Clinical effectiveness of golimumab in Crohn’s disease: an observational study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)

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Clinical effectiveness of golimumab in Crohn’s disease : an observational study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG). / Rundquist, Sara; Eriksson, Carl; Nilsson, Linda; Angelison, Leif; Jäghult, Susanna; Björk, Jan; Grip, Olof; Hjortswang, Henrik; Strid, Hans; Karlén, Per; Montgomery, Scott; Halfvarson, Jonas.

I: Scandinavian Journal of Gastroenterology, 2018.

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Rundquist, Sara ; Eriksson, Carl ; Nilsson, Linda ; Angelison, Leif ; Jäghult, Susanna ; Björk, Jan ; Grip, Olof ; Hjortswang, Henrik ; Strid, Hans ; Karlén, Per ; Montgomery, Scott ; Halfvarson, Jonas. / Clinical effectiveness of golimumab in Crohn’s disease : an observational study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG). I: Scandinavian Journal of Gastroenterology. 2018.

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TY - JOUR

T1 - Clinical effectiveness of golimumab in Crohn’s disease

T2 - Scandinavian Journal of Gastroenterology

AU - Rundquist, Sara

AU - Eriksson, Carl

AU - Nilsson, Linda

AU - Angelison, Leif

AU - Jäghult, Susanna

AU - Björk, Jan

AU - Grip, Olof

AU - Hjortswang, Henrik

AU - Strid, Hans

AU - Karlén, Per

AU - Montgomery, Scott

AU - Halfvarson, Jonas

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

KW - biological treatment

KW - Crohn’s disease

KW - Golimumab

KW - IBD

KW - SWIBREG

U2 - 10.1080/00365521.2018.1519597

DO - 10.1080/00365521.2018.1519597

M3 - Article

JO - Scandinavian Journal of Gastroenterology

JF - Scandinavian Journal of Gastroenterology

SN - 1502-7708

ER -