Treatment-emergent Candida infections in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis treated with ixekizumab: an integrated safety analysis of 25 clinical studies
Por:
Schwartzman, S, Puig, L, Cohen, AD, Khattri, S, Jossart, C, Diaz, C, Garrelts, A, Ngantcha, M, Eberhart, N, Eleftheriadi, A, Tangsirisap, N, Schuster, C, Gottlieb, AB
Publicada:
2 oct 2024
Ahead of Print:
1 sep 2024
Resumen:
BackgroundThis 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).Research design and methodsSafety data were pooled from 25 clinical studies. Incidence rates (IRs) are expressed as per 100 patient-years (PY), using the entire duration of exposure.ResultsCandida 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.ConclusionsThis 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.Trial registrationA comprehensive list of the clinical trials and their registration numbers is reported in Table S1 of the supplemental material.
Ixekizumab (IXE) is a drug approved for the treatment of psoriasis, psoriatic arthritis, and axial spondyloarthritis. IXE belongs to the class of molecules that blocks a protein called interleukin-17A. Since interleukin-17A is involved in the defense against fungi, the clinical use of this class of drug has the potential to increase the risk of developing fungal infections, such as Candida infections.Therefore, researchers collected safety data from 25 clinical studies comprising 9225 adult patients treated with IXE: 6892 with psoriasis, 1401 with psoriatic arthritis, and 932 with axial spondyloarthritis. Researchers looked at the rate of new cases of Candida infections, the so-called incidence rate, and found that 1.9 per 100 patient-years experienced at least 1 Candida infection in the psoriasis group, 2.0 per 100 patient-years in the psoriatic arthritis group, and 1.2 per 100 patient-years in the axial spondyloarthritis group.Across indications, the majority of Candida infections (i) were experienced only once by patients, (ii) were mild or moderate in severity, (iii) involved infections caused by superficial skin fungus in the mouth or genitals, (iv) were considered recovered/resolved during the studies, (v) did not lead to IXE discontinuation, (vi) were managed with topical anti-fungal medications or no medications, and (vii) were typically resolved before next visit.In conclusion, this 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.
Filiaciones:
Schwartzman, S:
Hosp Special Surg, Dept Rheumatol, New York, NY USA
Puig, L:
Hosp Santa Creu & Sant Pau, Dept Dermatol, Barcelona, Spain
Cohen, AD:
Clalit Hlth Serv, Dept Qual Measurements & Res, Tel Aviv, Israel
Khattri, S:
Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY USA
Jossart, C:
Eli Lilly & Co, Indianapolis, IN USA
Diaz, C:
Eli Lilly & Co, Indianapolis, IN USA
Garrelts, A:
Eli Lilly & Co, Indianapolis, IN USA
Ngantcha, M:
Eli Lilly & Co, Indianapolis, IN USA
Eberhart, N:
Eli Lilly & Co, Indianapolis, IN USA
Eleftheriadi, A:
Eli Lilly & Co, Indianapolis, IN USA
Tangsirisap, N:
Eli Lilly & Co, Indianapolis, IN USA
Schuster, C:
Eli Lilly & Co, Indianapolis, IN USA
Med Univ Vienna, Dept Dermatol, Vienna, Austria
Gottlieb, AB:
Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY USA
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