Kevzara (sarilumab)

P=N/A, N=5000, Recruiting, Duke University | Trial primary completion date: Sep 2026 --> Mar 2027

P2, N=300, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting

This review synthesizes current mechanistic and clinical evidence on IL-6 inhibitors, particularly sarilumab and tocilizumab, concerning their effect on pain in RA. Differences in their pharmacokinetics, receptor binding, and suppression of CRP may translate into differences in their analgesic profiles. However, it is analyzed that a subset of patients with persistently painful rheumatoid arthritis despite IL-6 inhibition demonstrates the existence of non-inflammatory drivers like nociplastic pain and the inadequacy of conventional indices of disease activity to capture the burden of pain.

P1, N=10, Not yet recruiting, Stanford University

P1/2, N=65, Recruiting, University of Southern California | Trial completion date: Sep 2027 --> May 2027

P2, N=105, Recruiting, NYU Langone Health | N=69 --> 105 | Trial completion date: Dec 2025 --> Feb 2028 | Trial primary completion date: Jun 2025 --> Aug 2026

P4, N=300, Not yet recruiting, Sanofi

Recent postmarketing surveillance (PMS) data on the safety and effectiveness of sarilumab (SAR) in Japanese patients with RA, along with PMS data from Japan and registry data from France and Germany of tocilizumab (TCZ), provide valuable insights for both current and future management of RA. While the effectiveness of TCZ was somewhat lower in older patients compared with younger ones, the effectiveness of SAR was similar across age groups. Consequently, the use of anti-IL-6R antibodies is anticipated to expand to other IMIDs beyond RA, particularly in increasingly superaged societies worldwide.

P2, N=300, Not yet recruiting, Regeneron Pharmaceuticals

For RA, 34.2% of patients were difficult to treat (D2T) (98 pt), 54.8% (157 pt) were in monotherapy (tocilizumab-sarilumab-upadacitinib-filgotinib). Abatacept was the most prescribed treatment in RF and ACPA-positive patients and in those with ILD. The anti-IL-17A secukinumab was prescribed in 12% of SpA, of which 71% had enthesitis and dactylitis (14 pt). Ixekizumab was prescribed in 10.4% of PsA patients over 65 years with previous CV events, enthesitis, and dactylitis (21 pt). Apremilast was present in 71% of PsA with previous cancer...The cross-sectional analysis of prescriptions in patients with RA, SpA, and PsA demonstrates how the ITABIO recommendations can guide towards the correct appropriateness of prescription. RA and especially D2T-RA remains the disease with the greatest therapeutic failures, with the highest percentage of monotherapy (anti-IL-6 and Jak-i) and of discontinuation of MTX.

P1/2, N=612, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Apr 2027 --> Nov 2027

P3, N=400, Recruiting, University of Nebraska | Trial completion date: Mar 2028 --> Mar 2029 | Trial primary completion date: Mar 2027 --> Mar 2028