Gastroenterologists in the U.S. and EU5 Agree that Improved Maintenance of Remission is One of the Greatest Unmet Needs, According to a New Report from Decision Resources
April 29, 2013—Burlington, Mass. —Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed U.S. and EU5 gastroenterologists agree that new moderate to severe ulcerative colitis (UC) therapies that offer improved effect on maintenance of remission over current therapies would be well received and poised for strong uptake. While available clinical data and thought leader opinion indicate that the currently available therapies azathioprine (GlaxoSmithKline/Prometheus Laboratories/UCB’s Imuran, Eisai’s Imurek, generics) and adalimumab (AbbVie/Eisai’s Humira) and the emerging therapies golimumab (Janssen/Merck/Mitsubishi Tanabe’s Simponi) and tofacitinib (Pfizer’s Xeljanz) offer comparable or lower efficacy than sales-leading infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade) on this attribute, Takeda’s emerging agent vedolizumab has the potential to offer improvement in maintenance of remission, based on Phase III data. Interviewed thought leaders report that some of their patients experience loss of response to infliximab over time.
The DecisionBase 2013 report entitled Ulcerative Colitis: Which Clinical Attributes Will Most Effectively Position Emerging Agents Against Infliximab in the Moderate to Severe Patient Segment? also finds that vedolizumab may more effectively reduce the need for corticosteroids than infliximab and offers potential safety advantages over the sales leader.
“Interviewed thought leaders consistently express the need for drugs which more effectively maintain and sustain long-term remission, due to either the modest or waning efficacy of current therapies,” said Decision Resources Analyst Kathrina Quinn, Ph.D. “According to Phase III trial data, treatment with vedolizumab resulted in a maintenance of remission rate that was approximately 60 percent greater than the rate seen in an infliximab trial, in a population that included TNF-failure patients. This novel agent is also perceived to have a lower risk of hypersensitivities reactions and minor adverse effects than the first-line TNF-alpha inhibitor”.
Surveyed U.S. managed care organization pharmacy directors agree that therapies with improved maintenance of remission represent a significant unmet need in UC and they indicate a willingness to place such therapies on a favorable formulary tier. Pharmacy directors also express a need for therapies with improved effect on avoidance of surgical intervention. Such therapies reduce the need for surgical procedures such as colectomy, thus reducing the costs associated with hospitalization. Despite this unmet need, no long-term data exist that evaluate the efficacy of emerging therapies on surgical intervention. As a result, this represents an opportunity for drug manufacturers to consider including such an end point in their future clinical trial design, to allow emerging therapies to be differentiated from current therapies based on their effect on avoidance of surgery.
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