Long-term safety and efficacy of upadacitinib compared with adalimumab in patients with rheumatoid arthritis: 7-year data from the SELECT-COMPARE study
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Published on: April 7, 2023
Roy Fleischmann1,2, Jerzy Swierkot3, Patrick Durez4
1University of Texas Southwestern Medical Center, Dallas, Texas, USA rfleischmann@arthdocs.com.
Objectives:
To assess the safety and efficacy of upadacitinib versus adalimumab through 7 years in the ongoing SELECT-COMPARE study.
Methods:
Patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX) were randomised to placebo, upadacitinib 15 mg once daily or adalimumab 40 mg every other week (on background MTX). Inadequate responders were rescued to the alternate therapy, with placebo recipients switching to upadacitinib by week 26. Patients completing 48 weeks were eligible to enter the 10-year extension. Safety was assessed as treatment-emergent adverse events (TEAEs); efficacy was analysed by randomised group (non-responder imputation [NRI]) or treatment sequence (as observed [AO]).
Results:
Upadacitinib was generally well tolerated, displaying TEAE rates comparable to adalimumab, but numerically higher rates of herpes zoster, creatine phosphokinase elevation, non-melanoma skin cancer, lymphopenia and hepatic disorders. Responses with continuous upadacitinib or adalimumab were maintained through 372 weeks; week 372 Clinical Disease Activity Index remission (≤2.8) and 28-joint Disease Activity Score based on C-reactive protein<2.6 were achieved by 145/230 (63.0%) and 178/204 (83.2%) (AO)/142/651 (21.8%) and 172/651 (26.4%) (NRI) of patients with upadacitinib versus 46/86 (53.5%) and 59/81 (72.8%) (AO)/43/327 (13.1%) and 55/327 (16.8%) (NRI) with adalimumab. Initial non-responders/incomplete responders benefited from switching, with improvements in efficacy endpoints maintained through week 336 post switch, without additional safety concerns.
Conclusion:
The safety profile of upadacitinib remained consistent with previous analyses, with no new safety concerns through 7 years. Upadacitinib and adalimumab (continuous or rescue treatment) maintained disease activity targets throughout the 7-year treatment period. Upadacitinib exhibited an acceptable benefit-risk profile for long-term RA treatment.
Trial Registration Number:
NCT02629159.
