Sara Rundquist (1), Carl Eriksson (1), Linda Nilsson (2), Leif Angelison (3), Susanna Jäghult (4), Jan Björk (5), Olof Grip (6), Henrik Hjortswang (7), Hans Strid (8), Per Karlén (2), Scott Montgomery (9-11), Jonas Halfvarson (1)

Affiliates

1. Dept. of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden 2. Dept. of Internal Medicine, Danderyd Hospital, Stockholm, Sweden 3. Dept. of Internal Medicine, Helsingborg Hospital, Helsingborg, Sweden 4. Stockholm Gastro Center, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden 5. Dept. of Medicine, Center for Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden 6. Dept. of Gastroenterology, Skåne University Hospital Malmö, Malmö, Sweden 7. Dept. of Gastroenterology, Linköping University, Linköping, Sweden 8. Dept. of Internal Medicine, Södra Älvsborgs Sjukhus, Borås, Sweden 9. Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, Sweden 10. Clinical Epidemiology Unit, Department of Medicine; Karolinska Institutet, Stockholm, Sweden 11. Department of Epidemiology and Public Health, University College London, UK

Abstract

Background: The effectiveness of golimumab in Crohn’s disease (CD) is largely unknown as it is not approved for the treatment of the disease. Off-label use of drugs is not prohibited in Sweden. We aimed to identify the population of CD patients treated with golimumab in Sweden, to assess the effectiveness of golimumab (defined as the drug retention rate), and to identify predictors of drug discontinuation.
Methods: Patients with CD who received at least one injection of golimumab were identified through the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG), which includes prospectively collected clinical information. Kaplan-Meier curves were used to illustrate the duration of golimumab treatment. Cox regression models were used to identify predictors of golimumab discontinuation.
Results: The study cohort involved 94 patients of whom the majority (96.8%) had previously discontinued at least one anti-TNF agent. The drug retention rate at 12 weeks was 85.1% (Figure 1). Predictors of golimumab discontinuation at 12 weeks were previous surgery (adjusted HR=7.52, 95% CI 1.12-50.36), concomitant corticosteroid use at baseline (adjusted HR=5.70, 95% CI: 1.13‒28.68) and female sex (adjusted HR=6.59; 95% CI: 1.04‒41.62). Median duration of follow-up was 89 (IQR: 32‒158) weeks. The drug retention at the most recent follow-up was 35.1%. Predictors of golimumab discontinuation at the most recent follow-up were corticosteroid use at baseline (adjusted HR=2.60, 95% CI: 1.17‒5.79) and female sex (adjusted HR=2.24; 95% CI: 1.19‒4.23).
Conclusions: Patients with CD treated with golimumab were a treatment-refractory group. Despite this, more than one third of the patients appeared to have had clinical benefit after a median follow-up of more than one and half years.