Journal of the American Academy of Dermatology · 2016
Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis.
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van de Kerkhof Peter C M, Griffiths Christopher E M, Reich Kristian, Leonardi Craig L, Blauvelt Andrew, Tsai Tsen-Fang, Gong Yankun, Huang Jiaqing, Papavassilis Charis, Fox Todd
Аннотация
BACKGROUND: Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe plaque psoriasis.
OBJECTIVE: We reviewed safety data from the secukinumab psoriasis phase II/III program.
METHODS: Data were pooled from 10 phase II/III secukinumab psoriasis studies.
RESULTS: Analysis included 3993 subjects; 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs; 236.1, 239.9, and 243.4, respectively); infections (91.1, 85.3, and 93.7, respectively); serious AEs (7.4, 6.8, and 7.0, respectively); serious infections (1.4, 1.1, and 1.4, respectively); malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively); and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively).
LIMITATIONS: There was a limited number of patients in comparator groups and the exposure to placebo was short.
CONCLUSION: Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis.
OBJECTIVE: We reviewed safety data from the secukinumab psoriasis phase II/III program.
METHODS: Data were pooled from 10 phase II/III secukinumab psoriasis studies.
RESULTS: Analysis included 3993 subjects; 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs; 236.1, 239.9, and 243.4, respectively); infections (91.1, 85.3, and 93.7, respectively); serious AEs (7.4, 6.8, and 7.0, respectively); serious infections (1.4, 1.1, and 1.4, respectively); malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively); and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively).
LIMITATIONS: There was a limited number of patients in comparator groups and the exposure to placebo was short.
CONCLUSION: Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis.
Предметные рубрики MeSH
AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCardiovascular DiseasesClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicEtanerceptFemaleHumansImmunosuppressive AgentsInfectionsInflammatory Bowel DiseasesInterleukin-17MaleMental DisordersMiddle AgedNeoplasmsNeutropeniaPsoriasisRandomized Controlled Trials as TopicSeverity of Illness IndexTime Factors