Real-world Sarilumab use and rule testing to predict treatment response in patients with rheumatoid arthritis: findings from the RISE registry

Curtis, Jeffrey R., Yun, Huifeng, Chen, Lang, Ford, Stephanie S., van Hoogstraten, Hubert, Fiore, Stefano, Ford, Kerri, Praestgaard, Amy, Rehberg, Markus and Choy, Ernest ORCID: https://orcid.org/0000-0003-4459-8609 2023. Real-world Sarilumab use and rule testing to predict treatment response in patients with rheumatoid arthritis: findings from the RISE registry. Rheumatology and Therapy 10 (4) , pp. 1055-1072. 10.1007/s40744-023-00568-8

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Abstract

Introduction: Clinical trial findings may not be generalizable to routine practice. This study evaluated sarilumab effectiveness in patients with rheumatoid arthritis (RA) and tested the real-world applicability of a response prediction rule, derived from trial data using machine learning (based on C-reactive protein [CRP] > 12.3 mg/l and seropositivity [anticyclic citrullinated peptide antibodies, ACPA +]). Methods: Sarilumab initiators from the ACR-RISE Registry, with ≥ 1 prescription on/after its FDA approval (2017–2020), were divided into three cohorts based on progressively restrictive criteria: Cohort A (had active disease), Cohort B (met eligibility criteria of a phase 3 trial in RA patients with inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi]), and Cohort C (characteristics matched to the phase 3 trial baseline). Mean changes in Clinical Disease Activity Index (CDAI) and Routine Assessment of Patient Index Data 3 (RAPID3) were evaluated at 6 and 12 months. In a separate cohort, predictive rule was tested based on CRP levels and seropositive status (ACPA and/or rheumatoid factor); patients were categorized into rule-positive (seropositive with CRP > 12.3 mg/l) and rule-negative groups to compare the odds of achieving CDAI low disease activity (LDA)/remission and minimal clinically important difference (MCID) over 24 weeks. Results: Among sarilumab initiators (N = 2949), treatment effectiveness was noted across cohorts, with greater improvement noted for Cohort C at 6 and 12 months. Among the predictive rule cohort (N = 205), rule-positive (vs. rule-negative) patients were more likely to reach LDA (odds ratio: 1.5 [0.7, 3.2]) and MCID (1.1 [0.5, 2.4]). Sensitivity analyses (CRP > 5 mg/l) showed better response to sarilumab in rule-positive patients. Conclusions: In real-world setting, sarilumab demonstrated treatment effectiveness, with greater improvements in the most selective population, mirroring phase 3 TNFi-refractory and rule-positive RA patients. Seropositivity appeared a stronger driver for treatment response than CRP, although optimization of the rule in routine practice requires further data.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine
Additional Information:	License information from Publisher: LICENSE 1: URL: http://creativecommons.org/licenses/by-nc/4.0/, Type: open-access. This paper has a correction: Curtis, J.R., Yun, H., Chen, L. et al. Correction: Real-World Sarilumab Use and Rule Testing to Predict Treatment Response in Patients with Rheumatoid Arthritis: Findings from the RISE Registry. Rheumatol Ther 11, 217 (2024). https://doi.org/10.1007/s40744-023-00607-4
Publisher:	Springer
ISSN:	2198-6576
Related URLs:	https://doi.org/10.1007/s40744-023-00607...
Date of First Compliant Deposit:	10 July 2023
Date of Acceptance:	30 May 2023
Last Modified:	19 Jan 2024 10:01
URI:	https://orca.cardiff.ac.uk/id/eprint/160925

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