Disproportionate articular pain is a frequent phenomenon in rheumatoid arthritis and responds to treatment with sarilumab

Author:

Choy Ernest1ORCID,Bykerk Vivian2,Lee Yvonne C3,van Hoogstraten Hubert4,Ford Kerri5,Praestgaard Amy6,Perrot Serge7,Pope Janet8ORCID,Sebba Anthony9

Affiliation:

1. CREATE Centre, Division of Infection and Immunity, Cardiff University School of Medicine , Cardiff, UK

2. Inflammatory Arthritis Centre, Hospital for Special Surgery , New York, NY, USA

3. Division of Rheumatology, Northwestern University Feinberg School of Medicine , Chicago, IL, USA

4. Neurology and Immunology, Sanofi , Bridgewater, NJ, USA

5. Medical Affairs Immunology and Inflammation-Rheumatology, Rare Inflammatory Disorders, Sanofi, Bridgewater, NJ, USA

6. Biostatistics, Immunology, Sanofi , Cambridge, MA, USA

7. Pain Center, Cochin Hospital, Paris University , Paris, France

8. Division of Rheumatology, Schulich School of Medicine, University of Western Ontario, St. Joseph’s Health Care , London, ON, Canada

9. Department of Rheumatology, University of South Florida , Tampa, FL, USA

Abstract

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.

Funder

Sanofi

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Rheumatology

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