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Addition of pulse corticosteroids to oral prednisone in moderately active ulcerative colitis: a randomized, multicentre, open-label study by GETECCU

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Llao, J
  • Mañosa, M
  • Martín-Arranz, E
  • Zabana, Y
  • Navarro-Llavat, M
  • Téller, M
  • Garcia-Planella, E
  • Busquets, D
  • Monfort, D
  • Pineda, JR
  • Gutiérrez, A
  • Villoria, A
  • Menchén, L
  • García-Alonso, FJ
  • Rivero, M
  • Chaparro, M
  • de Francisco, R
  • Merino, O
  • Rodríguez-Lago, I
  • Acosta, MBD
  • Rodríguez-Fortúnez, P
  • Rodríguez-Jiménez, C
  • Calafat, M
  • Domènech, E
  • CECUM Study Grp GETECCU

Grupos

Abstract

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.

© The Author(s) 2025. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

Datos de la publicación

ISSN/ISSNe:
1873-9946, 1876-4479

Journal of Crohns & Colitis  OXFORD UNIV PRESS

Tipo:
Article
Páginas:
-
PubMed:
41258993
Factor de Impacto:
2,429 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 1

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Keywords

  • corticosteroids; ulcerative colitis; remission; endoscopy

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