Infection outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study.

Autor: Simon TA; Bristol Myers Squibb, 7 Haines Cove Drive, Toms River, Princeton, NJ 08753, USA. Electronic address: teresa.simon1@verizon.net., Suissa S; McGill University, Montreal, QC, Canada., Skovron ML; Bristol Myers Squibb, 7 Haines Cove Drive, Toms River, Princeton, NJ 08753, USA., Frisell T; Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden., Askling J; Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden., Michaud K; University of Nebraska Medical Center, Omaha, NE, USA; FORWARD, The National Databank for Rheumatic Diseases, Wichita, KS, USA., Pedro S; FORWARD, The National Databank for Rheumatic Diseases, Wichita, KS, USA., Strangfeld A; Pharmacoepidemiology and Health Services Research, German Rheumatism Research Center, Berlin, Germany; Charité University Medicine, Berlin, Germany., Meissner Y; Pharmacoepidemiology and Health Services Research, German Rheumatism Research Center, Berlin, Germany., Boers M; Department of Epidemiology & Data Science, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, Netherlands., Hoffman V; Optum Epidemiology, Ann Arbor, MI, USA., Dominique A; Bristol Myers Squibb, 7 Haines Cove Drive, Toms River, Princeton, NJ 08753, USA., Gomez A; Bristol Myers Squibb, 7 Haines Cove Drive, Toms River, Princeton, NJ 08753, USA., Hochberg MC; Departments of Medicine and Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Jazyk: angličtina
Zdroj: Seminars in arthritis and rheumatism [Semin Arthritis Rheum] 2024 Feb; Vol. 64, pp. 152313. Date of Electronic Publication: 2023 Nov 10.
DOI: 10.1016/j.semarthrit.2023.152313
Abstrakt: Objective: To evaluate risk of infections requiring hospitalization and opportunistic infections, including tuberculosis, in patients with rheumatoid arthritis (RA) treated with abatacept versus conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biologic/targeted synthetic (b/ts) DMARDs.
Methods: Five international observational data sources were used: two biologic registries (Sweden, Germany), a disease registry (USA) and two healthcare claims databases (Canada, USA). Crude incidence rates (IRs) per 1000 patient-years, with 95 % CIs, were used to estimate rate ratios (RRs) comparing abatacept versus csDMARDs or other b/tsDMARDs. RRs were adjusted for demographic factors, comorbidities, and other potential confounders and then pooled across data sources using a random effects model (REM).
Results: The data sources included 6450 abatacept users, 136,636 csDMARD users and 54,378 other b/tsDMARD users, with a mean follow-up range of 2.2-6.2 years. Across data sources, the IRs for infections requiring hospitalization ranged from 16 to 56 for abatacept, 19-46 for csDMARDs, and 18-40 for other b/tsDMARDs. IRs for opportunistic infections were 0.4-7.8, 0.3-4.3, and 0.5-3.8; IRs for tuberculosis were 0.0-8.4, 0.0-6.0, and 0.0-6.3, respectively. The pooled adjusted RR (95 % CI), only reported for infections requiring hospitalization, was 1.2 (0.6-2.2) for abatacept versus csDMARDs and 0.9 (0.6-1.3) versus other b/tsDMARDs.
Conclusions: Data from this international, observational study showed similar hospitalized infection risk for abatacept versus csDMARDs or other b/tsDMARDs. IRs for opportunistic infections, including tuberculosis, were low. These data are consistent with the known safety profile of abatacept.
Competing Interests: Declaration of Competing Interest TAS and AG were employees of (at the time of the analysis) Bristol Myers Squibb. SS has attended scientific advisory committee meetings for Atara, Boehringer Ingelheim, Merck, Pfizer, and Seqirus; received speaking fees from AstraZeneca, Boehringer Ingelheim, and Novartis; and received grant/research support from Boehringer Ingelheim. MLS is an employee of, shareholder in, and consultant for Bristol Myers Squibb. JA has received grant/research support from and has served as a PI for AbbVie, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Janssen, Merck, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB. AS has received grant/research support from a consortium of 14 companies (AbbVie, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Gilead/Galapagos, Hexal, Lilly, Mylan/Viatris, Merck Sharp & Dohme, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB); and has received honoraria from AbbVie, Bristol Myers Squibb, Celltrion, Merck Sharp & Dohme, Pfizer, and Roche. YM (for the German RABBIT register) is supported by a joint, unconditional grant from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Hexal, Lilly, Merck Sharp & Dohme, Pfizer, Roche, Samsung Bioepis, Sanofi-Aventis, UCB, and Viatris; and has received honoraria from Pfizer. MB has received speaker fees from Novartis and Pfizer and provides expert testimony for Celltrion. VH was an employee of and shareholder in Optum at the time of the analysis; and has received grant/research support from Bristol Myers Squibb (to institution). AD is an employee of Bristol Myers Squibb. MCH has received personal fees from Bristol Myers Squibb (advisory board member) and is Editor-in-Chief of Seminars in Arthritis and Rheumatism. No other disclosures relevant to this article were reported.
(Copyright © 2023. Published by Elsevier Inc.)
Databáze: MEDLINE
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