Skip to content 
Treatment with abatacept is associated with a higher risk for nonmelanoma skin cancer (NMSC) compared with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) among patients with rheumatoid arthritis (RA). However, there is insufficient evidence to establish causation or to determine if the risk is higher compared with other biologic/targeted synthetic DMARDS (b/tsDMARDs), according to study results published in Annals of Rheumatic Disease.
Researchers conducted a post hoc analysis of clinical trials and observational studies, reporting on the risk for NMSC associated with abatacept treatment among patients with RA. They compared incidence rates (IRs) of NMSC per 1000 patient-years (PYs) among those treated with abatacept vs placebo, csDMARDs, and other b/tsDMARDs.
Overall, 16 studies were included in the analysis, comprised of 9 randomized trials and 7 open-label extensions (~49,000 total patients).
A total of 4138 participants who were exposed to abatacept were included in the randomized trials, with a median treatment duration of 12 months. The IRs for NMSC were comparable between the abatacept (IR, 6.0; 95% CI, 3.3-10.0) and placebo (IR, 4.0; 95% CI, 1.3-9.3) groups.
Consistent with treatment guidelines, healthcare providers should continue to perform routine dermatological screening for early detection of NMSC.
This trend persisted over the long-term, open-label period, with a median cumulative exposure of 28 months.
During the cumulative period, 106 (1.5%) patients treated with abatacept reported at least one NMSC event (IR, 5.0; 95% CI, 4.1- 6.1), consistent with rates observed in the double-blind period.
Over a span of 3 years, 21,335 PYs of exposure were observed among 7044 patients.
According to registry databases, the IRs of NMSC per 1000 PYs ranged from 5.0 to 12.0 for abatacept, from 1.6 to 10.0 for csDMARDs, and from 3.0 to 8.0 for b/tsDMARDs.
In claims databases, the rates were from 19.0 to 22.0 for abatacept, 15.0 to 18.0 for csDMARDs, and 14.0 to 17.0 for other b/tsDMARDs.
The combined relative risks (RRs) from observational studies indicated higher rates of NMSC among patients treated with abatacept compared with csDMARDs (RR, 1.84; 95% CI, 1.0-3.37) and similar rates compared with other b/tsDMARDs (RR, 1.11; 95% CI, 0.98-1.26).
Study results were limited by the short treatment periods and absence of a comparator group throughout the cumulative clinical trial data.
Study authors concluded, “Consistent with treatment guidelines, healthcare providers should continue to perform routine dermatological screening for early detection of NMSC.”
Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. Abatacept Treatment Associated With Greater Risk for Nonmelanoma Skin Cancer in RA – Rheumatology Advisor
