Abstract
Objectives: In some patients with RA, joint pain is more severe than expected based on the amount of joint swelling [referred to as disproportionate articular pain (DP)]. We assessed DP prevalence and the effects of sarilumab, an IL-6 inhibitor, on DP. Methods: Data from RA patients treated with placebo or 200 mg sarilumab in the phase 3 randomized controlled trials (RCTs) MOBILITY and TARGET, adalimumab 40 mg or sarilumab 200 mg in the phase 3 RCT MONARCH and sarilumab 200 mg in open-label extensions (OLEs) were used. DP was defined as an excess tender 28-joint count (TJC28) over swollen 28-joint count (SJC28) of ≥7 (TJC28 - SJC28 ≥ 7). Treatment response and disease activity were determined for patients with and without DP. Results: Of 1531 sarilumab 200 mg patients from RCTs, 353 (23%) had baseline DP. On average, patients with DP had higher 28-joint DAS using CRP (DAS28-CRP) and pain scores than patients without DP, whereas CRP levels were similar. After 12 and 24 weeks, patients with baseline DP treated with sarilumab were more likely to be DP-free than those treated with placebo or adalimumab. In RCTs, more sarilumab-treated patients achieved low disease activity vs comparators, regardless of baseline DP status. In OLEs, patients were more likely to lose rather than gain DP status. Conclusion: About one-quarter of patients with RA experienced DP, which responded well to sarilumab. These data support the concept that other mechanisms (potentially mediated via IL-6) in addition to inflammation may contribute to DP in RA. Trial registrations: NCT01061736, NCT02332590, NCT01709578, NCT01146652.
Original language | English (US) |
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Pages (from-to) | 2386-2393 |
Number of pages | 8 |
Journal | Rheumatology (United Kingdom) |
Volume | 62 |
Issue number | 7 |
DOIs | |
State | Published - Jul 1 2023 |
Funding
The authors and Sanofi thank the patients for their participation in the trials, as well as the MOBILITY, MONARCH and TARGET Steering Committees and investigators. Gregory St John, an employee of Regeneron Pharmaceuticals, Inc. (current affiliation: Intercept Pharmaceuticals), contributed to the design and analysis of this study when it was undertaken. Medical writing assistance was provided by Richard J. Hogan, Jonathon Gibbs and Vojislav Pejović, of Elevate Scientific Solutions, a division of Envision Pharma Group, and editorial and graphics assistance was provided by Elevate Scientific Solutions, funded by Sanofi. Some of the data included in this manuscript were presented previously at the Annual European Congress of Rheumatology, 3–6 June 2020 (Virtual Congress; Choy et al., SAT0102) and the American College of Rheumatology Annual Meeting, 5–9 November 2020 (Virtual Congress; Choy et al., 1234).
Keywords
- IL-6
- RA
- analgesia
- pain
- sarilumab
ASJC Scopus subject areas
- Rheumatology
- Pharmacology (medical)