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Background: We aimed to establish a cohort of persons with Crohn's disease (CD) enrolled from 14 Canadian centers to describe the contemporary presentation of CD in Canada., Methods: All enrollees were at least 18 years old and underwent chart review for phenotype documentation by Montreal Classification at time of enrollment, comorbidities, inflammatory bowel disease (IBD) and other surgeries, and use IBD and other therapies., Results: Of 2112 adults, 59% were female, and the mean age was 44.1 (+/-14.9SD) years. The phenotype distribution was B1 = 50.4%, B2 = 22.4%, B3 = 17.3%, and missing information = 9.9%. Perineal disease was present in 14.2%. Pertaining to disease location, 35.2% of patients had disease in L1, 16.8% in L2, 48% in L3, and 0.4% in L4. There was no difference in phenotype by gender, anxiety score, depression score. Disease duration was significantly different depending on disease behavior type (B1 = 12.2 ± 10.1; B2 = 19.4 ± 12.9; B3 = 18.9 ± 11.8, P < .0001). Isolated colonic disease was much less likely to be fibrostenotic or penetrating than inflammatory disease. Penetrating disease was more likely to be associated with ileocolonic location than other locations. Perineal disease was most commonly seen in persons with B3 disease behavior (24%) than other behaviors (11% B1; 20% B2 disease, P < .0001) and more likely to be seen in ileocolonic disease (L3;19%) vs L2 (17%) and L1 (11%; P < .0001). Surgery related to IBD occurred across each behavior types at the following rates: B1 = 23%, B2 = 64%, and B3 = 74%. Inflammatory bowel disease-related surgery rates by location of disease were L1 = 48%, L2 = 21%, and L3 = 51%., Conclusions: In exploring this large contemporary CD cohort we have determined that inflammatory disease is the main CD phenotype in Canada and that CD-related surgery remains very common., (© 2024 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)

Background: Interleukin-23 inhibition is effective in treating ulcerative colitis. Guselkumab is a dual-acting, human IgG1, interleukin-23p19 subunit inhibitor that potently neutralises interleukin-23 and can bind to CD64. We aimed to evaluate the efficacy and safety of guselkumab as induction and maintenance therapy in patients with ulcerative colitis., Methods: The primary populations of these two phase 3, randomised, double-blind, placebo-controlled studies (QUASAR phase 3 induction and maintenance) included randomised and treated adults with moderately to severely active ulcerative colitis (induction baseline modified Mayo score from 5 to 9) with inadequate response or intolerance to conventional or advanced ulcerative colitis therapy. Patients were randomly assigned (3:2) to receive guselkumab 200 mg given intravenously or placebo at weeks 0, 4, and 8 (phase 3 induction study). All patients were randomly assigned using web-based interactive response technology. Patients in clinical response 12 weeks after guselkumab induction given intravenously (from QUASAR phase 2b and phase 3 induction studies) were randomly assigned (1:1:1) at maintenance week 0 to guselkumab 200 mg given subcutaneously every 4 weeks or 100 mg every 8 weeks or placebo for 44 weeks (maintenance). Primary endpoints were clinical remission at induction week 12 and maintenance week 44. This study is registered with ClinicalTrials.gov, NCT04033445., Findings: The induction study primary population included 701 patients (guselkumab 200 mg given intravenously 60% [421 patients]; placebo 40% [280 patients]). The maintenance study primary population included 568 guselkumab induction responders randomly assigned to receive guselkumab 200 mg given subcutaneously every 4 weeks (190 [33%] patients) or 100 mg every 8 weeks (188 [33%] patients) or placebo (guselkumab withdrawal 190 [33%] patients). A significantly greater proportion of patients treated with guselkumab given intravenously had clinical remission at induction week 12 (23% [95 of 421 patients]) than did placebo-treated patients (8% [22 of 280 patients]; adjusted treatment difference 15%, 95% CI 10-20; p<0·0001). Clinical remission at maintenance week 44 was achieved by a significantly greater proportion of patients treated with guselkumab 200 mg given subcutaneously every 4 weeks (50% [95 of 190 patients]; adjusted treatment difference 30%, 95% CI 21-38; p<0·0001) and 100 mg every 8 weeks (45% [85 of 188 patients]; adjusted treatment difference 25%, 16-34; p<0·0001) than with placebo (19% [36 of 190 patients]). The overall safety profile was favourable and consistent with that of guselkumab in approved indications. In the induction study, adverse events were reported by 49% of patients in both groups (208 of 421 guselkumab-treated patients