Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment.

Autor:	Feist E; Rheumatology and Clinical Immunology, HELIOS Fachklinik Vogelsang/Gommern, Vogelsang, Germany Eugen.Feist@helios-gesundheit.de.; Experimental Rheumatology, Otto-von-Guericke University Magdeburg, Magdeburg, Germany., Fleischmann RM; Medicine, University of Texas Southwestern, Dallas, Texas, USA.; Metroplex Clinical Research Center, Dallas, Texas, USA., Fatenejad S; SFC Medica, LLC, Charlotte, North Carolina, USA., Bukhanova D; Medical, R-Pharm JSC, Moscow, Russian Federation., Grishin S; Medical, R-Pharm JSC, Moscow, Russian Federation., Kuzkina S; Medical, R-Pharm JSC, Moscow, Russian Federation., Luggen M; University of Cincinnati College of Medicine, Cincinnati, Ohio, USA., Nasonov E; Institute of Rheumatology, V.A. Nasonova Research, Moscow, Russian Federation., Samsonov M; Medical, R-Pharm JSC, Moscow, Russian Federation., Smolen JS; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Wien, Austria.
Jazyk:	angličtina
Zdroj:	Annals of the rheumatic diseases [Ann Rheum Dis] 2024 Oct 21; Vol. 83 (11), pp. 1454-1464. Date of Electronic Publication: 2024 Oct 21.
DOI:	10.1136/ard-2023-225473
Abstrakt:	Objective: To report long-term safety and tolerability of olokizumab (OKZ) in combination with methotrexate (MTX) in subjects with active rheumatoid arthritis (RA), using pooled data from three randomised clinical trials (RCT) followed by open-label extension (OLE) study. Methods: Cumulative data from three phase 3 core trials and their OLE were analysed. Safety variables assessed included treatment-emergent adverse events (AEs), serious AEs (SAEs), AEs of special interest and laboratory results. Efficacy assessments included ACR20/50/70 responses, Disease Activity Score 28 (C-reactive protein) <3.2, CDAI remission and low disease activity (LDA), SDAI remission and LDA, HAQ-DI decrease of 0.22 unit and Boolean 2.0 remission. Results: A total of 2304 patients received OKZ in combination with MTX either once every 2 weeks or once every 4 weeks. Event rates per 100 patient-years in OKZ every 2 weeks and OKZ every 4 weeks, respectively, were 9.57 and 9.13 for SAEs; 2.95 and 2.34 for serious infections; 0.09 and 0.05 for gastrointestinal perforations; 0.58 and 0.83 for major adverse cardiovascular events; and 0.45 and 0.50 for malignancies. No increase in the rate of any AE was observed over 106 weeks of treatment. The evaluation of laboratory variables demonstrated the expected changes, like neutropenia, elevation of liver enzymes and blood lipids. Clinical response rates remained stable during the OLE. Conclusion: The long-term safety and tolerability of OKZ in combination with MTX remained stable. The efficacy of OKZ was maintained through week 106. These findings support OKZ as a treatment option for patients with active RA. Competing Interests: Competing interests: The analysis was funded by JSC R-Pharm. EF: research grants from BMS, Eli Lilly, Novartis, Roche; consulting fees from Abbvie, BMS, Eli Lilly, Gilead Sciences, Galapagos, Novartis, Roche, Sanofi, Sobi; speakers’ bureau for Abbvie, BMS, Eli Lilly, Gilead Sciences, Galapagos, Medac, Novartis, Roche, Sanofi, Sobi; RF: Consultant for AbbVie, Arthrosi, BMS, Galvani, Genentech, Gilead, GSK, InventisBio, Janssen, Eli Lilly, Novartis, Pfizer, Proviant, Recor, UCB, Vyne; Clinical Study grants: AbbVie, Acceleron, Arthrosi, Biosplice, BMS, Cugene, Flexion, Galvani, Gilead, GSK, Horizon, Idorsia, Janssen, LG Chem, Eli Lilly, Novartis, Pfizer, Proviant, Sankyo, UCB, Viela. SF: consulting fees from ICON and PPD contract research organisations, shareholder of Pfizer, INC stocks, consulting fees from R-Pharm; EK: employee of R-Pharm, with no R-Pharm stock; ML: research grants from Amgen, Biogen, UCB, Sun Pharmaceuticals, Abbvie, Pfizer, Novartis, Lilly, GSK, R-Pharm; EN: speakers’ bureau for AbbVie, Eli Lilly, Janssen, Novartis, Pfizer; DB, SG, SK and MS: employee of R-Pharm, with no R-Pharm stock; JS: Editor-in-Chief of ARD, research grants from Abbvie, Astra-Zeneca, Lilly; consulting fees from Abbvie, Galapagos/Gilead, Novartis-Sandoz, BMS, Samsung, Sanofi, Chugai, R-Pharma, Lilly; speakers’ bureau for Samsung, Lilly, R-Pharm, Chugai, MSD, Janssen, Novartis-Sandoz; RF: consulting fees from AbbVie, BMS, Gilead, Galvani, GSK, Janssen, Eli Lilly, Novartis, Pfizer, R-Pharm, UCB; speakers bureaus for AbbVie; Pfizer; R-Pharm. Disclosure forms provided by the authors are available in the full text of this article. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)
Databáze:	MEDLINE
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