A new study entitled “Early Trough Levels and Antibodies to Infliximab Predict Safety and Success of Reinitiation of Infliximab Therapy” published in the journal Clinical Gastroenterology and Hepatology reports the safety and efficacy of reintroducing Infliximab therapy for patients with Crohn’s disease or ulcerative colitis.
Inflammatory bowel disease is characterized by chronic inflammation in the digestive tract, and few treatments are available to these patients, which frequently become unresponsive to biologics (a class of drugs used to IBD). Infliximab (commercialized as Remicade) is a monoclonal antibody against tumor necrosis factor alpha (TNF-α) used to treat autoimmune diseases.
In this study, the authors wanted to determine the feasibility of reinitiating infliximab therapy in patients who previously developed unresponsiveness or reactivity to infliximab. They analyzed 128 consecutive patients with IBD (specifically, 105 patients with Crohn’s disease and 23 patients with ulcerative colitis) that restarted infliximab after a period of discontinuation of 15 months. Additionally, they analyzed the serum from patients treated once with infliximab (T -1), when therapy was reintroduced (T0) and later in therapy (T +1, T +2).
They found reintroducing infliximab therapy yielded positive results for 84.5% of patients ( at week 14 of treatment) and 70% of patients (within one year). Moreover, undetectable antibodies to infliximab at T +1 was associated with reintroducing therapy safety.
Baert, MD, PhD, department of gastroenterology, University Hospitals Leuven, Belgium and study first author commented, “Our findings suggest that starting infliximab after a history of prior therapy can be very beneficial to patients. Most striking, response to infliximab can be regained in a subset of patients who previously had lost response to the treatment and failed several other treatments thereafter.”
Andres J. Yarur, MD, and Maria T. Abreu, MD, both from the University of Miami Miller School of Medicine and not authors of the study noted, “The first important message in this study was that restarting infliximab after a drug holiday is feasible. Incorporation of testing drug levels and [antibodies to infliximab] appears useful and allows a more personalized approach to their care. With the recent approval of vedolizumab (Entyvio, Takeda Pharmaceuticals), we expect that patients who have a lack of response in spite of adequate through levels of anti-TNF will benefit from a change in mechanism of biologic action.”