients with psoriatic arthritis (PsA) who had an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs), according to a study published in 

“Current treatment options for PsA include… bDMARDs, including tumor necrosis factor (TNF), Interleukin (IL)-12/23, IL-23, and IL-17A inhibitors,” investigators explained. “Despite the recent increase in available advanced therapies for PsA, a significant number of patients still fail to achieve adequate disease control, resulting in substantial health-related quality of life (HRQOL) impairments, which are reported in patient surveys, and highlighting a continued need for novel and effective treatment options.”

The placebo-controlled, multicenter, randomized controlled trial (RCT), phase 3 SELECT-PsA 2 (

) study focused on patients aged 18 years or older who fulfilled the Classification Criteria for PsA (CASPAR), experienced symptoms for 6 months or longer, had a documented history of plaque psoriasis, and an inadequate response to at least 1 bDMARD. Eligible patients were then randomized 2:2:1:1 to receive oral upadacitinib 15 mg once daily (QD), upadacitinib 30 mg QD, or placebo that was then switched to either upadacitinib 15 mg QD or upadacitinib 30 mg QD at week 24 through week 56. Participants were allowed to continue treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and 2 or fewer non-bDMARDs.

At week 2, investigators compared baseline assessments of pain, Health Assessment Questionnaire- Disability Index (HAQ-DI), and Patient Global Assessment of Disease Activity (PtGA) to determine any minimum clinically important differences (MCID). They also analyzed changes from baseline and week 12 using assessments including the Functional Assessment of Chronic Illness Therapy-Fatigue, 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) score, HAQ-DI, and PtGA. The Self-Assessment of Psoriasis Symptoms (SAPS) determined differences from baseline to week 16. Other PRO assessments included SF-36 mental component summary (MCS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Work Productivity and Activity Impairment (WPAI), as well as specific questions regarding morning stiffness, itch, and pain.

In total, 641 participants received either placebo (n = 212), upadacitinib 15 mg (n = 211), or upadacitinib 30 mg (n = 218). The demographics, disease characteristics, and disease severity were similar among all patients.

Improvements in pain (15 mg: 67%, 30 mg: 69%, placebo: 50%), HAQ-DI (15 mg: 32%, 30 mg: 42%, placebo: 19%), and PtGA (15 mg: 70%, 30 mg: 72%, placebo: 52%) were seen as early as week 2 for those receiving upadacitinib when compared with the placebo cohort.

There were significant improvements from baseline at both week 12 and week 24 in the upadacitinib cohorts when compared with placebo (p <0.05) except for the WPAI survey, as it only assessed patients working outside of the home. A total of 80% of patients reported that their responses were maintained or improved through the duration of the study. At week 12, more patients in the upadacitinib cohorts had improvements ≥ MCID across all PROs, including all SF-36 domains, except for the SF-36 MCS, and the highest percentage of participants reported improvements in PtGA and pain.

Significantly more participants in the upadacitinib cohorts achieved BASDAI 50 responses when compared with placebo at both week 12 (15 mg: 20%, 30 mg: 29%, placebo: 7%) and week 24 (15 mg: 32%, 30 mg: 35%, placebo: 4%).

When patients switched from placebo to either upadacitinib 15 mg or 30 mg, PtGA, pain, HAQ-DI, and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) quickly improved and showed similar responses through week 56 as the upadacitinib cohorts.

The RCT was not designed to detect differences between the 2 upadacitinib groups and an active comparator was not used after week 24, which limits the study. Further, investigators warn that the results may not be generalizable outside of the trail participant population.

“Patients with active PsA who had failed ≥ 1 bDMARD reported significant and clinically meaningful improvements in PROs with upadacitinib 15 or 30 mg QD through 24 weeks, maintained or further improved through 56 weeks,” investigators concluded. “Significantly more patients receiving upadacitinib reported scores ≥ normative values across all evaluated PROs… These results highlight the potential for upadacitinib to provide substantial improvement in HRQOL and other important patient-reported outcomes in patients with PsA.”

Strand V, Van den Bosch F, Ranza R, et al. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2 [published online ahead of print, 2021 Oct 18]. 

. 2021;10.1007/s40744-021-00377-x. doi:10.1007/s40744-021-00377-x

Articles

A significant number of patients with psoriatic arthritis fail to achieve adequate disease control, resulting in health-related quality of life (HRQOL) impairments. 

Upadacitinib Improves Patient-Reported Outcomes in Patients With Psoriatic Arthritis 

Ultrasound (US) imaging verifies steroid injection for dactylitis is an effective treatment method, resolving extra-articular inflammation in soft tissue oedema (STO) and flexor tenosynovitis (FT), according to an article published in 

Dactylitis, a uniform swelling of an entire digit, occurs in up to half of patients with psoriatic arthritis (PsA) and is sometimes presented as the first manifestation of the condition.

“The most common first-line therapies for dactylitis are non-steroidal anti-inflammatory drugs (NSAIDs) and local corticosteroid injections,” investigators stated. “Even though infiltrative therapy is commonly used in everyday clinical practice, this therapeutic strategy is largely empirical since no formal studies on local corticosteroid injections in PsA dactylitis have been published.”

The multicenter, longitudinal, observational study enrolled PsA patients with symptomatic hand dactylitis at 3 Italian rheumatology centers. Active dactylitis was determined through a physical examination by a rheumatologist and confirmed using the dactylometer and related Leeds Dactylitis Index basic (LDI-b). Disease Activity for Psoriatic Arthritis (DAPSA) information was collected at baseline.

Infiltrative therapy was offered to all patients, and those who received the steroid injection were placed in the local treatment (LT) cohort. Those who opted out of local therapy received a 4-week treatment of NSAIDS instead and were placed in the systemic treatment (ST) cohort. If patients did not achieve clinical response at 1 month, the type of NSAIDs was changed. Baseline therapies of either conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or oral corticosteroids were continued through the duration of the study. Patients in the LT group received an injection of 20 mg methylprednisolone acetate (Depo-medrol, Pfizer, Italy).

US assessments, in both greyscale (GS) and power Doppler (PD), were performed at baseline (T0), month 1 (T1), and month 3 (T3). Sonographers evaluated the presence of FT, STO, peritendon extensor inflammation (PTI), and synovitis. Images of both affected and non-affected digits were collected.

US response was defined as DACTylitis glObal Sonographic (DACTOS) score of < 3 and remission was defined as a score of 0.

