Baricitinib step down feasibility demonstrated in RA-BEYOND
medwireNews: The majority of patients with rheumatoid arthritis (RA) who step down treatment with baricitinib from 4 to 2 mg/day maintain low disease activity (LDA) or remission at 48 weeks, shows an analysis of data from the RA-BEYOND trial.
However, some patients who step down their dosage experience earlier and more frequent relapse than those who maintain their dose, report Tsutomu Takeuchi (Keio University School of Medicine, Tokyo, Japan) and co-authors in the Annals of the Rheumatic Diseases.
The researchers explain that RA-BEYOND is a long-term extension of four pivotal phase III studies (RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON) that resulted in the approval of baricitinib for RA in over 40 countries.
The current analysis of RA-BEYOND data included 559 patients who received baricitinib, a selective Janus kinase 1 and 2 inhibitor, at a dose of 4 mg/day for at least 15 months and maintained low disease activity (LDA) or remission on the Clinical Disease Activity Index (CDAI). The patients were randomly assigned to continue with baricitinib 4 mg/day or to taper to 2 mg/day. Those in the latter group could return to 4 mg if needed.
Takeuchi and team found that although the majority of patients in each group maintained LDA or remission over the 48-week trial, the rates were significantly lower among patients in the 2 mg than the 4 mg group, at a respective 67% versus 80% for LDA and 33% versus 40% for remission
Compared with baseline, patients who reduced their baricitinib dose had small but statistically significant increases in disease activity at 12, 24 and 48 weeks, whereas those who maintained their original dose did not.
In addition, significantly more patients on the reduced baricitinib dose had lost their state of disease control by week 48 compared with those who maintained their dose (43 vs 29%), and this loss occurred at a significantly earlier time.
At the end of the study period, 10% of patients receiving baricitinib 4 mg and 18% of those receiving baricitinib 2 mg needed rescue medication; approximately two-thirds of patients who stepped up from 2 mg to 4 mg regained LDA or remission after 24 weeks.
Rates of serious adverse events and adverse events leading to discontinuation were similar between the treatment groups, but the researchers note that the rate of non-serious infection was lower among the patients who stepped down their dose compared with those who did not (24.9 vs 30.6%).
Takeuchi et al say that their study “provides robust data to inform the use of baricitinib according to professional treatment guidelines regarding consideration of DMARD taper following induction of sustained disease control in RA.”
They conclude that “attempted dose taper after induction of sustained RA control appears a reasonable consideration with baricitinib.”
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group