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Abstract
Objective The 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).
Design Prospective non-interventional study with 24-month observation per patient.
Setting 158 office-based and clinical-based physicians in Germany.
Intervention GLM administered in the 50 mg dose subcutaneously in monthly intervals under real-life conditions.
Results Of 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<0.0001) in patients with RA, and Bath Ankylosing Spondylitis Disease Index score decreased from 5.1 to 2.4 (p<0.0001) in patients with AS. Response rate calculated in patients with PsA by modified Psoriatic Arthritis Response Criteria was 67.9% after 24 months. Most adverse events were of mild or moderate nature, and no new safety signals were detected. According to the physicians’ clinical assessments, treatment with GLM was successful (no adverse drug reaction and a clear or moderate therapeutic effect in an individual patient) in 55.0%–56.6% of patients with RA, PsA and AS, respectively, at month 3, increasing from 74.5% to 76.1% at month 24.
Conclusions GLM subcutaneously once monthly led to substantial improvements in clinical effectiveness in patients with various inflammatory rheumatic diseases who could be followed up in a real-life setting in Germany. The treatment was well tolerated, and the safety profile of GLM was consistent with that observed in the previous randomised controlled trials.
Trial registration number NCT01313858.
- real-life setting
- non-interventional
- golimumab
- rheumatoid arthritis
- psoriatic arthritis
- ankylosing spondylitis
- biologics
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Footnotes
Contributors All authors contributed to the design of the study and interpretation of the results. KK and MHT: wrote the first version of the manuscript. GRB, SW and MB-B: provided input into the concept and the interpretation of results. All authors reviewed and approved the final version.
Funding This study was sponsored by MSD Sharp & Dohme GmbH, Haar, Germany.
Competing interests KK has received funds for consultancy or research from: AbbVie, BMS, Celgene, Janssen Biologics, MSD, Pfizer, Roche and Sanofi-Aventis. GRB has received funds for consultancy or research from AbbVie, Bristol-Myers Squibb, MSD, Pfizer, Roche and UCB. SW has received funds for consultancy or research from AbbVie, Chugai, Janssen Biologics, MSD, Novartis, Pfizer and Roche. MB-B has received funds for consultancy or research from: AbbVie, Hexal, MSD, Roche and UCB. MHT is full-time employee of MSD Sharp & Dohme GmbH.
Patient consent Obtained.
Ethics approval Ethics Committee of the Ludwig-Maximilian University in Munich.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The datasets generated and/or analysed during the current study are not publicly available as they concern a proprietary product and sharing is not explicitly covered by patient consent.