Patient-reported outcomes (PROs) included the visual analogue scale (VAS), the VAS pain (VAS-p), and the VAS functional impairment (VAS-FI) to evaluate dactylitis-affected digits.

All assessors were blinded to treatment information.

A total of 61 PsA patients presented 88 dacylitic fingers throughout the study. The mean age was 47.2 years, 36 patients were male, 25 were female, and all presented PsA minimal disease activity (DAPSA < 14). While no patient had more than one affected finger simultaneously, 15 participants had more than 1 episode. There were 31 patients, with 45 dactylitic fingers, in the LT cohort and 30 patients, with 43 dactylitic fingers, in the ST cohort.

VAS-FI was significantly different between the 2 groups at baseline FI (LT 7.8 ± 1.6 vs. ST 6.6 ± 2.3, p = 0.010). While there were no significant differences for US lesions between the groups, a significant difference was reported at T1 regarding GS FT (p = 0.002), PD FT (p < 0.001), GS STO (p < 0.001), and PD STO (p < 0.001), which continued through T3. At the T3 follow up, some grade 3 lesions were completely cleared in the LT group, while only reduced in the ST group.

The ST cohort had significantly higher rates of GS FT, PD FT, GS STO, PD STO, and metacarpophalangeal (MCP) synovitis (p = 0.001) at T3.

The LT cohort had significantly greater US response at both T1 (50% vs 7%, p < 0.001) and T3 (76% vs 7% p <0.001) when compared with the ST cohort, and remission only occurred in LT patients (31% vs 0%, p < 0.001).

DACTOS < 3 was higher in the LT group when compared with the ST group at both T1 (49% v 5%, p < 0.001) and T3 (76% vs 7%, p < 0.001). VAS-p and VAS-FI were significantly higher for those with DACTOS < 3 when compared with those with DACTOS ≥ 3 at T3 follow-up (1.49 ± 1.72 vs 4.37 ± 2.69, p = 0.001, for VAS-p and 1.43 ± 1.46 vs 4.98 ± 2.81, p < 0.001, for VAS-FI).

Clinical remission was only achieved in the LT cohort with 3 cases at T1 and 10 cases at T3.

Multiple logistic regression analysis reported that treatment with local injection was the only variable impacting US remission (odds ratio T1 13.33 [95% CI 3.52–49.60, p < 0.001], odds ratio T3 41.21 [95% CI 10.62–159.92, p < 0.001]).

The study was limited by the lack of randomization; however, it does reflect common clinical practice. Further, investigators did not utilize a placebo arm. This limitation is mitigated by having US assessors blind to treatment. While the follow-up period was short, > 3 months is an adequate amount of time to make changes to oral therapies. A larger number of cases would help validate results.

“To the best of our knowledge, this is the first study that provides evidence of the value of US in the detection of changes induced by local steroid injection in the flexor tendon sheaths of patients with acute dactylitis. Such changes can be clearly seen even after a short-term follow-up and maintained for at least 3 months with good correlation with the clinical evolution of the dactylitis,” investigators concluded. “US examination of dactylitic fingers may be considered a useful adjunctive tool for assessing articular and extra-articular changes after steroid injection in the flexor tendon sheath of patients with acute dactylitis.”

Girolimetto N, Macchioni P, Tinazzi I, et al. Ultrasound Effectiveness of Steroid Injection for hand Psoriatic Dactylitis: Results from a Longitudinal Observational Study [published online ahead of print, 2021 Oct 15]. 

. 2021;10.1007/s40744-021-00383-z. doi:10.1007/s40744-021-00383-z

Dactylitis, a uniform swelling of an entire digit, occurs in up to half of patients with psoriatic arthritis and is sometimes the first manifestation of the condition. 

Steroid Injection Effectively Treats Psoriatic Hand Dactylitis 

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.

The risk of osteoporosis is influenced by a number of factors, including the disease process itself, low activity levels due to pain and loss of joint function associated with the disease, and treatments for rheumatoid arthritis and other conditions.

Osteoporosis is a common comorbidity for patients with rheumatoid arthritis. How much do you know about how drugs impact bone health in rheumatoid arthritis? 


Rheumatoid Arthritis Quiz: How do Drugs Affect Risk of Osteoporosis in RA?

The US Food and Drug Administration (FDA) 

 adalimumab-adbm (Cyltezo), the first interchangeable biosimilar to treat inflammatory disease, to Boehringer Ingelheim on October 15, 2021. Adalimumab-adbm may be substituted for adalimumab (Humira) and is the first interchangeable monoclonal antibody and second interchangeable biosimilar to be approved by the FDA. Biosimilars may aide in access to treatments for a variety of conditions.

Adalimumab-abdm is approved to treat active psoriatic arthritis and ankylosing spondylitis, moderate-to-severe rheumatoid arthritis, moderate-to-severe chronic plaque psoriasis, moderate-to-severe Crohn’s disease, and moderate-to-severe ulcerative colitis. The drug is also indicated for moderate-to-severe polyarticular juvenile idiopathic arthritis in patients aged 2 years or older and Crohn’s disease in patients aged 6 years or older.

Adalimumab is administered via subcutaneous injection and is offered in single-dose glass syringes of either 40 mg/0.8 mL or 20 mg/0.4 mL. Side effects include upper respiratory infections, sinus infections, injection site reactions, rash, and headache. Serious adverse events are infections and malignancies (cancers). The boxed warning includes a note to physicians and patients that indicates an increased risk of serious infections and states that lymphoma and other malignancies have been reported in children and adolescent patients who were receiving tumor necrosis factor blockers, such as adalimumab.

“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said Acting FDA Commissioner Janet Woodcock, MD. “We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.”

Biosimilars are biological products that have no clinically significant differences, including safety and efficacy, from an already FDA-approved biological product. Interchangeable biosimilars, such as adalimumab-adbm, are designed to produce the same result as the reference drug and patients are able to switch between the 2 without increased risks or reduced efficacy. Biosimilars generally cost less than brand-name drugs and may be substituted in the pharmacy without a physician having to change the prescription.

The US Food and Drug Administration (FDA) approved adalimumab-adbm (Cyltezo), the first interchangeable biosimilar to treat inflammatory diseases such as rheumatoid arthritis and psoriatic arthritis. 

