Despite advances in treatment, a large proportion of patients with inflammatory bowel disease (IBD) do not achieve or stay in remission even after further lines of treatment have been given. Up until now, one major obstacle has impeded our interpretation of studies focusing on patients suffering from this chronic condition: the lack of standard criteria and terminology among authors.
Under the guidance of the endpoints cluster of the International Organization for the Study of Inflammatory Bowel Disease (IOIBD), a group of experts held a consensus meeting to propose a common operative definition for "difficult-to-treat IBD." It's the first step to better understanding this condition and designing targeted studies and interventions.
After the meeting, the experts agreed that "difficult-to-treat IBD" is defined by these characteristics:
· The failure of biologics and advanced small molecules with at least two different mechanisms of action · Postoperative recurrence of Crohn's disease after two surgical resections in adults or one in children
· Chronic antibiotic-refractory pouchitis (inflammation of the ileal pouch-anal anastomosis [J-pouch] created in patients with ulcerative colitis who have had total colectomy surgery)
· Complex perianal disease (difficult-to-treat Crohn's disease)
· Comorbid psychosocial complications that impair disease management (eg, comorbid disorders that obstruct treatment compliance, participation in follow-up visits, or objective assessment of symptoms by clinicians)
The starting point was the IOIBD-sponsored 2022 global survey in which doctors treating patients with IBD were asked what they thought contributed to difficult-to-treat IBD. Using the responses from that survey, a series of statements were drawn up covering these three main areas: failure of medical and surgical treatments, disease phenotypes, and specific complaints from patients (not limited to bowel disease).
The statements were scrutinized by a 16-person task force made up of experts from eight European countries, Canada, Japan, Israel, and the United States. These experts took part in this initiative on behalf of Italy: Silvio Danese, MD, PhD, and Tommaso Lorenzo Parigi, MD (San Raffaele Hospital Scientific Institute for Research, Hospitalization, and Healthcare, Vita-Salute San Raffaele University, Milan); and Ferdinando D'Amico, MD (Humanitas University, Rozzano, Milan). The project and its findings were published in the journal The Lancet Gastroenterology & Hepatology. Danese is the corresponding author of the article and a member of the IOIBD.
Using the modified Delphi technique, the experts argued for or against the 20 statements proposed. Consensus was achieved for five of these statements (meaning that at least 75% of voters were in agreement).
"The scope of this consensus initiative was twofold," explain the authors. "First, we wanted to help standardize study reporting and promote clinical study designs that include patients with difficult-to-treat IBD by proposing common terminology. Second, we hoped to identify, within clinical practice, a group of patients requiring specific treatment or referral to a specialist unit. For patients with conditions resistant to two or more advanced drug types (what is referred to as difficult-to-treat IBD), more aggressive treatment strategies, such as combined therapies or multidisciplinary approaches, should be taken into consideration.
"In the field of rheumatology, the creation of common criteria for difficult-to-treat rheumatoid arthritis has allowed researchers to concentrate their efforts on identifying progressive disease markers, assessing drug efficacy, mechanisms of inefficacy, personalized management strategies, and analyzing the use of healthcare resources and costs. Similar advances could be achieved in the area of inflammatory bowel disease."
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