P28 Effect of endoscopic disease criteria on endoscopic outcomes in the SEAVUE study

<h3>Introduction</h3> Endoscopic response is a co-primary endpoint in Crohn’s disease (CD) studies. Endoscopic remission (ER) and deep remission (DR) are major secondary endpoints. SEAVUE is a treat-through study, comparing ustekinumab (UST) to adalimumab (ADA) in CD patients (pts) who had ≥1 ulcer of any size (simple endoscopic score - CD [SES-CD]≥3). We evaluated endoscopic outcomes at week (wk) 52 in pts with moderate-severe baseline SES-CD scores and pts with clinical response post induction. <h3>Methods</h3> Biologic-naïve pts with CDAI≥220/≤450 and SES-CD≥3 failing or intolerant to conventional therapy were eligible. Pts were randomized 1:1 to UST (~6mg/kg IV at wk0 then 90mg SC every-8-weeks) or ADA (SC 160mg at wk0, 80mg at wk2, then 40mg every-2-weeks). Endoscopic outcomes were evaluated in the full cohort of pts (SES-CD≥3) and the moderate-severe subgroup (baseline SES-CDs: ileocolonic/colonic disease, ≥6; isolated ileal disease, ≥4). Endoscopic response was a ≥50% reduction from baseline in SES-CD, SES-CD≤3, or SES-CD=0 for pts with baseline SES-CD=3. ER was SES-CD≤3/0 in pts with baseline SES-CD=3. DR was CDAI&lt;150 + ER. <h3>Results</h3> The full cohort and moderate-severe subgroup of pts demonstrated similar endoscopic outcomes. Wk52 endoscopic responses (full cohort, subgroup) were UST-treated (41.9%, 43.1%) vs ADA-treated (36.9%, 35.4%) pts (Table 1). For clinical responders after induction, endoscopic response was (full cohort, subgroup): UST (48.2%, 49.5%) and ADA (44.8%, 43.1%). Full cohort and subgroup ER and DR rates were generally similar (Table 2). ER and DR rates were 3%-7% higher in induction responders vs full cohort. Some induction nonresponders attained endoscopic outcomes at wk52 (e.g., endoscopic response: UST 21.4%; ADA 13.3%). <h3>Conclusion</h3> UST and ADA groups achieved high endoscopic response, ER, and DR rates at wk52. Results in pts with moderate-severe endoscopic disease were similar to the full cohort, but induction responders had higher rates than the full cohort. <h3>Disclosures</h3> <b>Matthieu Allez:</b> Reports consulting and/or lecture fees from AbbVie, Amgen, Biogen, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Ferring, Genentech, Gilead, IQVIA, Janssen, Novartis, Pfizer, Roche, Takeda, and Tillots and grant support from Innate Pharma, Janssen, Takeda, and Genentech/Roche <b>James D. Lewis</b>: Reports consulting fees from Arena Pharmaceuticals, AbbVie, Bridge Biotherapeutics, Bristol Myers Squibb, Entasis Therapeutics, Gilead, Janssen, Lilly, Merck, Nestle Health Science, Pfizer, Protagonist Therapeutics, Samsung Bioepis, Scipher Medicine, and UCB and research grants from AbbVie, Janssen, and Takeda. <b>Stephen B. Hanauer</b>: Reports grant support and fees for consulting, lectures, and serving on an advisory board from AbbVie, Janssen, and Takeda; consulting and or advisory board fees from Allergan, Amgen, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Ferring, Genentech, Gilead, Merck, Novartis, Pfizer, Protagonist, Receptos, Salix, Samsung Bioepis, Seres Therapeutics, TiGenix, and Vhsquared; and grant support from AbbVie, Celgene, Boehringer-Ingelheim, Gilead, Janssen, Pfizer, and Takeda. <b>Silvio Danese:</b> Reports consulting and/or lecture fees from AbbVie, Alimentiv, Allergan, Amgen, AstrraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion Healthcare, Enthera, Ferring Pharmaceuticals, Gilead Sciences, Hospira, Inotrem, Janssen, Johnson &amp; Johnson, Lilly, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor International. <b>Peter M. Irving</b>: Reports lecture fees from AbbVie, Celgene, Falk Pharma, Ferring, Janssen, MSD, Pfizer, Sapphire Medical, Sandoz, Shire, Takeda, Tillots, and Warner Chilcott; financial support for research from MSD, Pfizer, and Takeda; and advisory fees from AbbVie, Arena, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Prometheus, Roche, Sandoz, Samsung Bioepis, Takeda, Topivert, VH2, Vifor Pharma, and Warner Chilcott. <b>Christopher Gasink, Timothy Hoops, James L. Izanec, Tony Ma</b>: Report employment with Janssen Scientific Affairs, LLC, a wholly owned subsidiary of Johnson &amp; Johnson, or Immunology Global Affairs, Janssen Pharmaceutical Companies of Johnson &amp; Johnson and stock ownership in Johnson &amp; Johnson. <b>Edward V. Loftus Jr</b>: Reports consulting fees from AbbVie, Amgen, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Calibr, Celgene, Genentech, Gilead, Iterative Scopes, Gossamer Bio, Janssen, Lilly, Ono Pharma, Pfizer, Scipher Medicine, Sun Pharma, Takeda, and UCB and research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Gilead, Gossamer Bio, Janssen, Pfizer, Receptos, Robarts