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Clinical efficacy of sarilumab versus upadacitinib over 12 weeks: an indirect treatment comparison

Huizinga, Thomas, Choy, Ernest ORCID: https://orcid.org/0000-0003-4459-8609, Praestgaard, Amy, van Hoogstraten, Hubert, LaFontaine, Patrick R., Guyot, Patricia, Aletaha, Daniel, Müller-Ladner, Ulf, Tanaka, Yoshiya, Curtis, Jeffrey R. and Fleischmann, Roy 2023. Clinical efficacy of sarilumab versus upadacitinib over 12 weeks: an indirect treatment comparison. Rheumatology and Therapy 10 , pp. 539-550. 10.1007/s40744-022-00521-1

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Abstract

Introduction The efficacy of sarilumab and upadacitinib, in combination with disease-modifying antirheumatic drugs (DMARDs), was demonstrated in phase 3 clinical trials of patients with rheumatoid arthritis (RA) refractive to previous biologic DMARDs. In the absence of head-to-head clinical trials, the matching-adjusted indirect comparison (MAIC) and simulated treatment comparison (STC) estimate the relative efficacy of sarilumab and upadacitinib in patients with RA who had an inadequate response to previous biologic DMARDs. Methods Patient-level data for sarilumab were obtained from the TARGET trial (NCT01709578) and published aggregate data for upadacitinib were obtained from the SELECT-BEYOND trial (NCT02706847). For the MAIC, individual patient data from the TARGET trial were assigned weights such that weighted mean baseline characteristics of the treatment effect modifiers matched those from SELECT-BEYOND. For the STC, the TARGET patient-level data and mean baseline values from SELECT-BEYOND were used to simulate sarilumab treatment effects for a SELECT-BEYOND population. Endpoints evaluated included the American College of Rheumatology (ACR) response criteria ACR20/50/70, Disease Activity Score-28 for Rheumatoid Arthritis with C-reactive protein (DAS28-CRP) < 3.2, DAS28-CRP < 2.6, Simple Disease Activity Index (SDAI) < 3.3, and Clinical Disease Activity Index (CDAI) < 2.8 at 12 weeks. Results The analysis included 365 patients from TARGET and aggregated data of 333 patients from SELECT-BEYOND. Matching for potential treatment effect baseline modifiers (i.e., age, oral glucocorticoid use, tender joint count of 68 counts, swollen joint count of 66 counts, serum CRP level, and patient global assessment of disease activity) resulted in a reduction of the effective sample size of TARGET population to 166. Following MAIC and STC analysis, the odds of achieving all aforementioned clinical outcomes versus placebo at week 12 were similar for sarilumab and upadacitinib. Conclusion In the MAIC and STC analyses from TARGET and SELECT-BEYOND trials, the efficacy of sarilumab and upadacitinib were comparable.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: Springer
ISSN: 2198-6576
Date of First Compliant Deposit: 10 February 2023
Date of Acceptance: 12 December 2022
Last Modified: 30 May 2023 17:25
URI: https://orca.cardiff.ac.uk/id/eprint/156889

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