Therapy Change from Adalimumab to Baricitinib in Patients with Rheumatoid Arthritis

Baricitinib in RA Treatment

Baricitinib belongs to the targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs). It is an oral inhibitor of Janus kinases (JAK1/2), which play a role in the pathogenesis of RA. In the Czech Republic, it is approved for the treatment of patients with moderate to severe active RA who have not had an adequate response to one or more DMARDs.

Switching from one type of DMARD to another or adding another DMARD to the therapy is a common situation in clinical practice. For this reason, it is particularly important to monitor the efficacy and safety of new preparations from the DMARD group during therapy changes.

RA-BEAM Study and Its Analysis

RA-BEAM was a randomized, double-blind, placebo- and actively-controlled phase III clinical study that compared the efficacy of baricitinib and adalimumab in patients with rheumatoid arthritis (RA) who had not responded to prior methotrexate (MTX) therapy.

Patients enrolled in the study were randomized into 3 groups in a 3 : 2 : 3 ratio. The first group received baricitinib at a dose of 4 mg daily, the second group received 40 mg of adalimumab every 2 weeks, and the third group received placebo. At week 16 from the start of the study or at later follow-up visits, patients who did not respond adequately to treatment were switched to open-label baricitinib in a “rescue” regimen. From the rescue moment, additional use of corticosteroids, nonsteroidal anti-inflammatory drugs, or painkillers was allowed.

After 52 weeks of starting the study, participants could enter the long-term extension (LTE) of the RA-BEYOND study and either continue the original baricitinib treatment or switch to baricitinib from adalimumab. Therapy was switched without a wash-out period. The percentage of patients who achieved low disease activity or remission, physical status, safety, and patient-reported pain levels were evaluated.

The aim of the presented analysis was to evaluate treatment efficacy in two groups of patients from the RA-BEAM study: those who were switched to baricitinib during the RA-BEAM study (52 weeks) and those who were switched to baricitinib at the start of the RA-BEYOND study.

Results

A total of 1305 patients were enrolled in the RA-BEAM study (487 received baricitinib, 330 adalimumab, and 488 placebo). 35 patients (7%) treated with baricitinib and 40 patients (12%) treated with adalimumab were switched to open-label baricitinib treatment during the RA-BEAM study. 78% of patients initially treated with baricitinib and 72% of patients initially treated with adalimumab who were not switched to open-label baricitinib treatment during RA-BEAM entered the LTE phase and received baricitinib in the RA-BEYOND study.

In patients who were switched from initial baricitinib or adalimumab treatment to open-label baricitinib treatment during the RA-BEAM study, significant improvement was observed according to all evaluated parameters at weeks 4, 8, and 12 after the therapy change. In patients initially treated with adalimumab, switching to baricitinib resulted in a significant decrease in inflammatory phase marker levels, which was not observed in patients continuing baricitinib treatment.

During the LTE phase, improved function maintenance and pain reduction were observed in participants continuing baricitinib treatment and also in those who were switched from adalimumab to baricitinib at the start of the LTE phase. After 24 weeks of the LTE phase, treatment efficacy was comparable in both groups.

Conclusion

Switching therapy from adalimumab to baricitinib without a wash-out period was associated with improved disease control, functional improvement, and pain reduction during the 12 weeks following the therapy change without a concurrent increase in the occurrence of adverse events.

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Source: Tanaka Y., Fautrel B., Keystone E. C. et al. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis 2019; 78 (7): 890–898, doi: 10.1136/annrheumdis-2018-214529.