Is Baricitinib Suitable for Long-Term Treatment of Rheumatoid Arthritis?
The nature of rheumatoid arthritis requires effective and long-term treatment. The current analysis of data from the long-term extension RA-BEYOND reveals the potential of baricitinib in maintaining low disease activity and remission with long-term use.
Therapeutic Goals in RA Treatment
Long-term, effective, and safe treatment of rheumatoid arthritis (RA) should reduce disease symptoms, prevent irreversible joint damage, and reduce the occurrence of comorbidities.
Baricitinib is an oral, selective, and reversible inhibitor of Janus kinases (JAK) 1 and 2 approved for the treatment of active RA in adults. In clinical studies, it has proven its efficacy in patients naive to disease-modifying antirheumatic drugs (DMARDs) and in patients with insufficient therapeutic response (non-responders) to methotrexate (MTX), conventional synthetic DMARDs, or biological DMARDs.
In clinical practice, the main factor in choosing therapy is its long-term safety and efficacy. The main aim of the cited work was to evaluate the achievement and maintenance of low disease activity (LDA − low disease activity), remission, and normalization of physical functions in patients (naive to DMARDs or with insufficient response to MTX) treated with 4 mg of baricitinib for up to 3 years.
Analyzed Studies
RA-BEAM and RA-BEGIN are Phase III studies that evaluated the efficacy and safety of baricitinib over 52 weeks in adult patients with moderate to severe RA, naive to DMARD treatment or with insufficient response to MTX. The RA-BEGIN study included 584 patients who were randomized into 3 treatment arms: baricitinib 4 mg monotherapy (n = 159), baricitinib 4 mg + MTX (n = 215), and MTX monotherapy (n = 210). In the RA-BEAM study, 1305 patients were randomized into 3 treatment arms: placebo (+ MTX; n = 488), baricitinib (+ MTX; n = 487), and adalimumab (+ MTX; n = 330).
RA-BEYOND is a long-term extension (LTE) of both studies aiming to evaluate the efficacy and safety of baricitinib. In the RA-BEYOND study, patients were switched to open-label monotherapy with 4 mg of baricitinib (RA-BEGIN) or a combination of 4 mg baricitinib with MTX (RA-BEAM).
Results
Achievement of Low Disease Activity
In week 148, 61% (monotherapy with baricitinib 4 mg), 58% (baricitinib 4 mg + MTX), and 48% (MTX monotherapy) of previously untreated patients in each group achieved low disease activity based on SDAI (Simplified Disease Activity Index) scores of ≤ 11. The treatment response in patients initially treated with baricitinib was stable from week 24 to week 148. MTX-treated patients showed improvement soon after switching to baricitinib in LTE. Similar results were observed among MTX non-responders in the RA-BEAM study. Low disease activity was achieved by 59% of patients (baricitinib 4 mg + MTX), 61% (those who started with adalimumab + MTX and were switched to baricitinib + MTX in the extension study), and 56% (placebo + MTX).
Achievement of Remission
Among previously untreated patients, remission (SDAI score ≤ 3.3) was achieved in week 148 by 34% of patients (monotherapy with baricitinib 4 mg), 34% (baricitinib 4 mg + MTX), and 32% (MTX monotherapy). Among MTX non-responders, remission according to SDAI was achieved in week 148 by 24% of patients (baricitinib 4 mg + MTX), 28% (original adalimumab + MTX arm, switched to baricitinib + MTX in the extension), and 23% (placebo + MTX).
Up to 48% of previously untreated patients and 38% of MTX non-responders initially treated with baricitinib achieved a HAQ-DI (Health Assessment Questionnaire Disability Index) score of ≤ 0.5.
During the 148 weeks, therapy was discontinued by 3.6% of MTX non-responders due to insufficient efficacy and by 10.7% due to the occurrence of adverse events. In previously untreated patients, the rate of treatment discontinuation was similar.
Conclusion
The results confirm the long-term efficacy of 4 mg baricitinib in RA therapy for up to 3 years. Given the low rate of treatment discontinuation, baricitinib can be considered well-tolerated and highly effective for long-term therapy.
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Source: Smolen J. S., Xie L., Jia B. et al. Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study. Rheumatology (Oxford) 2020 Nov 17; keaa576, doi: 10.1093/rheumatology/keaa576 [Epub ahead of print].
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