Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study

Funding

This study was funded by Celltrion, Inc. (Incheon, Republic of Korea).

Conflicts of Interest

K.A. Papp has received grants for clinical studies from AbbVie, Akros, Amgen, Anacor, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermavant, Dermira, Dow Pharma, Eli Lilly, Evelo, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Merck (MSD), Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, and UCB; consulting fees from AbbVie, Acelyrin, Akros, Amgen, Aralez Pharmaceuticals, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Celltrion, Coherus, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo, Forbion, Galderma, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Merck (MSD), Mitsubishi Pharma, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor; has participated in speakers bureaus for AbbVie, Amgen, Bausch Health/Valeant, Celgene, Eli Lilly, Galderma, Incyte, Janssen, Kyowa Hakko Kirin, LEO Pharma, Merck (MSD), Novartis, Pfizer, and Sanofi-Aventis/Genzyme; has received honoraria for attending meetings and/or travel from AbbVie, Acelyrin, Akros, Amgen, Aralez Pharmaceuticals, Bausch Health/Valeant, Boehringer Ingelheim, Celgene, Celltrion, Coherus, Dermavant, Dice Pharmaceuticals, Eli Lilly, Forbion, Galderma, Janssen, Kyowa Hakko Kirin, LEO Pharma, Meiji Seika Pharma, Mitsubishi Pharma, Merck (MSD), Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor; has served on advisory boards for AbbVie, Amgen, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Galderma, Janssen, Merck (MSD), Novartis, Pfizer, Regeneron, Sanofi-Aventis/Genzyme, Sun Pharma, and UCB; has served as a scientific officer for Akros, Anacor, Arcutis, Dice Pharmaceuticals, Kyowa Hakko Kirin; and has served on steering committees for AbbVie, Amgen, Bausch Health/Valeant, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Kyowa Hakko Kirin, Merck (MSD), Novartis, Pfizer, Regeneron, Reistone, and Sanofi-Aventis/Genzyme. M.G. Lebwohl has received grants/contracts from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc.; and has received consulting fees from Aditum Bio, Almirall, AltruBio Inc., AnaptysBio, Apogee Therapeutics, Arcutis, Inc., Aristea Therapeutics, Atomwise, Avotres Therapeutics, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Celltrion, Corevitas, Dermavant Sciences, Dr. Reddy, EPI, Evommune, Inc., Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Galderma, Genentech, Helsinn, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, National Society for Cutaneous Medicine, Pfizer, Seanergy, Strata, Trevi, and Verrica, and Vial Health Technologies. D. Thaçi has received grants/contracts from AbbVie, LEO Pharma and Novartis; received consulting fees from AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Janssen-Cilag, LEO Pharma, MorphoSys, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Samsung, Sanofi and UCB; received honoraria from AbbVie, Almirall, Amgen, Beiersdorf, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, LEO Pharma, MorphoSys, New-Bridge, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Samsung, Sandoz, Sanofi, Sun Pharma and UCB; and participated on data safety monitoring boards or advisory boards for AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi and UCB. A. Dudek has received grants for clinical trials from AbbVie, Bristol Myers Squibb, Celltrion, Eli Lilly, GSK, Horizon, Janssen, UCB and VieLaBio. J.C. Szepietowski has received consulting fees from AbbVie, LEO Pharma, Novartis, Pfizer, Sanofi-Genzyme, Trevi, UCB and Vifor; and honoraria from AbbVie, Almirall, Janssen-Cilag, Eli Lilly, LEO Pharma, Novartis, Pfizer and Sanofi-Genzyme. N. Reznichenko has received grants for clinical trials from Alvotech, Argenx, Celltrion, Eli Lilly and Samsung. A. Reich has received grants for clinical trials from AnaptysBio, Argenx, Celltrion, Drug Delivery Solutions, Galderma, Genentech, Inflarx, Janssen, Kymab Ltd, LEO Pharma, Menlo Therapeutics, MetrioPharm, MSD, Novartis, Pfizer, Trevi, Eli Lilly, UCB and VielaBio; and speaker fees from AbbVie, Bausch Health, Bioderma, Celgene, Chema Elektromet, Eli Lilly, Galderma, Janssen, LEO Pharma, Medac, Novartis, Pierre Fabre, Pfizer, Sandoz and Trevi. Y. Andrashko has received grants for clinical trials from Alfa Sigma, Alvotech, Amgen, Celltrion, Dong-A Pharmaceutical, Eli Lilly, Galderma, Mayne Pharma and Samsung Bioepis; and speaker fees from Blausch Health, Delta Medical, GSK, Novartis and Pfizer. S. Kim, Y. Bae, D. Jeon, J. Jung, H. Lee and T. Pyo are employees of Celltrion and own stocks in Celltrion. W. Ko is an employee of Celltrion. J. Jaworski, J. Trefler, J. Narbutt, W. Baran, J. Kolinek, S. Daniluk, K. Bartnicka-Maslowska and B. Kwiek report no conflicts of interest.

Data Availability

The data that support the findings of this study are available in the supplementary material of this article.

Code Availability

Not applicable (no software or custom code).

Ethics Approval

The study was conducted according to Good Clinical Practice and the principles of the Declaration of Helsinki, as well as national, state and local laws or regulations. Study materials were approved by independent ethics committee/institutional review boards at each site.

Consent to Participate

All patients in this manuscript have given written informed consent for participation in the study and the use of their de-identified, anonymized, aggregated data and their case details (including photographs) for publication.

Consent for Publication

Not applicable (no identifiable data).

Author Contributions

KAP, MGL, DT, SK, YB, DJ, JJ, HL, TP, and WK contributed to the study design. JJ, BK, JT, AD, JCS, NR, JN, WB, JK, SD, KB-M, AR and YA collected study data. All authors contributed to data analysis or interpretation, reviewed and critically revised the manuscript, provided final approval of the version to be published, and agree to be accountable for accuracy and integrity.

Congress Presentations

Selected data from the CT-P43 3.1 study were shared in an oral presentation at the 31st European Academy of Dermatology and Venereology (EADV) congress (7–10 September 2022; Milan, Italy).

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