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Registries, multidisciplinary approaches needed to recognize biologics’ role in RA infections
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AMSTERDAM — Multicenter registries and multidisciplinary approaches are needed to better understand the risks for infection associated with individual drugs used to treat rheumatoid arthritis, according to a presenter at the EULAR Annual Congress.
“It is not so easy to decipher the relationship between biologics and infection during rheumatoid arthritis,” Olivier Lortholary, MD, PhD, of Paris Descartes University and the Necker-Pasteur Center for Infectious Diseases and Tropical Medicine, told attendees. “In fact, there is an increased rate of infections among patients with RA who have not been treated, there is a high rate of comorbidities in patients — especially COPD and diabetes — and there is an association between immunosuppressant and disease severity, confounding by indication.”
Further complicating matters, patients with RA often receive multiple immunosuppressants, according to Lortholary.
“There is also a clear impact of steroids,” he said. “So, how do we best determine the risk of an individual drug?”
The answer, according to Lortholary, is not randomized clinical trials — which are not typically designed to detect rare infections, as they have a relatively low number of highly selected patients, with limited exposure to the tested drug — but registries.
The quality and necessity of registries, which are heterogenous but correspond to real-life patients, and offer larger sample sizes for detecting rare events, should be emphasized, as infectious complications may not be observed during pivotal studies, he said.
As an example, Lortholary noted that the first studies of infliximab (Remicade, Janssen), in combination with methotrexate, among patients with RA failed to produce any reports of tuberculosis. The link between infliximab and tuberculosis did not emerge until 2001, by researchers reviewing data from the FDA Adverse Event Reporting System.
“We are facing an increasing number of therapeutic families and indications and keeping up with the literature can be a real challenge for us,” Lortholary said. “There is a relative value of pivotal trials to detect rare infectious events, as they can currently over look them. There are complexities in the assessment of attributable risk for infection, and the role of comorbidities must be emphasized. In addition, there is a need to multicenter registries and multicenter approaches.”– by Jason Laday
Reference:
Lortholary O. Infectious complications of rheumatic disease (treatment). Presented at: EULAR Annual Congress; June 13-16, 2018; Amsterdam.
Disclosure: Lortholary reports no relevant financial disclosures.