TY - JOUR
T1 - Long-term safety of vedolizumab for inflammatory bowel disease
AU - Loftus, Edward V.
AU - Feagan, Brian G.
AU - Panaccione, Remo
AU - Colombel, Jean Frédéric
AU - Sandborn, William J.
AU - Sands, Bruce E.
AU - Danese, Silvio
AU - D’Haens, Geert
AU - Rubin, David T.
AU - Shafran, Ira
AU - Parfionovas, Andrejus
AU - Rogers, Raquel
AU - Lirio, Richard A.
AU - Vermeire, Séverine
N1 - Funding Information:
This study was sponsored by Takeda. Medical writing support was provided by Liz Gooch, PhD, of ProEd Communications, Inc, and was funded by Takeda.
Funding Information:
This study was sponsored by Takeda. The authors thank the patients who participated in this study, their caregivers, and the study investigators and members of the GEMINI LTS study team. The authors thank Harisha Kadali for support with additional analyses of the safety database, and to Liz Gooch, PhD, of ProEd Communications, Inc for medical writing support funded by Takeda.
Publisher Copyright:
© 2020 Takeda Pharmaceuticals USA. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Background: Vedolizumab, a gut-selective α4β7 integrin antibody, is approved for moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). Aim: To report the final results from the vedolizumab GEMINI long-term safety (LTS) study. Methods: The phase 3, open-label GEMINI LTS study (initiated May 2009) enrolled patients with UC or CD from four prior clinical trials and vedolizumab-naïve patients. Vedolizumab LTS was evaluated; efficacy and patient-reported outcomes were exploratory endpoints. Results: Enrolled patients (UC, n = 894; CD, n = 1349) received vedolizumab 300 mg IV every 4 weeks; median cumulative exposure was 42.4 months (range: 0.03-112.2) for UC and 31.5 months (range: 0.03-100.3) for CD. Over 8 years, adverse events (AEs) occurred in 93% (UC) and 96% (CD) of patients, with UC (36%) and CD (35%) exacerbations most frequent. Serious AEs were reported for 31% (UC) and 41% (CD) of patients. Vedolizumab discontinuation due to AEs occurred in 15% (UC) and 17% (CD) of patients. There were no new trends for infections, malignancies, infusion-related reactions, or hepatic events, and no cases of progressive multifocal leukoencephalopathy. Of the ten deaths (UC, n = 4; CD, n = 6), two were considered drug-related by local investigators (West Nile virus infection-related encephalitis and hepatocellular carcinoma). Continuous vedolizumab maintained clinical response long-term, with 33% (UC) and 28% (CD) of patients in clinical remission at 400 treatment weeks. Conclusions: The safety profile of vedolizumab remains favourable with no unexpected or new safety concerns. These results further establish the safety of vedolizumab and support its long-term use (NCT00790933/EudraCT 2008-002784-14).
AB - Background: Vedolizumab, a gut-selective α4β7 integrin antibody, is approved for moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). Aim: To report the final results from the vedolizumab GEMINI long-term safety (LTS) study. Methods: The phase 3, open-label GEMINI LTS study (initiated May 2009) enrolled patients with UC or CD from four prior clinical trials and vedolizumab-naïve patients. Vedolizumab LTS was evaluated; efficacy and patient-reported outcomes were exploratory endpoints. Results: Enrolled patients (UC, n = 894; CD, n = 1349) received vedolizumab 300 mg IV every 4 weeks; median cumulative exposure was 42.4 months (range: 0.03-112.2) for UC and 31.5 months (range: 0.03-100.3) for CD. Over 8 years, adverse events (AEs) occurred in 93% (UC) and 96% (CD) of patients, with UC (36%) and CD (35%) exacerbations most frequent. Serious AEs were reported for 31% (UC) and 41% (CD) of patients. Vedolizumab discontinuation due to AEs occurred in 15% (UC) and 17% (CD) of patients. There were no new trends for infections, malignancies, infusion-related reactions, or hepatic events, and no cases of progressive multifocal leukoencephalopathy. Of the ten deaths (UC, n = 4; CD, n = 6), two were considered drug-related by local investigators (West Nile virus infection-related encephalitis and hepatocellular carcinoma). Continuous vedolizumab maintained clinical response long-term, with 33% (UC) and 28% (CD) of patients in clinical remission at 400 treatment weeks. Conclusions: The safety profile of vedolizumab remains favourable with no unexpected or new safety concerns. These results further establish the safety of vedolizumab and support its long-term use (NCT00790933/EudraCT 2008-002784-14).
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U2 - 10.1111/apt.16060
DO - 10.1111/apt.16060
M3 - Article
C2 - 32876349
AN - SCOPUS:85090160222
SN - 0269-2813
VL - 52
SP - 1353
EP - 1365
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 8
ER -