and 138 of 280 placebo-treated patients), serious adverse events were reported by 3% (12 of 421) of guselkumab-treated patients and 7% (20 of 280) of placebo-treated patients, and adverse events leading to treatment discontinuation were reported by 2% (seven of 421) of guselkumab-treated patients and 4% (11 of 280) of placebo-treated patients. In the maintenance study, adverse event rates were similar among groups, and the most frequently reported adverse events in all groups were ulcerative colitis, COVID-19, and arthralgia. No active tuberculosis, anaphylaxis, serum sickness, or clinically important hepatic disorders were reported in either study., Interpretation: Guselkumab was effective and safe as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis., Funding: Janssen Research and Development., Competing Interests: Declaration of interests DTR reports consulting, speaker fees, and advisory board participation for AbbVie, Altrubio, Apex, Avalo, Bristol Myers Squibb, Buhlmann Diagnostics, Celgene, Connect BioPharma, Iterative Health, Janssen (Johnson & Johnson), Lilly, Pfizer, Samsung Neurologica, and Takeda; Altrubio, Datos Health, and Iterative Health stock options; grants from Takeda; and is on the Board of Directors of Cornerstones Health and on the Crohn's & Colitis Foundation's Board of Trustees. JRA reports research support from Merck and Pfizer; consulting and speaker fees from AbbVie, Artugen Therapeutics, Bristol Myers Squibb, Ferring, Finch Therapeutics, Iterative Scopes, Janssen, Merck, Pfizer, and Seres Therapeutics; and is a steering committee member and investigator for Janssen. JP reports consulting fees from AbbVie, Alimentiv, Athos, Boehringer Ingelheim, Celsius, Ferring, Galapagos, Genentech (a subsidiary of Roche), GlaxoSmithKline, Janssen, Mirum, Nimbus, Pfizer, Progenity, Prometheus, Protagonis, Revolo, Sanofi, Sorriso, Surrozen, Takeda, and Wasserman; and fees for data safety monitoring board or advisory board participation from Alimentiv, Sanofi, Sorriso, and Surrozen. NS, SSY, K-HGH, MG, RW, HZ, and JJ are employees of Janssen Research & Development, which is a wholly owned subsidiary of Johnson & Johnson, and might own stock in Johnson & Johnson. BGF reports consulting and speaker fees from AbbVie, AbolerIS, AgomAB Therapeutics, Allianthera, Amgen, AnaptysBio, Applied Molecular Transport, Arena, Avoro Capital Advisors, Atomwise, BioJamp, Biora (Progenity), Boehringer-Ingelheim, Boxer, Business Intelligence Pharma, Celsius Therapeutics, Celgene (a subsidiary of Bristol-Myers Squibb), Connect BioPharma, Cytoki Pharma, Disc Medicine, Duality, EcoR1 Capital, Equillium, Ermium, First Wave, First Word Group, Galapagos, Galen Atlantica, Genentech (a subsidiary of Roche), Gilead, Gossamer Bio, GlaxoSmithKline, Hinge Bio, Hot Spot Therapeutics, Imhotex, Immunic Therapeutics, InDex Pharmaceuticals, JAKAcademy, Janssen, Japan Tobacco, Kaleido Biosciences, Landos Biopharma, Leadiant, L.E.K. Consulting, LifeSci Capital, Lilly, Lument AB, Millennium, MiroBio, Morphic Therapeutic, Mylan, OM Pharma, Origo BioPharma, Orphagen, Pandion Therapeutics, Pendopharm, Pfizer, PlayToKnow AG, Prometheus Therapeutics and Diagnostics, Protagonist, PTM Therapeutics, Q32 Bio, Rebiotix, REDX Pharma, Roche, Sandoz, Sanofi, Seres Therapeutics, Silverback Therapeutics, Surrozen, Takeda, Teva, Thelium, Tigenix, Tillotts, Ventyx Biosciences, VHsquared, Viatris, Ysios, Ysopia, and Zealand Pharma; payment for expert testimony from Morgan Lewis and Lenczner Slaght; support for meeting attendance and travel from AbbVie, Business Intelligence Pharma, Janssen, Pfizer, and Takeda; data safety monitoring board or advisory board participation for AbbVie, Amgen, AMT Pharma, AnaptysBio, Axio Research, Biora (Progenity), Boehringer-Ingelheim, Celgene, EcoR1 Capital, Genentech (a subsidiary of Roche), GlaxoSmithKline, InDex Pharmaceuticals, Janssen, Lilly, MiroBio, Morphic Therapeutic, Origo BioPharma, Pfizer, Prometheus Biosciences, REDX Pharma, Sanofi, Takeda, Teva, and Tillotts; and stock or stock option ownership in Gossamer Bio. TH reports research grants from AbbVie, Boston Scientific, Daiichi-Sankyo, EA Pharma Co, JIMRO Co, Mitsubishi Tanabe Pharma Corporation, Kissei Pharmaceutical, Kyorin Pharmaceutical Co, Mochida Pharmaceutical Co, Nippon Kayaku Co, Pfizer, Takeda Pharmaceutical Co, Zeria Pharmaceutical Co; and consulting fees and honoraria from AbbVie GK, Bristol Myers Squibb, EA Pharma Co, Gilead Sciences, Janssen Pharmaceutical, Kyorin Pharmaceutical Co, Lilly, Mitsubishi Tanabe Pharma Corp, Nichi-Iko Pharmaceutical Co, Pfizer, Takeda Pharmaceutical Co, and Zeria Pharmaceutical Co. GRL reports consulting fees, speaker fees, and meeting attendance or travel support from AbbVie, Allergan, American Gastroenterological