Isabella Visuri [1], Carl Eriksson [1], Lina Vigren [2], Linda Nilsson [3], Henrik Hjortswang [4], Ruzan Udumyan [5], Sven Almer [6], Maria Seddighzadeh [7], Erik Hertervig [8], Per Karlén [3], Hans Strid [9], The GO-SWIBREG study group, Jonas Halfvarson [1]

Affiliates

Örebro University, Department of Gastroenterology, Faculty of Medicine and Health, Sweden [1] Hospital of Trelleborg, Department of Medicine, Division of Gastroenterology, Sweden [2] Danderyd Hospital, Department of Internal Medicine, Stockholm, Sweden [3] Linköping University, Department of Gastroenterology and Department of Clinical and Experimental Medicine, Sweden [4] Örebro University, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine and Health, Sweden [5] Karolinska Institute, Department of Medicine, Gastrocentrum, Stockholm, Sweden [6] Merck Sharp and Dohme, Stockholm, Sweden [7] Skåne University Hospital, Department of Gastroenterology, Lund, Sweden [8] Södra Älvsborgs Hospital, Department of Internal Medicine, Borås, Sweden [9]

Abstract

Background: Clinical trials may not reflect clinical practice. Therefore, we aimed to assess the effectiveness of golimumab in a real world cohort.

Methods: This is a prospective, observational, multi-centre cohort study. Eligible patients had moderate-to-severe disease activity ulcerative colitis, defined as a Mayo endoscopic subscore ≥2. Clinical characteristics, treatment, disease activity and quality of life measures were recorded at baseline and prospectively, using an electronic Case Record Form, integrated with the Swedish National Quality Registry for IBD (SWIBREG). Primary objective was clinical effectiveness at 12 weeks and 52 weeks, i.e. clinical response (defined as a decrease in Mayo score by ≥3 points or 30% from baseline) and remission (defined as a score of ≤2 with no individual subscores >1). Data from the 12 week induction part are presented.

Results: At study entry, 24/50 (48%) were on concomitant treatment with immunomodulators, 16/50 (32%) on oral corticosteroids and 27/50 (54%) on 5-ASA. In total, 35/50 (70%) had previously been exposed to at least one TNF-antagonist (table 1). At 12 weeks, 37/50 (74%) were still on treatment with golimumab (figure 1). Of the patients continuing golimumab until week 12, 8 (22%) were in clinical remission and 13 (35%) had a clinical response. The median Mayo score decreased from 7 (6-10) at baseline to 5 (1-8) at 12 weeks (p<0.01). Consistently, median faecal calprotectin decreased from 710 (275-1850) µg/g to 390 (45-870) µg/g (p=0.02). Quality of life improved in golimumab treated patients, with a significant reduction of the overall short health scale (SHS) score (p=0.04).

Conclusions: This cohort of golimumab treated patients represents a treatment-refractory group. Improvements in disease activity and quality of life can be achieved already at 12 weeks.

The study was financially supported by MSD.