Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study 

Abstract

Objective To evaluate the long-term efficacy of once-daily baricitinib 4 mg in patients with active RA who were either naïve to DMARDs or who had inadequate response (IR) to MTX. Methods Analyses of data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naïve) and RA-BEAM (MTX-IR), and one ongoing long-term extension (LTE) study (RA-BEYOND) were performed (148 total weeks). At week 52, DMARD-naïve patients treated with MTX monotherapy or baricitinib 4 mg+MTX in RA-BEGIN were switched to open-label baricitinib 4 mg monotherapy; MTX-IR patients treated with adalimumab (+MTX) in RA-BEAM were switched to open-label baricitinib 4 mg (+MTX) in the LTE. Patients who received placebo (+MTX) were switched to baricitinib 4 mg (+MTX) at week 24. Low disease activity (LDA) [Simple Disease Activity Index (SDAI) ≤11], clinical remission (SDAI ≤ 3.3), and physical functioning [Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5] were assessed. Data were assessed using a non-responder imputation. Results At week 148, SDAI LDA was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI ≤ 0.5 was reached in up to 48% of DMARD-naïve patients and 38% of MTX-IR patients initially treated with baricitinib. Over 148 weeks, 3.6% and 10.7% of MTX-IR patients discontinued across treatment groups due to lack of efficacy or due to adverse events, respectively; discontinuation rates were similar in the DMARD-naïve population. Conclusion Treatment with baricitinib 4 mg demonstrated efficacy for up to 3 years and was well tolerated.

Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND

“…Most patients also maintained at least LDA, as assessed with the SDAI. This observation is similar to a previous report on RA-BEYOND (up to 3 years) of SDAI LDA data from patients originating in RA-BEGIN and RA-BEAM originally treated with or switched to baricitinib (13,20). Thus, these patients had both important clinical responses and marked decreases in radiographic progression.…”

“…For SDAI ≤11, nonresponder imputation, in which discontinued patients were considered nonresponders, and completer analyses, based on patients with data available at the analysis time point, were performed. Data collected from patients originally treated with baricitinib 4 mg who received baricitinib 2 mg in the dose step-down substudy of the LTE were imputed based on data from patients in the substudy who remained on baricitinib 4 mg, using previously reported methods (20).…”

2023 Management Recommendations of Bangladesh Rheumatology Society on Pharmacological Treatment of Rheumatoid Arthritis With Synthetic and Biologic Disease-Modifying Drugs

“…Since generic tsDMARDs are cheaper and oral, we recommend them before bDMARDs (Figure 1 ). Despite the excellent initial response, secondary treatment inefficacy can occur with anti-TNF and other biologics (due to anti-drug antibodies) [ 49 ]. The secondary loss of treatment efficacy has not yet been observed with the tsDMARDs [ 49 ].…”

Alopecia areata—New updates with long‐term use of JAK inhibitors

“…Similarly, Smolen et al completed a long‐term study of three years of once‐daily baricitinib 4 mg in patients with moderate‐to‐severe RA, who had inadequate response to methotrexate (MTX‐IR), or were naïve to biologic disease‐modifying anti‐rheumatic drugs (DMARDs). A total of 3770 patients from two completed 52‐week, phase 3 studies, and one long‐term extension study (148 weeks) were performed to assess disease activity clinical remission and physical functioning were assessed 69 . After 148 weeks across all groups, 3.6% discontinued baricitinib due to lack of efficacy and 10.7% discontinued baricitinib due to adverse events 69 .…”

“…A total of 3770 patients from two completed 52‐week, phase 3 studies, and one long‐term extension study (148 weeks) were performed to assess disease activity clinical remission and physical functioning were assessed 69 . After 148 weeks across all groups, 3.6% discontinued baricitinib due to lack of efficacy and 10.7% discontinued baricitinib due to adverse events 69 . Overall, baricitinib 4 mg treatment demonstrated efficacy for up to 3 years and was well tolerated.…”