Fecal lactoferrin early predicts long-term outcomes in ulcerative colitis: A post-hoc analysis of the UNIFI and PURSUIT trials.

Abstract

Fecal lactoferrin (FL) is associated with disease activity and relapse in ulcerative colitis. However, whether FL could early predict long-term outcomes in ulcerative colitis is poorly understood. This post-hoc analysis included participants who received biologics and had available data of FL concentration at week 4 from the UNIFI and PURSUIT trials (n=1063). Therapeutic outcomes, including clinical remission, endoscopic improvement and remission, and histological improvement and remission, were evaluated at the end of maintenance therapy. The incidence of colectomy was observed from week 0 to maximum week 228 in the PURSUIT trial (n=667). Multivariate logistic and Cox proportional-hazard regression were conducted to evaluate the associations between FL and therapeutic outcomes and colectomy, respectively. A high FL level at week 4 was associated with poor long-term clinical, endoscopic and histologic outcomes. FL >84.5μg/mL predicted a low likelihood of clinical (OR [95% CI]: 0.43 [0.32, 0.57]; p<0.001), endoscopic (OR [95% CI]: 0.40 [0.29, 0.56]; p<0.001), and histological (OR [95% CI]: 0.27 [0.14, 0.53]; p<0.001) remission. Moreover, week-4 FL could add prognostic value to fecal calprotectin and clinical and endoscopic scores for informing long-term therapeutic outcomes. For the risk of colectomy, patients with week-4 FL <20.1 and ≥20.1µg/mL had an incidence rate of 1.10% and 6.39%, respectively. Patients with FL ≥20.1µg/mL had a 995% higher risk of colectomy (HR [95% CI], 10.95 [1.45, 82.74]). FL could be a promising prognostic biomarker for long-term therapeutic outcomes and risk of colectomy in patient of ulcerative colitis.