Dose Reduction of Baricitinib in Patients with Rheumatoid Arthritis Achieving Sustained Disease Control: Results of a Prospective Study
Takeuchi T, Genovese MC, Haraoui B, Li Z, Xie L, Klar R, Pinto Correia A, Otawa S, Lopez-Romero P, de la Torre I, Rooney TP, Smolen JS. - Ann Rheum Dis. 2019 Feb;78(2):171-178. DOI 10.1136/annrheumdis-2018-213271
In active RA patients, with an inadequate response (IR) to DMARDs who achieve low disease activity (LDA) following baricitinib (BARI) 4 mg treatment, disease control is better maintained with continued BARI 4 mg compared to tapering to 2 mg.
The objective of this study was to investigate the effect of BARI tapering in patients achieving sustained disease control with BARI 4 mg.
In the long-term extension study RA-BEYOND, patients receiving BARI 4 mg who achieved sustained LDA or remission at two consecutive visits, were re-randomized to either continue BARI 4 mg or step down to 2 mg. Efficacy and safety were assessed through 48 weeks.
Majority of patients in both groups maintained LDA or remission over the 48-week period. Dose reduction resulted in significant increases in disease activity at 12, 24, and 48 weeks, with significantly more patients relapsing over 48 weeks compared to the BARI 4 mg group. In addition, dose reduction was associated with a lower rate of non-serious infections while rates of SAEs and AEs leading to discontinuation were similar across groups.
Overall, the data indicate disease control was better maintained on the 4 mg dose than 2 mg. Most stepped-down patients maintained LDA/remission or regained control on return to the 4 mg dose.