Assessing Long-Term Risks and Benefits of Biologic Therapy in IBD

Prior to study initiation, patients were initiated on various biologics, including infliximab, adalimumab, golimumab, cetrolizumab pegol, vedolizumab, and ustekinumab.

Patients with inflammatory bowel disease (IBD) who receive treatment with biologic therapy may be at risk for lymphoma and other cancers, according to study results published in Clinical Gastroenterology and Hepatology.

The ongoing, observational, European prospective cohort study is seeking to prospectively assess the presence and extent of safety concerns, such as cancer, particularly lymphoma, and serious infection risks for anti-tumor necrosis factor (TNF) or other biologics alone or in combination with thiopurines in patients with IBD.

I-CARE is being conducted in 15 countries. The participants are aged 18 years and older with an established diagnosis of Crohn disease (CD), ulcerative colitis (UC), or IBD unclassified (UBDu) for at least 3 months.

A total of 10,206 patients (mean age, 39.8±13.1 years; women, 52.8%) were enrolled from March 2016 to April 2019. Of the cohort, 60.4% had CD, 37.8% had UC, and 1.8% had IBDu. Their mean disease duration [SD] was 10.6 [8.9] years. Approximately one-fourth of patients (26.8%) had previous IBD-related surgery (41.7% of CD patients vs 4.0% of UC and IBDu patients, P <.0001).

Future findings from I-CARE and sub-studies will likely be implemented in IBD guidelines and used to guide the decision-making process in daily practice.

Among the participants, 36.4% had received previous treatment with oral 5-aminosalycilates (ASA; mesalazine), and 2229 (23.6%) with topical 5-ASA. At study entry, 35% of participants were receiving oral 5-ASA, and 9.9% were receiving topical 5-ASA.

Almost two-thirds of patients (65.9%) had received previous treatment with systemic steroids. At enrollment, 5.6% of participants were receiving systemic corticosteroids.

Of the cohort, 30.7% of patients had previous treatment with azathioprine, 6.3% with methotrexate, and 4.7% with 6-mercaptopurine. At enrollment, 32.3% of patients were receiving thiopurines, 4.6% were receiving 6-mercaptopurine, and 3.2% were receiving methotrexate.

Regarding use of biologic therapy before study entry, 17.8% of patients had received infliximab, 14.0% had used adalimumab, 1.5% had used golimumab, 0.6% had used certolizumab pegol, 1.5% had used vedolizumab, and 0.4% had used ustekinumab. At study entry, 26.7% of participants were receiving infliximab, 19% adalimumab, 1.5% golimumab, 0.1% certolizumab pegol, 8.8% vedolizumab, and 3.4% ustekinumab.

A total of 2.9% of patients had had any type of cancer, including 135 with UC or IBDu and 163 with CD. Furthermore, 1.1% had a medical history of high-grade dysplasia — 20 participants had colonic high-grade dysplasia, 3 had esophageal high-grade dysplasia, and 71 had uterine cervix high-grade dysplasia. Also, 11.3% of participants had a first-degree relative with lymphoma, colorectal cancer, melanoma, or breast cancer.

“Future findings from I-CARE and substudies will likely be implemented in IBD guidelines and used to guide the decision-making process in daily practice,” the study authors wrote.

Disclosure: This work was supported by Abbvie, Amgen, Ferring, Pfizer, Janssen, MSD, and Takeda. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Peyrin-Biroulet L, Rahier J-F, Kirchgesner J, et al; for the I-CARE Collaborator Group. I-CARE, a European prospective cohort study assessing safety and effectiveness of biologics in inflammatory bowel disease. Clin Gastroenterol Hepatol. Published online September 21, 2022. doi:10.1016/j.cgh.2022.09.018