No Increase in Malignancies, Infections for Abatacept vs Other DMARDs

Computer illustration of cancer cells, showing the blood vessel formation providing the the cells with oxygens and nutrigens. The cells with their nuclei are shown in blue.
Researchers found data that were consistent across randomized controlled trials of abatacept, but they believe that further examination of observational studies could show the risks of treatment with abatacept.

Abatacept does not have an increased risk for malignancies, infections, or autoimmune diseases compared with other biologic disease-modifying antirheumatic drugs (bDMARDs) or conventional synthetic DMARDs (csDMARDs), according to results published in Arthritis Research and Therapy.

The study included participants aged ≥18 years with rheumatoid arthritis who were registered with the FORWARD (the National Databank for Rheumatic Diseases) study and who initiated abatacept, other bDMARDs, or csDMARDs between 2005 and 2015. If participants switched treatment during the study period, then they could belong to more than a single study group.

Related Articles

The researchers calculated the incidence rates by treatment for malignancies, hospitalized infections, and autoimmune diseases, which were identified by 6 monthly questionnaires and medical records. They used marginal structural models adjusted for clinical confounders to determine the hazard ratios (HRs) for all outcomes with abatacept compared with other bDMARDs or csDMARDs.

During the study period, 1496 participants initiated abatacept, 3490 initiated another bDMARD, and 1520 initiated a csDMARD.

The results indicated that abatacept did not have a significantly higher risk for malignancies in patients who had never been diagnosed with a malignancy compared with other bDMARDs (HR, 1.89; 95% CI, 0.93-3.84) or csDMARDs (HR, 0.93; 95% CI, 0.20-4.27).

Participants initiating abatacept had a lower risk of being hospitalized for infections compared with other bDMARDs (HR, 0.37, 95% CI, 0.18-0.75) and csDMARDs (HR, 0.31; 95% CI, 0.09-1.05). Those initiating abatacept also had a lower risk for severe infusion/injection reactions compared with other bDMARDs (incidence rate, 1.57 [95% CI, 1.11-2.17] vs 2.31 [95% CI, 1.87-2.82] per 100 person-years).

The researchers found that abatacept had a similar relative risk for psoriasis compared with bDMARDs (HR, 1.46, 95% CI, 0.76-2.81) and csDMARDs (HR, 2.05, 95% CI, 0.59-7.16).

“Given that patients with [rheumatoid arthritis] are already at a higher risk of malignancy and infections than the general population, our findings are likely to be of clinical interest in making therapeutic decisions,” the researchers wrote.


Ozen G, Pedro S, Schumacher R, et al. Safety of abatacept compared with other biologic and conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: data from an observational study. Arthritis Res Ther. 2019;21:141.