Assessing the Safety of a Treatment With A Label Warning for Patients With RA, COPD

According to the findings of a recent study, patients with rheumatoid arthritis (RA) and COPD that are treated with abatacept are not at an increased risk of adverse respiratory events compared with patients treated with other biologic DMARDs [bDMARDs].  

“The ASSURE randomized trial of abatacept safety in [RA] reported more frequent respiratory adverse events with abatacept among the subgroup of 54 patients with [COPD], leading to a label warning,” said lead study author Samy Suissa, PhD, and colleagues. “We assessed the risk of adverse respiratory events associated with abatacept, compared with other [bDMARDs], among patients with RA and COPD in a real-world observational setting.” 

To better understand the findings of the study, we spoke to lead author Dr Suissa, professor of Epidemiology, Biostatistics and Medicine at McGill University in Montreal, and specialist in pharmacoepidemiology.  

Briefly discuss the prevalence of COPD among patients with RA. Does this patient population have limited treatment options? 

Some studies suggest that the prevalence of COPD in RA is as high as 10%. A label warning raises some concern that abatacept may induce more frequent respiratory events in those patients.

How often do patients with RA receive abatacept? Because the label warning says patients may experience more frequent respiratory events if they are diagnosed with COPD, are clinicians less likely to prescribe abatacept?  

In our study, abatacept accounted for around 12% of the patients with RA and COPD who received a biologic DMARD.  It is difficult to know how much physicians are influenced by label warnings. 

Can you briefly discuss the findings of your study?

In our large-scale safety study from a real world clinical setting, including over 1800 patients with RA and COPD receiving abatacept, we found no increased risk of adverse respiratory events with abatacept compared with other biologic DMARDs.  Our study does not substantiate this respiratory safety signal raised by the smaller ASSURE trial, which was based on only 54 patients with RA and COPD. On the contrary, it provides a lot of reassurance to physicians who need to resort to alternative therapies. 

Based on the findings of your study, no increased risk of adverse respiratory evens with abatacept were identified. How will this impact prescribing rates of abatacept compared with other available bDMARDs? 

Our study suggests that the choice of biologic treatment in patients with RA and COPD should not be based on this safety concern, but rather on other evidences of the alternative medications. 

What can payers and clinicians learn from your study? Can they use PROs to determine the best treatment regimen? 

The best treatment regimens should be based on the overall evidence of benefit and risk. Our study is contributing to this evidence.

Is there anything else you would like to add?

Our study exemplifies the importance of large-scale real world evidence studies of the safety and effectiveness of medications used in the clinical practice setting to complement observations made in smaller and limited randomized trials.