SOPRANO: Prevention of postoperative endoscopic disease recurrence in Crohn's disease (KCE-201262)

Summary (French or Dutch)

Relapsing small bowel Crohn’s disease (CD) remains a major challenge after a curative intestinal resection. Several postoperative prophylactic therapies have been suggested to prevent further bowel damage. However, such therapies could significantly affect healthcare resources as well as work productivity and may be associated with adverse events and decreased quality of life. Although strong evidence is lacking, most guidelines suggest the introduction of immediate postoperative prophylactic therapy in order to prevent postoperative recurrence, and this especially in patients with an increased risk for postoperative recurrence.
Such systematic postoperative treatment will, however, lead to overtreatment and could put patients unnecessary at risk of potential adverse events related to the prophylactic therapy.
Biological therapies, adalimumab, infliximab, ustekinumab and vedolizumab, have all been shown efficacious for the treatment of moderate-to-severe CD, but data on postoperative prevention of CD recurrence are only available for adalimumab and infliximab. Nevertheless, 50% of Belgian IBD specialists would consider immediate postoperative prophylaxis with expensive biologicals such as ustekinumab and vedolizumab in bio-naïve patients if one or more risk factors were present. This number increases to 73% in patients who previously received anti-TNF therapy. However, it is not clear if the immediate and systematic postoperative introduction of biological therapy is superior to a more personalized endoscopy-driven approach, where biological therapy is only initiated in case of early endoscopic disease recurrence.
With this prospective, randomized, parallel group, pragmatic trial, we will evaluate if endoscopy-driven introduction of biological therapy is as efficacious as systematic prophylactic therapy in order to prevent postoperative endoscopic recurrence at week 86 in patients with CD undergoing an ileocolonic resection. Secondary analyses will include influence on clinical and surgical CD recurrence, serious adverse events, costs, work productivity, and quality of life.