Background: Current management of mild-to-moderate ulcerative colitis (UC) involves monitoring clinical markers of disease activity, such as stool frequency (SF) and rectal bleeding (RB), and adjusting treatment accordingly. Our aim was to assess whether targeting treatment based on faecal calprotectin (FC) levels (treat-to-target; T2T) provides greater UC disease control versus a symptom-based approach. Methods: This was a pragmatic, randomised (1:1) controlled study of patients with mild-to-moderate UC (global Mayo score 2-6) treated with ≤2.4 g/day 5-aminosalicylic acid that compared the effectiveness of two management strategies with (interventional arm) and without (reference arm) FC home monitoring over 12 months of follow-up. Treatment was optimised in the interventional arm using FC values and clinical symptoms (PRO-2), while the reference arm used only PRO-2. Results: 193 patients completed the study. No significant difference was found for the primary endpoint (Mayo Endoscopic Subscore [MES] = 0 at 12 months). A numerical advantage for the interventional arm over the reference arm for the primary endpoint (37.0% vs. 33.4%, respectively) and for MES ≤ 1, RB = 0, and SF ≤ 1 at 12 months was found following imputation for missing data. The composite endpoint of MES = 0, RB = 0, and SF ≤ 1 at 12 months was achieved at a significantly higher rate in the interventional arm than the reference arm (effect size [ES]: 0.17, 95% CI 0.02-0.32; p < 0.05). A similar result was obtained for MES ≤ 1, RB = 0 and SF ≤ 1 (ES: 0.22; 95% CI 0.07-0.37; p < 0.05). Conclusions: T2T using FC monitoring was effective in patients with mild-to-moderate UC at 12 months. Further longer-term studies are required to confirm the results.

Centrum Medyczne Lukamed in Chojnice 89 600 Chojnice Poland

Clinical Trial Unit Hospital Lariboisière APHP 75010 Paris France

Department of Gastroenterology and Digestive Endoscopy San Raffaele Hospital Vita Salute San Raffaele University 20132 Milan Italy

Department of Gastroenterology and Hepatology Catharina Hospital Eindhoven 5623 EJ Eindhoven The Netherlands

Department of Gastroenterology and Hepatology Franciscus Gasthuis and Vlietland 3045 PM Rotterdam The Netherlands

Department of Gastroenterology and Inserm NGERE U1256 University Hospital of Nancy University of Lorraine 54000 Vandoeuvre lès Nancy France

Department of Gastroenterology Centrum Diagnostyczno Lecznicze Barska 87 806 Włocławek Poland

Department of Gastroenterology Medical University of Lodz 92 213 Lodz Poland

Department of Gastroenterology Nancy University Hospital 54500 Vandœuvre lès Nancy France

Division of Gastroenterology and Hepatology McGill University Health Centre Montreal QC H4A 3J1 Canada

Ferring International Center S A 1162 Saint Prex Switzerland

Ferring Pharmaceuticals A S 2770 Kastrup Denmark

FHU CURE Nancy University Hospital 54500 Vandœuvre lès Nancy France

Groupe Hospitalier Privé Ambroise Paré Hartmann Paris IBD Center 92200 Neuilly sur Seine France

Hepato Gastroenterologie HK s r o 50012 Hradec Králové Czech Republic

IBD Unit Department of Gastroenterology and Digestive Endoscopy San Camillo Forlanini Hospital 00152 Rome Italy

INFINY Institute Nancy University Hospital 54500 Vandœuvre lès Nancy France

Institute of Human Genetics Polish Academy of Sciences 61 772 Poznan Poland

Institute of Medical Sciences Medical College University of Rzeszów 35 310 Rzeszów Poland

Internal Department Military Hospital Brno 61500 Brno Czech Republic

Melita Medical Centrum Proktologii Onkologii i Chorób Jelit 50 449 Wrocław Poland

Ośrodek Badań Klinicznych CLINSANTE S C Ewa Galczak Nowak Małgorzata Trzaska Chałubińskiego 85 004 Bydgoszcz Poland

Polish Society of Gastroenterology 58 521 Jezów Sudecki Poland

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