Greater endoscopic healing at 1 year might be achieved in people with Crohn’s disease if they are treated with anti–tumor necrosis factor (TNF) drugs than if they are treated with certain other biologics it appears.
In a pooled analysis of data from four different clinical trial programs, which altogether included 344 patients with Crohn’s disease, both an infliximab biosimilar and adalimumab were associated with better endoscopic healing rates of both the ileum and colon than were either vedolizumab or ustekinumab.
The difference disappeared for ileal not colonic involvement, however, if patients had been biologic naive before receiving any of the four drugs that were compared.
“Recent studies have suggested that the ileum and colon differ with regards to their ability to achieve healing in Crohn’s disease,” Neeraj Narula, MD, said in reporting the analysis at the 17th congress of the European Crohn’s and Colitis Organisation.
“Our group has shown that larger ulcers in the ileum and rectum in particular do not heal as well as other areas of the colon when using infliximab therapies,” added Dr. Narula, who is an assistant professor of medicine at McMaster University, Hamilton, Ont., and the director of the IBD clinic and staff gastroenterologist at Hamilton Health Sciences.
Whether there are differences in how the ileal and colonic regions heal in response to biologic therapy is not known, which is why Dr. Narula and colleagues carried out their analysis.
Pooling pivotal trial program data
“Our primary aim was to evaluate the efficacy of four approved biologic therapies for Crohn’s disease with regards to their ability to achieve endoscopic healing after continuous use for 1 year,” he noted.
For their analysis, original data from the EXTEND, UNITI, VERSIFY, and infliximab biosimilar CT-P13 clinical trial programs were obtained and pooled.
The extent of mucosal inflammation and thereby healing were determined using a modified version of the Simple Endoscopic Score for Crohn’s disease (SES-CD), which is a measure often used in clinical trials.
At inclusion, patients had to have had an SES-CD score of 3 or more in at least one segment of the ileum or colon and confirmed ulceration. The primary endpoint was endoscopic healing defined as an SES-CD score of 0 after 1 year’s continuous treatment.
Multivariate logistic regression was used, and adjustments were made for potential confounding factors, such as how long people had had Crohn’s disease, the use of steroids, and if there had been prior anti-TNF failure.
Main results
Overall, 299 patients were in the final analysis; most (n = 141) had been treated with the infliximab biosimilar, with 61 treated with adalimumab, 56 vedolizumab, and 41 ustekinumab.
The highest rate of endoscopic healing at 1 year for ileal involvement was seen with the infliximab biosimilar (36.7% of patients) and the lowest rate with vedolizumab (18.6%), with rates of 30% and 22.7% for adalimumab and ustekinumab, respectively. Only the comparison between the infliximab biosimilar and vedolizumab was statistically significant (P = .038).
As for ileal ulcers, there were fewer seen with both anti-TNF treatments than with either ustekinumab or vedolizumab, at 40.8% for the infliximab biosimilar, 30% for adalimumab, 17.7% for ustekinumab, and 8.7% for vedolizumab. Rates of ileal ulcer absence in biologic-naive patients were a respective 36.7%, 37.5%, 40%, and 21.9%.
In terms of colonic involvement, the lowest rate of endoscopic healing occurred in patients treated with ustekinumab, at 29%, and the highest for adalimumab (62.5%), followed by the infliximab biosimilar (52.4%) and then vedolizumab (31.3%).
Absence of colonic ulcers was similarly low for ustekinumab (29.6%) and higher for the other three groups (64.9%, 70.5%, and 41.2%, respectively). When considering biologic-naive patients, there was a significant difference in the absence of colonic ulcers comparing adalimumab (66.7; P = .004) and the infliximab biosimilar (52.4%; P = .022), but not vedolizumab (37.1%) versus ustekinumab (29.4%).