Results
Table 1Baseline demographic and clinical characteristics (full analysis set)
Data are mean (SD) or n (%). JAK=Janus kinase. MMS=modified Mayo score.
Table 2Summary of adverse events and most frequent adverse events
Data are n (%). The most frequent adverse events were defined as those that occurred in ≥3% of etrasimod-treated patients and those that occurred as a greater rate in the etrasimod group versus the placebo in either study. Data were not exposure adjusted.
Across both trials, three patients had macular oedema: one patient in the etrasimod group of ELEVATE UC 52 who discontinued because of the event; one patient in the placebo group of ELEVATE UC 12 who continued without study treatment interruption; and one patient in the etrasimod group of ELEVATE UC 12 (who had a preceding moderate adverse event of uveitis) and continued without study treatment interruption. All events of macular oedema resolved.
All authors meet the International Committee of Medical Journal Editors criteria for authorship for this Article, take responsibility for the integrity of the work as a whole, were involved in drafting and critical review of the manuscript, and approved the final version for submission. WJS, SV, LP-B, MCD, JP, BES, GD, SD, and BGF conceived and designed the study. AY, TR, FB, MC, DCW, and SSc did the research. WJS, SV, LP-B, MCD, JP, SSc, SSl, FC, KS, CJR, AY, MC, DCW, BES, GD, SD, MG, and BGF analysed the data. KS and CJR accessed and verified the underlying data. All authors had full access to the data, were involved in drafting the manuscript and its revisions, made the decision to submit the manuscript for publication, and vouch for the accuracy and completeness of the data and fidelity of the trials to the protocols.
Declaration of interests
WJS reports research grants from AbbVie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Genentech, Gilead Sciences, GSK, Janssen, Lilly, Pfizer, Prometheus Laboratories, Seres Therapeutics, Shire Pharmaceuticals, Takeda, and Theravance Biopharma; consulting fees from AbbVie, Abivax, Alfasigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Allakos, Amgen, Arena Pharmaceuticals, AstraZeneca, Atlantic Pharmaceuticals, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, ClostraBio, Forbion, Galapagos, Genentech (Roche), GSK, Gossamer Bio, Index Pharmaceuticals, Iota Biosciences, Janssen, Lilly, Morphic Therapeutics, Novartis, Oppilan Pharma (now Ventyx Biosciences), Pfizer, Pharm Olam, Polpharma, Progenity, Prometheus Biosciences, Protagonist Therapeutics, PTM Therapeutics, Seres Therapeutics, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Vedanta Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivreon Gastrosciences, Xencor, and Zealand Pharmaceuticals; stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma (now Ventyx Biosciences), Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Gastrosciences; and is Chief Medical Officer at Ventyx Biosciences. SV reports grants from AbbVie, J&J, Pfizer, Galapagos, and Takeda; and has received consulting or speaking fees from AbbVie, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, CVasThera, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, IMIDomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MRM Health, Mundipharma, MSD, Pfizer, ProDigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillotts Pharma AG, and Zealand Pharma. LP-B reports consulting fees from AbbVie, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, Bristol Myers Squibb, Celltrion, Connect Biopharma, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, HAC-Pharma, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Norgine, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Pfizer, Prometheus, Protagonist, Roche, Sandoz, Takeda, Theravance, Thermo Fisher, TiGenix, Tillotts, Viatris, Vifor, Ysopia, and Abivax; grants from Takeda, Fresenius Kabi, and Celltrion; and lecture or speaker fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillotts, Celltrion, Takeda, Pfizer, Sandoz, Biogen, MSD, Amgen, Vifor, Arena, Lilly, Gilead, Viatris, and Medac. MCD reports consulting fees from AbbVie, Arena, Bristol Myers Squibb, Celgene, Eli Lilly, Genentech, Gilead, Janssen, Pfizer, Prometheus Labs, and Takeda; and is founder and a shareholder of Trellus Health. JP