Clinical Trial: Long Versus Short Tapering of Steroids in Steroid Responsive Moderate to Severely Active Ulcerative Colitis—A Randomised Controlled Trial
Ankit Kumar, Amol N. Patil, Jyoti Grewal, J Kumaravel, Muhammad Aaqib Shamim, Aravind Sekar, Anuraag Jena, Anupam K. Singh, Ashish Kumar Kakkar, Usha Dutta, Vishal Sharma
Abstract
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.