Ustekinumab Effectiveness for Ulcerative Colitis Over Two Years

R Pannacionne et al. AP&T. 2020; https://doi.org/10.1111/apt.16119. Full text link: Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy

Methods: Overall, 399 (adult) “responders to intravenous ustekinumab induction and who were randomised to maintenance therapy were treated in the long‐term extension (115 received subcutaneous placebo, 141 received ustekinumab 90 mg every 12 weeks [q12w], and 143 received ustekinumab 90 mg q8w). Placebo treatment was discontinued at unblinding after week 44”

Key Findings:

  • Symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively ((Intent-to-treat population).
  • At week 44 of maintenance, measures of UC disease activity (eg Mayo scores) were generally comparable among patients randomised to ustekinumab q12w and q8w with 46.1% and 52.4% in clinical remission and 56.7% and 61.5% with endoscopic improvement respectively
  • Among randomised patients treated in the long‐term extension, 78.7% and 83.2% of patients receiving q12w and q8w, respectively, attained symptomatic remission at week 92; >95% of patients in symptomatic remission at week 92 were corticosteroid‐free
  • No new safety signals were observed
Steroid-free Remission (Intent-to-treat population)

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