Final results from the GEMINI trial revealed that Entyvio had a suitable safety profile for long-term treatment of inflammatory bowel disease, according to data presented at the Congress of the European Crohn’s and Colitis Organisation.
Remo Panaccione, MD, FRCPC, of the University of Calgary in Canada, said that the GEMINI long-term safety trial is the longest study to date of continuous Entyvio (vedolizumab, Takeda) treatment and has provided some unique data about the drug’s therapeutic profile.
“The long-term safety study was a multinational, multicenter, open label, phase 3 study conducted between May 2009 and October 2017 representing patients who had been exposed up to nine years of vedolizumab therapy,” he said during his presentation.
The study comprised 894 patients with ulcerative colitis and 1,349 with Crohn’s disease. All patients previously took at least one conventional therapy. Patients received 300 mg of vedolizumab intravenously every 4 weeks after they completed or withdrew from a phase 2 study, one of the GEMINI phase 3 studies or if they enrolled as a vedolizumab-naive de novo patient. They continued their treatment until the study was completed or lost to follow-up.
Researchers assessed long-term safety of the drug as the primary endpoint and looked at efficacy as an exploratory endpoint.
Investigators observed adverse events in 93% of patients with UC and 96% of patients with CD. Nasopharyngitis and disease exacerbations were the most frequent adverse events. The study did not uncover any new trends for infections, malignancies, infusion-related reactions or hepatic events.
Researchers determined that serious adverse events were reported in 31% of patients with UC and 41% of patients with CD, with disease exacerbation being the most common (13% in UC; 17% in CD). Patients discontinued vedolizumab treatment in 15% of UC cases and 17% of CD cases.
In their assessment of efficacy, Panaccione and colleagues found that patients who continued receiving the drug throughout the study were able to maintain clinical response. However, their analysis was limited because of an expected, protocol-defined patient loss to follow-up.
“Vedolizumab was safe and well-tolerated for long-term treatment of IBD. There was no increased risk in clinical important safety concerns over the long term,” Panaccione said. “[These] final data are consistent with and complement the known safety profile of vedolizumab based on published clinical and other real-world studies.” – by Alex Young
Reference: Vermeire S, et al. Abstract OP26. Presented at: Congress of the European Crohn’s and Colitis Organisation; Mar. 7-9, 2019; Copenhagen.
Disclosure: Panaccione reports serving as a consultant for AbbVie, Allergan, AstraZeneca, Baxter, BMS, Celgene, Centocor, Cubist, Elan, Elsai, Eli Lilly, Ferring, Genentech, Gilead, Glaxo Smith Kline, Janssen, Merck, Pfizer, Robarts, Salix, Samsung, Schering-Plough, Shire, Takeda and UCB. He also reports being on a speaker’s bureau for AbbVie, Abbott, Aptails, AstraZeneca, Ferring, Janssen, Merck, Prometheus, Shire and Takeda. He has also received research/educational support from AbbVie, Abbott, Ferring, Janssen and Takeda. Please see the ECCO disclosure database for all other authors’ relevant financial disclosures.