Treatment-emergent Candida infections in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis treated with ixekizumab : an integrated safety analysis of 25 clinical studies
Schwartzman, S. (Hospital for Special Surgery)
Puig Sanz, Lluís (Institut de Recerca Sant Pau)
Cohen, A.D. (Clalit Health Services (Tel Aviv, Israel))
Khattri, S. (Icahn School of Medicine at Mount Sinai (Nova York, Estats Units d'Amèrica))
Jossart, C. (Eli Lilly and Company)
Diaz, C. (Eli Lilly and Company)
Garrelts, A. (Eli Lilly and Company)
Ngantcha, M. (Eli Lilly and Company)
Eberhart, N. (Eli Lilly and Company)
Eleftheriadi, A. (Eli Lilly and Company)
Tangsirisap, N. (Eli Lilly and Company)
Schuster, C. (Medical University of Vienna)
Gottlieb, A.B. (Icahn School of Medicine at Mount Sinai (Nova York, Estats Units d'Amèrica))
Universitat Autònoma de Barcelona

Data:	2024
Resum:	This safety analysis investigates treatment-emergent mucosal/cutaneous Candida infections in patients treated with ixekizumab (IXE), an anti-interleukin-17A monoclonal antibody, across the approved indications: psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Safety data were pooled from 25 clinical studies. Incidence rates (IRs) are expressed as per 100 patient-years (PY), using the entire duration of exposure. Candida infections had an IR of 1. 9 per 100 PY in patients with PsO (N = 6892; total PY = 18025. 7), 2. 0 per 100 PY in patients with PsA (N = 1401; total PY = 2247. 7), and 1. 2 per 100 PY in patients with axSpA (N = 932; total PY = 2097. 7). The majority of treatment-emergent Candida infections were: (i) experienced only once by patients (IR = 1. 3;IR = 1. 6;IR = 1. 0), (ii) mild/moderate in severity (IR = 0. 8/0. 9;IR = 1. 5/0. 4;IR = 0. 8/0. 5) as opposed to severe (IR = 0. 0; IR = 0. 0; IR = 0. 0), (iii) oral Candida or genital Candida (IR = 0. 9/0. 6;IR = 1. 0/0. 7;IR = 0. 4/0. 6), (iv) marked as recovered/resolved during the studies (89. 3%;93. 8%;90. 3%), (v) not leading to IXE discontinuation (0. 0%;0. 0%;0. 1% discontinued), (vi) managed with topical (34. 7%;22. 2%;11. 5%) or no anti-fungal medications (63. 5%;77. 8%;80. 8%) as opposed to systemic therapies (1. 5%;0. 0%;7. 7%), (vii) typically resolved before next visit. This integrated safety analysis shows that the risk of developing Candida infections is low with IXE, and the severity is mild-to-moderate in most instances across the approved IXE indications. A comprehensive list of the clinical trials and their registration numbers is reported in Table S1 of the supplemental material.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Axial spondyloarthritis ; Candida infections ; Integrated long-term safety ; Ixekizumab ; Psoriasis ; Psoriatic arthritis
Publicat a:	Expert Opinion on Drug Safety, Vol. 23 Núm. 10 (2024) , p. 1347-1357, ISSN 1744-764X

DOI: 10.1080/14740338.2024.2399092
PMID: 39234767

12 p, 1.8 MB

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