Journal of Crohn's & colitis · 2025
Addition of pulse corticosteroids to oral prednisone in moderately active ulcerative colitis: a randomized, multicentre, open-label study by GETECCU.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Llaó Jordina, Mañosa Míriam, Martín-Arranz Eduardo, Zabana Yamile, Navarro-Llavat Mercè, Téller Marta, Garcia-Planella Esther, Busquets David, Monfort David, Pineda Juan-Ramón, Gutiérrez Ana, Villoria Albert, Menchén Luis, Bastida Guillermo, García-Alonso Francisco Javier, Rivero Montserrat, Chaparro María, de Francisco Ruth, Merino Olga, Rodríguez-Lago Iago, Barreiro-de Acosta Manuel, Rodríguez-Fortúnez Patricia, Rodríguez-Jiménez Consuelo, Calafat Margalida, Domènech Eugeni, CECUM study group of the GETECCU
Аннотация
BACKGROUND: Oral corticosteroids remain the treatment of choice for moderately active ulcerative colitis (UC), achieving clinical remission in 30%-60% of patients.
OBJECTIVE: To compare the rates of steroid-free clinical-endoscopic remission at weeks 8 and 54 in patients treated with 3 methyl-prednisolone pulses before oral corticosteroids in moderately active UC versus those only receiving oral corticosteroids.
DESIGN: Prospective, open, multicentre, randomized, controlled trial. Patients with left/extensive, moderately active UC, naive to immunosuppressants and biological agents, were randomized to receive conventional treatment (CT) with oral prednisone 60 mg/day or the same regimen preceded by an additional daily pulse (AP) of 500 mg of methyl-prednisolone for 3 days. All patients who responded started oral mesalazine and were followed up until month 12 or clinical relapse.
RESULTS: Seventy-five patients were randomized: 39 were allocated to the CT arm and 36 to the AP arm. Overall, 21 patients achieved clinical-endoscopic remission (28%; 95% confidence interval [CI]: 23%-33%) at both weeks 8 and 54 without needing rescue treatments, being not significantly different between both study groups (23% [95%CI: 14%-32%] CT vs. 33% [95%CI: 21%-45%] AP; P = 0.323). Patients in the AP group had higher rates of clinical response at day 3 and remission at day 7. No significant differences in adverse events were observed. Due to early termination, the study was underpowered, and findings should be interpreted as exploratory.
CONCLUSIONS: The addition of 3 pulses of high-dose corticosteroids to a conventional regimen of oral prednisone does not improve medium and long-term clinical outcomes in moderately active UC.
TRIAL REGISTRATION CODES: EudraCT number 2016-001170-15; ClinicalTrials.gov identifier NCT02921555.
OBJECTIVE: To compare the rates of steroid-free clinical-endoscopic remission at weeks 8 and 54 in patients treated with 3 methyl-prednisolone pulses before oral corticosteroids in moderately active UC versus those only receiving oral corticosteroids.
DESIGN: Prospective, open, multicentre, randomized, controlled trial. Patients with left/extensive, moderately active UC, naive to immunosuppressants and biological agents, were randomized to receive conventional treatment (CT) with oral prednisone 60 mg/day or the same regimen preceded by an additional daily pulse (AP) of 500 mg of methyl-prednisolone for 3 days. All patients who responded started oral mesalazine and were followed up until month 12 or clinical relapse.
RESULTS: Seventy-five patients were randomized: 39 were allocated to the CT arm and 36 to the AP arm. Overall, 21 patients achieved clinical-endoscopic remission (28%; 95% confidence interval [CI]: 23%-33%) at both weeks 8 and 54 without needing rescue treatments, being not significantly different between both study groups (23% [95%CI: 14%-32%] CT vs. 33% [95%CI: 21%-45%] AP; P = 0.323). Patients in the AP group had higher rates of clinical response at day 3 and remission at day 7. No significant differences in adverse events were observed. Due to early termination, the study was underpowered, and findings should be interpreted as exploratory.
CONCLUSIONS: The addition of 3 pulses of high-dose corticosteroids to a conventional regimen of oral prednisone does not improve medium and long-term clinical outcomes in moderately active UC.
TRIAL REGISTRATION CODES: EudraCT number 2016-001170-15; ClinicalTrials.gov identifier NCT02921555.