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Comparative Study
. 2024 Nov 4;18(11):1863-1869.
doi: 10.1093/ecco-jcc/jjae092.

Adaptive Steroid Tapering Impedes Corticosteroid-free Remissions Compared with Forced Tapering in Clinical Trials of Ulcerative Colitis

Neeraj Narula  1 , Hasan Hamam  1 , Jasmine Liu  1 , Emily C L Wong  1 , John K Marshall  1 , Vipul Jairath  2 , Stephen B Hanauer  3 , Walter Reinisch  4 , Parambir S Dulai  3
Affiliations
Comparative Study

Adaptive Steroid Tapering Impedes Corticosteroid-free Remissions Compared with Forced Tapering in Clinical Trials of Ulcerative Colitis

Neeraj Narula et al. J Crohns Colitis. .

Abstract

Introduction: It is unclear if steroid tapering protocols can affect clinical trial outcomes in ulcerative colitis [UC], particularly fixed versus adaptive steroid tapering. Fixed steroid tapering involves incremental dose decreases at prespecified intervals, and adaptive steroid tapering uses investigator discretion as determined by the patient's response.

Methods: In this post-hoc analysis from six clinical trials of UC [VARSITY, ACT 1, PURSUIT, GEMINI1, OCTAVE, and ULTRA2], responders to induction therapy with baseline corticosteroid use were considered as the primary population of interest. Adjustments were made to account for treat-through versus re-randomisation designs, and multivariate regression was performed to account for other potential confounding variables. The primary outcome was corticosteroid-free clinical remission [CR] at 1 year, and secondary outcomes were CR and endoscopic improvement.

Results: There was a total of 861 patients who had achieved clinical response after induction and were using corticosteroids. Within multivariate analysis, patients using adaptive steroid tapering regimens were less likely to achieve corticosteroid-free CR at 1 year (odds ratio [OR] 0.66 [95% confidence interval, CI, 0.48-0.92], p = 0.015) but had increased odds for achieving CR at 1 year (OR 1.9 [95% CI 1.43-2.52], p < 0.001). The steroid tapering regimen was not associated with achievement of endoscopic improvement at 1 year.

Conclusions: Among patients with UC on corticosteroids in clinical trials, patients using adaptive steroid weaning regimens were less likely to achieve corticosteroid-free CR at 1 year but more likely to achieve CR at 1 year. Consideration should be given to implementing mandatory fixed steroid weaning protocols in future clinical trials of UC.

Keywords: Corticosteroid; steroid; ulcerative colitis; weaning.

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Conflict of interest statement

NN has received honoraria from Janssen, Abbvie, Takeda, Pfizer, Sandoz, Novartis, Iterative Health, Innomar Strategies, Fresinius Kabi, Amgen, Organon, Eli Lilly, and Ferring. PSD has received research support, consulting, and/or speaker fees from Abbvie, Abivax, Adiso, Bristol Meyers Squibb, GSK, Janssen, Lilly, Pfizer, Roivant, Takeda; and royalties from University of California San Diego. JKM has receive consulting and/or speaking fees from AbbVie, Alimentiv, Amgen, Astra Zeneca, Bausch Health, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, Lilly, Lupin, Organon, Paladin, Pfizer, Pharmascience, Qu Biologics, Roche, Sandoz, SCOPE, Takeda, Teva, Viatris. WR has served as a speaker for AbbVie, Celltrion, Falk Pharma GmbH, Ferring, Janssen, Galapagos Medice, MSD, Roche, Pfizer, Pharmacosmos, Shire, Takeda, Therakos; as a consultant for AbbVie, Amgen, AOP Orphan, Arena Pharmaceuticals, Astellas, Astra Zeneca, Bioclinica, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celgene, Celltrion, Eli Lilly, Falk Pharma GmbH, Ferring, Galapagos, Gatehouse Bio, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Janssen, Landos Biopharma, Medahead, MedImmune, Microbiotica, Mitsubishi Tanabe Pharma Corporation, MSD, Novartis, OMass, Otsuka, Parexel, Periconsulting, Pharmacosmos, Pfizer, Protagonist, Provention, Quell Therapeutics, Sandoz, Seres Therapeutics, Setpointmedical, Sigmoid, Sublimity, Takeda, Teva Pharma, Therakos, Theravance, Zealand; as an advisory board member for AbbVie, Amgen, Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Galapagos, Janssen, Mitsubishi Tanabe Pharma Corporation, MSD, Pharmacosmos, Pfizer, Sandoz, Takeda; and has received research funding from AbbVie, Janssen, MSD, Sandoz, Sanofi, Takeda. VJ has received consulting/advisory board fees from AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Avoro Capital, Bristol Myers Squibb, Celltrion, Eli Lilly, Endpoint Health, Enthera, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, Gilde Healthcare, GlaxoSmithKline, Genentech, Gilead, Innomar, JAMP, Janssen, Merck, Metacrine, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus Biosciences, Reistone Biopharma, Roche, Roivant, Sandoz, SCOPE, Second Genome, Sorriso, Takeda, TD Securities, Teva, Topivert, Ventyx, Vividion; speaker’s fees from Abbvie, Ferring, Bristol Myers Squibb, Galapagos, Janssen Pfizer Shire, Takeda, Fresenius Kabi. SBH declares potential conflicts of interest including: Abbvie consultant, Clinical Research [Institution], speaker,; Amgen consultant, Clinical Research [Institution]; Boehringer-Ingelheim consultant; BMS consultant, DSMB; Celltrion consultant; Fresnius-Kabi consultant; Genentech consultant, Clinical Research, [Institution]; Gilead consultant, Clinical Research [Institution]; Gossamer DSMB, GSK consultant, Clinical Research [Institution]; Immunic consultant; Intercept Pharmaceiticals; Janssen consultant, Clinical Research [Institution], speaker; Lilly consultant, Clinical Research [Institution]; Merck consultant; Novartis consultant, Clinical Research [Institution]; Organon consultant; Pfizer consultant, Clinical Research [Institution], Speaker; Progenity consultant; Prometheus consultant, Clinical Research [Institution]; Protagonist consultant, DSMB; Receptos consultant, Clinical Research [Institution]; Salix consultant; Samsung Bioepis consultant; Seres Therapeutics consultant, Clinical Research [Institution]; Takeda consultant, Clinical Research [Institution], speaker; UCB consultant, Clinical Research [Institution]; Ventyx DSMB VHsquared consultant. No other authors have any relevant conflicts of interest.

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