Association, American Regent (Creative Educational Concepts), Amgen (continuing medical education sponsor), Boehringer Ingelheim (continuing medical education sponsor), Bristol Meyers Squibb, Celgene, Exact Sciences (continuing medical education sponsor), Ferring, Focus Medical Communications, Gilead, IBD Horizon, Ironwood, Janssen (continuing medical education sponsor), Janssen Biotech (continuing medical education sponsor), Janssen Orthobiotech, Janssen Scientific (continuing medical education sponsor), Lilly, MedEd Consultants, Pennsylvania Society of Gastroenterology, Pfizer, Pharmacosmos, Physician Education Resource, Prometheus Laboratories, Salix (continuing medical education sponsor), Sandoz, Sanofi (continuing medical education sponsor), Seres Pharmaceuticals (continuing medical education sponsor), Takeda, UCB, and Vindico; research support from Bristol Meyers Squibb, Celgene, Janssen Orthobiotech, Pfizer, Takeda, and UCB; data safety monitoring board participation with Lilly; honoraria from Gastroenterology and Hepatology (Gastro-Hep Communications; editor), Springer Science and Business Media (editor), and Up-To-Date-Walters Kluwer (author); royalties from SLACK (book royalty) and Professional Communications (textbook royalty); and Chair, Professional Education Committee and Member of the National Scientific Advisory Committee for Crohn's Colitis Foundation. BB reports consulting and speaker fees from AbbVie, Alimentiv, Amgen, Bausch Health, BioJamp Pharma, Bristol Myers Squibb, Celgene, Celltrion, Eupraxia, Ferring, Fresenius Kabi, Gilead, Iterative Health, Janssen, Lifelabs, Lilly, Merck, Mylan, Novartis, Organon, Pendopharm, Pfizer, Sandoz, Takeda, and Viatris; serves on a data safety monitoring board or advisory board for Eupraxia; and owns Qu Biologic stock. LP-B reports grants or contracts from Celltrion, Fresenius Kabi, Medac, Merck Sharp & Dohme, and Takeda; consulting and payment or honoraria and data safety monitoring board or advisory board participation for AbbVie, Abivax, Adacyte, Alfasigma, Alimentiv, Amgen, Applied Molecular Transport, Arena, Banook, Biogen, Bristol Myers Squibb, Celltrion, Connect Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GlaxoSmithKline, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Kern Pharma, Lilly, Medac, Mopac, Morphic, Merck Sharp & Dohme, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Par' Immune, Pfizer, Prometheus, Protagonist, Roche, Samsung, Sandoz, Sanofi, Satisfay, Takeda, Telavant, Theravance, Thermo Fischer, Tigenix, Tillots, Viatris, Vectivbio, Ventyx, and Ysopia; and meeting attendance and travel support from AbbVie, Alfasigma, Amgen, Celltrion, Connect Biopharm, Ferring, Galapagos, Genentech, Gilead, Gossamer Bio, Janssen, Lilly, Medac, Morphic, Merck Sharp & Dohme, Pfizer, Sandoz, Takeda, Thermo Fischer, and Tillots. BES reports medical writing support from AbbVie, Abivax, Bristol Myers Squibb, Celltrion, Janssen (a subsidiary of Johnson & Johnson), Lilly, Merck, Pfizer, and Takeda; institutional grants or contracts from Bristol Myers Squibb and Janssen (a subsidiary of Johnson & Johnson); consulting fees and payment or honoraria and data safety monitoring board or advisory board participation for AbbVie, Abivax, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, Artugen Therapeutics, AstraZeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calibr, Celgene, Celltrion, ClostraBio, Equilium, Enthera, Enveda Biosciences, Evommune, Ferring, Fresenius Kabi, Galapagos, Genentech (Roche), Gilead Sciences, Glaxo SmithKline, Gossamer Bio, Imhotex, Immunyx Pharmaceuticals, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Janssen, Johnson & Johnson, Kaleido, Kallyope, Lilly, Merck, Microbiotics, Mitsubishi Tanabe, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, Palisade Bio, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biopharma, Sanofi, Sorriso Therapeutics, Spyre Therapeutics, Sun Pharma, Surrozen, Takeda, Target RWE, Teva, Theravance Biopharma, TLL Pharmaceutical, Tr1X, Union Therapeutics, and Ventyx Bioscience; meeting attendance and travel support from Janssen, Lilly, Mitsubishi Tanabe, and Pfizer; and stock in Ventyx Bioscience. AD reports consulting and speaker fees from AbbVie, Abivax, Amgen, Arena, Biogen, Bristol Myers Squibb, Celgene (a subsidiary of Bristol Myers Squibb), Celltrion, Falk Foundation, Ferring, Fresenius Kabi, Galapagos, Gilead, High5MD, Janssen, Lilly, Materia Prima, MedToday, Novartis, Pfizer, Pharmacosmos, Roche (a subsidiary of Genentech), Sandoz, Sandoz (a subsidiary of Hexal), Streamed-Up, Takeda, Tillotts, and Vifor and payment for manuscript preparation from Biogen, Falk Foundation, Janssen, Takeda, and Thieme., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)