Long-term Efficacy of Vedolizumab for Ulcerative Colitis

Loftus, Edward V.; Colombel, Jean–Frédéric; Feagan, Brian G.; Vermeire, Séverine; Sandborn, William J.; Sands, Bruce E.; Danese, Silvio; D’Haens, Geert R.; Kaser, Arthur; Panaccione, Remo; Rubin, David T.; Shafran, Ira; McAuliffe, Megan; Kaviya, Arpeat; Sankoh, Serap; Mody, Reema; Abhyankar, Brihad; Smyth, Michael

doi:10.1093/ecco-jcc/jjw177

Cited by 134 publications

(157 citation statements)

References 27 publications

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“…Notably, the associated GEMINI inclusion criteria stipulated that patients with a prior history of malignancy were not eligible for participation. These trials, and the LTS study (using a June 2013 data cut‐off), have been described previously . In the LTS study, patients randomised to vedolizumab in GEMINI 1, GEMINI 2 and GEMINI 3 continued to receive vedolizumab, whereas patients randomised to placebo switched to vedolizumab.…”

Section: Methodsmentioning

confidence: 99%

Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post‐marketing data

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Ungaro

Bhayat

et al. 2019

Aliment Pharmacol Ther

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Summary Background Vedolizumab is a gut‐selective antibody to α4β7 integrin approved to treat moderate‐to‐severe Crohn's disease and ulcerative colitis in adults. Inflammatory bowel disease (IBD) and immunosuppressant use are associated with increased risk of malignancy. Aim To analyse the incidence of malignancy with vedolizumab treatment in the GEMINI long‐term safety (LTS) study and post‐marketing (PM) setting. Methods Malignancy data from the LTS study (May 2009 to May 2018), and data from the vedolizumab Global Safety Database (20 May 2014 to 19 May 2018), were identified using Medical Dictionary for Regulatory Activities coding. The number of patients experiencing malignancies in the LTS study (excluding malignancies within 1 year following vedolizumab initiation) was indirectly standardised against the number expected, using age‐ and sex‐specific rates in patients with IBD from Optum's Clinformatics™ Data Mart (CDM) database. Results Among 1785 patients with ≥1 year of follow‐up post‐vedolizumab initiation in the LTS study (total 5670 patient‐years), observed numbers of malignancies were similar to those expected compared with CDM data (31 vs 29; ratio of observed to expected events = 1.08; P = 0.71; 95% confidence intervals [CI] 0.73, 1.53). The most common malignancies were renal and bladder (6). PM, 293 patients reported 299 malignancies (including malignancies within 1 year following vedolizumab initiation), in approximately 208 050 patient‐years of vedolizumab exposure. Lower gastrointestinal malignancies were most common (59). Conclusions The number of malignancies in the LTS study was similar to that expected from an IBD population with no statistically significant differences, although few confounders could be corrected for. Limitations of PM safety reporting require consideration; however, the number of malignancies with vedolizumab appeared low.

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Section: Methodsmentioning

confidence: 99%

Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post‐marketing data

Card

Ungaro

Bhayat

et al. 2019

Aliment Pharmacol Ther

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“…There is evidence for an exposure–efficacy relationship for vedolizumab induction therapy 2. Increasing dosing frequency of vedolizumab to every 4 weeks leads to an improvement in clinical response in both ulcerative colitis (UC)3 and Crohn’s disease (CD) 4. In contrast to anti-tumour necrosis factor (TNF) agents, the correlation between the response to dose optimisation and changes in the pharmacokinetic profile of vedolizumab-treated patients remains unknown.…”

mentioning

confidence: 99%

Early changes in the pharmacokinetic profile of vedolizumab-treated patients with IBD may predict response after dose optimisation

Gouynou

Pouillon²,

Rousseau

et al. 2018

Gut

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“…When data were analyzed conservatively, with incomplete data considered to represent treatment failures, the clinical remission for CD (GEMINI 2) was 71, 69, and 43% at weeks 52, 104, and 152, respectively . For UC (GEMINI 1), clinical remission was 74, 78, and 46% at week 52, 104, and 152, respectively . Anti‐TNF‐naïve patients responded better to vedolizumab compared with anti‐TNF‐experienced CD patients .…”

Section: Vedolizumabmentioning

confidence: 99%

A review of vedolizumab and ustekinumab for the treatment of inflammatory bowel diseases

et al. 2018

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Recent advancement in the understanding of the pathophysiology of inflammatory bowel disease has seen an expansion in therapeutic options. Vedolizumab, a selective α4β7 inhibitor, and ustekinumab, an IL 12/23 p40 inhibitor, have provided the much‐awaited out‐of‐class alternatives for patients who have failed or who are intolerant to anti‐Tumor Necrosis Factor (TNF) therapy. However, questions remain as to how we may best use these novel therapeutic agents. We evaluate the evidence available from randomized controlled trials and postmarketing cohort studies and discuss their safety, efficacy, and limitations, in relation to anti‐TNF therapy, in optimizing the treatment outcomes.

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Long-term Efficacy of Vedolizumab for Ulcerative Colitis

Abstract: Patients with UC experienced clinical and HRQL improvements with continued vedolizumab treatment. Increased dosing frequency to every 4 weeks was beneficial in patients who had loss of response to 8-weekly dosing.

Cited by 134 publications

References 27 publications

Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post‐marketing data

Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post‐marketing data

Early changes in the pharmacokinetic profile of vedolizumab-treated patients with IBD may predict response after dose optimisation

A review of vedolizumab and ustekinumab for the treatment of inflammatory bowel diseases

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