FDA Approves Adalimumab-adbm (Cyltezo), Interchangeable Biosimilar to Adalimumab

Rheumatology Network interviewed Jeffrey Stark, MD, to discuss the recent studies, BE BRIGHT, BE SURE, and BE VIVID, in which investigators analyzed the impact bimekizumab had on patients with psoriasis. Stark is the Head of Immunology Medical Affairs at UCB. He explains the study designs, the clinical significance of the results, and future research UCB plans on tackling.

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Can you tell me a bit about bimekizumab and how it works to help clear psoriasis?

Thank you, Lana. It's exciting to have the opportunity to talk about bimekizumab. As you know, and some of your listeners may know as well, bimekizumab is an investigational treatment that's part of the clinical development program at UCB. I would say it’s a unique molecule and that it's the first molecule of its kind to selectively target not only interleukin (IL)-17a, but also IL-17f. The reason that's important is we understand that that well, IL-17f and IL-17a share some structural similarities, IL-17f can actually drive inflammation separately from IL-17a. And therefore, there is a hypothesis that inhibiting both cytokines may have a greater suppressive effect on inflammation. Inflammation that we see manifest as skin plaques in patients with plaque psoriasis. Some very intriguing data specific to psoriasis as well gives us great hopes for what the bimekizumab might bring to those patients. In particular, we know that IL-17f is actually more abundant in simulations than IL-17a in patients who have plaque psoriasis. And so, this has been a molecule about which there's been much excitement at UCB and certainly in the clinical community.

What first sparked your interest in evaluating long term safety and efficacy of this drug?

Long-term safety and efficacy are always important topics but never more so than when the disease that you're studying is a chronic and lifelong disease. Patients who develop plaque psoriasis have that disease for the rest of their lives, therefore we certainly hope that they achieve a state of good control. But long-term data on efficacy and safety are important because patients typically require medications long-term, and therefore they and their treating health care providers really want to know what to expect from a medicine when not taken over a brief period of time, but over a longer period of time. And so, we've really invested in developing a body of data around the long-term safety and efficacy of bimekizumab, most notably through the BE BRIGHT study. And our hope is that this long-term efficacy and safety data will really provide new insights for the dermatology community as they're making decisions about the treatment of their patients, but also for UCB as we continue to study bimekizumab not only in psoriasis, but also in other potential indications and other disease state areas in the future.

What is the clinical significance of these results?

The clinical significance is really what we care about most at the end of the day. It's wonderful to generate new data. It's wonderful to explore science. But ultimately, we care about the clinical application of these data and how they have the potential in the future to contribute to new standards of patient care for patients who are living with plaque psoriasis. And so, these data really add to the body of data already published for bimekizumab from the phase 3 clinical program in psoriasis and we hope will offer new insights to the dermatology community, but also reflect UCB’s commitment to improving the standard of care for patients who are living with plaque psoriasis. We also know that in the real world, patients frequently have an inadequate response to therapies that may be available to them today and have to switch therapies in order to work towards optimal control of their disease. And so not only the long-term nature of these data, but also the fact that these data help to inform help patients switching from adalimumab and ustekinumab to bimekizumab may achieve higher thresholds of efficacy and better control of their moderate-to-severe psoriasis is certainly an important way in which these data contribute to the understanding of disease in the clinical community.

Is there anything else you would like our audience to know before we wrap up?

I'd like to first say thank you for the opportunity to talk about bimekizumab. It's an exciting topic for me, and certainly we hope these data also are exciting and valuable to the clinical community. But I’d just like to reinforce that bimekizumab is exciting, because of 2 reasons: certainly, the efficacy signals that we've seen in the studies are exciting, but also because of the science behind it. And the fact that it really is the first and only treatment, or potential treatment, of its kind that targets these multiple aspects of the IL17 cytokine family, both IL-17a and IL-17f. We've had the opportunity to mention but I’d like to revisit that UCB is conducting the largest simultaneous clinical development program for a single molecule that we ever have, which is reflective of our enthusiasm and optimism about bimekizumab and we really look forward to the opportunity to bring out further data not only for plaque psoriasis but for hidradenitis suppurativa and the spectrum of spondyloarthritis diseases that we're studying in rheumatology as well.

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Jeffrey Stark, MD, discusses the recent studies, BE BRIGHT, BE SURE, and BE VIVID, in which investigators analyzed the impact bimekizumab had on patients with psoriasis. 

Jeffrey Stark, MD: Safety and Efficacy of Bimekizumab as Psoriasis Treatment

Engaging in physical activity (PA) may increase quality of life (QoL) and function in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and spondyloarthritis (SpA), but future research is necessary, according to a study published in 

“During the past several decades, good-quality evidence has accumulated on the effectiveness of aerobic and muscle strengthening PA to reduce disease-related symptoms such as pain and

comorbidity risk in people with RA,” investigators stated. “Nevertheless, more studies are needed to determine whether PA can improve QoL and self-reported function for patients with inflammatory arthritis.”

This systematic review and meta-analysis searched the databases PubMed, Embase, CINAHL, and Cochrane Central Register of Controlled Trials (CENTRAL) through September 2020 to identify randomized controlled trails (RCTs). The search included terms such as rheumatoid arthritis, RA, arthritis, rheumatoid, inflammatory joint diseases, psoriatic, psoriatic arthritis, inflammatory arthritis, ankylosing spondylitis, ankylosing, axial spondylarthritis, spondylarthritides, physical activity, physical exercise, exercise training, resistance training, and aerobic fitness.

Searches, risk of bias, and data extraction were performed by 2 investigators with a third investigator adjudicated if agreement was not achieved. Eligible studies fulfilled the PICOS (participants, interventions, comparators, outcomes, study design) criteria. All patients were aged 18 years or older and had a diagnosis of RA, SpA, or PsA. Eligible studies included QoL, an individuals’ perception of their position in life, and self-reported function. QoL was the primary outcome and function was the secondary outcome. Author, year of publication, participant characteristics, comparators, features of interventions, and outcomes were recorded.

Of 11,276 articles identified, 55 RCTs were analyzed in the systematic review and 37 RCTs were available for meta-analysis. Most studies were from Brazil (n =6), Sweden (n = 6), Netherlands (n = 6), UK (n = 5), and USA (n = 5). The median sample size was 60 participants and the mean age ranged from 36.2 to 73.7 years. The majority of patients were female (70%). Of these studies, 76% focused on RA, 20% analyzed SpA, and 4% investigated PsA.

