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Adverse events more likely with biologic DMARDs in patients with RA
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Adverse events were significantly more likely to occur in patients with rheumatoid arthritis taking biologic disease-modifying anti-rheumatic drugs compared with patients taking conventional disease-modifying anti-rheumatic drugs, according to researchers.
Medical records from 1,403 adults (1,108 women) with rheumatoid arthritis (RA) between 1985 and 2013 were studied retrospectively at the University of Athens’ Medical School. Common Terminology Criteria for Adverse Events (CTCAE, version 4.03, 2010, U.S. Department of Health and Human Services) was used to identify and classify adverse events as mild to moderate (neither requiring hospitalization), severe, life-threatening or resulting in death.
Patient demographics and other information were collected, including sex; age at initiation of treatment; disease and treatment duration; dose and sequence of administration of each drug following the first administration; erythrocyte sedimentation rate (ESR) in two categories above and below 40 mm per hour; initial and final disease activity according to Disease Activity Score (DAS28, three variables) in four categories; titers of rheumatoid factor (RF); smoking status and comorbidities at first treatment initiation, such as cardiovascular disease, cancer, metabolic disease, lung disease, gastrointestinal and liver disease, tuberculosis and other details. Mean and cumulative dose of steroids were also calculated.
Patients treated with any biologic disease-modifying anti-rheumatic drugs (bDMARDs), including infliximab, adalimumab, etanercept, or other biologic agent since first approval in Greece in 1997 — regardless of other medications prior or co-administered — comprised the biologic group of 434 patients. Of those patients, 40% switched to a second biologic later in their treatment. The other 969 patients were treated only with conventional DMARDs (cDMARDs), 71% of whom took methotrexate.
Of the patients in the bDMARD group, 519 adverse events were recorded, with an incidence rate of adverse events of 35.5 per 100 patient years and an incident risk ratio of 2.24. In the cDMARD group, 407 adverse events occurred over the course of 15.9 patient years. Adjustment for duration of follow-up preceding initiation of a biologic agent increased the number to 609, but the incidence rate remained at 2.14. For secondary outcomes, the incidence rate was 4.43 for a serious adverse event, 5.27 for first infection and 7.93 for the first serious infection in the bDMARD group, according to the researchers.
Adjusted Cox proportional-hazards models showed none of the potential confounders altered the hazard ratio of the treatment group by more than 6%. Patients with comorbidities, higher disease activity, steroid dosage above 500 mg and patients switching to a second biologic were significantly at higher risk for an adverse event, according to the researchers. – by Shirley Pulawski
Disclosures: The authors report no relevant financial disclosures.
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