Ulcerative Colitis Resource Center

Ulcerative Colitis Resource Center

Disclosures: Danese reports receiving lecture fees from and serving as a consultant for AbbVie, Allergan, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Hospira, Johnson & Johnson, Merck, MSD, Mundipharma, Pfizer, Sandoz, Takeda, TiGenix and UCB.
November 24, 2020
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Entyvio shows high patient persistence after dose frequency reduction

Disclosures: Danese reports receiving lecture fees from and serving as a consultant for AbbVie, Allergan, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Hospira, Johnson & Johnson, Merck, MSD, Mundipharma, Pfizer, Sandoz, Takeda, TiGenix and UCB.
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Patients with inflammatory bowel disease who reduced the frequency of Entyvio dosing showed high persistence and low rates of relapse, according to study results.

“The [Entyvio (vedolizumab, Takeda)] extended access program (XAP) was initiated to monitor ongoing safety and to provide continued access to vedolizumab for patients who participated in the GEMINI LTS and VERSIFY studies and who were benefiting from vedolizumab maintenance therapy but did not have access to commercial vedolizumab,” Silvio Danese, MD, PhD, head of the IBD Center at Humanitas University, Milan, Italy, and colleagues wrote. “This 2-year data analysis now reports treatment persistence of patients with ulcerative colitis or CD on every-8-week dosing following the reduction of dosing frequency, the incidence of relapse, and safety results up to 2 years after enrolment in the XAP from GEMINI LTS.”

After rollover from GEMINI LTS, researchers enrolled 142 patients with UC and 169 with Crohn’s disease who were experiencing continued benefit from vedolizumab. These patients reduced their dosing frequency from every 4 weeks to every 8 weeks.

Investigators assessed patient persistence after dose frequency reduction, incidence of relapse and safety 2 years after enrollment.

At baseline, 93.7% of patients with UC and 89.3% of patients with CD were in clinical remission. At enrollment, 93% of patients with UC and 84.6% of patients with CD reduced dosing frequency.

Among patients with UC who reduced their dosing frequency, 93.9% remained on that reduced frequency, while 6.1% re-escalated to every 4 weeks. In patients with CD, 91.6% remained and 8.4% re-escalated.

Researchers found that 9.1% of patients with UC and 14% with CD experienced relapse after reducing their dosing frequency. However, adverse events related to vedolizumab were not sporadic, and investigators observed no new safety events.

“Overall, this 2-year data analysis suggests the reduction of vedolizumab dosing frequency to every 8 weeks is a safe and clinically relevant long-term treatment strategy in patients with well controlled UC or CD,” Danese and colleagues wrote. “High treatment persistence together with low rates of relapse in patients on every-8-weeks dosing may help inform physician decisions on necessary dose adjustments in patients with UC or CD treated with vedolizumab.”