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Patient-reported outcomes are in line with clinical trial results for baricitinib, an international research team reports.
Baricitinib for rheumatoid arthritis continues to perform well in clinical trials across the globe.
An extended report by an international team of researchers found that baricitinib, a once-daily oral janus kinase inhibitor (JAK), was associated with clinical improvement and inhibition of progression of radiographic joint damage in patients with rheumatoid arthritis. The study was published in January in the Annals of the Rheumatic Diseases.
The phase three, double-blind, 24-week study of 684 patients who previously had an inadequate response to or intolerance a conventional synthetic disease-modifying anti-rheumatic drug (DMARD), showed that patients receiving 2 mg or 4 mg of baricitinib once daily achieved ACR20 response at week 12 with baricitinib 4 mg.
Statistically significant improvements in DAS28, SDAI remission, Health Assessment Questionnaire-Disability Index, morning joint stiffness, worst joint pain and worst tiredness were also observed.
Interestingly, at five percent, the rates of serious adverse events were similar among both the 4 mg baricitinib group. In addition, one patient in the 4 mg group developed tuberculosis and one patient developed a non-melanoma skin cancer.
A systematic review published last month in Zeitschrift fur Rheumatologie found that patients receiving baricitinib 4 mg in combination with a DMARD, had significantly higher rates of achieving ACR20 response. The review is based on a meta-analysis of seven randomized controlled trials involving 3,461 patients.
This was followed by baricitinib 4 mg alone, baricitinib 2 mg with a DMARD, adalimumab 40 mg with methotrexate and lastly, DMARD alone. “The safety based on the number of treatment-emergent adverse events, did not differ significantly among the five interventions,” researchers wrote.
The improvement of symptoms and health-related quality of life are usually more important to patients than clinical or serological changes alone, writes Dr. Josef Smolen in the October 31 issue of the Annals of the Rheumatic Diseases.
Dr. Smolen led an international team of researchers who describe patient-reported outcomes reported from the RA-BEACON study. The goal was to determine whether the efficacy of baricitinib as shown in RA-BEACON translated into clinically meaningful changes patient deemed important (pain, disease activity, physical functioning, fatigue, sleep disturbance, psychological disorders, well-being at work and quality of life).
The study included 527 patients: 176 placebo, 174 baricitinib 2 mg and 177 baricitinib 4 mg. Previously, 60 percent of the patients received more than one biologic DMARD (221, 160 and 142, respectively). And, more than one-third of patients in RA-BEACON had an inadequate response to, or side effects associated with TNFi and non-TNFi bDMARDs.
At the beginning of the study, some of the patients were severely impaired with limited physical function and high levels of pain and fatigue. All of the patients in the treatment groups complained of "significant disease burden."
Over 24 weeks, most patient-reported outcomes improved significantly with patients receiving baricitinib 4 mg reporting a more rapid and greater magnitude of change than the baricitinib 2 mg group. All but one of the eight measured health domains improved: mental health. While mental health status did improve, it did not achieve statistical significance.
At 12 weeks, physical functioning, body pain, vitality and social functioning ranked highest for baricitinib 4 mg. And, for baricitinib 2 mg, physical functioning, body pain, general health and vitality improved at 12 weeks. At 24 weeks, significant differences were observed in for baricitinib 4 mg in physical functioning, vitality and social functioning and in only two domains for baricitinib 2 mg: physical functioning and social functioning.
Status in the United States
Baricitinib is currently under review by the Food and Drug Administration. On January 13, the FDA extended the review period for baricitinib by three months. The FDA extended the review period to consider the results of newly published clinical trials.
Status in Europe
On Feb. 13, Eli Lilly and Incyte Corp. announced that the European Commission granted marketing authorization for baricitinib (Olumiant) for the treatment of adults with moderate to severe active rheumatoid arthritis. It is recommended for use in patients who have not responded to DMARD treatment or cannot tolerate DMARDs.
The decision came two months after the European Medicines Agency recommended that baricitinib be approved for rheumatoid arthritis patients.
Maxime Dougados, DÃ©sirÃ©e van der Heijde, Ying-Chou Chen, et al. "Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study," the
Annals of the Rheumatic Diseases
. Published first online Sept. 29, 2016. Josef S Smolen, Joel M Kremer, Carol L Gaich, et al. "Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON),"
Annals of the Rheumatic Diseases
. Oct. 31, 2017. http://dx.doi.org/10.1136/annrheumdis-2016-209821 Y. H. Lee, S.C. Bae. "Comparative efficacy and safety of baricitinib 2 mg and 4 mg in patients with active rheumatoid arthritis : A Bayesian network meta-analysis of randomized controlled trials,"
Zeitschrift fÃ¼r Rheumatologie
. Jan. 17, 2017. DOI: 10.1007/s00393-016-0254-4 “New oral treatment for rheumatoid arthritis. Olumiant to reduce inflammation and other symptoms,”
Eurpoean Medicines Agency
. Dec. 12, 2016. "European Commission Approves Once-Daily Olumiant Tablets for Treatment of Adults with Moderate-to-Severe Active Rheumatoid Arthritis,"
. Feb. 13, 2017.