Sara Rundquist1, Carl Eriksson1, Linda Nilsson2, Leif Angelison3, Susanna Jäghult4, Jan Björk5, Olof Grip6, Henrik Hjortswang7, Hans Strid8, Per Karlén2, Scott Montgomery9,10,11, Jonas Halfvarson1. 1. a Department of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden. 2. b Department of Internal Medicine , Danderyd Hospital , Stockholm , Sweden. 3. c Department of Internal Medicine , Helsingborg Hospital , Helsingborg , Sweden. 4. d Stockholm Gastro Center, Karolinska Institutet , Danderyd Hospital , Stockholm , Sweden. 5. e Department of Medicine, Center for Digestive Diseases , Karolinska University Hospital , Stockholm , Sweden. 6. f Department of Gastroenterology , Skåne University Hospital Malmö , Malmö , Sweden. 7. g Department of Gastroenterology , Linköping University , Linköping , Sweden. 8. h Department of Internal Medicine , Södra Älvsborgs Sjukhus , Borås , Sweden. 9. i Clinical Epidemiology and Biostatistics, School of Medical Sciences , Örebro University , Örebro , Sweden. 10. j Clinical Epidemiology Unit, Department of Medicine , Karolinska Institutet , Stockholm , Sweden. 11. k Department of Epidemiology and Public Health , University College London , London , UK.
Abstract
OBJECTIVE: The effectiveness of golimumab in Crohn's disease (CD) is largely unknown as it is not approved for the treatment of the disease. 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, which includes prospectively collected clinical information. 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-tumour necrosis factor (anti-TNF) agent. The drug retention rate at 12 weeks was 85.1%. 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). The 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). CONCLUSION: 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 1.5 years.
OBJECTIVE: The effectiveness of golimumab in Crohn's disease (CD) is largely unknown as it is not approved for the treatment of the disease. We aimed to identify the population of CDpatients 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, which includes prospectively collected clinical information. 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-tumour necrosis factor (anti-TNF) agent. The drug retention rate at 12 weeks was 85.1%. 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). The 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). CONCLUSION: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 1.5 years.
Authors: Joel Thunberg; Olle Björkqvist; Charlotte R H Hedin; Anders Forss; Charlotte Söderman; Daniel Bergemalm; Ola Olén; Henrik Hjortswang; Hans Strid; Jonas F Ludvigsson; Carl Eriksson; Jonas Halfvarson Journal: United European Gastroenterol J Date: 2022-07-14 Impact factor: 6.866