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Biologics comparison study underway for Crohn’s disease
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A new trial underway through Janssen Scientific Affairs will pit two biologics against each other for the treatment of Crohn’s disease.
Janssen enrolled the first patient in the SEAVUE trial that will compare the efficacy of Humira (adalimumab, AbbVie) and Stelara (ustekinumab, Janssen) in biologic-naive patients with moderately to severely active CD.
Andrew Greenspan, MD, vice president of United States Medical Affairs at Janssen Immunology told Healio Gastroenterology and Liver Disease that the trial is intended to help the health care community make treatment-related decisions in an area that is rapidly changing.
“The landscape for treating Crohn’s disease has changed dramatically in the last few years – not only are there multiple biologics to choose from, but also multiple mechanisms of action,” he wrote in an email. “As the first-ever prospective, randomized head-to-head trial of biologics in Crohn’s disease, SEAVUE addresses this need for treatment-related comparative data in the IBD community. The medical community of patients, providers and payors have been eagerly awaiting direct comparative studies.”
The SEAVUE trial will include approximately 350 patients recruited from 200 sites worldwide whom researchers will randomly assign to receive either ustekinumab or adalimumab during a 52-week treatment phase. There will be no placebo arm for the trial.
The primary endpoint of the trial will be the percentage of patients with clinical remission at week 52. Investigators will also compare steroid-free remission and endoscopic remission at week 52, as well as clinical remission at week 16. Safety endpoints of the trial include patient-reports of quality of life, use of steroids and narcotics, CD-related health care use and the need to initiate another biologic treatment.
Janssen expects the trial to wrap up by 2020.
“Addressing the need for effective Crohn’s disease therapies has been an area of focus at Janssen for more than 20 years, so we understand the challenges that accompany living with, and treating, a complex, lifelong condition,” Greenspan said. “Trials like SEAVUE offer valuable data that can help better inform physicians and their patients as they assess treatment options.” – by Alex Young
Disclosures: Greenspan is employed by Janssen.
Perspective
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Stephen B. Hanauer, MD
The AGA pathways for ulcerative colitis and Crohn’s disease do not prioritize therapies for moderate-to-severe disease due to an absence of “head-to-head” comparative effectiveness trials. The absence of prioritization has led third-party payers to determine the “ordering” of therapies rather than the shared decision making between patients and clinicians. Hence, pharmacy benefit managers are making the clinical decisions for us and our patients. This has become the single greatest impediment to our IBD practices (along with the exorbitant administrative efforts to gain insurance approval and re-authorizations that can lead to therapeutic delays and interruptions). Hence, comparative effectiveness studies are a high priority to advance clinical evidence for therapeutic decision making in both ulcerative colitis and Crohn’s disease. Within limits, the SEAVUE study comparing ustekinumab (anti-IL-12/23) vs. adalimumab (anti-TNF) as therapies for moderate-to-severe Crohn’s disease will be a step in the right direction. One limitation to the study design is that, while “approved” doses will be compared, in clinical practice dose-adjustments are common and are not going to be adequately assessed. Nevertheless, these trials will never be perfect, and the comparative data will hopefully be useful in discussions with patients and justifications for clinical decisions.
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