Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data - 18/04/17
Doi : 10.1016/j.jaad.2016.09.026
Bruce Strober, MD, PhD a, ⁎ 
, Craig Leonardi, MD b, Kim A. Papp, MD, PhD, FRCPC c, Ulrich Mrowietz, MD d, Mamitaro Ohtsuki, MD, PhD e, Robert Bissonnette, MD, MSc, FRCPC f, Laura K. Ferris, MD, PhD g, Carle Paul, MD, PhD h, Mark Lebwohl, MD, FAAD i, Daniel K. Braun, MD, PhD j, Lotus Mallbris, MD, PhD j, Stefan Wilhelm, MD j, Wen Xu, PhD j, Anders Ljungberg, MD j, Nayan Acharya, MBBS, MRCP, MFPM j, Kristian Reich, MD, PhD k
, Craig Leonardi, MD b, Kim A. Papp, MD, PhD, FRCPC c, Ulrich Mrowietz, MD d, Mamitaro Ohtsuki, MD, PhD e, Robert Bissonnette, MD, MSc, FRCPC f, Laura K. Ferris, MD, PhD g, Carle Paul, MD, PhD h, Mark Lebwohl, MD, FAAD i, Daniel K. Braun, MD, PhD j, Lotus Mallbris, MD, PhD j, Stefan Wilhelm, MD j, Wen Xu, PhD j, Anders Ljungberg, MD j, Nayan Acharya, MBBS, MRCP, MFPM j, Kristian Reich, MD, PhD k a Department of Dermatology, University of Connecticut Health Center and Probity Medical Research, Farmington, Connecticut
b Central Dermatology PC, St Louis, Missouri
c K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada
d Psoriasis-Center, University Medical Center Schleswig-Holstein, Campus Kiel, Germany
e Jichi Medical University, Shimotsuke, Tochigi, Japan
f Innovaderm Research, Montreal, Canada
g Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
h Dermatology, Paul Sabatier University, Toulouse, France
i Icahn School of Medicine at Mount Sinai, New York, New York
j Eli Lilly and Company, Indianapolis, Indiana
k Dermatologikum Hamburg and SCIderm, Hamburg, Germany
∗Reprint requests: Bruce Strober, MD, PhD, Department of Dermatology, University of Connecticut Health Center and Probity Medical Research, 21 South Rd, Second Floor, Farmington, CT 06032.Department of DermatologyUniversity of Connecticut Health Center and Probity Medical Research21 South RdSecond FloorFarmingtonCT06032
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.
Le texte complet de cet article est disponible en PDF.Key words : adverse events, etanercept, integrated analysis, interleukin-17A, ixekizumab, psoriasis, safety
Abbreviations used : AE, IBD, IL, IR, ISR, MACE, NMSC, PY, SAE, TB, TEAE
Plan
| Supported by Eli Lilly and Company. |
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| Disclosure: Dr Strober is a member of the AbbVie speakers bureau and receives honoraria. He is a consultant for and serves on advisory boards of AbbVie, Amgen, AstraZeneca, Celgene, Dermira, Forward Pharma, Janssen, LEO Pharma, Eli Lilly and Company, Maruho, Medac, Novartis, Pfizer, Sun, Stiefel/GlaxoSmithKline, UCB, and Boehringer Ingelheim and receives honoraria for all. He is an investigator for AbbVie, Amgen, Novartis, Eli Lilly and Company, Janssen, Merck, XenoPort, Xoma, and Celgene, and payments from all were made to the University of Connecticut. He is a scientific director for CORRONA Psoriasis Registry and receives consulting fees. Grant support to the University of Connecticut for a fellowship program was received from AbbVie and Janssen (payments to the University of Connecticut). Dr Leonardi is a consultant/advisory board member for AbbVie, Amgen, Boehringer-Ingelheim, Dermira, Eli Lilly and Company, Janssen, LEO Pharma, Pfizer, Sandoz, and VCB and received honoraria paid to him. He is an investigator for Actavis, AbbVie, Amgen, Celgene, Coherus, Dermira, Eli Lilly and Company, Galderma, Janssen, Merck, Pfizer, Sandoz, Stiefel, LEO Pharma, Novartis, and Wyeth and money was paid to his institution. He is a member of the speakers bureau of AbbVie, Celgene, and Novartis and received honoraria paid to him. Dr Papp is speakers bureau member/consultant/investigator/advisory board member of/for Abbott/AbbVie, Amgen, Astellas, Boehringer Ingelheim, Celgene, Eli Lilly and