Vedolizumab for Ulcerative Colitis Works Best When Given Early

More ulcerative colitis patients responded to vedolizumab (Entyvio) when they started it soon after their diagnosis rather than after other therapies, insurance claims data suggested.

Among more than 1,300 patients who received vedolizumab, 88.8% of those who received the drug within 30 days after being diagnosed responded to treatment versus 70.1% to 79.8% when the treatment was delayed until after one or multiple other therapies, reported Noa Krugliak Cleveland, MD, of the University of Chicago Medicine.

Those treated first with corticosteroids, immunomodulators, and aminosalicylates (5-ASA) beforehand had the lowest likelihood of responding to vedolizumab once initiated (odds ratio [OR] 0.30, 95% CI 0.15-0.59), followed by those initially treated with immunomodulators only (OR 0.42, 95% CI 0.19-0.94) and those treated with corticosteroids and immunomodulators (OR 0.46, 95% CI 0.22-0.96), she said at the virtual Crohn's & Colitis Congress (CCC).

There was no significant difference in likelihood of vedolizumab response for patients who first received corticosteroids and 5-ASA (OR 0.51, 95% CI 0.26-1.03), Cleveland added.

Newly diagnosed ulcerative colitis is frequently treated with these conventional therapies, but delaying biologics may result in suboptimal outcomes, according to her presentation.

"There's also some emerging data that is showing ulcerative colitis is progressive, and perhaps by us wasting time or having the disease course go on for a while prior to the initiation of vedolizumab, [it] does have an impact on the treatment response," said Cleveland.

The findings "hopefully will help providers prescribe vedolizumab sooner in the appropriate patients," she added.

CCC session moderator Millie Long, MD, MPH, of the University of North Carolina Health at Chapel Hill, asked if it were possible that some of the newly diagnosed patients included in the study "might have been people who had been stable in remission on vedolizumab, and then changed insurance."

"We did include a washout period of a year in order to ensure patients were not on any biologics previously," Cleveland responded.

For the so-called RALEE study, the researchers used MarketScan's Commercial Claims and Encounters data and Medicare Supplemental data and included 1,342 adults diagnosed with ulcerative colitis from 2017 to 2018 who had at least one vedolizumab claim and 12 months of enrollment before and after their initial diagnosis.

Overall, 89 started on vedolizumab (within 30 days of initial diagnosis; early use group) while the rest had delayed vedolizumab use: 101 received immunomodulators first; 199 received corticosteroids and immunomodulators first; 505 received corticosteroids and 5-ASA initially; and 448 received corticosteroids, immunomodulators, and 5-ASA first.

The main outcome assessed response among early versus delayed vedolizumab. Patients were considered to have responded to treatment if none of the following occurred within 60 days of starting vedolizumab: discontinuation, increased vedolizumab administration, a treatment switch, starting new concomitant corticosteroids, or surgery related to inflammatory bowel disease.

Patients were a median age of 43, and 51% were men. Most were diagnosed in 2017 (86%) and nearly all (96%) had commercial insurance.

Responses to vedolizumab in the delayed group included 70.1% of those who started on corticosteroids, immunomodulators, and 5-ASA; 77.2% of those who first received immunomodulators; 78.4% of those who received corticosteroids and immunomodulators first; and 79.4% of those who first received corticosteroids and 5-ASA.

The researchers acknowledged several limitations to the data, including unmeasured confounders, such as prescribing factors and "relevant patient and/or clinical variables." Also, diagnostic codes may be subject to information and selection bias, and findings are mostly generalizable to patients with commercial insurance, they added.

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