The safety of canakinumab in systemic juvenile idiopathic arthritis and autoinflammatory diseases in pediatric patients: a multicenter study

ABSTRACT

Objective

To evaluate the safety of canakinumab using real-world data in patients with systemic juvenile idiopathic arthritis (sJIA) and autoinflammatory diseases (AID).

Research design and methods

This was a cross-sectional observational, multicenter study. Patients diagnosed with AID and sJIA treated with canakinumab were included in the study. The participating 13 centers retrospectively collected their patients’ data.

Results

A total of 335 patients were involved in the study. Among these patients, 280 were in the AID group and 55 were in the sJIA group. Canakinumab was administered at a median dose of 3 (2.5–4) mg/kg. The median total exposure time to canakinumab was 1.9 (0.8–3.2) years, corresponding to 759.5 patient-years. Seven hundred and seventy-nine total adverse events (AE) were identified. The total incidence of AE, and serious adverse events (SAE) throughout the study period was 1.02 per patient-years. The upper respiratory tract infection rate was 0.7 per patient-years, while the other infection rate was 0.13 per patient-years. While no death was observed in any patient, SAE were observed in 8 patients. Interstitial lung disease, anaphylaxis, or anaphylactoid reactions were not observed in any patient.

Conclusions

Real-life data from a large cohort of patients suggests that canakinumab is as safe as claimed in clinical trials.

KEYWORDS:

• Canakinumab
• safety
• autoinflammatory diseases
• systemic juvenile idiopathic arthritis

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

The study protocol was reviewed and approved by the Ethics Committee of the University of Health Sciences, Umraniye Training and Research Hospital (Approval No: B.10.1.TKH.4.34.H.GP.0.01/401) based on ethical principles in the Declaration of Helsinki. Written informed consent was obtained from legal guardians.

Author contributions

B Sözeri and T Coşkuner conceptualized and designed the study, drafted the initial manuscript, and had full access to all the data in the study. All authors conducted the data analyses, drafted the initial manuscript, and had full access to all the data in the study. All authors reviewed and revised the manuscript and approved the final version of the manuscript.

Additional information

Funding

This paper was not funded.