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P682 GO-CARE: a prospective multi-centre observational study of golimumab effectiveness and quality of life in a real life UC patient population in Italy

A. Armuzzi1, A. Gasbarrini2, S. Marchi3, S. Saibeni4, V. Germano*5, S. Cercone5, F. Bossa7, A. C. Privitera8

1IBD Unit, Presidio Columbus, Fondazione Policlinico Gemelli Università Cattolica, Rome, Italy, 2Internal Medicine, Gastroenterology and Liver Unit, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy, 3Division of Gastroenterology, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy, 4Gastroenterology Unit, RhoHospital, Rho, Italy, 5MSD Italia, Rome, Italy, 7Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Foggia, Italy, 8IBD and Pelvic Floor Unit, Azienda Ospedaliera per l'Emergenza, Ospedale Cannizzaro, Catania, Italy

Background

The ultimate treatment target in UC must be the restoration of patient (PT) quality of life (QoL).1 Aim of the study is to identify predictors of improvement QoL 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 PMS) were enrolled 8 weeks after the start of GLM (wk8) and clinical-demographic data, present at start of GLM (baseline), were collected retrospectively. Predictors of IBDQ increase considered were: age, gender, weight, height, BMI, smoking status, comorbidities, disease duration/localisation, concurrent/previous therapy, CS dependence, FMS, PMS, endoscopic score, CRP and ESR. An interim analysis was conducted to evaluate (primary endpoint) predictors of IBDQ increase (≥16 points), achieved at wk8 and wk56 compared with baseline. Mean change in IBDQ at wk8, 32 and 56, clinical response (PMS decrease ≥2 points or ≥30% and decrease ≥1 point in rectal bleeding) and clinical remission (PMS ≤2 with no sub-score >1) at wk8, 32 and 56 [also per FMS] were also assessed (secondary endpoints).

Results

110 patients were enrolled. At baseline: mean age was 43years(69 males), mean disease duration was 9.5years,77.3% of patients were steroid-dependent, 48.2% had pancolitis and 46.4% left-sided colitis. 80.9% of patients had moderate disease activity (median PMS 6) and 72.7% had a moderate endoscopic score (Mayo = 2), 20%, 12.7% and 77.3% of patients were treated with Corticosteroids, AZA, oral 5-ASA, mean IBDQ was 137. 27.3% of patients were anti-TNF experienced. By univariate analysis oral 5-ASA and higher disease activity (by PMS and FMS) were identified as predictors of QoL improvement at wk8 and wk32 respectively. From baseline(N = 110) to wk8 (n = 110), 32 (n = 67) and 56 (n = 44): a significant increase of mean IBDQ(p < 0.05) (137, 170, 172, 178) and a significant reduction of median PMS(p < 0.0001) (6, 1, 0, 0) were observed. Median FMS significantly decreased from baseline (N = 110) to wk56 (N = 44) (p < 0.001). Twenty-six and 12pts discontinued treatment before wk32 and wk56 respectively. At wk32: 59/93(63%) and 58/93(62%) were in sustained clinical response and remission. At wk56: sustained clinical response was observed in 44/82(53.3%) and 30/82(36.5%) and remission in 38/82(46.3%) and 23/82(28.0%) by PMS and FMS, respectively.

Conclusion

This interim analysis of GO-CARE study identified the concomitant therapy with oral 5-ASA and higher disease activity as predictors of significant improvement of QoL. The analysis confirms the effectiveness of GLM in a real life setting with sustained response and remission, and improvement of QoL.

Reference

1. L. Peyrin-Biroulet, et al. Am J Gastroenterol 2015; 110:1324–1338.