Peter C M van de Kerkhof1, Christopher E M Griffiths2, Kristian Reich3, Craig L Leonardi4, Andrew Blauvelt5, Tsen-Fang Tsai6, Yankun Gong7, Jiaqing Huang8, Charis Papavassilis9, Todd Fox9. 1. Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. Electronic address: peter.vandeKerkhof@radboudumc.nl. 2. Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom. 3. Dermatologikum Hamburg and Georg-August-University, Göttingen, Germany. 4. Saint Louis University Health Sciences Center, Saint Louis, Missouri. 5. Oregon Medical Research Center, Portland, Oregon. 6. National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. 7. Beijing Novartis Pharma Co Ltd, Shanghai, China. 8. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. 9. Novartis Pharma AG, Basel, Switzerland.
Abstract
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.
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 secukinumabpsoriasis phase II/III program. METHODS: Data were pooled from 10 phase II/III secukinumabpsoriasis 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 unspecifiedtumors (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.
Authors: Chunsheng Zhou; Leticia Monin; Rachael Gordon; Felix E Y Aggor; Rami Bechara; Tara N Edwards; Daniel H Kaplan; Sebastien Gingras; Sarah L Gaffen Journal: J Immunol Date: 2020-06-29 Impact factor: 5.422
Authors: Peter K K Wong; Hanish Bagga; Claire Barrett; Geoff Chong; Patrick Hanrahan; Teja Kodali; Mona Marabani; H Miles Prince; John Riordan; Phillip Swarbrick; Ray White; Laurel Young Journal: Curr Rheumatol Rep Date: 2018-09-01 Impact factor: 4.592