Biologics have only ‘slight impact’ vs. conventional therapy on surgery-free survival in CD
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Key takeaways:
- Shorter surgery-free survival was observed among patients on conventional therapy only in the pre-biologics era.
- No significant difference was found between biological and post-biologics conventional therapy.
The introduction of biologics as a therapeutic option for Crohn’s disease had “only a slight impact” on eventual surgery occurrence, although it may delay the first intestinal resection compared with conventional therapy, data showed.
“Recently, conventional therapy has become increasingly unattractive due to its lower effectiveness in inducing and maintaining remission in the short-term period, compared to biological therapy,” Marco Valvano, MD, of the gastroenterology unit at University of L’Aquila, and colleagues wrote in BMC Gastroenterology. “Despite this, a paradigm shift concerning the surgical approach in CD is nowadays occurring.”
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They continued: “It is therefore evident that the evaluation of the incidence of intestinal resection after the introduction of biological therapy is very complex and subject to several potential sources of bias, the most prominent being the shift in IBD management over the last few decades.”
Seeking to assess the effect of biological vs. conventional therapy on surgery-free survival time and on overall risk for surgery in patients with CD, Valvano and colleagues conducted a retrospective, double-arm study of 203 patients, of whom 49 had been treated with biological therapy since 1998. Researchers divided 154 participants on conventional therapy — which included mesalamine, immunomodulators, antibiotics or steroids — into pre-1998 (n = 61) and post-1998 (n = 93) groups. The cumulative study period was 11,618 months.
Among those with at least 5 years of disease duration, 8.8% of patients in the biologic group and 32.3% in the conventional group underwent surgery. There were six surgical events among 49 patients in the biologic group vs. 23 events among 154 patients in the conventional group.
Kaplan-Meier survivorship estimate demonstrated that patients in the biologic group had longer surgery-free survival (P = .03), although this difference was not significant among 143 propensity score-matched patients.
According to subgroup analysis, only patients on conventional therapy in the pre-1998 group had shorter surgery-free survival (P = .02; HR = 2.9; 95% CI, 8.54), with no significant difference reported between biological and post-1998 conventional treatment groups (HR = 2.1; 95% CI, 0.69-6.44). The number needed to treat for biological vs. conventional therapy was 37.
“This study shows that introduction of biological therapy had only a slight impact on the eventual occurrence of surgery in CD patients, over a long period of observation,” Valvano and colleagues wrote. “Although biological therapy is able to delay the first intestinal resection, the cumulative incidence of first intestinal resection between patients who underwent biological or conventional therapy ends up being similar considering a very long period.”
They concluded: “Thus, once again a definitive treatment for the IBD treatment is far from being achieved.”
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