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Article History

Accepted: 16 February 2023

First Online: 1 April 2023

Declarations

:

: This post hoc analysis was funded in full by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). Medical writing support for this article was funded by Celltrion Healthcare Co., Ltd. Open access funding was provided by Celltrion Healthcare Co., Ltd.

: Geert D’Haens has served as a speaker for AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Celltrion, Eli Lilly, Galapagos, Immunic, Johnson and Johnson, and Pfizer; served on a Data Safety Monitoring Board for AbbVie, Ablynx, Allergan, AstraZeneca, Galapagos, GlaxoSmithKline, and Seres Health; served as a consultant for AbbVie, Agomab, AM Pharma, AMT, Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Exeliom Biosciences, Exo Biologics, Galapagos, Gilead, GlaxoSmithKline, Gossamerbio, Immunic, Index Pharmaceuticals, Johnson and Johnson, Kaleido, Origo, Pfizer, Polpharma, Procise Diagnostics, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist, and Roche; and received grants or contracts from AbbVie, Bristol Myers Squibb, Helmsley Foundation, Pfizer, and Takeda. Walter Reinisch has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Celltrion, Falk Pharma, Ferring, Janssen, Medice, Mitsubishi Tanabe Pharma Corporation, MSD, Pfizer, Pharmacosmos, PLS Education, Roche, Shire, Takeda, Therakos, and Vifor; served as a consultant for AbbVie, Algernon, Amgen, Arena Pharmaceuticals, Astellas, AstraZeneca, Bioclinica, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celgene, Celltrion, Eli Lilly, Ernst & Young, Falk Pharma, Ferring, Fresenius, Galapagos, Gatehouse Bio, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Intrinsic Imaging, Janssen, Johnson & Johnson, Landos Biopharma, LivaNova, Mallinckrodt, Medahead, MedImmune, Mitsubishi Tanabe Pharma Corporation, MSD, Nash Pharmaceuticals, Nestle, Novartis, OMass, Otsuka, Parexel, Periconsulting, Pfizer, Pharmacosmos, Prometheus, Protagonist, Provention, Quell Therapeutics, Robarts Clinical Trial, Roche, Sandoz, Schering-Plough, Second Genome, Seres Therapeutics, Setpoint Medical, Sigmoid, Sublimity, Takeda, Teva Pharma, Therakos, Theravance, Vifor, and Zealand; received support for attending meetings and/or travel from AbbVie, Janssen, and Takeda; and served on a Data Safety Monitoring Board or advisory board for OSE Pharma. Stefan Schreiber has served as a consultant or advisory board member for AbbVie, Amgen, Arena, Bristol Myers Squibb, Biogen, Celltrion, Celgene, Falk, Ferring, Fresenius, Galapagos, Gilead, IMAB, Janssen, Lilly, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Sandoz/Hexal, Takeda, Theravance, and UCB. Fraser Cummings has served as a consultant for AbbVie, Amgen, Biogen, Bristol Myers Squibb, Galapagos, Janssen, Samsung Bioepis, and Tillots; received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Biogen, Dr Falk, Galapagos, Janssen, Pfizer, Pharmacosmos, and Tillots; received support for attending meetings and/or travel from Janssen and Tillots; received grants for conducting investigator-initiated studies from Biogen, Celltrion, and Janssen; and is a member of the British Society of Gastroenterology IBD section (unpaid) and is the UK IBD registry clinical lead (paid). Peter M. Irving has served as a consultant for AbbVie and Bristol Myers Squibb; received lecture fees from AbbVie, Bristol Myers Squibb, Celgene, Celltrion, Falk Pharma, Galapagos, Janssen, Lilly, Pfizer, and Takeda; served on Data Safety Monitoring Boards or advisory boards for AbbVie, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Prometheus, Roche, Sandoz, Samsung Bioepis, and Takeda; and received financial support for research from Celltrion, Galapagos, Pfizer, and Takeda. Byong Duk Ye has served on advisory boards for AbbVie Korea, Celltrion, Daewoong Pharma, Ferring Korea, Janssen Korea, Organoid Sciences Ltd, Pfizer Korea, Takeda, and Takeda Korea; served as a consultant for Chong Kun Dang Pharm., CJ Red BIO, Daewoong Pharma, Kangstem Biotech, Korea Otsuka Pharm, Korea United Pharm. Inc., Medtronic Korea, NanoEntek, Organoid Sciences Ltd, and Takeda; received speaker fees from AbbVie Korea, Celltrion, Curacle, Ferring Korea, IQVIA, Janssen Korea, Pfizer Korea, Takeda, and Takeda Korea; and received research grants from Celltrion and Pfizer Korea. Dong-Hyeon Kim and SangWook Yoon are employees of and hold stock or stock options in Celltrion Healthcare Co., Ltd. Shomron Ben-Horin has served as a consultant or advisory board member for AbbVie, Celltrion, Falk, Ferring, Galmed, GSK, Janssen, Novartis, Pfizer, and Takeda; and received research support from AbbVie, Celltrion, Galmed, Janssen, Pfizer, and Takeda.

: The data underlying this article are available in the article and in its online supplementary material. The individual participant data cannot be shared publicly for the privacy of individuals.

: Not applicable.

: This post hoc analysis is based on the primary study (NCT02883452) that was conducted according to International Council for Harmonisation guidelines and following the principles of the Declaration of Helsinki and all applicable national, state, and local laws. The protocol and written study materials were approved by institutional review boards/independent ethics committees prior to study initiation.

: All patients provided written informed consent.

: Not applicable.

: GD’H: Conceptualisation (lead), methodology (lead), supervision (lead), visualisation (equal), writing—original draft (equal), and writing—reviewing and editing (equal). WR: conceptualisation (equal), methodology (equal), writing—original draft (equal), and writing—reviewing and editing (equal). SS: conceptualisation (equal), methodology (equal), writing—original draft (equal), and writing—reviewing and editing (equal). FC: conceptualisation (equal), methodology (equal), writing—original draft (equal), and writing—reviewing and editing (equal). PMI: conceptualisation (equal), methodology (equal), writing—original draft (equal), and writing—reviewing and editing (equal). BDY: conceptualisation (equal), methodology (equal), writing—original draft (equal), and writing—reviewing and editing (equal). D-HK: conceptualisation (equal), formal analysis (lead), methodology (equal), validation (lead), writing—original draft (equal), and writing—reviewing and editing (equal). SWY: conceptualisation (equal), formal analysis (lead), methodology (equal), validation (lead), writing—original draft (equal), and writing—reviewing and editing (equal). SB-H: conceptualisation (lead), methodology (lead), supervision (lead), visualisation (equal), writing—original draft (equal), and writing—reviewing and editing (equal). All authors had access to the post hoc analysis data and contributed to manuscript drafting, critical review, and revision. All authors approved the final manuscript for submission.