Vedolizumab useful against Crohn's disease in routine practice

Last Updated: 2016-07-01

By David Douglas

NEW YORK (Reuters Health) - Real-world safety and efficacy of vedolizumab in treatment of moderate-to-severe Crohn's disease appears comparable to that seen in clinical trials, according to a new multicenter study.

"These data help to create a better understanding of treatment expectations with vedolizumab in routine practice, which will improve the overall shared decision making process when starting this biologic agent," Dr. Parambir S. Dulai of the University of California, San Diego, in La Jolla, told Reuters Health by email.

"Furthermore," he added, "the risk factors identified for failing to achieve key clinical outcomes (remission and mucosal healing) will allow patients and providers an opportunity to personalize treatment decisions based on their individual probability of responding to therapy."

In a report online June 14 in The American Journal of Gastroenterology, Dr. Dulai and colleagues note that although vedolizumab received FDA approval in 2014 for such use, "uncertainty remains regarding its real-world effectiveness and safety given the strict inclusion criteria employed in clinical trials."

To investigate further, the researchers studied retrospective data on 212 patients from seven medical centers with a median age of 34 years who were followed for a median of 39 weeks after initiation of therapy with the anti-integrin antibody.

The 12-month cumulative rate of clinical remission was 35%. For mucosal healing, it was 63% and for both remission and mucosal healing, it was 26%.

The 90% of patients with prior tumor necrosis factor (TNF)-antagonist therapy were significantly less likely to achieve clinical remission (hazard ratio, 0.40). This was also the case in those with a history of smoking (HR, 0.47), active perianal disease (HR, 0.49) and severe disease activity (HR, 0.54).

Patients with prior TNF-antagonist exposure were also less likely to achieve mucosal healing (HR, 0.29) as were those with severe disease (HR, 0.54).

Serious adverse events or serious infections occurred in up to 10% of patients starting vedolizumab, but, "the majority of these could be readily managed without discontinuation of therapy."

The researchers note that in the GEMINI clinical trials, 39% of patients achieved clinical remission and 32% achieved steroid-free clinical remission by 12 months. In the current study, clinical remission and steroid-free remission were achieved in about 35% of participants.

"Similar to recent observations from the GEMINI trial, we also observed that the effectiveness of vedolizumab was time dependent, and the greatest benefit appeared to be after 6 months of therapy," the team writes.

Thus, the researchers say, "providers should allow a minimum of 6 months to determine treatment response."

The study did not have commercial funding. A number of Dr. Dulai's coauthors reported having financial ties to Takeda, which markets vedolizumab as Entyvio.

SOURCE: http://bit.ly/29gW2zO

Am J Gastroenterol 2016.