Patient-reported outcome measures (PROMs) were used to measure general health, physical and mental health, emotional and social aspects, wellbeing, and vitality. Instruments utilized included the EuroQol Health, Arthritis Impact Measurement Scale (AIMS) Psychological Health and Components, Life Orientation Test, Short Form Health Survey (SF36), Short Form Health Survey (SF12), and RAND-36 score.

A total of 12 studies determined the effect of PA on QoL in patients with RA. Results indicated a significant post-intervention improvement in QoL when compared with the control group (SMD = 0.50, 95% CI:0.10 to 0.90, P < 0.01, I2 = 66%). However, in the meta-analysis comparing patients with RA and an active control group, there was no longer a significant difference. Overall, 26 studies met inclusion criteria for function regarding PA in patients with RA. Results were based on the Health Assessment Questionnaire (HAQ), the Multidimensional Health Assessment Questionnaire (MHAQ), and the visual analogue scale (VAS). PA intervention significantly improved activity performance, disease activity, fatigue, pain, disease symptoms, and physical function in patients with RA when compared with the control group. However, when compared with an active control group, no significant difference was found.

In total, 5 studies were included for analysis of PA on QoL in patients with SpA. Post intervention improvement was seen in favor of the control group (MD = 3.22, 95% CI:1.99 to 4.45, P < 0.001).

Nine of the studies focused on function of patients with SpA were included in meta-analysis. Improvement was determined by increased scores in sleep, self-efficacy, and physical function. Improvements were found in the cohort that utilized PA interventions when compared with the control group (SMD = −0.60, 95% CI: −1.09 to −0.12, P < 0.02, I2 = 57%) as well as disease activity and symptoms, fatigue (SMD = −1.97, 95% CI: −2.44 to −1.51, P < 0.001), pain (SMD = −1.12, 95% CI: −2.12 to −0.12, P < 0.03, I2=94%), depression, anxiety, and other mental manifestations.

There were no significant results reported for QoL in patients with PsA. Regarding function, only 1 study showed significant improvements in performance for this patient population. Overall, the quality of evidence was low for both QoL and function analysis.

The number of studies, including the sample size, were small, thus limiting the study by not being able to provide sensitivity analyses nor subgroup analyses for SpA and PsA. However, sensitivity analysis was available for patients with RA. Adequately reported data was low, which reduced the number of studies in the meta-analysis. Additionally, long-term effect of PA was not assessed in the study. Lastly, the limited number of studies comparing PA and active controls or follow-ups emphasizes the need for more research into PA intervention.

“The synthesized evidence shows that PA can lead to less pain, fatigue, and improved mental and activity performance in inflammatory arthritis with the most comprehensive information on RA and SpA,” investigators concluded. “This might improve both short-term and long-term compliance to PA interventions with health benefits for the individual. Patient-reported aspects of health are as important as objective measures of disease activity and function in the care of patients with IA. Future research need to focus on effects of PA in PsA, as well on larger, powered studies with standardized protocols to understand the effect of different kind of PA interventions.”

Björk M, Dragioti E, Alexandersson H, et al. Inflammatory Arthritis and the Effect of Physical Activity on Quality of Life and Self-reported Function: A Systematic Review and Meta-analysis - The ENHANCE Study [published online ahead of print, 2021 Oct 11]. 

. 2021;10.1002/acr.24805. doi:10.1002/acr.24805

“Evidence has accumulated on the effectiveness of physical activity to reduce disease-related symptoms such as pain and comorbidity risk in people with rheumatoid arthritis,” investigators stated.

Physical Activity Improves Function and Quality of Life in Patients With Rheumatic Disease

Rheumatology Network's Top 5: October 15, 2021

Take 5 minutes to catch up on Rheumatology Network's highlights from the week ending October 15, 2021.


Patients with systemic lupus erythematosus (SLE) had a higher rate of retinopathy at initial diagnosis, indicating that retinopathy is an early manifestation of the condition, according to a study published in 

 Further, investigators urge ophthalmologic screenings at the time of diagnosis and to analyze any correlation between retinopathy, disease activity, and ocular involvement.

“While data is scarce and based on low-level evidence, approximately a third of SLE patients manifest ocular involvement,” investigators stated. “Ocular manifestations of SLE might be a primary finding related to the disease pathophysiology, due to a secondary disorder, or a complication of treatment.”

In this cross-sectional study, investigators assessed patients with SLE at a tertiary referral clinic in Tehran, Iran, between March 2016 and March 2017. Eligible patients were aged 18 years or older and were diagnosed with SLE according to American College of Rheumatology (ACR) criteria. Patients were either newly diagnosed at the clinic or diagnosed at another hospital but had not received any treatment at the time of enrollment.

Demographics and clinical data were reported, including vasculitis, constitutional symptoms, headache, and musculoskeletal involvement. Laboratory tests involved a complete blood count, C-reactive protein (CRP), liver enzymes, erythrocyte sedimentation rate (ESR), serum creatinine, urinalysis, and anticardiolipin antibody (aCL). Disease activity was determined using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI).

An ophthalmologist, who had no prior knowledge of disease severity or clinical manifestation, performed a slit-lamp examination. Retinal pathologies included optic atrophy, papilledema, retinal vascular attenuation, cotton wool spots, and intraretinal hemorrhages. Patients were categorized as either those with retinopathy or those without retinopathy.

Out of a total of 114 patients, 18 (15.8%) were diagnosed with retinopathy, although none had any ophthalmic symptoms. The mean age was 31.4 ± 9.5 years and 99 (87%) were female. The most common retinal findings were cotton-wool spots (n = 14, 78%), retinal hemorrhage (n = 3, 17%), and Roth spot (n = 1, 5%).

Patients with retinopathy had a significantly higher SLEDAI score when compared with those without (22 ± 7.9 vs 11 ± 6, P < 0.001). They were also more likely to have casts in their urinalysis (P = 0.006) and had significantly lower hemoglobin levels (P = 0.012) and serum C3 and C4 levels (55 ± 15 vs 85 ± 15, P = 0.001; 12 ± 10 vs 90 ± 18, P = 0.036, respectively). Additionally, anti-nuclear antibody (ANA) and anti-double-strand DNA (anti-dsDNA) autoantibody levels were significantly higher in the retinopathy cohort (5.7 ± 1.1 vs 4.5 ± 0.8, P = 0.012; 109 ± 22 vs 71 ± 17, P = 0.049, respectively).

