medwireNews: Individuals with rheumatoid arthritis (RA) and chronic obstructive pulmonary disease (COPD) who are treated with abatacept do not have an elevated risk for adverse respiratory events relative to those given other biologics, real-world study results suggest.
Findings from the ASSURE trial demonstrated higher rates of serious respiratory events – including COPD exacerbation, bronchitis, and pneumonia – among patients receiving abatacept versus placebo, and consequently the prescribing information for abatacept warns that “COPD patients may develop more frequent respiratory adverse events,” say Samy Suissa (Jewish General Hospital, Montreal, Québec, Canada) and study co-authors.
They explain that “[t]his safety concern is important because it is estimated that close to 10% of RA patients also have COPD, twice as many as non-RA subjects.”
The researchers used a US database to analyze data from 1807 patients with RA and COPD initiating abatacept and 3547 matched patients initiating another biologic DMARD between 2007 and 2014. The most frequently used comparator biologics were etanercept (24.6%) and adalimumab (23.6%), followed by rituximab (16.4%), infliximab (13.0%), and tocilizumab (7.2%).
As reported in Seminars in Arthritis and Rheumatism, the incidence rate of severe COPD exacerbation was 1.2 per 100 person–years over an average 235 days of abatacept use and 2.1 per 100 person–years over an average 171 days use of other biologics.
Rates of bronchitis in the abatacept and comparator groups were 4.2 and 5.3 per 100 person–years, respectively, and the corresponding rates of hospitalization with pneumonia or influenza were 3.6 and 2.6 per 100 person–years.
The main study endpoint, a composite of hospitalization for COPD exacerbation, bronchitis, and hospitalized pneumonia or influenza, occurred 101 times in the abatacept and 165 times in the comparator group, giving incidence rates of 8.7 versus 9.9 per 100 person–years and a nonsignificant hazard ratio of 0.87 after adjustment for potentially confounding factors.
Suissa and colleagues say that their findings remained consistent in the majority of sensitivity analyses conducted, including when the comparator biologic agents were analyzed separately.
“This study does not substantiate the safety signal” demonstrated in the ASSURE trial, they conclude.
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Semin Arthritis Rheum 2019; doi:10.1016/j.semarthrit.2019.03.007