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|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.|
Warren, R. B.
Szepietowski, J. C.
Langley, R. G. B.
|Keywords:||Chair of Dermatology, Epworth HealthCare, Victoria, Australia|
Department of Dermatology, Epworth Health Care, Victoria, Australia
Head & Neck Clinical Institute, Epworth HealthCare, Victoria, Australia
|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.|
|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|
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