Bruce Strober1, Craig Leonardi2, Kim A Papp3, Ulrich Mrowietz4, Mamitaro Ohtsuki5, Robert Bissonnette6, Laura K Ferris7, Carle Paul8, Mark Lebwohl9, Daniel K Braun10, Lotus Mallbris10, Stefan Wilhelm10, Wen Xu10, Anders Ljungberg10, Nayan Acharya10, Kristian Reich11. 1. Department of Dermatology, University of Connecticut Health Center and Probity Medical Research, Farmington, Connecticut. Electronic address: strober@uchc.edu. 2. Central Dermatology PC, St Louis, Missouri. 3. K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada. 4. Psoriasis-Center, University Medical Center Schleswig-Holstein, Campus Kiel, Germany. 5. Jichi Medical University, Shimotsuke, Tochigi, Japan. 6. Innovaderm Research, Montreal, Canada. 7. Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 8. Dermatology, Paul Sabatier University, Toulouse, France. 9. Icahn School of Medicine at Mount Sinai, New York, New York. 10. Eli Lilly and Company, Indianapolis, Indiana. 11. Dermatologikum Hamburg and SCIderm, Hamburg, Germany.
Abstract
BACKGROUND: Safety of biologics is important when treating patients with psoriasis. OBJECTIVE: We sought to determine the safety of ixekizumab in psoriasis. METHODS: Integrated safety data are presented from a 12-week induction period, a 12- to 60-week maintenance period, and from all ixekizumab-treated patients from 7 clinical trials. Exposure-adjusted incidence rates (IRs) per 100 patient-years are reported. RESULTS: Overall, 4209 patients received ixekizumab (total exposure: 6480 patient-years). During the induction period, the IRs of patients experiencing 1 or more treatment-emergent adverse event (AE) were 251 and 236 among ixekizumab- and etanercept-treated patients, respectively, and for serious AEs was 8.3 in both groups. During maintenance, for ixekizumab, the IRs of treatment-emergent AEs and serious AEs were 100.4 and 7.8, respectively. Among all ixekizumab-treated patients from 7 trials, the IR of Candida infections was 2.5. The IRs of treatment-emergent AEs of special interest (including serious infections, malignancies, major adverse cardiovascular events) were comparable for ixekizumab and etanercept during the induction period. LIMITATIONS: Additional long-term data are required. CONCLUSION: Ixekizumab had an acceptable safety profile with no unexpected safety findings during ixekizumab maintenance in psoriasis.
BACKGROUND: Safety of biologics is important when treating patients with psoriasis. OBJECTIVE: We sought to determine the safety of ixekizumab in psoriasis. METHODS: Integrated safety data are presented from a 12-week induction period, a 12- to 60-week maintenance period, and from all ixekizumab-treated patients from 7 clinical trials. Exposure-adjusted incidence rates (IRs) per 100 patient-years are reported. RESULTS: Overall, 4209 patients received ixekizumab (total exposure: 6480 patient-years). During the induction period, the IRs of patients experiencing 1 or more treatment-emergent adverse event (AE) were 251 and 236 among ixekizumab- and etanercept-treated patients, respectively, and for serious AEs was 8.3 in both groups. During maintenance, for ixekizumab, the IRs of treatment-emergent AEs and serious AEs were 100.4 and 7.8, respectively. Among all ixekizumab-treated patients from 7 trials, the IR of Candida infections was 2.5. The IRs of treatment-emergent AEs of special interest (including serious infections, malignancies, major adverse cardiovascular events) were comparable for ixekizumab and etanercept during the induction period. LIMITATIONS: Additional long-term data are required. CONCLUSION:Ixekizumab had an acceptable safety profile with no unexpected safety findings during ixekizumab maintenance in psoriasis.
Authors: Christopher E M Griffiths; Melinda Gooderham; Jean-Frederic Colombel; Tadashi Terui; Ana P Accioly; Gaia Gallo; Danting Zhu; Andrew Blauvelt Journal: Dermatol Ther (Heidelb) Date: 2022-05-27
Authors: Joel M Gelfand; Daniel B Shin; Kristina Callis Duffin; April W Armstrong; Andrew Blauvelt; Stephen K Tyring; Alan Menter; Scott Gottlieb; Benjamin N Lockshin; Eric L Simpson; Farid Kianifard; Rajendra Prasad Sarkar; Elisa Muscianisi; Jennifer Steadman; Mark A Ahlman; Martin P Playford; Aditya A Joshi; Amit K Dey; Thomas J Werner; Abass Alavi; Nehal N Mehta Journal: J Invest Dermatol Date: 2020-02-21 Impact factor: 8.551