In a direct comparison with Humira, Entyvio won out as the top choice for second line therapy for patients with ulcerative colitis who failed therapy with Remicade, according to research published in Inflammatory Bowel Diseases.
Massimo Claudio Fantini, MD, PhD, from the University of Rome, and colleagues wrote that there are no solid data to support which drug should be used as a follow-up in patients who do not respond or lose response to Remicade (infliximab, Janssen).
“At the moment, there is no clear indication on the most appropriate second-line biological therapy in case of failure to [infliximab], and in the absence of head-to-head comparative efficacy data, the choice between a second anti-TNF-alpha or the anti-integrin [Entyvio (vedolizumab, Takeda)] is often based on clinician’s personal experience, drug availability, and economic issues,” they wrote.
Researchers analyzed clinical records of 161 patients with UC who failed infliximab therapy and were candidates to receive either Humira (adalimumab, AbbVie) or vedolizumab. The primary endpoint was therapeutic failure at week 52, and secondary endpoints included therapy discontinuation at weeks 8, 24 and 52, discontinuation-free survival and safety.
Patients in the study were either primary (n = 9.2%) or secondary (n = 83, 51.7%) infliximab failures or infliximab intolerants (n = 63, 39.2%). Researchers determined that 64 patients received adalimumab (40%) and 97 patients received vedolizumab (60%).
After 52 weeks, 37.5% of patients on adalimumab and 28.9% on vedolizumab had therapeutic failure. The failure rate was significantly higher in the adalimumab group compared with vedolizumab among patients who experienced secondary failure to infliximab (48% vs. 22.4%; P = .035). The therapy discontinuation-free survival was also higher in the group of secondary failure who received vedolizumab compared with adalimumab (OR = 2.79; 95% CI, 1.23–6.34).
Investigators found no difference in the failure and biologic discontinuation-free survival in the infliximab primary failure and intolerant subgroups.
“In a real-life setting and in the absence of therapeutic drug monitoring, although [vedolizumab] and [adalimumab] might be equally effective in UC patients who stopped [Infliximab] due to intolerance, [vedolizumab] should be considered the therapy of choice in patients with secondary failure,” Fantini and colleagues concluded. – by Alex Young
Disclosures: Fantini reports serving as a speaker or consultant and advisory board member for AbbVie, Janssen-Cilag, MSD, Pfizer, Takeda and Zambon. He also reports research funding from Janssen-Cilag and Pfizer Please see the full study for all other authors’ relevant financial disclosures.