Real-world practice data show that less than 10% of patients with inflammatory bowel disease (IBD) receive early treatment with monoclonal antibody vedolizumab, despite better outcomes with earlier initiation. That said, earlier initiation of vedolizumab appears to be more common in younger patients and women, according to the study findings.
Previous research supports the early use of biologics in the management of IBD, given findings that show earlier treatment is associated with increased likelihood of response and remission compared with delayed management. In actual clinical practice, biologic agents are often delayed, potentially contributing to suboptimal outcomes and increased risks of IBD-associated adverse effects.
In a real-world study presented during the 2021 Advances in Inflammatory Bowel Diseases (AIBD) meeting by Maja Kuharic, a PhD candidate at the University of Illinois at Chicago, researchers assessed administrative datasets to gauge the timing of vedolizumab utilization in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC).
Data from the 2017 to 2019 MarketScan commercial and Medicare claims databases were examined in the study. Patients with continuous enrollment in the same health plan for 12 months or longer both before and after their initial IBD diagnosis were included. Additionally, the analysis included patients with 1 or more vedolizumab claim following the index IBD diagnosis.
A total of five treatment pathways were predefined for the study. First, early vedolizumab use was defined as treatment with the monoclonal antibody therapy within 30 days of the first IBD diagnostic claim. A “delayed vedolizumab 1” initiation group was defined as initial treatment with immunomodulators followed by switching to vedolizumab. Additionally, “delayed vedolizumab 2” was defined by initial utilization of corticosteroids with immunomodulators prior to vedolizumab initiation. “Delayed vedolizumab 3” was characterized by the initial use of 5-aminosalicylic acid (5-ASA) with corticosteroids before vedolizumab. Finally, “delayed vedolizumab 4” was defined by the use of 5-ASA with corticosteroids and immunomodulators before vedolizumab.
The real-world cohort study included 1,342 patients with UC (median age, 43 years; 51.0% male) and 964 patients with CD (median age, 45 years; 43.6% male) who received vedolizumab. Early vedolizumab initiation was observed in 6.6% of patients with UC and 9.6% of patients with CD. In the UC population, the proportions of patients classified in the delayed vedolizumab 1, 2, 3, and 4 groups were 7.5%, 14.8%, 37.6%, and 33.4%, respectively. Among the CD group, the proportions of patients in each delayed vedolizumab arms were 19.0%, 36.8%, 19.0%, and 15.6%, respectively.
In the UC cohort, patients who experienced early vedolizumab initiation had a median younger age than those in the delayed groups (40 vs. 44 years, respectively). Additionally, the proportion of men was lower in the early vedolizumab cohort (46.1% vs. 51.4%). Similar findings were observed in the CD group: those who initiated vedolizumab earlier had a lower median age (43 vs. 45 years) and were less frequently men (39.8%% vs. 43.9%).
Across both treatment indications, there were no clinically meaningful differences between treatment groups in terms of geographic location, payer type (that is, commercial vs. Medicare), or year of diagnosis.
According to Jean-Frederic Colombel, MD, who was asked to comment on the study, a limitation of the findings is the lack of explanation as to why early initiation of vedolizumab is higher in younger patients and women. “Rather, it just reflects clinical practice in the real world with no justification,” said Dr. Colombel, a gastroenterologist and director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai in New York, who wasn’t involved in the study.
“[The findings] may look surprising since the drug, because of its safety, could be considered first-line in elderly fragile patients with higher risk of infection,” added Dr. Colombel. He noted that what is missing from the study is the longitudinal assessment of early treatment in terms of disease modification. In particular, he asked, what needs to be further explored is the “long-term impact of early vedolizumab initiation on the risk of surgery and complications.”
During another session at the AIBD 2021 meeting on, Anita Afzali, MD, of the Ohio State University Wexner Medical Center in Hilliard, Ohio, noted that for newly diagnosed patients, early initiation of vedolizumab may be most appropriate for patients with unfavorable pharmacokinetics. For instance, Dr. Afzali said, vedolizumab or ustekinumab could be the biologics of choice for an older woman with ileocolonic CD and the HLA-DQA1*04 genotype in whom clinicians would want to avoid an immunomodulator.
“When you look at different factors, whether you’re discussing the drug itself or the patient, there’s different considerations” for selecting a therapy in IBD, explained Dr. Afzali. These considerations, she stated, include those related to drug efficacy and safety as well as disease and individual characteristics such as age, comorbidities, preferences, and costs.
Ms. Kuharic is a PhD candidate and is also a Health Economics and Outcomes Research Fellow at Takeda. Dr. Colombel has consulted for Takeda, which markets vedolizumab for CD and UC. Dr. Afzali has reported relationships with several pharmaceutical companies, including BMS, Eli Lilly, Gilead, Pfizer, IBD Horizons, AbbVie, Takeda, and Janssen.