K A Papp1, C L Leonardi2, A Blauvelt3, K Reich4, N J Korman5, M Ohtsuki6, C Paul7, S Ball8, G S Cameron8, J Erickson8, L Zhang8, L Mallbris8, C E M Griffiths9. 1. K Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada. 2. Saint Louis University, St Louis, MO, U.S.A. 3. Oregon Medical Research Center, Portland, OR, U.S.A. 4. Dermatologikum Hamburg and SCIderm GmbH, Hamburg, Germany. 5. Case Western Reserve University School of Medicine, Cleveland, OH, U.S.A. 6. Department of Dermatology, Jichi Medical University, Tochigi, Japan. 7. Department of Dermatology, Paul Sabatier University, Toulouse, France. 8. Eli Lilly and Company, Indianapolis, IN, U.S.A. 9. Dermatology Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester Academic Health Science Centre, Manchester, U.K.
Abstract
BACKGROUND:Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, is approved for the treatment of moderate-to-severe psoriasis. OBJECTIVES: This analysis represents an overview of the efficacy outcomes from three phase III psoriasis studies. METHODS: Data were integrated from the 12-week induction period of three studies in which patients received ixekizumab 80 mg every 2 weeks (IXE Q2W; n = 1169) or every 4 weeks (IXE Q4W; n = 1165) after an initial 160-mg dose for both; etanercept (50 mg biweekly; n = 740; two studies) or placebo (n = 792). The coprimary end points were the percentages of patients with response of static Physician's Global Assessment (sPGA; score 0 or 1) and ≥ 75% improvement in baseline Psoriasis Area and Severity Index (PASI 75) at week 12. Response rates were compared between treatments using the Cochran-Mantel-Haenszel test stratified by study. Treatment comparisons with placebo included data from three studies, whereas etanercept comparisons were based on two studies. RESULTS:Ixekizumab treatment was superior to placebo (P < 0·001) and etanercept (P < 0·001) on sPGA (0, 1) and PASI 75, with significant differences in PASI improvement at week 1. With IXE Q2W, at week 12, the frequencies of patients achieving PASI 75, 90 and 100 were nearly 90%, 70% and 40%, respectively. Ixekizumab-treated patients showed significantly greater improvement vs. placebo and etanercept in percentage body surface area involvement and fingernail psoriasis. IXE Q2W was superior to IXE Q4W on all treatment outcomes. CONCLUSIONS:Ixekizumab therapy at both dosing regimens demonstrated rapid onset and superior efficacy to placebo and etanercept, with IXE Q2W providing better outcomes than IXE Q4W during the first 12 weeks of treatment.
RCT Entities:
BACKGROUND:Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, is approved for the treatment of moderate-to-severe psoriasis. OBJECTIVES: This analysis represents an overview of the efficacy outcomes from three phase III psoriasis studies. METHODS: Data were integrated from the 12-week induction period of three studies in which patients received ixekizumab 80 mg every 2 weeks (IXE Q2W; n = 1169) or every 4 weeks (IXE Q4W; n = 1165) after an initial 160-mg dose for both; etanercept (50 mg biweekly; n = 740; two studies) or placebo (n = 792). The coprimary end points were the percentages of patients with response of static Physician's Global Assessment (sPGA; score 0 or 1) and ≥ 75% improvement in baseline Psoriasis Area and Severity Index (PASI 75) at week 12. Response rates were compared between treatments using the Cochran-Mantel-Haenszel test stratified by study. Treatment comparisons with placebo included data from three studies, whereas etanercept comparisons were based on two studies. RESULTS:Ixekizumab treatment was superior to placebo (P < 0·001) and etanercept (P < 0·001) on sPGA (0, 1) and PASI 75, with significant differences in PASI improvement at week 1. With IXE Q2W, at week 12, the frequencies of patients achieving PASI 75, 90 and 100 were nearly 90%, 70% and 40%, respectively. Ixekizumab-treated patients showed significantly greater improvement vs. placebo and etanercept in percentage body surface area involvement and fingernail psoriasis. IXE Q2W was superior to IXE Q4W on all treatment outcomes. CONCLUSIONS:Ixekizumab therapy at both dosing regimens demonstrated rapid onset and superior efficacy to placebo and etanercept, with IXE Q2W providing better outcomes than IXE Q4W during the first 12 weeks of treatment.
Authors: Vivaswath S Ayyar; Jong Bong Lee; Weirong Wang; Meghan Pryor; Yanli Zhuang; Thomas Wilde; An Vermeulen Journal: Front Pharmacol Date: 2022-04-25 Impact factor: 5.988
Authors: J Seneschal; J-P Lacour; A Bewley; M Faurby; C Paul; G Pellacani; C De Simone; L Horne; A Sohrt; M Augustin; E Hammond; K Reich Journal: J Eur Acad Dermatol Venereol Date: 2020-06-08 Impact factor: 6.166
Authors: Tim Raine; Maria Angeliki Gkini; Peter M Irving; Arvind Kaul; Eleanor Korendowych; Philip Laws; Amy C Foulkes Journal: BioDrugs Date: 2021-02-26 Impact factor: 5.807
Authors: Craig Leonardi; Kristian Reich; Peter Foley; Hideshi Torii; Sascha Gerdes; Lyn Guenther; Melinda Gooderham; Laura K Ferris; Christopher E M Griffiths; Hany ElMaraghy; Heidi Crane; Himanshu Patel; Russel Burge; Gaia Gallo; David Shrom; Ann Leung; Chen-Yen Lin; Kim Papp Journal: Dermatol Ther (Heidelb) Date: 2020-03-21