Please use this identifier to cite or link to this item: http://hdl.handle.net/11434/853
Title: Secukinumab exhibits low immunogenicity during 104 weeks of treatment in subjects with moderate to severe plaque psoriasis.
Epworth Authors: Sinclair, Rodney
Other Authors: Reich, K.
Blauvelt, A.
Warren, R. B.
Szepietowski, J. C.
Sigurgeirsson, B.
Langley, R. G. B.
Tyring, S.
Messina, I.
Fox, T.
Papavassilis, C.
Bruin, G.
Keywords: Chair of Dermatology, Epworth HealthCare, Victoria, Australia
Department of Dermatology, Epworth Health Care, Victoria, Australia.
Head and Neck Clinical Institute, Epworth HealthCare, Victoria, Australia.
Monoclonal Antibodies
Immunogenicity
Psoriasis
Secukinumab
Poster 37
Issue Date: Jul-2016
Conference: Epworth Research Institute Research Week 2016
Conference Location: Epworth HealthCare, Richmond, Victoria, Australia.
Abstract: Introduction: Secukinumab is a fully Human monoclonal antibody that selectively Targets IL-17A for the treatment of Psoriasis. Biological drugs can induce anti-bodies (ADA) that may affect pharmacokinetics, diminish response, or cause hypersensitivity. Here, in a 4- year extension of two phase 3 studies ERASURE and FIXTURE, we evaluated the immunogenicity of secukinumab at Wk104 of treatment. Methods: Subjects completing either core study with at least a partial response (PASI >50) to secukinumab at Wk52 were eligible for inclusion. PASI 75 responders in each secukinumab dose group of the core studies were randomized 2:1 to continue the same doses of secukinumab (300mg or 150 mg) or receive placebo (300mg-PBO or 150mg-PBO) every 4 weeks. Blood samples obtained at Wk52, Wk76 and Wk104 were assayed for treatment-emergent ADA (TE- ADA). Confirmed TE- ADA samples were analysed for neutralizing potential. Results: Te-ADA were detected in 6/1142 (0.53%) subjects tested; one in the 300mg arm, three in the 150mg arm, and two in the 150mg-PBO arm. Two subjects, one each in the 300mg and 150mg-PBO treatment groups, tested positive for neutralizing antibodies at Wk76, Among the six subjects with TE-ADA, four later reverted to a seronegative state during therapy, TE-ADA, including in the 2 subjects with neutralizing antibodies, were not associated with loss of response of hypersensitivity reactions. Conclusion: TE-ADA and neutralizing antibodies were reported rarely with secukinumab treatment out to 2 years, and were not associated with loss of secukinumab efficacy or other issues of clinical concern.
URI: http://hdl.handle.net/11434/853
Type: Conference Poster
Affiliated Organisations: Dermatologikum Hamburg and Georg-August-University Gotingen, Hamburg, Germany.
Oregon Medical Research Center, Portland, Oregon, USA.
The Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester, U.K.
Wroclaw Medical University, Wroclaw, Poland.
Hudlaeknastooin Smaratorg 1 201 Kopavogur, Iceland .
Dalhousie University, Halifax NS B3H, Canada.
University of Texas,USA.
Type of Clinical Study or Trial: Randomized Clinical Trial
Appears in Collections:Head & Neck
Dermatology

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