P762 GO-CARE: A prospective multi-centre observational study of golimumab effectiveness and quality of life in a real-life UC patient population in Italy

• Published in: Journal of Crohn's and colitis Vol. 12; no. supplement_1; pp. S496 - S497
• Main Authors: Armuzzi, A, Marchi, S, Gasbarrini, A, Saibeni, S, Geccherle, A, Principi, M, Germano, V, Bossa, F, Privitera, A C
• Format: Journal Article
• Language: English
• Published: UK Oxford University Press 16.01.2018
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjx180.889

Abstract Background The ultimate treatment target in UC must be the restoration of patient (PT) Quality of Life (QoL).1 The aim of the study was to identify predictors of QoL improvement measured by Inflammatory Bowel Disease Questionnaire (IBDQ) after 8 and 56 weeks of treatment with Golimumab (GLM) and to investigate other effectiveness outcomes in a real-life setting. Methods Responders to GLM induction therapy (by Partial Mayo Score (PMS) at 8 weeks after the start of GLM) were enrolled and clinical-demographic characteristics at start of GLM were collected. An interim analysis was conducted 18 months after the start of the study to evaluate predictors of IBDQ increase (< or ≥16 points) achieved after 8 weeks of GLM therapy compared to baseline (primary endpoint). Mean change in IBDQ after 8 and 32 weeks of GLM treatment, clinical response (decrease ≥2 points or ≥30% of the PMS and decrease ≥1 point in rectal bleeding) and clinical remission (PMS ≤2 with no sub-score >1) at week 32 were also assessed (secondary endpoints). Results In total, 83 and 38 patients completed 8 and 32 weeks of treatment and were included in the interim analysis. Mean age was 43 years (57 males) and mean disease duration was 9.5 years. 80.7% of patients were steroid-dependent, 47% had pancolitis and 49.4% had left-sided colitis. 75.9% of patients had moderate disease activity (median PMS 6) and comorbidities occurred in 19.3%. Moderate endoscopic activity (Mayo 2) was reported in 68.7% of patients. 27.7% of patients were previously treated with anti-TNF. Baseline concomitant therapies were: 25.3% of patients treated with CS, 15.7% AZA, 75.9% oral 5-ASA. Mean (range) baseline IBDQ was 139 (54–214). By univariate analysis of predictors of IBDQ increase [age, gender, weight, height, BMI, smoking status, comorbidities, disease duration and localisation, concomitant therapy (CS, AZA, 6MP, 5-ASA), previous therapy (CS, AZA, 6MP, anti-TNFα), CS dependence, FMS, PMS, endoscopic score, CRP and ESR], oral 5-ASA (concomitant therapy) was identified as unique predictor of improvement of QoL at 8 weeks. From baseline (start of induction) to week 8 and week 32 a significant IBDQ mean increase (p < 0.05) (32.9 and 25.2; mean value 172 and 170), a significant reduction of median PMS (p < 0.0001) (6vs 2vs 1, respectively) and of median CRP (p < 0.03) (3.6vs 3vs 2.1 mg/l, respectively)were observed. At week 32, 34/38 patients (89.5%) were in sustained clinical response and 32/38 patients (84.2%) were in remission. No safety issues were observed. Conclusions This interim analysis of GO-CARE study identified the concomitant therapy oral 5-ASA as predictor of significant improvement of QoL. The analysis confirms the effectiveness of GLM in real life with sustained response and remission, and improvement of QoL. Reference 1. Peyrin-Biroulet, et al. Am J Gastroenterol 2015;110:1324–38.