Background/Purpose: Tocilizumab was recently approved for the treatment of systemic JIA (sJIA) and polyarticular JIA (pJIA). Published data on the tolerability of tocilizumab in patients with JIA are rare. The aim of the study was to investigate the safety of tocilizumab in routine care in young adults with JIA.

Methods: Patients with JIA were enrolled in the national JIA biologic register BiKeR and were prospectively followed into adulthood in the follow-up register JuMBO.  All adverse events (AE) were recorded by physicians over the observation period and were categorized on the basis of MedDRA. An event was attributed to tocilizumab when the treatment was either ongoing or terminated in less than 3 months prior to the event. Rates of AE and serious AE (SAE) were calculated per 100 years of tocilizumab exposure (EY).

Results: A total of 929 JIA patients were included in the JuMBO register by the end of January 2015. The tolerability of tocilizumab could be studied in 87 patients (143 EY) who were ever exposed to tocilizumab (14 sJIA, 63 pJIA). Tocilicumab was the first-line biologic disease modifying antirheumatic drugs (DMARD) in 4 (5%) patients, the other 83 patients were treated with tocilizumab after treatment failures with other biologics (second-line bDMARD in 26%, third-line in 47%). In the majority of cases (78%) tocilicumab was first prescribed in young adulthood. At the last available JuMBO visit, 63 patients (8 sJIA, 49 pJIA) were on current treatment with tocilizumab. At treatment start with tocilizumab, patients had a mean disease duration of 13 years, a mean age of 23 years and had been treated in mean by 4.5 other DMARDs before tocilizumab. A total of 81 AE (56.6 events/100 EY) were recorded and 19 (13.3 events/100 EY) AE were rated as serious. Among the SAE, 10 surgical and medical procedures (7.0 events/ 100EY), 4 infections (2.8 events/ 100EY, herpes zoster, genital herpes, norovirus infection, pneumonia) and 2 gastrointestinal disorders (1.4 events/ 100EY) were reported.

Conclusion: Tocilizumab is often started at first time in JIA patients in young adulthood and after treatment failure with other biologic DMARDs. Thus, the JuMBO register supplements the findings about drug safety from the BiKeR register. The obtained safety data are similar to those of tocilizumab in children and of other biologics used in young adults with JIA. However, the number of observed years of drug exposure is still very limited.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-tocilizumab-in-young-adults-with-juvenile-idiopathic-arthritis-jia/