Limitations include the study design, not including patients undergoing treatment for SLE, and that prevalence of retinopathy may be different than other patients, as participants were referred from an SLE clinic. However, excluding patients with hypertension and diabetes and utilizing a priori power analysis strengthen the study.

“Our findings suggest that retinopathy might be an early manifestation of the disease, and ophthalmologic screening might be considered for SLE patients at the time of diagnosis, especially for those with severe disease,” investigators concluded. “We also encourage researchers to further evaluate the correlation between retinopathy and disease activity, and the prognosis of ocular involvement with current treatment algorithms.”

Bashiri H, Karimi N, Mostafaei S, Baghdadi A, Nejadhosseinian M, Faezi ST. Retinopathy in newly-diagnosed systemic lupus erythematosus: should we screen for ocular involvement?. 

. 2021;5(1):34. Published 2021 Oct 1. doi:10.1186/s41927-021-00203-5

Approximately a third of systemic lupus erythematosus patients experience ocular involvement, which may be linked to disease pathophysiology. 

High Rates of Retinopathy Seen in Patients With Systemic Lupus Erythematosus 

Hydroxychloroquine (HCQ) did not play a protective role against COVID-19 in patients with rheumatic disease (RD) when compared with household cohabitants, according to a study published in 

“Initial data have suggested that SARS-CoV-2 does not appear to cause more serious disease in immunosuppressed patients and this clinical observation has drawn attention to a potential beneficial or ‘protective’ effect of medications used to control RDs,” investigators explained.

In this cross-sectional, observational, multi-center, paired study, investigators enrolled patients with rheumatic disease and their cohabitants to evaluate whether HCQ impacted the frequency of COVID-19 in this patient population. Eligible participants were aged 18 years or older and registered at 22 Brazillian academic outpatient centers. A known diagnosis of RD and a history of HCQ use for at least 30 days were required for the RD cohort. Information, obtained through phone calls, included COVID-19 symptoms, RD status, current treatments, and demographic and epidemiological data. COVID-19 was defined using the Brazilian Ministry of Health (BMH) criteria and symptoms, hospitalization, intensive care, and death were reported. Tests were only performed for moderate-to-severe cases. Data was stored in an electronic online platform called REDCap.

Between March 29 and May 17, 2020, 9589 participants were enrolled in the study, including 5166 (53.9%) in the RD cohort on HCQ (5 mg/kg/day) and 4423 (46.1%) cohabitants in the control group. A total of 854 (8.1%) were eventually excluded. Mean age and COVID-19 contact were similar in both groups, however, the numbers were higher for females in the RD group and higher for males in the cohabitant cohort. The most common RDs were systemic lupus erythematosus (SLE) (82.5%) and rheumatoid arthritis (RA) (7.8%). The majority of patients were using HCQ (97.5%), with 89.9% using it in combination with other therapies and 10.1% receiving it as monotherapy.

Within the 30 days prior to enrollment, 1822 (19.1%) of participants reported flu-like symptoms, of which 3.1% fulfilled BMH criteria of potential COVID-19 infection. While the flu symptoms were higher in patients with RD, there were no significant differences between the RD cohort (4.03%) and the controls (3.25%) for those suspected of COVID-19.

Participants with a history of lung disease (OR 1.63; 95% CI 1.03–2.58, p = 0.038) were more likely to have clinically confirmed COVID-19 and men (OR 0.71; 95% CI 0.52–0.98, p = 0.043) were less likely.

After adjusting for sex, age, immunosuppressant drugs, comorbidities, and medication a systemic sclerosis diagnosis (OR 2.8; 95% CI 1.19–6.63) and glucocorticoid usage above (above 10 mg/day) (OR 2.05; 95% CI 1.31–3.19) were proven to have a harmful effect for diagnosis. Participants who received an influenza vaccination were more protected from the illness (OR 0.674; 95% CI 0.46–0.98).

Strengths of the study include the large sample size, inclusion of a control group, and frequent data quality monitoring. However, due to the need for social distancing, investigators only accumulated self-reported data, with a small number of confirmed lab tests. Further, there weren’t enough patients with RD not using HCQ to represent a second control group.

“This study provides evidence of a non-protective role of chronic HCQ use (5 mg of the sulfate/kg/day) concerning uncomplicated COVID-19 in RD patients, regardless of comorbidities, immunosuppression therapy, and social distancing,” investigators concluded.

Pileggi GS, Ferreira GA, Reis APMG, et al. Chronic use of hydroxychloroquine did not protect against COVID-19 in a large cohort of patients with rheumatic diseases in Brazil. 

. 2021;61(1):60. Published 2021 Oct 7. doi:10.1186/s42358-021-00217-0

Investigators analyzed the potential beneficial effect of hydroxychloroquine to prevent COVID-19 infection in patients with rheumatic disease.

Hydroxychloroquine did not Protect Patients With Rheumatic Disease Against COVID-19

While the costs of juvenile idiopathic arthritis (JIA) are sizable, the highest costs stemmed from medication and medical appointments, according to a study published in 

“The treatment of JIA must be multilevel, with a pediatric rheumatologist, psychological support, physical therapy, nutrition, and family support. Within pharmacological treatment, a wide range of options with different costs and effectiveness could be found,” investigators explained. “With this perspective, considering the multiple medical appointments, laboratory tests, medications, and indirect costs, this disease generates elevated costs, which results in a high economic impact for the family.”

An experienced librarian conducted a systematic review of the databases MEDLINE, EMBASE, Web of Science, Scopus, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials to determine both direct and indirect costs in patients with JIA for at least 1 year. They included studies from January 2000 to July 2019, with an additional updated search in March 2021. Quality of the studies was assessed by a board of reviewers, comprised of 2 pediatric rheumatologists, 1 fellow in Pediatric Rheumatology, and 3 medical students. Eligible studies were ones that included either complete economic evaluations, partial economic evaluations, or individual studies that reported cost, such as clinical trials and observational studies.

DC included medical appointments, medications, hospitalizations, surgeries, alternative medicine, laboratory tests, clinical imaging, complications, travel expenses, insurance payments, and patient care. IC focused on loss of productivity via missed school or workdays, work impact on the patient or caregiver, early retirement of the patient or caregiver, and costs of caregiver productivity.

Costs were converted to United States dollars (USD).

Ultimately, of the 1334 studies obtained in the search, 18 studies with 6540 patients were analyzed. The most common were economic studies (n = 11), followed by cohorts (n = 4), and retrospective observational (n = 3). The countries of origin included Europe (n = 12), North American (n = 4), both Europe and North America (n = 1), and Asia (n = 1).

