Alimentary pharmacology & therapeutics · 2026
Clinical Trial: Long Versus Short Tapering of Steroids in Steroid Responsive Moderate to Severely Active Ulcerative Colitis-A Randomised Controlled Trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Kumar Ankit, Patil Amol N, Grewal Jyoti, Kumaravel J, Shamim Muhammad Aaqib, Sekar Aravind, Jena Anuraag, Singh Anupam K, Kakkar Ashish, Dutta Usha, Sharma Vishal
Аннотация
BACKGROUND: Appropriate tapering strategy for corticosteroids in ulcerative colitis (UC) is uncertain.
AIM: To compare the efficacy and safety of two steroid tapering regimens in patients with active UC.
METHODS: We randomised patients with active UC with initial steroid response after 2 weeks to short (total 6 weeks) or long taper (total 10 weeks). Randomization was stratified for acute severe UC. The primary outcome was steroid-free clinical remission at 6 months. Secondary outcomes included assessment of symptomatic remission, relapse rate, endoscopic and histological scores, and safety.
RESULTS: Of 94 patients (48 in long, 46 in short taper) randomised, short taper was inferior to long taper in inducing clinical remission at 6 months (RR = 2.19; CI 1.08-4.46; p = 0.02). The relapse rates were similar in the long (37%) and short taper (46%) arms (HR: 0.34; CI: 0.10-1.11; p = 0.42). The median UCEIS scores (3 vs. 2; p = 0.23) and Nancy scores [2 (IQR 0-3) vs. 1.5 (0.75-3); p = 0.4] were not different between arms. Adverse events in the long and short taper arms, such as acne (14.58% vs. 2.16%), myopathy (8.33% vs. 6.52%), skin changes (2.08% vs. 2.17%), mood changes (0% vs. 4.34%), cytopenia (0% vs. 2.17%), and headache (6.25% vs. 6.52%) were similar.
CONCLUSION: A shorter taper duration of 6 weeks was inferior to a longer taper of 10 weeks in achieving clinical remission of UC at 6 months.
TRIAL REGISTRATION: CTRI Number: CTRI/2021/06/034129.
AIM: To compare the efficacy and safety of two steroid tapering regimens in patients with active UC.
METHODS: We randomised patients with active UC with initial steroid response after 2 weeks to short (total 6 weeks) or long taper (total 10 weeks). Randomization was stratified for acute severe UC. The primary outcome was steroid-free clinical remission at 6 months. Secondary outcomes included assessment of symptomatic remission, relapse rate, endoscopic and histological scores, and safety.
RESULTS: Of 94 patients (48 in long, 46 in short taper) randomised, short taper was inferior to long taper in inducing clinical remission at 6 months (RR = 2.19; CI 1.08-4.46; p = 0.02). The relapse rates were similar in the long (37%) and short taper (46%) arms (HR: 0.34; CI: 0.10-1.11; p = 0.42). The median UCEIS scores (3 vs. 2; p = 0.23) and Nancy scores [2 (IQR 0-3) vs. 1.5 (0.75-3); p = 0.4] were not different between arms. Adverse events in the long and short taper arms, such as acne (14.58% vs. 2.16%), myopathy (8.33% vs. 6.52%), skin changes (2.08% vs. 2.17%), mood changes (0% vs. 4.34%), cytopenia (0% vs. 2.17%), and headache (6.25% vs. 6.52%) were similar.
CONCLUSION: A shorter taper duration of 6 weeks was inferior to a longer taper of 10 weeks in achieving clinical remission of UC at 6 months.
TRIAL REGISTRATION: CTRI Number: CTRI/2021/06/034129.