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Biologic therapy for patients with rheumatoid arthritis not linked to increased malignancy risk
Biologic response modifiers used to treat patients with rheumatoid arthritis in randomized control trials lasting at least 6 months did not significantly increase malignancy risk compared with other treatments or placebo, according to study results.
Researchers used meta-analysis to search for randomized control trials (RCTs) focusing on biologic response modifiers (BRMs) abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab and tocilizumab in rheumatoid arthritis (RA) from inception through July 2012. The RCTs compared the safety of BRMs used among patients with RA vs. traditional disease-modifying antirheumatic drugs (DMARDs), with a minimum of 24 weeks of follow-up.
The results included 63 RCTs with 29,423 RA patients (mean range, 44.8 years to 56.5 years; 76% women) assigned either BRMs plus methotrexate (MTX and/or other DMARDs, n=15,989) or BRM monotherapy (n=3,615) and the remainder serving as controls (n=9,819). Two hundred eleven patients developed malignancies, including 118 solid tumors, 48 skin cancers, 14 lymphomas, five hematologic nonlymphomas and 26 unspecified, during the trials (0.72%; 95% CI, 0.63%-0.82%).
In the BRM plus methotrexate (0.77%; 95% CI, 0.65%-0.92%), BRM monotherapy (0.64%; 95% CI, 0.42%-0.95%) and control groups (0.66%; 95% CI, 0.52%-0.84%), the incidence rate for any malignancy during the first year of treatment was extremely low. Anakinra plus MTX resulted in lower odds compared with MTX monotherapy (Peto OR=0.11; 95% CI, 0.03-0.45).
Meta-analysis limitations included lack of report details, data that was not blinded and studies funded by pharmaceutical companies, the researchers said.
“Overall, our findings do not support an increased risk of malignancy for patients with RA receiving BRMs in RCTs of at least 24 weeks’ duration,” the researchers concluded. “Although the findings suggest that BRMs may be generally safe with respect to risk of malignancy in the short term, the risk of recurrence in patients with RA with history of cancer or cancer risk factors remains unknown.”