More than two-thirds of patients with ulcerative colitis treated with a calcineurin inhibitor in combination with Entyvio experienced colectomy-free survival for a year, according to research published in Clinical Gastroenterology and Hepatology.
Laharie, MD, PhD, of the department of gastroenterology and hepatology at the University of Bordeaux, and colleagues wrote that although Entyvio (vedolizumab, Takeda) is used to treat patients with UC, it can take as long as 14 days to reach full efficacy. They wanted to test it in combination with a calcineurin inhibitor — like cyclosporine or tacrolimus — to treat patients with acute severe UC (ASUC).
“Vedolizumab has never been evaluated in the setting of ASUC where a prompt efficacy is needed,” they wrote. “Therefore, a strategy combining a calcineurin inhibitor (cyclosporine or tacrolimus) as an induction therapy with vedolizumab as maintenance could be an attractive approach for UC patients who have failed a treatment with thiopurines and anti-TNF or that have a contra-indication to these drugs.”
Laharie and colleagues reviewed data from 39 patients with active steroid-refractory UC (31 with active severe UC; 36 also failed anti-TNF therapy) taken from 12 referral centers in France. Each patient had received a calcineurin inhibitor as an induction therapy and vedolizumab during maintenance. The outcomes for the study were survival without colectomy, survival without vedolizumab discontinuation and safety.
Laharie and colleagues found that after a median follow-up period of 11 months, 11 patients underwent colectomy (28%), of which six underwent early surgery before week 14. After 12 months, 68% of patients survived without colectomy (95% CI, 53%–84%), and 44% survived without vedolizumab discontinuation (95% CI, 27%–61%).
None of the patients died, and investigators observed four severe adverse events.
Laharie and colleagues wrote that physicians have been reluctant to use vedolizumab in some scenarios because of its delayed efficacy. However, they wrote that their findings show that this combination strategy can be effective and safe in steroid-refractory patients and patients who have failed anti-TNF.
“It can be considered in patients with ASUC or non-severe UC when they are refractory to all conventional therapies, including anti-TNF agents,” they wrote. “The safety profile of this combination will require further investigation.” – by Alex Young
Disclosures: Laharie reports financial ties to AbbVie, Celgene, Ferring, Janssen, MSD, Novartis, Pfizer, Roche and Takeda. Please see the full study for all other authors’ relevant financial disclosures.