Long-Term Registries of Biologic Therapies May Determine Risk for Rare Adverse Events in JIA

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Investigators compared long-term safety with regard to rare adverse events between various biologics to treat juvenile idiopathic arthritis.

Long-term surveillance of biologic therapies can help establish risks for rare adverse events (AEs) in patients with juvenile idiopathic arthritis (JIA), according to study results published in ACR Open Rheumatology. Researchers did not find any new safety signals for patients with JIA receiving biologics.

The study included data from patients with nonsystemic JIA enrolled in the German BIKER registry, which has documented treatment of JIA with biologics since 2001. Researchers based safety assessments on reports of AEs; they analyzed the number of AEs, serious AEs, and 25 predefined AEs of special interest, including medically important infections, uveitis, inflammatory bowel disease, cytopenia, hepatic events, anaphylaxis, depression, pregnancy, malignancy, and death. Using AEs reported after the first dose through 70 days after the last dose, the researchers calculated event rates and relative risks.

A total of 3873 patients with JIA contributed 7467 years of exposure to biologics with 733 reported AEs of special interest. Researchers also included in the study data from 1404 biologic-naive patients who started treatment with methotrexate. The most frequently used biologic was etanercept followed by adalimumab, tocilizumab, abatacept, golimumab, and infliximab. There were differences between cohorts treated with different biologics and disease duration before initiation of therapy.

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Among patients who received biologics, the most common AEs of special interest were uveitis (n=231) and medically important infections (n=101). Patients receiving tocilizumab had a higher risk ratio (RR) of cytopenia (8.0; 95% CI, 4.2-15.0) and elevation of transaminases (4.7; 95% CI, 1.8-12.2). Results indicated that anaphylactic events were associated with intravenously administered biologics, including infliximab (4.62/100 patient-years [PYs]; 95% CI, 1.9-11.1 PYs), tocilizumab (2.29/100 PYs; 95% CI, 1.1-4.8 PYs), and abatacept (2.54/100 PYs; 95% CI, 0.8-7.9 PYs).

Among patients who received to biologics, 8 malignancies were reported compared with 3 among biologic-naive patients. No deaths were observed in the patient cohort during the study.

Study limitations included the difference in the cohorts for each biologic and the nonrandomized approach of the study.

“Long-term surveillance of biologic therapies in JIA is an important task,” the researchers concluded. “Through registries, it is possible to establish risks [for] rare events.”


Klein A, Becker I, Minden K, et al. Biologic therapies in polyarticular juvenile idiopathic arthritis. Comparison of long-term safety data from the German BIKER registry. ACR Open Rheumatol. 2020;2(1):37-47.