reports consulting fees from AbbVie, Arena Pharmaceuticals, Athos, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Genentech, GSK, Janssen, Mirum, Morphic, Nestle, Origo, Pandion, Progenity, Pfizer, Revolo, Robarts, Roche, Takeda, Theravance, and Wassermann; speaker fees from AbbVie, Biogen, Ferring, Janssen, Pfizer, and Takeda; and research funding from AbbVie and Pfizer. AY reports consulting fees from Takeda, Prometheus Labs, Arena Pharmaceuticals, and Bristol Myers Squibb; and speaker bureau fees from Bristol Myers Squibb. TR served on advisory boards or speaker panels for Gilead, AbbVie, Arena Pharmaceuticals, Ferring Pharmaceuticals, Genentech, Gossamer, Intercept, Janssen, Eli Lilly, Pfizer, Prometheus, and Takeda. FB reports grant or research support from AbbVie, Amgen, Janssen, and Takeda; honoraria from AbbVie, Amgen, Arena Pharmaceuticals, Celgene, Celltrion, Ferring, Fresenius Kabi, Janssen, MSD, Pfizer, Sandoz, and Takeda; and was on speakers bureaus for AbbVie, Arena Pharmaceuticals, Ferring, Galapagos, Janssen, MSD, Pfizer, and Takeda. SSc has been a consultant for AbbVie, Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, Dr Falk Pharma, Ferring, Fresenius, Galapagos, Genentech, GSK, Gilead, I-MAB Biopharma, Janssen, Lilly, Merck, Novartis-Sandoz, Pfizer, Protagonist, Takeda, and Theravance. FC was a previous employee and stockholder of Arena Pharmaceuticals at the time of research. SSl, KS, CJR, and MG are employees and stockholders of Arena Pharmaceuticals, a wholly-owned subsidiary of Pfizer Inc. MC has been a speaker for AbbVie, Janssen, Medtronic, Pfizer, Bristol Myers Squibb, and Takeda; and has served as a consultant for AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Medtronic, Pfizer, Lilly, Prometheus, and Takeda. DCW has received consulting or speaker honoraria from AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Janssen, Lilly, Pfizer, and Takeda. BES reports consulting fees from Abivax, Amgen, Arena Pharmaceuticals, Artugen Therapeutics, AstraZeneca, Bacainn Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calibr, Celltrion Healthcare, ClostraBio, Entera, Evommune, Galapagos, Genentech, Gilead Sciences, GSK, Gossamer Bio, Index Pharmaceuticals, Inotrem, Innovation Therapeutics, Ironwood Pharmaceuticals, Janssen, Kaleido, Kallyope, Lilly, Miro Bio, Morphic Therapeutics, MRM Health, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Q32 Bio, Surrozen, Takeda, Teva, TLL Pharmaceutical, USWM Enterprises, and Viela Bio; speaking fees from Abivax, Bristol Myers Squibb, Janssen, Pfizer, and Takeda; and grant or research support from Janssen. GD has been a consultant for AbbVie, AgomAb, AstraZeneca, AM Pharma, AMT, Arena Pharmaceuticals, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Exo Biologics, Galapagos, Index Pharmaceuticals, Kaleido, Roche, Gilead, GSK, Gossamer Bio, Pfizer, Immunic, J&J, Origo, Polpharma, Procise Diagnostics, Prometheus Laboratories, Prometheus Biosciences, Progenity, and Protagonist; and has received speakers bureau fees from AbbVie, Arena Pharmaceuticals, Galapagos, Gilead, Pfizer, Bristol Myers Squibb, and Takeda. SD reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, J&J, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor; and payment for expert testimony from AbbVie, Amgen, Ferring Pharmaceuticals, Gilead, Janssen, Mylan, Pfizer, and Takeda. BGF has been a consultant for AbbVie, Admirx, AgomAb Therapeutics, Applied Molecular Transport, Arena Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Ferring, Galapagos, Galen Atlantica, Genentech-Roche, Gilead, Gossamer Pharma, GSK, F Hoffmann-La Roche, Janssen, Morphic Therapeutics, OM Pharma, Pandion Therapeutics, Pfizer, Prometheus Therapeutics and Diagnostics, Progenity, Sanofi, Seres Therapeutics, Surrozen, Takeda, Theravance, TiGenix, Tillotts, and Zealand Pharma; has received speaker bureau fees from AbbVie, Janssen, and Takeda; served on the scientific advisory board for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Bristol Myers Squibb, Genentech, Roche, Janssen, Novartis, Origo BioPharma, Pfizer, Prometheus, Takeda, Tillotts Pharma, Teva, Progenity, Index, and GSK; is a stockholder of Gossamer Pharma; and is an employee of Western University and Alimentiv.
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