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Multiple factors linked to Crohn’s disease relapse after biological therapy
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Several factors, including prior treatment experience and steroid use, can increase the risk for relapse among patients with Crohn’s disease in remission following biological therapy, according to recent results.
In a prospective, multicenter observational study, researchers evaluated 121 patients with Crohn’s disease (CD) who experienced clinical remission after 1 year of biological therapy. The cohort included 87 patients treated with infliximab and 34 who received adalimumab, and 25 participants who had received biological therapy before the 1-year regimen. Incidence of and time to clinical relapse following cessation of treatment were recorded, and potential factors associated with relapse risk were assessed.
Nearly half of participants (45%) experienced relapse within 1 year of treatment cessation, requiring the re-initiation of biological therapy. The median time to re-initiation was 6 months (range 3.75 to 12 months). Of these patients, 54.7% again experienced remission with subsequent treatment, while 9.1% underwent surgery.
Multivariate logistic regression analysis indicated associations between the risk for restarting therapy and prior experience with biologicals (OR=4.23, 1.39-12.84), as well as with the need for dose intensification during the 1-year regimen (OR=12.96, 1.39-120.5). Investigators also noted nonsignificant associations between restarting biological therapy and smoking (OR=2.74, 0.99-7.59) and corticosteroid use (OR=1.67, 0.97-2.83) and elevated levels of C-reactive protein (CRP) (OR=2.38, 0.92-6.19) at the start of the 1-year treatment (95% CI for all).
After excluding 13 steroid-dependent patients from analysis, prior biological therapy and dose intensification remained independently predictive of re-treatment risk, and the associations with smoking and steroid use became statistically significant. Further sensitivity analysis excluding patients who received dose intensification during the 1-year treatment indicated that prior therapy (OR=3.50; 95% CI, 1.10-11.1) and male sex (OR=2.92; 95% CI, 1.06-8.2) were associated with the risk for restarting biological therapy.
“Our findings indicated that previous biological therapy, steroid use and high CRP level at the start of the 1-year period of biological therapy, dose intensification and smoking may predict the need to restart biological therapy in patients with CD,” the researchers wrote. “Although the optimal duration of biological therapy is still to be determined, these results suggest that … biological therapy should probably be continued for more than one year.”
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