The TC, reported in 10 articles, ranged from $310 to $44,832 USD, with European countries reporting significantly higher costs compared with other regions. DC, available in 16 articles, ranged from $193 and $32,446 USD and was attributed to 55% to 98% percent of TC. Most DC was related to medications, hospitalizations, and medical appointments. IC, shown in 6 studies, ranged from $117 to $12,385 USD.

There was a correlation between polyarticular JIA and higher TC and DC, which increased costs up to 3-fold in those receiving biological therapy.

In an analysis of costs by country, TC varied between $4050 and $51,578 USD, with Bulgaria reporting the lowest costs and the United Kingdom reporting the highest costs. Of the 8 studies that reported both DC and TC, annual TC ranged from $1122 to $44,832 USD, with at least half of which relating to DC.

Interestingly, costs from JIA, ranging from $10,830 to $32,446 US, were higher than those reported in chronic arthritis in adults or patients with rheumatoid arthritis, ranging from $1862 to $20,262 USD.

Investigators utilized available evidence following a pre-designed protocol and performed an extensive search among different databases, which strengthened the study. Unfortunately, there is a high risk of reporting bias due to lack of consistency in economic aspects, different definitions, and data based on the perspective of external payers or health institutions. Additionally, a meta-analysis of costs was not performed, which would have aided in identifying areas of unmet support for patients with JIA and their families.

“This study synthesized the costs of JIA and highlights the financial risk that families could face during the disease trajectory,” investigators concluded. “It is necessary to standardize the reports and generate information from developing countries to obtain a more accurate analysis of the impact of the disease in the world.”

García-Rodríguez F, Gamboa-Alonso A, Jiménez-Hernández S, et al. Economic impact of Juvenile Idiopathic Arthritis: a systematic review. 

. 2021;19(1):152. Published 2021 Oct 9. doi:10.1186/s12969-021-00641-y

“Considering medical appointments, laboratory tests, medications, and indirect costs, juvenile idiopathic arthritis generates elevated costs, which results in a high economic impact for the family,” investigators stated. 

The Financial Impact of Juvenile Idiopathic Arthritis 

Patients with psoriatic arthritis (PsA) who achieved both Psoriasis Area Severity Index (PASI100) and American College of Rheumatology criteria (ACR50) were associated with better outcomes, including health-related quality of life (HRQoL), according to a study published in 

“To optimize the benefits of treatment and improve the HRQoL of patients with PsA, all symptoms need to be considered,” investigators stated. “Therefore, a number of unidimensional and multidimensional tools and treatment targets have been developed and validated to assess the musculoskeletal (articular and extra-articular) or non-musculoskeletal manifestations of PsA and the impact of disease on HRQoL.”

Investigators utilized data from SPIRIT-H2H (

), a 52-week, multicenter, randomized, open-label study evaluating the safety and efficacy of ixekizumab compared with adalimumab. All patients met the Classification for Psoriatic Arthritis criteria, had active psoriasis (PsO), were biologic disease-modifying antirheumatic drug (bDMARD) naïve, and had an inadequate response to at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Participants were able to continue any csDMARDs during the study. Patients were randomized into 2 sets of 4 response groups at Week 24: those achieving ACR50 and PASI100 (CR24), those achieving only ACR50 (JR24), those achieving only PASI100 (SR24), and those who did not achieve either (NR24). They were reallocated at Week 52 as well. Patients achieving both ACR50 and PASI100 were then compared with other response groups.

The post hoc analyses evaluated HRQoL and efficacy across the 4 groups. Assessments included Disease Activity in Psoriatic Arthritis (DAPSA), minimal disease activity (MDA), Leeds Enthesitis Index (LEI), Leeds Dactylitis Index-Basic (LDI-B), a Health Assessment Questionnaire-Disability Index (HAQ-DI), Nail Psoriasis Severity Index (NAPSI), a 36-Item Short Form Survey (SF-36), and a Dermatology Life Quality Index score (DLQI).

A total of 566 patients were included in the study, of which 283 received ixekizumab and 283 received adalimumab. At Week 24, 181 attained CR24, 94 attained JR24, 121 attained SR24, and 170 were placed in the NR24 cohort. At Week 52, 185 patients were reallocated into the CR52 group, 97 patients achieved JR52 criteria, 114 patients achieved SR52, and 170 were labeled NR52.

Patients who achieved both ACR50 and PASI100 during the study had HRQoL improvement, higher rates of ACR70 response, resolved enthesitis and dactylitis, had minimal disease activity and a Disease Activity in Psoriatic Arthritis score of ≤ 4 when compared with the other response groups at both Week 24 and Week 52.

The clinical and patient-reported outcomes at weeks 24 and 52 are as follows:

Musculoskeletal outcomes in patients achieving both ACR50 and PASI100 response (CR24 and CR52)

Patients in CR24 and CR52 had significantly (p < 0.05) higher rates of MDA and very low disease activity (VLDA) when compared with patients in other response groups. Additionally, DAPSA, HAQ-DI, and enthesitis resolution was higher in CR24 and CR52 compared with the other groups, especially with SR24, SR52, NR24, and NR52, respectively.

Musculoskeletal outcomes in patients achieving ACR50 response (JR24 and JR52)

A total of 48.9% and 60.8% achieved ACR70 at 24 and 52 weeks, respectively. MDA, VLDA< DAPSA, HAQ-DI, and enthesitis were higher in both JR24 and JR52 when compared with SR24, SR52, NR24, and NR52.

Musculoskeletal outcomes in patients achieving a PASI100 response (SR24 and SR52)

Patients in SR24 and SR52 achieved PASI75, PASI90, and PASI100 in significantly higher percentages when compared with JR24, JR52, NR24, and NR52.

CR24 and CR52 had the highest rates of NAPSI compared with other groups (62.8% and 80.2%, respectively), with a statistically significant difference compared with NR24 and NR52. Those in JR24 and JR52 had the highest baseline PASI scores and most resolved nail symptoms (50.0% and 67.6%, respectively).

Comparison between Week 24 and Week 52 responses

Most (62.7%) patients in the CR52 cohort had already achieved ACR50 and PASI100 by Week 24. Of the other response groups, only 13.0% had an ACR50 and 15.1% had a PASI100 response within the same period. At Week 24, 51.5% achieved ACR50 in the JR52 group and 29.9% achieved PASI100 in the SR52 cohort.

