Infliximab retreatment results in remission in 35% of patients with Crohn’s disease
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After previously discontinuing infliximab, 35% of patients with Crohn’s disease achieved remission at 26 weeks with drug retreatment, according to a study published in The American Journal of Gastroenterology.
“Although the therapeutic arsenal of CD has increased considerably in 5 years with the availability of monoclonal antibodies targeting [interleukin-12/interleukin-23] (ustekinumab) or leukocyte trafficking (vedolizumab), the response rates of these new drugs are not higher than those obtained with [infliximab], especially because the effectiveness of the biologics decreases with the number of treatment lines previously used,” Gilles Boschetti, MD, PhD, of the department of gastroenterology at Lyon-Sud Hospital in Lyon, France, and colleagues wrote.
“The aim of the REGAIN study was to prospectively assess the efficacy, safety and tolerability of retreatment with [infliximab] after stopping for intolerance or [loss of response],” the researchers continued.
The prospective, observational cohort study was conducted at 16 French academic centers from June 2015 to June 2018. Of 97 patients enrolled in the study, researchers included 69 (61% women; median age, 34 years; median disease duration, 10.1 years) in their analysis.
The median duration between patients discontinuing infliximab, a tumor necrosis factor-alpha inhibitor, and study inclusion was 43.4 months, with 48 patients (70%) having discontinued due to loss of response and 21 patients (30%) due to intolerance.
Infliximab was reintroduced at a dose of 5 mg/kg of body weight and infused over a 2-hour period at weeks 0, 4 and 8 for the induction regimen, followed by administration over 1 hour during the maintenance regimen every 8 weeks through week 26.
The primary endpoint was infliximab retreatment efficacy at week 26, defined as a score of less than 150 on the Crohn’s Disease Activity Index.
At week 26, 24 patients (35%) reached the primary endpoint, and there was no significant difference between rates of clinical remission in patients who previously discontinued the drug due to loss of response (35%) vs. intolerance (33%).
Regarding safety, 314 adverse events were reported in 91 patients, and 56 were considered serious in 40 patients. Further, 124 were attributed to infliximab treatment. Infections were the most common adverse event.
Twenty-seven patients experienced 32 acute infusion reactions, resulting in 20 patients discontinuing treatment. The researchers noted 21 of these infusion reactions (66%) occurred during the maintenance period.
“When a decision to resume [infliximab] treatment is considered, safety concerns are at the forefront for gastroenterologists. ... the prospective design of our study and the exhaustive collection of [adverse events] provide reliable and reassuring safety data for physicians and patients,” the researchers wrote.
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