After sustained CD remission, risk of relapse higher with infliximab withdrawal
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Patients with Crohn’s disease who stopped infliximab had a significantly higher risk of relapse vs. those who continued combination therapy, according to results presented at the Congress of the European Crohn’s and Colitis Organization.
“Infliximab withdrawal, but not anti-metabolite withdrawal was associated with a significantly higher relapse rate than continuation of combination therapy,” Edouard Louis, MD, PhD, professor and head of gastroenterology and dean of the faculty of medicine at the University of Liège in Belgium, said during the presentation. “Almost all patients who stopped infliximab achieved rapid remission when resuming treatment and failure rates were similar across groups.”
Louis and colleagues screened 254 patients with CD from 64 centers in Europe, Australia and the United Kingdom who were treated with combination therapy of infliximab and anti-metabolite for more than 8 months. All participants had achieved steroid-free remission for more than 6 months. Of these, 205 were randomly assigned to either continue combination therapy (n = 67), discontinue infliximab (n = 71) or discontinue anti-metabolite (n = 67).
Relapse rates and mean survival time in remission over 2 years served as the primary endpoints; other endpoints included treatment failure, such as complications or not recapturing remission.
The 2-year relapse rate among patients assigned to continue combination therapy was 14% (95% CI, 4-23), 40% (95% CI, 28-51) in those stopping infliximab and 10% (95% CI, 2-18) in those stopping anti-metabolite. The time spent in remission was 1.91 years, 1.89 years and 1.93 years, respectively.
“Over the 2-year study duration, in patients stopping infliximab the time spent in remission was 6 days lower vs. combination therapy and 14 days lower vs. patients stopping anti-metabolite,” Louis told attendees. “Although small, these differences did not meet the prespecified criteria for non-inferiority.”
According to study results, there were 39 patients who relapsed, and 28 were retreated and optimized. One of two retreated patients who continued combination therapy achieved remission, as did 22 of 23 patients who stopped infliximab and two of three who stopped anti-metabolite. Treatment failure was observed in four patients from both the combination and infliximab groups and three patients from the anti-metabolite group.
Investigators observed no malignances among participants, although one patient developed tuberculosis in the anti-metabolite group and two patients developed severe infections in the infliximab group. There were 31 serious adverse events in 20 patients: 10 among patients who continued combination therapy, eight in those who stopped infliximab and 13 in those who stopped anti-metabolite.
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Louis E, et al. Abstract OP01. Presented at: Congress of European Crohn’s and Colitis Organization; February 16-19, 2022 (virtual meeting).
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