Risk of opportunistic infections in patients with rheumatoid arthritis initiating abatacept: cumulative clinical trial data

Teresa A. Simon, Lixian Dong, Kevin L. Winthrop

Research output: Contribution to journalArticlepeer-review

Abstract

Background: To evaluate incidence of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with abatacept in clinical trials. Methods: This pooled analysis of 16 randomized, double-blind/open-label trials, with ≥ 1 abatacept (intravenous or subcutaneous) arm, and with/without placebo control covered cumulative (controlled short-term and open-label long-term) abatacept exposure periods. OIs were analyzed separately in controlled (abatacept and placebo individually) and cumulative periods. OIs were identified using a prespecified list; events were independently adjudicated. Unadjusted incidence rates (IRs; per 100 patient-years) with 95% confidence intervals (CIs) were calculated. Results: In cumulative periods, 7044 patients received abatacept, with a mean (standard deviation) duration of exposure of 36.9 (26.2) months (21,274 patient-years of exposure). IRs (95% CIs) of OIs were 0.17 (0.05–0.43) for abatacept and 0.56 (0.22–1.15) for placebo during the controlled periods and 0.21 (0.15–0.28) for abatacept during the cumulative periods. There was 1 case of tuberculosis in both the abatacept (IR [95% CI] 0.04 [0.00–0.24]) and placebo (IR [95% CI] 0.08 [0.00–0.44]) groups during the controlled periods; 13 verified tuberculosis cases (IR [95% CI] 0.06 [0.03–0.10]) were reported in the cumulative period. Herpes zoster was reported numerically more often with abatacept (IR 1.9 [1.4–2.5]), versus placebo (1.7 [1.1–2.6]) in the controlled periods; within the cumulative period, herpes zoster IR (95% CI) was 1.53 (1.36–1.71) for abatacept-treated patients. Conclusion: In controlled periods of the clinical trials, abatacept-treated patients had similarly low rates of OIs compared with placebo-treated patients. Overall, OI rates were similar among abatacept-treated patients in the controlled and cumulative periods and consistent with the ranges reported in the literature.

Original languageEnglish (US)
Article number17
JournalArthritis Research and Therapy
Volume23
Issue number1
DOIs
StatePublished - Dec 2021

Keywords

  • Abatacept
  • Herpes
  • Infection
  • Opportunistic infections
  • Rheumatoid arthritis
  • Serious infection
  • Shingles
  • Tuberculosis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

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