Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ULTRA 1, 2, and 3

Jean-Frederic Colombel, William J Sandborn, Subrata Ghosh, Douglas C Wolf, Remo Panaccione, Brian Feagan, Walter Reinisch, Anne M Robinson, Andreas Lazar, Martina Kron, Bidan Huang, Martha Skup, Roopal B Thakkar

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Abstract

OBJECTIVES: The safety and efficacy of adalimumab for patients with moderately to severely active ulcerative colitis (UC) has been reported up to week 52 from the placebo-controlled trials ULTRA (Ulcerative Colitis Long-Term Remission and Maintenance with Adalimumab) 1 and 2. Up to 4 years of data for adalimumab-treated patients from ULTRA 1, 2, and the open-label extension ULTRA 3 are presented.

METHODS: Remission per partial Mayo score, remission per Inflammatory Bowel Disease Questionnaire (IBDQ) score, and mucosal healing rates were assessed in adalimumab-randomized patients from ULTRA 1 and 2 up to week 208. Corticosteroid-free remission was assessed in adalimumab-randomized patients who used corticosteroids at lead-in study baseline. Maintenance of remission per partial Mayo score and mucosal healing was assessed in patients who entered ULTRA 3 in remission per full Mayo score and with mucosal healing, respectively. As observed, last observation carried forward (LOCF) and nonresponder imputation (NRI) were used to report efficacy. Adverse events were reported for any adalimumab-treated patient.

RESULTS: A total of 600/1,094 patients enrolled in ULTRA 1 or 2 were randomized to receive adalimumab and included in the intent-to-treat analyses of the studies. Of these, 199 patients remained on adalimumab after 4 years of follow-up. Rates of remission per partial Mayo score, remission per IBDQ score, mucosal healing, and corticosteroid discontinuation at week 208 were 24.7%, 26.3%, 27.7% (NRI), and 59.2% (observed), respectively. Of the patients who were followed up in ULTRA 3 (588/1,094), a total of 360 patients remained on adalimumab 3 years later. Remission per partial Mayo score and mucosal healing after ULTRA 1 or 2 to year 3 of ULTRA 3 were maintained by 63.6% and 59.9% of patients, respectively (NRI). Adverse event rates were stable over time.

CONCLUSIONS: Remission, mucosal healing, and improved quality of life were maintained in patients with moderately to severely active UC with long-term adalimumab therapy, for up to 4 years. No new safety signals were reported.

Original languageEnglish
Pages (from-to)1771-1780
Number of pages10
JournalThe American Journal of Gastroenterology
Volume109
Issue number11
Early online date26 Aug 2014
DOIs
Publication statusPublished - Nov 2014

Keywords

  • Adalimumab
  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal, Humanized
  • Colitis, Ulcerative
  • Double-Blind Method
  • Female
  • Humans
  • Maintenance Chemotherapy
  • Male
  • Quality of Life
  • Remission Induction
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha
  • Clinical Trial, Phase III
  • Journal Article
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

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