How Does Abatacept Compare to Other DMARDs?

Abatacept (ORENCIA) has a similar safety profile in comparison with other biologic (b) disease-modifying antirheumatic drugs and conventional synthetic (cs)DMARDs in patients with rheumatoid arthritis (RA), a recent study suggested. 

The introduction of bDMARDs and csDMARDs in the world of rheumatic disease has been a significant step in the right direction for RA patients, according to the study authors. And while bDMARDs have proven to be safe in short-term clinical trials, long-term data are lacking—and necessary. 

“In particular, the risk of malignancies and hospitalized infections in patients with RA is higher than in the general population, and there is a need to differentiate between the long-term effects of RA and those associated with bDMARD treatment,” the study authors wrote. “Additionally, most safety data in the literature relate to tumour necrosis factor-α inhibitors (TNFis), and more studies are needed relating to the safety of other bDMARDs and targeted synthetic DMARDs.” 

The study included RA patients aged ≥ 18 years registered with FORWARD, an ongoing, longitudinal, prospective, observational, U.S.-based study, who began treatment with abatacept, other bDMARDs (adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab), or csDMARDs (methotrexate, hydroxychloroquine, leflunomide and sulfasalazine) between 2005 and 2015. Patients could be part of multiple groups if they switched their course of treatment during the study. Six monthly questionnaires, along with medical records, were used to determine incidence rates (IR) by treatment for malignancies, hospitalized infections, and autoimmune diseases. 

Abatacept Safe Compared to Other DMARDs 

Final analysis included 1,496 abatacept initiators, 3,490 patients starting another bDMARD, and 1,520 initiating csDMARD treatment. Abatacept patients did not have a significantly greater risk of malignancies compared to those initiating other bDMARDs (hazard ratio [HR] [95% confidence interval {CI})] 1.89 [0.93, 3.84]) or csDMARDs (HR [95% CI] 0.93 [0.20, 4.27]). The risk of hospitalized infection risk was lower among abatacept patients versus other bDMARDs (HR [95% CI] 0.37 [0.18, 0.75]), as well as compared to csDMARDs, although there was a significant GI gap (HR [95% CI] 0.31 [0.09, 1.05]). Psoriasis risks were not largely different for abatacept initiators compared to those using other bDMARDs (HR [95% CI] 1.46 [0.76, 2.81]) or csDMARDs (HR [95% CI] 2.05 [0.59, 7.16]). Abatacept patients had a lower incidence rate (95% CI) of severe infusion/injection reactions compared to those using other bDMARDs (1.57 [1.11, 2.17] vs 2.31 [1.87, 2.82] per 100 patient-years, respectively). 

The study authors concluded, “Our study showed that abatacept treatment in patients with RA is associated with low IRs of malignancies, infections, autoimmune diseases and infusion/injection reactions. Our findings suggest the risks of hospitalized infections, malignancies and psoriasis are similar with abatacept and csDMARDs and that the safety profile for abatacept versus other bDMARDs is favourable in terms of hospitalized infections and infusion/injection reactions.” They also called for future studies with longer follow-up in order to further assess abatacept’s safety compared to other bDMARDs and csDMARDs.