Practical Primer Addressing Real-World Use Scenarios of Subcutaneous Vedolizumab in Ulcerative Colitis and Crohn's Disease: Post Hoc Analyses of VISIBLE Studies.

Background: Vedolizumab, an anti-α ₄ β ₇ integrin approved for intravenous (IV) treatment of moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), was evaluated as a subcutaneous (SC) formulation in maintenance therapy for UC and CD in phase 3 VISIBLE 1, 2, and open-label extension studies, and recently approved in Europe, Australia, and Canada. Our aim was to evaluate efficacy and safety of IV and SC vedolizumab in clinically relevant UC and CD scenarios.
Methods: Post hoc data analyses from VISIBLE trials examined: (1) whether baseline characteristics predict clinical response to 2 vs 3 IV vedolizumab induction doses; (2) efficacy and safety of switching during maintenance vedolizumab IV to SC in patients with UC; (3) vedolizumab SC after treatment interruption of 1-46 weeks; (4) increasing dose frequency of vedolizumab SC from every 2 weeks (Q2W) to every week (QW) after disease worsening.
Results: No baseline characteristics were identified as strong predictors of response to 2 vs 3 vedolizumab infusions. Most patients achieved clinical response after 2 or 3 doses of IV vedolizumab maintained with SC treatment. Clinical remission and response rates were maintained in patients transitioned from maintenance vedolizumab IV to SC treatment. Of patients with UC, ≥75% achieved response following resumption after dose interruption. Escalation to QW dosing resulted in ≥45% of patients regaining response after loss while receiving vedolizumab Q2W.
Conclusions: Clinical real-world scenarios with vedolizumab SC were reviewed using VISIBLE studies data. Vedolizumab SC provides an additional dosing option for patients with UC and CD.
Competing Interests: E.V.L. has received consulting fees from AbbVie, Alvotech, Amgen, Arena Pharmaceuticals, Avalo Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, CALIBR, Celgene, Celltrion, Eli Lilly and Company, Fresenius Kabi, Genentech, Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Iota Biosciences, Iterative Scopes, Janssen, KSL Diagnostics, Morphic, Ono Pharma, Pfizer, Protagonist, Scipher Medicine, Sun Pharma, Surrozen, Takeda, and UCB; and research support from AbbVie, Alimentiv Inc., Bristol Myers Squibb, Celgene, Genentech, Gilead Sciences, Gossamer Bio, Janssen, Pfizer, Receptos, Takeda, Theravance Biopharma, and UCB. GD has served as an advisor for AbbVie, Ablynx, Alimentiv Inc., Allergan, Alphabiomics, Amakem, Amgen, AM Pharma, Applied Molecular Therapeutics, Arena Pharmaceuticals, AstraZeneca, Avaxia, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene/Receptos, Celltrion, Cosmo Pharmaceuticals, DSM Pharma, Echo Pharmaceuticals, Eli Lilly and Company, Engene, Exeliom Biosciences, Ferring, Dr FALK Pharma, Galapagos, Genentech/Roche, Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Hospira/Pfizer, Immunic, Johnson & Johnson, Kintai Therapeutics, Lycera, Medimetrics, Millennium/Takeda, Medtronics, Mitsubishi Pharma, Merck Sharp & Dohme, Mundipharma, Nextbiotics, Novo Nordisk, Otsuka, Photopill, ProciseDx, Prodigest, Prometheus Laboratories/Nestle, Progenity, Protagonist Therapeutics, RedHill Biopharma, Salix, Samsung Bioepis, Sandoz, Seres/Nestle, SetPoint Medical, Shire, Teva, TiGenix, Tillotts Pharma, Topivert, Versant, and Vifor. D.C.W. has received research support and consulting fees from AbbVie, Arena, Bristol Myers Squibb, Genentech, Janssen, Lilly, and Takeda. WJS reports research grants from AbbVie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Eli Lilly and Company, Pfizer, Prometheus Biosciences, Seres Therapeutics, Shire, Takeda, and Theravance Biopharma; consulting fees from AbbVie, Abivax, Admirx, Alfasigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Alivio Therapeutics, Allakos, Amgen, Applied Molecular Transport, Arena Pharmaceuticals, Bausch Health (Salix), Beigene, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Celgene, Celltrion, Cellularity, Cosmo Pharmaceuticals, Escalier Biosciences, Equillium, Forbion, Genentech/ Roche, Gilead Sciences, Glenmark Pharmaceuticals, Gossamer Bio, Immunic (Vital Therapies), Index Pharmaceuticals, Intact Therapeutics, Janssen, Kyverna Therapeutics, Landos Biopharma, Eli Lilly and Company, Oppilan Pharma, Otsuka, Pandion Therapeutics, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, Provention Bio, Reistone Biopharma, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shire, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tillotts Pharma, UCB, Vendata Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vivreon Biosciences, and Zealand Pharma; stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma, Prometheus Biosciences, Prometheus Laboratories Progenity, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Biosciences; and is an employee at Shoreline Biosciences. S.D. reports research support, fees, or other support from AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly and Company, Enthera, Ferring Pharmaceuticals, Gilead Sciences, Hospira, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB Inc., and Vifor. J.C., S.M.U., N.C., and K.K. are employees of Takeda Pharmaceuticals U.S.A., Inc., and have stock or stock options in that company. KL was employed by Takeda during analysis and manuscript development and has stock or stock options in that company.
(© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)