The post hoc nature of the analysis limited the study. Further, a small number of patients were experiencing dactylitis at baseline, so LDI-B responses should be viewed with caution. Correlations between achievement of both ACR50 and PASI100 coupled with inhibition of structural damage could not be assessed as radiographic progression was not included in the SPIRIT-H2H trial.

“This analysis of data from the SPIRIT-H2H study showed that the primary endpoint of simultaneous achievement of an ACR50 and PASI100 response at week 24, irrespective of active treatment arm [and] similar findings were seen in week-52 analyses,” investigators concluded. “Patients meeting this primary endpoint are more likely to achieve a disease state of remission, which is the stated aim of PsA treatment according to GRAPPA and EULAR recommendations.”

Behrens F, Leage SL, Sapin C, et al. Measuring treatment effect on psoriatic arthritis-related domains: insights from the SPIRIT-H2H study at weeks 24 and 52 [published online ahead of print, 2021 Sep 13]. 

. 2021;10.1007/s10067-021-05891-5. doi:10.1007/s10067-021-05891-5

The post hoc analyses evaluated health-related quality of life and efficacy across 4 subgroups treated with either ixekizumab or adalimumab. 

Higher Disease Control Linked to Better Outcomes for Patients With Psoriatic Arthritis 

The Fast-Track Clinic (FTC) significantly reduces hospitalization rates, which are historically high, in patients with polymyalgia rheumatica (PMR), according to a study published in 

“The vast majority of PMR patients are diagnosed and managed in general practice,” investigators stated. “Diagnosing PMR can be challenging as many conditions can mimic the disease. The variety of symptoms may lead to hospitalization to rule out other serious diseases.”

In this retrospective, observational, cohort study, patients with PMR who fulfilled 2012 The European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) classification criteria between April 2013 and December 2018 were included in the study. It was conducted using patient data from the Department of Internal Medicine and Rheumatology at South-West Jutland Hospital in Denmark. Demographics, such as age, gender, symptom duration, inflammatory markers, pain, and imaging examinations were included. Additionally, hospitalization, inpatient days, treatment, and imaging modalities were reported. The FTC was implemented in the rheumatologic department in January 2018.

A total of 254 patients were diagnosed within the study period, 54 of which were hospitalized with a mean duration of 4.02 inpatient days. Diagnostic imaging procedures were applied for hospitalized patients to exclude underlying conditions and were much higher in this group when compared with the non-hospitalized cohort (81.5% vs 15.9%, p < 0.00001, respectively). While there were no differences in either gender or PMR symptoms, those hospitalized were more likely to present a shorter duration of symptoms (p = 0.0018) and had higher initial C-reactive protein (CRP) levels (p < 0.0001).

The FTC significantly reduced hospitalization rates from 20.4% to 3.5% (p = 0.001) as well as inpatient days from 4.15 days to 1 day (p < 0.00001). There was a significant decrease in symptom duration before diagnosis in the FTC.

Further, healthcare costs in Danish hospitals, calculated by the DRG system, for the 56 newly diagnosed patients were reduced by 65% after the introduction of the FTC when compared with the 2013 through 2017 period.

The electronic journal system used ensured collection of necessary data from this endemic region and all instances of hospitalization were captured.

However, the retrospective nature of the study was limiting. Additionally, investigators only included patients referred to the hospital, which may have excluded patients who were treated in a primary care clinic. Despite this, investigators believe it reflects the population of patients with PMR in the Danish population. Severity of symptoms, comorbidities, and disabilities were not compared between both hospitalized and non-hospitalized cohorts. Another limitation was that patients with PMR suspicion were excluded from the study as patients were identified in the database based on final diagnosis and not any tentative or referred diagnosis. Other studies that analyze FTC on patients with PMR suspicion would help answer this question. 

“This is the first study to investigate the hospitalization rates and the reason for hospital admissions of newly diagnosed PMR patients. Furthermore, the implementation of an FTC approach decreases the hospitalization rates and inpatients’ days of care,” investigators concluded. “Future research should focus on PMR diagnosing challenges and how the primary sector and hospital departments can optimize their collaboration.”

Chrysidis S, Lage-Hansen PR, Svendsen N, Diamantopoulos AP. The fast-track outpatient clinic significantly decreases hospitalisation rates among polymyalgia rheumatica patients. 

. 2021;5(1):37. Published 2021 Oct 5. doi:10.1186/s41927-021-00210-6

The Fast-Track Clinic reduced hospitalization rates for patients with polymyalgia rheumatica, which is helpful as symptoms of PMR can mimic other diseases, leading to hospitalization to rule out other conditions. 

Fast-Track Clinic Reduces Hospitalization in Patients With Polymyalgia Rheumatica 

Rheumatology Network sat down with E Michael Lewiecki, MD to discuss his CCR West presentations entitled, “Controversies in Osteoporosis” and “What's New in Osteoporosis for 2021?” Lewiecki is Director at the New Mexico Clinical Research and Osteoporosis Center. We deep dive into recent controversies and trends in osteoporosis management, predictions for 2022, and how COVID-19 had impacted the treatment landscape for rheumatologists.

 What are some of the controversies and osteoporosis that you discuss in your presentation?

