Abstract
A few studies have reported the safety profile of interleukin (IL)-1 blockers from real life. The aim of this study is to describe anakinra (ANA) and canakinumab (CAN) safety profile in children and adults, based on data from a real-life setting. Demographic, clinical, and therapeutic data from patients treated with ANA and CAN were retrospectively collected and analyzed. Four hundred and seventy five patients were enrolled; ANA and CAN were prescribed in 421 and 105 treatment courses, respectively. During a mean follow-up of 24.39 ± 27.04 months, 89 adverse events (AE) were recorded; 13 (14.61%) were classified as serious AE (sAE). The overall estimated rate of AE and sAE was 8.4 per 100 patients/year. Safety concerns were more frequent among patients aged ≥ 65 years compared with patients <16 years (p = 0.002). No differences were detected in the frequency of safety concerns between monotherapy and combination therapy with immunosuppressants (p = 0.055), but a significant difference was observed when injection site reactions were excluded from AE (p = 0.01). No differences were identified in relation to gender (p = 0.462), different lines of biologic therapy (p = 0.775), and different dosages (p = 0.70 ANA; p = 0.39 CAN). The overall drug retention rate was significantly different according to the occurrence of safety concerns (p value <0.0001); distinguishing between ANA and CAN, significance was maintained only for ANA (p <0.0001 ANA; p > 0.05 CAN). Treatment duration was the only variable associated with onset of AE (OR = 0.399 [C.I. 0.250–0.638], p = 0.0001). ANA and CAN have shown an excellent safety profile; the risk for AE and sAE tends to decrease over time from the start of IL-1 inhibition. © 2018, International League of Associations for Rheumatology (ILAR).
Original language | English |
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Pages (from-to) | 2233-2240 |
Number of pages | 8 |
Journal | Clinical Rheumatology |
Volume | 37 |
Issue number | 8 |
DOIs | |
Publication status | Published - 2018 |
Keywords
- anakinra
- canakinumab
- immunosuppressive agent
- liver enzyme, aged
- anaphylaxis
- Article
- bacterial infection
- breathing disorder
- clinical practice
- cohort analysis
- drug safety
- drug withdrawal
- female
- flu like syndrome
- follow up
- gastrointestinal disease
- hematologic disease
- herpes simplex keratitis
- human
- infection
- injection site reaction
- macrophage activation syndrome
- major clinical study
- male
- monotherapy
- myocarditis
- neutropenia
- observational study
- pleura mesothelioma
- priority journal
- rash
- retrospective study
- side effect
- thrombophlebitis
- treatment duration