Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany

ObjectiveThe Non Interventional Evaluation with Golumimab (GO-NICE) study aimed to document patient and treatment characteristics as well as clinical effectiveness and safety in adult patients newly treated with the tumour necrosis factor inhibitor golimumab (GLM).DesignProspective non-interventiona...

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Bibliographic Details
Published in:BMJ open 2018-06, Vol.8 (6), p.e021082-e021082
Main Authors: Krüger, Klaus, Burmester, Gerd R, Wassenberg, Siegfried, Bohl-Bühler, Martin, Thomas, Matthias H
Format: Article
Language:English
Subjects:
Bias
Monoclonal antibodies
Patients
Personal health
Psoriasis
Psoriatic arthritis
Rheumatic diseases
Rheumatoid arthritis
Rheumatology
TNF inhibitors
Tumor necrosis factor-TNF
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Summary:ObjectiveThe Non Interventional Evaluation with Golumimab (GO-NICE) study aimed to document patient and treatment characteristics as well as clinical effectiveness and safety in adult patients newly treated with the tumour necrosis factor inhibitor golimumab (GLM).DesignProspective non-interventional study with 24-month observation per patient.Setting158 office-based and clinical-based physicians in Germany.InterventionGLM administered in the 50 mg dose subcutaneously in monthly intervals under real-life conditions.ResultsOf the 1613 included patients, 1458 patients were eligible for final analysis: 474 patients with rheumatoid arthritis (RA, 54.9±13.4 years, 72.8% women, 64.7% biologic-naïve), 501 with psoriatic arthritis (PsA, 50.5±12.1 years, 54.1% women, 56.5% biologic-naïve) and 483 with ankylosing spondylitis (AS, 43.6±12.3 years, 66.5% men, 61.0% biologic-naïve). 664 patients completed follow-up (2-year retention rate 45.5%). Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28-ESR) decreased from 5.0 to 2.9 after 24 months (p
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2017-021082