Company, EMDSerono, Galderma, Janssen, Merck, Novartis, and Pfizer. He serves as a consultant and investigator for Celtrion, Kyowa, MedImmune, Regeneron Pharmaceuticals Inc, Sanofi-Aventis, Takeda, and Valeant. He serves as a consultant for Akros, AstraZeneca, Baxter, Bayer, Cipher, Forward Pharma, Genentech, Kirin, Lypanosys, Mitsubishi Pharma, Mylan, Meiji Seika Pharma Co, Ltd, NovImmune, Serono, Stiefel UCB, and Vertex. He is a member of the advisory boards of Actelion, Mylan, Sanofi-Aventis, and UCB. He is an investigator for Allergan, Anacor, Baxalta, Celtic, Dermira, Dow Pharma, GSK, LEO Pharma, Roche, and Xenon. He is a member of the speakers bureau of LEO Pharma. Money was paid to Dr Papp's institution for all of the above. Dr Mrowietz has been an advisor and/or received speakers honoraria and/or received grants and/or participated in clinical trials of the following companies: Abbott/AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Boehringer-Ingelheim, Celgene, Centocor, Eli Lilly and Company, Foamix, Forward Pharma, Janssen, LEO Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, VBL, and Xenoport. Dr Ohtsuki has received honoraria as consultant and/or advisory board member and/or acted as paid speaker and/or participated in clinical trials sponsored by AbbVie, Boehringer Ingelheim, Celgene, Eisai, Janssen, Kyowa-Kirin, LEO Pharma, Eli Lilly and Company, Maruho, Novartis, Pfizer, and Tanabe-Mitsubishi. Dr Bissonnette is an advisory board member and has received honoraria from AbbVie, Amgen, Janssen, and Merck. He is a consultant for and receives honoraria from AbbVie, Amgen, Celgene, Eli Lilly and Company, Galderma, Incyte, Janssen, LEO Pharma, Merck, and Novartis. He is a speaker for and receives honoraria from AbbVie, Amgen, Galderma, Janssen, LEO Pharma, and Merck. He is an investigator for and his institution receives grant support from AbbVie, Amgen, Celgene, Eli Lilly and Company, Galderma, Merck, Novartis, Pfizer, Kineta, Incyte, Janssen, and LEO Pharma. Dr Ferris has served as an investigator for AbbVie, Amgen, Janssen, Celgene, Eli Lilly and Company, Medimmune, LEO Pharma, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Pfizer; her institution received payment for these activities. Dr Paul has received honoraria as an advisory board member from AbbVie, Amgen, Celgene, Janssen, LEO Pharma, Eli Lilly and Company, Novartis, Pfizer, and Sandoz; his institution also received payment from Sandoz. He has served as an investigator for Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Eli Lilly and Company, and Novartis and his institution received payments. Dr Lebwohl is an employee of the Mount Sinai Medical Center, which receives research funds from Amgen, Anacor, Boehringer Ingleheim, Celgene, Eli Lilly and Company, Janssen Biotech, Kadmon, LEO Pharmaceuticals, Medimmune, Novartis, Pfizer, Sun Pharmaceuticals, and Valeant. Dr Reich has received honoraria as consultant and/or advisory board member and/or acted as paid speaker and/or participated in clinical trials sponsored by AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Eli Lilly and Company, Medac, Merck Sharp & Dohme, Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB, and Xenoport. Drs Braun, Mallbris, Wilhelm, Xu, Ljungberg, and Acharya are employed by Eli Lilly and Company and own stock. Writing assistance was provided by Lori Kornberg, PhD, who is a full-time employee of INC Research, Raleigh, NC. Lingling Xie, MS, of Eli Lilly and Company provided statistical assistance. |
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| Supplementary tables and appendix are available at www.jaad.org. |
© 2016
American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 76 - N° 3
P. 432 - mars 2017 Retour au numéro
Article précédent
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