Background: Prospective studies specifically assessing the effectiveness and safety profile of current therapeutic strategies based on a wider use of biologics in inflammatory bowel disease (IBD) are lacking. The overall objectives of I-CARE are to assess: 1) the long-term safety profile (malignancy, infections) of immunomodulators (IMM), biologics (anti-TNF and vedolizumab) alone or in combination with an IMM 2) the potential for disease modification of biologics 3) the benefit-risk ratio of current therapeutic strategies 4) health economics of IBD care.
Methods: I-CARE is a prospective observational cohort study that will enroll more than 10,000 adult patients with IBD followed for 3 years in 15 European countries. Each investigator will enroll 22 patients divided into 5 groups: Group 1 (5 patients who have never received biologics or IMM); Group 2 (5 patients receiving IMM alone); Group 3 (5 patients treated with anti-TNF therapy alone); Group 4 (5 patients treated with anti-TNF therapy in combination with IMM); Group 5 (one patient treated with vedolizumab monotherapy and one patient in combination with IMM). At inclusion, investigators collect patients' and disease characteristics, history of cancer, previous medications, and vaccination status. Clinical disease activity, surgical procedures, all hospitalization reports, IBD-related medications, serious infections, dysplasia/cancers are reported monthly by the patient and yearly confirmed by the investigator who also reports endoscopy and radiology findings.
Results: As of 4 Nov 2016, a total of 2,089 IBD patients have been included: 406 in group 1 (19.4%), 431 in group 2 (20.6%), 641 in group 3 (30.7%), 454 in group 4 (21.7%), and 157 in group 5 (7.5%). Among 1095 anti-TNF patients, 507 had Remicade, 136 infliximab biosimilars (Inflectra or Remsima), 415 adalimumab and 37 golimumab. Mean age is 37.8 years (SD=12.3), 51.9% are female, and disease duration is 9.6 years (SD=7.8). We included 1,238 Crohn disease (59.3%/nileal=402 ncolonic=182 nileocolonic=472 others=182), 812 ulcerative colitis (38.9%/nProctitis=72 nLeft sided colitis=276 nExtensive UC=348 others =116), and 39 indeterminate colitis (1.9%) patients. 507 patients had a previous surgery (28.1%) and 46 a personal history of cancer (2.5%). The rate of follow-up at 1 month is 91% (n=1920).
Conclusions: The I-CARE project will provide unique information about the safety profile and the impact of biologics on patient- and disease-related outcomes in a real-life setting in a very large cohort of IBD patients followed for 3 years. This database will also offer a unique opportunity to investigate the pharmaco-epidemiology of current strategies in IBD. Recruitment is ongoing across Europe.