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

Affiliates

Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden [1], Department of Internal Medicine, Trelleborg Hospital, Trelleborg, Sweden [2], Department of Medicine, Danderyd Hospital, Stockholm, Sweden [3], MSD, Stockholm, Sweden [4], Department of Gastroenterology and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden [5], Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, Sweden [6], IBD-unit, Division of Gastroenterology, Karolinska university hospital, Stockholm, Sweden [7], Department of Gastroenterology, Skåne University hospital, Lund, Sweden [8], Department of Internal Medicine, Södra Älvsborgs Hospital, Borås, Sweden [9]

Abstract

Background: Clinical trials have demonstrated that golimumab is effective in anti-TNF naïve UC patients.

Aim and methods: The aim was to assess the clinical effectiveness of golimumab in a real world setting. Patients with moderate-to-severe ulcerative colitis, defined as Mayo endoscopic subscore ≥2 who initiated golimumab between June 2014 and June 2017 at 16 Swedish Hospitals were eligible. Clinical data were recorded at baseline and prospectively, using an electronic Case Report 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.) Continuous data are presented as median (interquartile range). Differences were assessed by Wilcoxon-signed rank test.

Results: 50 patients were included (table 1). At study entry, 24/50 (48%) were on concomitant treatment with immunomodulators and 16/50 (32%) on oral corticosteroids. The 12 and 52-week drug continuation rates were 37/50 (74%) and 23/50 (46%), respectively. The 12-week clinical response rate was 14/50 (28%), the remission rate, 8/50 (16%) and the corresponding figures at week 52 were 13/50 (26%) and 10/50 (20%) (figure 1A). Among patients who continued golimumab, the median Mayo score decreased from 7 (6-9) at baseline to 1 (0-5) at 52 weeks (p<0.01, figure 1B) and the median faecal calprotectin decreased from 862 (335-1759) µg/g to 90 (34-169) µg/g (p<0.01, figure 1C). Consistently, quality of life improved, with a reduction of the overall short health scale score (p<0.01).

Conclusions: Golimumab-treated patients, in Swedish clinical practice, seem to represent a treatment refractory patient-group. Despite this, our results confirm that golimumab is an effective therapy in UC.