Contrary to the findings of a previous trial, a new study has found that abatacept does not increase the risk of adverse events (AEs) in rheumatoid arthritis (RA) patients with chronic obstructive pulmonary disease (COPD).
“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,” the authors of the new study, published in Seminars in Arthritis and Rheumatism, wrote. “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.”
— DocWire News (@mydocwire) March 5, 2019
For the latest findings, researchers used the U.S.-based MarketScan databases to gather data from 2007 through 2014 on patients with RA and COPD who were treated with bDMARDs. Endpoints included hospitalized COPD exacerbation, bronchitis, and hospitalized pneumonia or influenza. Patients initiating abatacept (n = 1,807) were matched to patients initiating another bDMARD (n = 3,547).
The hazard ratio (HR) for the combined endpoint of all outcomes was 0.87 (95% CI: 0.68–1.12). When evaluated separately, the HR for hospitalized COPD exacerbation was 0.60 (95% CI: 0.32–1.11); for bronchitis, it was 0.80 (95% CI: 0.56–1.14). For hospitalized pneumonia or influenza it was 1.39 (95% CI: 0.91–2.13); for outpatient, it was 1.05 (95% CI: 0.86–1.29).
“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,” the study authors concluded. “This study does not substantiate the safety signal raised by the smaller ASSURE trial.”
" Use of Orencia in patients with RA and COPD should be undertaken with caution and such patients should be monitored for worsening of their respiratory status.” https://t.co/JYGLAOUkTN #COPD #rheumatoidarthritis
— ThereseABorden (@TBorden11) April 8, 2019
The ASSURE Trial
In the 2006 ASSURE trial, 54 patients had COPD, of whom 37 were treated with abatacept and 17 received placebo. Among the abatacept cohort, 97.3% of patients experienced AEs, compared to 88.2% in the placebo group. The rate of respiratory complications was significantly higher among abatacept patients than placebo patients (43.2% versus 23.5%), the most common of which were cough, rhonchi, exacerbation of chronic obstructive airway disease, chronic obstructive airway disease, dyspnea, and nasal congestion. COPD patients were also much more likely to report series AEs compared to the placebo arm (27% versus 5.9%). Serious respiratory AEs occurred in 10.8% of abatacept patients, but none of the placebo cohort.
The findings of this trial resulted to the Food and Drug Administration (FDA) including a warning for COPD patients on the label for Orencia (abatacept’s brand name).
— David Liew (@drdavidliew) April 9, 2019
“Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea,” the FDA wrote. “Use of ORENCIA in patients with RA and COPD should be undertaken with caution and such patients should be monitored for worsening of their respiratory status.”