Vedolizumab Is Safe Long-Term for Ulcerative Colitis and Crohn Disease

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Alimentary Pharmacology and Therapeutics reports on the final results from the GEMINI long-term safety study on vedolizumab, a gut-selective α4 β7 integrin antibody approved for moderately to severely active ulcerative colitis and Crohn disease.

Vedolizumab is safe and efficacious for as long as 9 years in patients with moderately to severely active ulcerative colitis (UC) and Crohn disease (CD), according to study results in Alimentary Pharmacology and Therapeutics.

The final results from the phase 3, open-label GEMINI long-term safety (LTS) study included patients with UC or CD from 4 previous clinical trials as well as vedolizumab-naive patients. A total of 894 patients with UC and 1349 with CD received vedolizumab, a gut-selective α4β7 integrin antibody, 300 mg IV every 4 weeks. Participants with UC had a median cumulative exposure of 42.4 (range, 0.03-112.2) months, and participants with CD had a median cumulative exposure of 31.5 (range, 0.03-100.3) months.

Among patients with UC, the mean age was 41.2 plus or minus 13.6 years (58.4% male; 85.2% White), with a mean disease duration of 8.1 plus or minus 7 years. For participants with CD, the mean age was 37.8 plus or minus 12.7 years (44.9% male; 90.4% white), with a mean disease duration of 10.1 plus or minus 8.3 years.

During an 8-year period, 93% of patients in the UC group and 96% of patients in the CD group experienced adverse events (AEs), with exacerbations of UC (36%) and CD (35%) the most frequently occurring event; 31% in the UC group reported serious AEs, as did 41% in the CD group. Vedolizumab discontinuation because of AEs occurred in 15% of patients with UC and 17% of patients with CD. A total of 10 deaths occurred (4 with UC; 6 with CD), of which 2 were considered drug-related.

“There were no new trends for infections, malignancies, infusion-related reactions, or hepatic events, and no cases of progressive multifocal leukoencephalopathy,” noted the study authors.

Continuous vedolizumab maintained clinical response long term, with 33% of the UC group and 28% of the CD group in clinical remission at 400 treatment weeks, according to the investigators.

“GEMINI LTS demonstrated that continuous vedolizumab treatment was efficacious over the long term (in some patients for as long as 9 years) in patients with UC or CD,” stated the researchers.

Study limitations include potential bias in a nonblinded, nonrandomized, uncontrolled study, and only patients up to age 65 years were initially enrolled.

“[T]he final analysis of GEMINI LTS comprehensively demonstrates that vedolizumab therapy has a safety and tolerability profile suitable for long-term treatment of patients with moderately to severely active UC or CD,” stated the researchers. “This is a key consideration in the management of [inflammatory bowel diseases] given that they are chronic conditions that typically require lifelong therapy.”

Disclosures: This study was sponsored by Takeda Pharmaceuticals North America, Inc.. Some of the authors reported affiliations with the pharmaceutical industry. Please see the original reference for a full list of disclosures.

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Loftus EV, Feagan BG, Panaccione R, et al. Long-term safety of vedolizumab for inflammatory bowel disease. Published online September 2, 2020. Aliment Pharmacol Ther. doi: 10.1111/apt.16060