Comparative safety of abatacept in rheumatoid arthritis with COPD: A real-world population-based observational study. 2019

Samy Suissa, and Marie Hudson, and Sophie Dell'Aniello, and Sophie Shen, and Teresa A Simon, and Pierre Ernst
Centre for Clinical Epidemiology, Lady Davis Institute - Jewish General Hospital, 3755 Cote Ste-Catherine, H-461, Montreal, Québec H3T 1E2, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Québec, Canada. Electronic address: samy.suissa@mcgill.ca.

The ASSURE randomized trial of abatacept safety in rheumatoid arthritis (RA) reported more frequent respiratory adverse events with abatacept among the subgroup of 54 patients with chronic obstructive pulmonary disease (COPD), leading to a label warning. We assessed the risk of adverse respiratory events associated with abatacept, compared with other biologic DMARDs (bDMARDs), among patients with RA and COPD in a real-world observational setting. We formed a prevalent new-user cohort of patients with RA and COPD treated with bDMARDs within the US-based MarketScan databases from 2007 to 2014. Abatacept users were matched on time-conditional propensity scores to users of other bDMARDs. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) of adverse respiratory events comparing abatacept with other bDMARDs were estimated using the Cox model. The cohort included 1807 patients initiating abatacept and 3547 matched patients initiating another bDMARD. The HR of the combined endpoint of hospitalized COPD exacerbation, bronchitis and hospitalized pneumonia or influenza with abatacept relative to other bDMARDs was 0.87 (95% CI: 0.68-1.12). For hospitalized COPD exacerbation it was 0.60 (95% CI: 0.32-1.11), 0.80 (95% CI: 0.56-1.14) for bronchitis, while for pneumonia or influenza it was 1.39 (95% CI: 0.91-2.13) if hospitalized and 1.05 (95% CI: 0.86-1.29) as outpatient. This large safety study from a real world setting finds no increased risk of adverse respiratory events with abatacept compared with other bDMARDs in patients with RA and COPD. This study does not substantiate the safety signal raised by the smaller ASSURE trial.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069594 Abatacept A fusion protein immunoconjugate of the extracellular domain of CTLA4 and the Fc domain of human IgG1. It functions as a T-cell co-stimulation blocker that inhibits TNF-ALPHA and prevents the activation of T-LYMPHOCYTES. It is used in the treatment of RHEUMATOID ARTHRITIS. BMS 188667,BMS-188667,BMS-224818,BMS224818,Belatacept,CTLA-4-Ig,CTLA4-Fc,CTLA4-Ig,CTLA4-Ig Immunoconjugate,Cytotoxic T Lymphocyte-Associated Antigen 4-Immunoglobulin,LEA29Y,Nulojix,Orencia,BMS 224818,BMS188667,CTLA4 Ig Immunoconjugate,Cytotoxic T Lymphocyte Associated Antigen 4 Immunoglobulin,Immunoconjugate, CTLA4-Ig
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D001172 Arthritis, Rheumatoid A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated. Rheumatoid Arthritis
D012189 Retrospective Studies Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons. Retrospective Study,Studies, Retrospective,Study, Retrospective
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes

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