Long-term safety profile and secondary effectiveness of Canakinumab in Pediatric Rheumatic diseases: a single-center experience

ABSTRACT

Background

To demonstrate the long-term safety profile of canakinumab over a nine-year period by documenting adverse events in patients with various pediatric rheumatic diseases.

Research design and methods

This retrospective observational study was conducted at the Pediatric Rheumatology Department of Istanbul University Cerrahpasa between 2015 and 2023. The analysis concerned individuals who had been administered canakinumab treatment for at least six months. The exposure-adjusted event rates were calculated as adverse events per 100 patient days and were compared among three groups based on the cumulative canakinumab dose of <35 mg/kg, 35-70 mg/kg, and >70 mg/kg.

Results

Among 189 patients, the median exposure time to canakinumab was 2.9 (1.5-4.1) years, corresponding to 573.4 patient years. The median cumulative dose of canakinumab was 2205 (1312-3600) mg. The most common adverse event was upper respiratory tract infection (0.76), followed by urinary tract infection (0.02), pneumonia (0.009), latent tuberculosis (0.009) and lymphadenitis (0.004). A total of 55 serious adverse events (0.025) were reported, 12 (0.006) of which led to drug discontinuation. The event rate of macrophage activation syndrome and disease exacerbation was statistically higher in patients receiving <35 mg/kg cumulative canakinumab dose (p < 0.05).

Conclusions

An increase in side effect was not observed with the increasing cumulative doses of canakinumab. Canakinumab demonstrated long-term safety with appropriate indication and monitoring.

KEYWORDS:

• Anti IL-1
• Canakinumab
• Colchicine
• Event rate
• Safety

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Declaration of interests

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.

Author contribution statement

Kasapcopur O. and Konte EK. conceptualized and designed the study, drafted the initial manuscript. All authors were responsible for data collection and analysis and had full access to all the data in the study. Konte EK. contributed to the drafting of the paper. Adrovic A., Sahin S. and Kasapcopur O. revised it critically for intellectual content. All authors agree to be accountable for all aspects of the work. All authors reviewed and revised the manuscript and approved the final version of the manuscript.

Ethics statement

The Istanbul University-Cerrahpasa Institutional Review Board approved this study (Approval date and protocol number: 28.12.2022-576635). Written informed consent was received from the legal representatives of patients. The study was performed according to the principles of the Declaration of Helsinki.

Additional information

Funding

This paper was not funded.