Well, it's interesting that almost everything we do in the field of osteo process has some controversial aspects to it. One thing that is somewhat confusing is conflicting clinical practice guidelines. There are numerous guidelines that are published and available on websites that inform healthcare professionals about how to manage patients with osteoporosis. And sometimes the recommendations are a little bit different and they often address different specialties. You know, 1 set of guidelines might be directed to endocrinologists, another to rheumatologists, another to primary care physicians. Some only are focused on a particular population of patients, such as postmenopausal women, some involve women and men, some are directed to subclasses of these patients such as glucocorticoid-induced osteoporosis. So, it can be a bit daunting to wade your way through all these guidelines and, you know, come up with the right kind of decision making that you need for your particular patient who is in front of you. I can mention a few other controversies. Another one has to do with how long to treat. There's a myth out there that all osteoporosis medicines should be stopped after 3 years or 5 years. And often that is done without regard to the level of fracture risk that the patient has or what medication they're on. And this idea of drug holidays was conceived years ago, and it just needs to be emphasized that the idea of a drug holiday only applies to patients on bisphosphonates. There's no drug holiday with any other medication. It's not a rule, it's just a consideration, that if a patient has been treated for 3 to 5 years with a bisphosphonate and fracture risk is no longer high, that they might be considered to get off of the medication for a year or a couple of years, be monitored, and sooner or later get back on to some sort of treatment when fracture risk is once again high. And for that reason, it's not called drug retirement it's just a drug holiday. Another controversy is what to do after stopping denosumab. This is a very potent, anti-resorptive agent that's given as a subcutaneous injection every 6 months. And soon after that 6-month period the effects of the medicine rapidly dissipate. Bone density can go down quickly. Bone turnover markers rise and go even higher than baseline and fracture risk goes back to baseline very quickly. And in some patients, there may be a risk of multiple vertebral fractures. So, patients stopping treatment with denosumab need to be followed up with another drug to try to mitigate that downward trend in bone density that might otherwise happen. And often, the drug that's given is a bisphosphonate. There is some uncertainty about which bisphosphonate might be best and how to administer it. Often the bisphosphonate used is zoledronic acid and there's consideration given to whether it should be given 6 months after the last dose of denosumab a little bit longer after the last dose of denosumab and whether the effects of that might be monitored with bone turnover markers in addition to bone density. And perhaps, in some patients, a second dose of zoledronic acid given sooner than 1 year after that first dose might be needed. So, a lot of active investigation into that sort of thing.

Have you noticed any trends in treatment over the past year?

Well, there's been challenges with code because some patients on injectable treatments that are given by a healthcare professional have been reluctant to go to a physician's office. And for that reason, some treatments have been delayed. So we've gone to a great deal of trouble to be innovative in giving treatments. For example, some patients who are on denosumab need an injection every 6 months and have not been willing to come inside the office. We've actually done drive-thru injections of denosumab in the parking lot. We've had patients drive into the parking lot, call us on their cell phone and a nurse has gone out to the car, patients rolled down the window, stuck their arm out, and we given them their injection. So, things like that are kind of new and different because of COVID. We're all having to adapt to the new world situation that we live in.

Do you have any predictions for osteoporosis or osteoarthritis moving into 2022?

Well, as I've learned in recent years, it's dangerous to make predictions about anything. But what I hope to see is a move towards, at least on a minimal level, is some harmonization of clinical practice guidelines. Since there are no new osteoporosis drugs in the clinical practice pipeline right now, I think we're all going to learn how to use better the medicines that we currently have. And I think there'll be more emphasis on this important concept of sequence of therapy making a difference in how patients respond. I think more recognition that patients at very high fracture risk may benefit from initial therapy with anabolic agents. And I think we're going to be seeing more biosimilar drugs for some of the ones that are now fairly expensive, at least in the US. And I hope to a certain degree that will help prices to come down in some of the drugs that are pretty expensive right now.

E Michael Lewiecki, MD, discusses his CCR West presentations entitled, “Controversies in Osteoporosis” and “What's New in Osteoporosis for 2021?” 

E Michael Lewiecki, MD: Controversies in Osteoporosis

This article was originally published on 

AbbVie announced that they achieved positive results from both studies of the Phase 3 SELECT-AXIS clinical trials.

 of the 2 studies, a clinical trial evaluating the efficacy and safety of upadacitinib (RINVOQ; 15 mg, once daily) in patients with active 

 (AS) who had an inadequate response to biologic disease-modifying antirheumatic drug (bDMARD) therapy, met its primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 response as well as all ranked secondary endpoints at week 14.

At week 14, significantly more patients treated with upadacitinib achieved ASAS40 response compared with placebo (45% compared with 18%, respectively; 

 of the Phase 3 SELECT-AXIS clinical trial in adults with active non-radiographic axial spondyloarthritis (nr-axSpA), the results showed that upadacitinib (RINVOQ; 15 mg, once daily) met the primary endpoint of ASAS40 response and the majority of ranked secondary endpoints at week 14.

Compared with placebo, a significantly higher amount of upadacitinib-treated patients achieved ASAS40 response at week 14 (23% compared with 45%, respectively; 

This study focused on adult patients with ankylosing spondylitis who had an inadequate response to bDMARDs as well as nonsteroidal anti-inflammatory drugs (NSAIDs). The results of Phase 2/3 SELECT-AXIS 1 were used to support the European Commission approval of upadacitinib for the treatment of active ankylosing spondylitis in January 2021.

No new risks were identified and safety data were found to be consistent with SELECT-AXIS 1, previous Phase 3 studies in other indications and the known safety profile of upadacitinib.

Treatment with upadacitinib showed statistically significant reductions in the symptoms of ankylosing spondylitis including inflammation and back pain. It also improved physical function and disease activity at week 14.

Patients who were treated with upadacitinib achieved a Low Disease Activity on the Ankylosing Spondylitis Disease Activity Score (ASDAS) compared to those treated with placebo (44% compared with 10%).

This was the first trial to examine the efficacy and safety of upadacitinib in adult patients with non-radiographic axial spondyloarthritis.

No new risks were identified, safety data were found to be consistent with SELECT-AXIS 1, previous Phase 3 studies in other indications as well as the known safety profile of upadacitinib. Of the secondary endpoints, 12 of 14 were met.

Patients with non-radial axial spondyloarthritis that were treated with upadacitinib showed reductions in symptoms including inflammation and back pain and improved physical function and disease activity at week 14.

When looking at the Ankylosing Spondylitis Disease Activity Score, significantly more patients treated with upadacitinib achieved Low Disease Activity compared with placebo (42% compared with 18%).

Upadacitinib is a selective and reversible JAK inhibitor, an oral therapy approved in the EU for the treatment of active ankylosing spondylitis. It is also being studied as a treatment for multiple immune-mediated diseases. It was discovered and developed by AbbVie.

“People living with active non-radiographic spondyloarthritis suffer from chronic inflammatory back pain and limited physical function that can be very debilitating,” said Michael Severino, M.D. vice chairman and president, AbbVie, 

. “These patients need treatments that help them improve their physical function and quality of life. We are encouraged by the potential of upadacitinib in helping to provide relief of these signs and symptoms through meaningful disease control.”

Upadacitinib achieved positive results from both Phase 3 SELECT-AXIS clinical trials, which focused on patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis.

Upadacitinib Meets Primary and Most Ranked Secondary Endpoints in 2 Phase 3 Clinical Trials

Rheumatology Network's Top 5: October 8, 2021

Take 5 minutes to catch up on Rheumatology Network's highlights from the week ending October 8, 2021.
