While anti–tumor necrosis factor (anti-TNF) therapies are effective in helping patients with Crohn disease (CD) gain remission, data on using anti-TNFs in patients with stricturing CD are conflicting; some reports suggest that anti-TNF agents increase the risk of intestinal obstruction.
At the time of the onset of Crohn disease (CD), most patients have inflammatory lesions that become stricturing or penetrating in the months or years after diagnosis. While medical therapy can treat inflammation, endoscopic treatment or surgery is often required to relieve small bowel obstructions resulting from stricturing lesions.
While anti—tumor necrosis factor (anti-TNF) therapies are effective in helping patients with CD gain remission, data on using anti-TNFs in patients with stricturing CD are conflicting; some reports suggest that anti-TNF agents increase the risk of intestinal obstruction. A new study, published in Gut, sought to estimate the efficacy of the anti-TNF agent adalimumab in patients with CD who had small bowel strictures and to identify factors predicting treatment success.
The prospective, multi-center, open-label, post-marketing observational study, conducted from January 2010 to December 2011, included patients (n = 97) aged 18 years or older who had a diagnosis of CD of a stricturing phenotype, a single or several strictures, obstructive symptoms within the last 8 weeks, failure of or contraindications with steroids or immunosuppressive agents and indications for anti-TNF treatments.
Adalimumab was administered subcutaneously at baseline at 160 mg, followed by 80 mg at week 2, then 40 mg every other week. Patients were assessed using the Crohn Disease Activity Index (CDA), complete blood cell count, and C-reactive protein serum level before inclusion and at weeks 8, 16, and 24. The primary endpoint of the study was success at week 24 (defined as no use of prohibited treatments, such as corticosteroids or other anti-TNF agents; no endoscopic dilation; no bowel surgery for resection of strictures; no severe adverse events leading to adalimumab withdrawal; no study withdrawal).
In total:
Among the 62 patients who achieved success at week 24, 88% had a Crohn Disease Activity Index (CDAI) score of less than 150.
Factors associated with treatment success were combined treatment with adalimumab and immunosuppressive agents, recent and severe obstructive symptoms, a stricture length of less than 12 cm, and intermediate dilation of the small bowel proximal to the stricture, marked enhancement on delayed phase, and an absence of fistula. Notably, low C-reactive protein levels were associated with high success rates; “Therefore, what is true for luminal disease is probably false for stricturing disease, a result that needs to be confirmed,” say the authors.
The researchers concluded that a successful response to adalimumab was found in approximately two-thirds of the cohort, and that more than half of all the patients treated with adalimumab, regardless of treatment success, were surgery-free at approximately 4 years after treatment initiation.
Biosimilars Gastroenterology Roundup: March 2025
April 1st 2025As the biosimilar industry celebrates a decade of growth, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.