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Long-term adalimumab therapy maintained remission, mucosal healing, QOL in UC patients
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Long-term adalimumab maintenance therapy was found to be effective in maintaining disease remission, promoting mucosal healing and improving quality of life in patients with ulcerative colitis in recent clinical trials.
William J. Sandborn
William J. Sandborn, MD, division of gastroenterology, Inflammatory Bowel Disease Center, University of California, San Diego, and colleagues evaluated the safety and efficacy of long-term adalimumab therapy in patients with moderately to severely active ulcerative colitis (UC). Researchers used data from the phase 3 placebo-controlled ULTRA 1 and 2 and open-label extension ULTRA 3 trials to assess remission and mucosal healing, quality of life (QOL) improvements and reductions in hospitalization in 600 patients. They were randomly assigned adalimumab and followed up to 208 weeks.
At year 4, remission rates were 24.7%, and mucosal healing was achieved in 27.7% when assessed using a conservative nonresponder imputation (NRI) methodology. An estimated 60% of patients who entered ULTRA 3 and had year-1 remission and mucosal healing maintained both at year 4, also assessed by NRI. The researchers observed no new safety concerns, and adverse events declined or remained stable over time. Work Productivity and Activity Impairment questionnaire scores decreased from ULTRA 2 baseline through week 208 representing improved QOL, and hospitalization rates were lower in ULTRA 3.
“Prolonged adalimumab treatment for up to 4 years is well tolerated and is beneficial for patients with moderately to severely active UC in maintaining remission and mucosal healing,” the researchers wrote. “The improvement in [QOL], work productivity, and low hospitalization and colectomy rates support the benefit of long-term adalimumab therapy in a patient population who failed conventional therapy and/or previous anti-TNF therapy.”
Disclosure: See the study for a full list of relevant financial disclosures.
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