The long-term effect of biologics in patients with ulcerative colitis emerging from a large Japanese cohort

Abstract

To gain a better understanding of the effects of biologics, we evaluated clinical outcomes in patients with moderate to severe exacerbations of ulcerative colitis (UC). This retrospective, multicenter study retrieved the entire clinical courses of UC patients who began treatments between 2004 and 2018. All exacerbations and clinical parameters, including treatment details for exacerbations and both remission and re-exacerbation dates, were identified during the observation period. Two different endpoints, the cumulative incidence rates of surgical resection and re-exacerbation, were evaluated separately in moderate to severe exacerbation events. Among 1401 patients, 1626 exacerbation events were determined according to a partial Mayo score (remission: < 2, mild: 2–4, moderate: 5–7, and severe: > 7). During the observation period, as administration rates of biologics increased, both surgical resection and hospitalization rates decreased, for 959 moderate to severe exacerbation events. We confirmed that biologics significantly reduced the cumulative re-exacerbation rate in moderate to severe exacerbation events during the study period compared with suboptimal therapies (a 0.507-fold decreased risk according to COX regression analysis, P < 0.001). However, they had not enough impact in reducing the cumulative incidence rate of surgical resection in moderate to severe exacerbation events that were corticosteroid-refractory or dependent (a 0.878-fold decreased risk according to COX regression analysis, P = 0.606). Biologics may improve remission duration, but these agents had no significant impact in reducing the risk of surgical resection in moderate to severe active UC.

Superior predictive value of transmural over endoscopic severity for colectomy risk in ulcerative colitis: a multicentre prospective cohort study

“… 3 , 4 The introduction of biological therapies is associated only with modest 5 or no impact in reducing colectomy rates in moderate-to-severe active UC. 6 , 7 Several clinical findings such as age ≤40 years, male sex, extensive disease extent, hospitalization, and exposure to corticosteroids, azathioprine, and infliximab before hospitalization are associated with an increased risk of colectomy. 8 , 9 In addition, baseline endoscopic activity and failure to achieve endoscopic healing [EH], commonly defined as Mayo Endoscopic Score [MES] ≤ 1, following treatment were associated with an increased risk of colectomy.…”