Four-year maintenance treatment with adalimumab in patients with moderately to
severely active ulcerative colitis: Data from ULTRA 1, 2, and 3.
Author(s): Colombel JF(1), Sandborn WJ(2), Ghosh S(3), Wolf DC(4), Panaccione R(3), Feagan
B(5), Reinisch W(6), Robinson AM(7), Lazar A(8), Kron M(8), Huang B(7), Skup
M(7), Thakkar RB(7).
Affiliation(s): Author information:
(1)Department of Gastroenterology, Icahn School of Medicine at Mt Sinai, New
York, New York, USA. (2)Division of Gastroenterology, Inflammatory Bowel Disease
Center, University of California San Diego, La Jolla, California, USA.
(3)Department of Medicine, Division of Gastroenterology, University of Calgary,
Calgary, Alberta, Canada. (4)Atlanta Gastroenterology Associates, Atlanta,
Georgia, USA. (5)Robarts Research Institute and University of Western Ontario,
London, Ontario, Canada. (6)Department of Medicine, Division of Gastroenterology,
McMaster University, Hamilton, Ontario, Canada. (7)AbbVie, North Chicago,
Illinois, USA. (8)AbbVie Deutschland, Ludwigshafen, Germany.
Publication date & source: 2014, Am J Gastroenterol. , 109(11):1771-80
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.
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