Over the past few years, clinical trial data for baricitinib use in rheumatoid arthritis has been growing. We have seen data from the Phase 3 studies (RA-BEGIN, RA-BEAM, RA-BUILD, and RA-BEACON), all of which show great promise for this new JAK 1/2 inhibitor. At EULAR 2016, further data on extension arms from these studies was presented, along with more pooled safety data, with no new surprises.
In addition to the wealth of efficacy and safety data, Eli Lilly has set a new bar in clinical development programs by providing very interesting data regarding clinical disease management and decision-making.
Thursday at EULAR 2016, Weinblatt et al. presented a poster regarding early efficacy with baricitinib and its use in helping guide clinical decisions. Similar to what we have seen with certolizumab pegol, the authors evaluated whether there could be a prediction rule to identify treatment non-responders at an early stage of treatment.
Using data from RA-BEAM and RA-BEGIN, they showed that those who did not respond to baricitinib at 4 weeks (defined as CDAI improvement <6) were unlikely to achieve LDA/remission at 12 and 24 weeks. The negative predictive values at 4 weeks ranged from 80-100%. Unlike certolizumab pegol, which has shown that a predictive decision can be made at 12 weeks, this data suggests that the decision with baricitinib can be made just 4 weeks after starting treatment!
The other question we often face in clinical practice relates to tapering drug in patients who are in remission. Another very clever clinical trial was presented at EULAR Thursday by Takeuchi et al. Using data from the RA-BEYOND study (mentioned above), patients on baricitinib 4 mg daily who were in sustained LDA or remission (>15 months) were randomized to remain on 4 mg daily or step down to 2 mg daily and were followed for 12-24 months. The data showed that those in sustained remission on 4 mg daily remained in remission when stepped down to 2 mg daily. In contrast, those in LDA on 4 mg daily had mild worsening of disease when stepped down to 2 mg daily.
The wealth of data on baricitinib continues to grow and I am pleasantly surprised and impressed that when this product is approved, not only will we have the traditional efficacy and safety information related to its use, but we will also have some guidance on how to best use it clinically in our patients. Well done Eli Lilly!
Dr. Jamal is a Clinical Associate Professor at the University of British Columbia and an active staff physician at Vancouver Coastal Health. Her interests include diagnosis and prognosis of early inflammatory arthritis, and timely assessment and access to care for patients with rheumatoid arthritis.View Full Bio