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Better Positioning has Improved Outcomes of Entyvio Therapy
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Changes in which patients are treated with Entyvio since the drug’s approval have led to improvement in inflammatory bowel disease-related outcomes, according to study results.
Parambir S. Dulai, MD, of the division of gastroenterology at the University of California San Diego, and colleagues wrote in Inflammatory Bowel Diseases that a significant portion of early Entyvio (vedolizumab, Takeda) users were likely sicker patients who were not responding to available therapy, which limits early data.
“Patients and providers were waiting for U.S. FDA approval of [vedolizumab] to see whether this drug with a new mechanism of action would help,” they wrote. “This ‘warehouse effect’ of a new drug waiting in storage for FDA approval could have significant implications for early response rates in this first cohort of patients receiving the drug.”
Researchers analyzed two data bases — an academic multicenter consortium (VICTORY) and the Truven MarketScan database — to compare treatment patterns and outcomes of vedolizumab in two different time frames; May 2014 to June 2015 (era 1) and July 2015 to June 2017 (era 2).
The study comprised 3,661 patients treated with vedolizumab (n = 1,087 VICTORY; n = 2,574 Truven). In both cohorts, patients with Crohn’s disease and ulcerative colitis treated in era 2 were more likely to be biologic naive.
Researchers found that patients from the VICTORY cohort with CD treated in era 2 had higher rates of clinical remission (40% vs. 31%; P = .03) and mucosal healing (58% vs. 42%; P < .01) compared with patients treated in era 1. However, they did not observe similar trends among patients with UC.
In their analysis of the Truven database, investigators determined that patients with UC treated in era 2 had lower rates of IBD-related hospitalization (9.6% vs. 22.4%; P < .001) and surgery (9.4% vs. 17.2%; P = .008) compared with patients treated in era 1. This trend did not extend to patients with CD.
Dulai and colleagues wrote that the improvement after changes in drug positioning show that the “warehouse effect” could be real and needs to be considered as newer drugs come to market.
“Patients treated within the first year of a drug’s approval are likely representative of a select group of high-risk patients who are refractory to currently available therapies and are being warehoused on ineffective and undesirable therapies to bridge them through until a promising agent is approved by the FDA and available in routine practice,” they wrote. “This effect will need to be considered going forward as newer agents come to market and understanding evolves of the relative positioning of therapies and the optimal use of real-world evidence being generated.” – by Alex Young
Disclosures: Dulai reports receiving research support, honorarium and travel support from Takeda and research support from Pfizer. He also reports being on the advisory board for Janssen. Please see the full study for all other authors’ relevant financial disclosures.
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