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

Abstract

OBJECTIVE:

To evaluate the effect of baricitinib on inhibiting radiographic progression of structural joint damage over 5 years in patients with active rheumatoid arthritis (RA).

METHODS:

Patients completed 1 of 3 phase III baricitinib trials (ClinicalTrials.gov: NCT01711359, NCT01710358, or NCT01721057) and entered the long-term extension RA-BEYOND (NCT01885078), in which patients received once-daily 4 mg or 2 mg baricitinib. Across these trials, patients initially receiving methotrexate (MTX) or adalimumab (ADA) switched to baricitinib 4 mg at Week 52. Patients initially receiving placebo (PBO) switched to baricitinib 4 mg at Week 24. Radiographs were scored at baseline and Years 2, 3, 4, and 5. Change from baseline in van der Heijde modified total Sharp score (ΔmTSS) was computed.

RESULTS:

Overall, 2125 of 2573 (82.6%) randomized patients entered RA-BEYOND; 1837 of 2125 (86.4%) entered this analysis. From Years 3 to 5, higher proportions of disease-modifying antirheumatic drug (DMARD)-naïve patients on initial baricitinib (monotherapy or with MTX) had no progression vs initial MTX (ΔmTSS ≤ 0 at Year 5: 59.6% baricitinib 4 mg; 66.2% baricitinib 4 mg + MTX; 40.7% MTX). Higher proportions of patients with inadequate response (IR) to MTX on initial baricitinib or ADA vs PBO had no progression (ΔmTSS ≤ 0 at Year 5: 54.8% baricitinib 4 mg; 55.0% ADA; 50.3% PBO). Higher proportions of patients with conventional synthetic DMARD-IR on initial baricitinib 4 mg had less progression vs initial PBO or baricitinib 2 mg (ΔmTSS ≤ 0 at Year 5: 66.7% baricitinib 4 mg; 58.2% baricitinib 2 mg; 60.0% PBO).

CONCLUSION:

Oral baricitinib maintained lower levels of radiographic progression than initial conventional synthetic DMARD or PBO through 5 years in patients with active RA.

• Authors: Désirée van der Heijde, Cynthia E Kartman, Li Xie, Scott Beattie, Douglas Schlichting, Daojun Mo, Patrick Durez, Yoshiya Tanaka, Roy Fleischmann
• Journal: The Journal of rheumatology (J Rheumatol) Vol. 49 Issue 2 Pg. 133-141 (02 2022) ISSN: 0315-162X [Print] Canada
• PMID: 34526397 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2022 by the Journal of Rheumatology.

Chemical References

• Antirheumatic Agents
• Azetidines
• Purines
• Pyrazoles
• Sulfonamides
• Adalimumab
• baricitinib
• Methotrexate

Topics

• Adalimumab (therapeutic use)
• Antirheumatic Agents (adverse effects)
• Arthritis, Rheumatoid (diagnostic imaging, drug therapy)
• Azetidines
• Disease Progression
• Double-Blind Method
• Drug Therapy, Combination
• Humans
• Methotrexate (therapeutic use)
• Purines
• Pyrazoles
• Sulfonamides
• Treatment Outcome