Biologic-naive patients with Crohn’s have greater chance for mucosal healing
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In a real-world Crohn’s disease population, biologic- naive patients, compared with biologic-experienced patients, had a significantly greater chance for achieving mucosal healing, according to research at Digestive Disease Week.
Benjamin L. Cohen, MD, from Cleveland Clinic, and colleagues reviewed data from 299 patients with inflammatory bowel disease from the TARGET-IBD registry and compared biologic-naive patients with biologic-experienced patients with Crohn’s disease.
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Inclusion criteria were active Crohn’s disease at enrollment, started a biologic 3 years or less prior, had a baseline colonoscopy less than 12 months prior to biologic start, were on the biologic at least 6 months, and had a follow-up colonoscopy 2 to 18 months after biologic start while still on the biologic.
Investigators evaluated presence of inflammation, erosion, ulceration, stricture and/or fistula at baseline and follow-up to determine if there was mucosal healing or not. They defined mucosal healing as normal colonoscopy among patients with abnormalities, steroid-free normal colonoscopy among patients and resolution of inflammation, erosion or ulcerations.
Cohen told Healio Gastroenterology that patients in the biologic-experienced group were significantly younger, had longer disease duration, and more often had IBD surgery than those in the biologic-naive group which may be correlated with a more severe disease course. Groups did not differ regarding smoking status, which would be associated with decreased responsiveness to biologic therapies.
“[In] terms of having a normal colonoscopy, 44.4% in the [biologic-naive] group had normalization of their colonoscopy vs. 27.7% in the biologic-experienced group,” Cohen said. “[In the biologic-naive group], 40.6% were steroid free vs. 19.1% in the biologic-experienced group, and the P values were significant for both of those. Then we looked at resolution of inflammation ulcerations or erosions seen from the index colonoscopy to the follow-up colonoscopy after treatment with the biologic agent, and 53.1% in the biologic-naive group had resolution of those signs of inflammation vs. 39.5% in the biologic-experienced group.”
Patients in the biologic-experienced group had a significantly greater history of surgery, which may be correlated with a more severe course, Cohen said.
“We performed a multivariable analysis including prior biologic use, duration of disease, age at biologic start, smoking, disease severity and inflammatory vs. structuring/fistulizing phenotype,” Cohen said. “When we put all those factors into the model, the only factor that was independently associated with having a steroid-free normal colonoscopy or resolution of all endoscopic signs of inflammation was having one or fewer biologic exposures.”
According to Cohen, the finding that patients on more than one biologic in the past were significantly less likely to have mucosal healing, after adjusting for factors correlated with biologic response is consistent with observations from clinical trials. He says it will be important to understand how specific sequences of biologic therapy may impact these findings.
According to Cohen, patients on more than one biologic in the past were significantly less likely to have mucosal healing, after adjusting for all the factors correlated with biologic response.
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Cohen BL et al. Poster 3524499. Presented at: Digestive Disease Week; May 21-24, 2021 (virtual meeting).
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