Early vedolizumab treatment uncommon in IBD

In patients with inflammatory bowel disease (IBD), the likelihood of early treatment with vedolizumab is low, a finding that diverts from guideline recommendations, according to a real-world study presented at AIBD 2021.

“In this administrative real-world dataset, fewer than 10 percent of patients with IBD were treated with vedolizumab within 30 days of diagnosis,” noted the authors.

Using the MarketScan commercial and Medicare claims databases between 2017 and 2019, the researchers identified adults (age ≥18 years) with Crohn’s disease (n=103,591) or ulcerative colitis (n=136,315) who had received treatment with vedolizumab. They limited the participants to those continuously enrolled in the same health plan for ≥12 months before the initial IBD diagnostic claim, with ≥1 claim for vedolizumab after the initial IBD diagnosis, and continuously enrolled for ≥12 months before and after their initial diagnosis of either ulcerative colitis or Crohn’s disease. Receipt of vedolizumab, anti-tumour necrosis factor (TNF), or any biologic therapy in the 12 months preceding the index period were grounds for exclusion.

A total of 1,342 patients with ulcerative colitis (median age 43 years, 51 percent male) and 964 patients with Crohn’s disease (median age 45 years, 43.6 percent male) met the inclusion criteria.

Vedolizumab exposure was categorized according to time of exposure and prior treatments. The categories were early vedolizumab (receipt of vedolizumab within 30 days of first IBD diagnostic claim), delayed vedolizumab 1 (receipt of immunomodulators followed by a switch to vedolizumab), delayed vedolizumab 2 (receipt of corticosteroids and immunomodulators before vedolizumab), delayed vedolizumab 3 (receipt of 5-aminosalicylic acid [5-ASA] and corticosteroids before vedolizumab), and delayed vedolizumab 4 (receipt of 5-ASA, corticosteroids, and immunomodulators before vedolizumab).

In this cohort, 6.6 percent of patients with ulcerative colitis and 9.6 percent with Crohn’s disease received early treatment with vedolizumab. [AIBD 2021, abstract P042]

Among patients with ulcerative colitis, 7.5, 14.8, 37.6, and 33.4 percent were categorized as delayed vedolizumab 1, 2, 3, and 4, respectively, while among patients with Crohn’s disease, 19.0, 36.8, 19.0, and 15.6 percent were in those respective categories.

Patients who received early vedolizumab treatment were more likely to be younger than those who received delayed treatment, regardless if they were diagnosed with ulcerative colitis (median age 40 vs 44 years) or Crohn’s disease (median age 43 vs 45 years). Men were also less likely than women to receive early vs delayed vedolizumab, both among those with ulcerative colitis (proportion of men: 46.1 percent [early] vs 51.4 percent [delayed]) or Crohn’s disease (39.8 percent vs 43.9 percent).

There were no between-group differences according to geographic region, type of insurance (commercial vs Medicare), and year of diagnosis.

“Pivotal trials in IBD demonstrate that earlier use of biologics is associated with greater likelihood of response/remission,” noted the authors.

“[However,] multiple studies have identified that in the real world, biologic treatment is often delayed, thereby limiting optimal effectiveness and increasing likelihood of adverse outcomes,” they continued.

“[This real-world study shows that] these findings are distinct from guidelines suggesting vedolizumab may be used earlier, or due to its safety profile, preferentially in older patients at higher risk for infection,” they pointed out.