Clinical Trial, Takeda, Theravance, and UCB. <b>Ellen Scherl</b>: Reports grant support from AbbVie, AstraZeneca, Celgene, Crohn’s and Colitis Foundation, Genentech, Janssen Research &amp; Development, LLC, New York Crohn’s Foundation, Pfizer, Seres Therapeutics, and UCB; consulting fees from AbbVie, Abgenomics, Crohn’s and Colitis Foundation, Evidera, GI Health Foundation, Janssen, Protagonist, Seres, and Takeda; stock ownership in Gilead; and speaker fees from GI Health Foundation and Prime Therapeutics. <b>Remo Panaccione</b>: Reports consulting fees from AbbVie, Abbott, Alimentiv (formerly Robarts), Amgen, Arena, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Ferring, Galapagos, Genentech, Gilead Sciences, Glaxo-Smith Kline, Janssen, Lilly, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Satisfai Health, Sandoz, Schering-Plough, Shire, Sublimity Therapeutics, Theravance, UCB, and Takeda; speaker fees from AbbVie, Arena, Celgene, Ferring, Gilead Sciences, Janssen, Lilly, Merck, Pfizer, Roche, Sandoz, Shire, and Takeda; research/educational support from AbbVie, Ferring, Janssen, Pfizer, and Takeda; and having served on advisory boards for AbbVie, Amgen, Arena, Bristol-Myers Squibb, Celgene, Celltrion, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmith Kline, Janssen, Lilly, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Sandoz, Shire, Sublimity Therapeutics, Theravance, and Takeda. <b>William J. Sandborn</b>: Reports grants from AbbVie, Aviva, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Lilly, Pfizer, Prometheus Biosciences, Seres Therapeutics, Shire, Takeda, and TheraVance Biopharma; consulting fees from AbbVie, Abivax, Admirx, Alfa sigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Alivio Therapeutics, Allakos, Allergan, Amgen, Applied Molecular Transport, Arena Pharmaceuticals, Avexegen Therapeutics, Bausch Health (Salix), BeiGene, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Meyers Squibb, Celgene, Celltrion, Cellularity, Conatus, Cosmo Pharmaceuticals, Equillium, Escalier Biosciences, Ferring, Forbion, Genentech/Roche, Gilead Sciences, Glenmark Pharmaceuticals, Gossamer Bio, Immunic (Vital Therapies), Incyte, Index Pharmaceuticals, Intact Therapeutics, Janssen, Kyowa Kirin Pharmaceutical Research, Kyverna Therapeutics, Landos Biopharma, Lilly, Miraca Life Sciences, Nivalis Therapeutics, Novartis, Nutrition Science Partners, Oppilan Pharma (acquired by Ventyx Biosciences), Otsuka, Pandion Therapeutics, Paul Hastings, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, Provention Bio, Reistone Biopharma, Ritter Pharmaceuticals, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shire, Shoreline Biosciences, Sienna Biopharmaceuticals, Sigmoid Biotechnologies, Sterna Biologicals, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tigenix, Tillotts Pharma, UCB Pharma, Vendata Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vivreon Biosciences, and Zealand Pharma; and stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma (acquired by Ventyx Biosciences), Prometheus Biosciences, Prometheus Laboratories, Progenity, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Biosciences; and employment at Shoreline Biosciences. Spouse: Iveric Bio - consultant, stock options; Oppilan Pharma (acquired by Ventyx Biosciences) - consultant, stock options; Progenity - stock; Prometheus Biosciences - employee, stock, stock options; Prometheus Laboratories – stock, stock options, consultant; Ventyx Biosciences – stock, stock options; and Vimalan Biosciences – stock, stock options. Bruce E. Sands BES discloses research grants from Takeda, Pfizer, Theravance Biopharma R&amp;D, Janssen; consulting fees from 4D Pharma, Abivax, Abbvie, Alimentiv, Allergan, Amgen, Arena Pharmaceuticals, AstraZeneca, Bacainn Therapeutics, Boehringer-Ingelheim, Boston Pharmaceuticals, Bristol-Myers Squibb, Calibr, Capella Bioscience, Celgene, Celltrion Healthcare, ClostraBio, Enthera, F.Hoffmann-La Roche, Ferring, Galapagos, Gilead, Glaxo SmithKline, GossamerBio, Immunic, Index Pharmaceuticals, Innovation Pharmaceuticals, Ironwood Pharmaceuticals, Janssen, Kaleido, Kallyope, Lilly, MiroBio, Morphic Therapeutic, Oppilan Pharma, OSE Immunotherapeutics, Otsuka, Palatin Technologies, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Redhill Biopharma, Rheos Medicines, Salix Pharmaceuticals, Seres Therapeutics, Shire, Sienna Biopharmaceuticals, Sun Pharma, Surrozen, Takeda, Target PharmaSolutions, Teva Branded Pharmaceutical Products R&amp;D, Thelium, Theravance Biopharma R&amp;D, TLL Pharma, USWM Enterprises, Ventyx Biosciences, Viela Bio, Vivante Health, Vivelix Pharmaceuticals; and stock for Vivante Health and Ventyx Biosciences.

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