Observational studyBMJ open2018
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.
Observational study in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01313858 (Non-Interventional Study Investigating the Use of Golimumab), which is not on this map. Cited by 23 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
Who cites it
23 citing papers in PubMed.
- Golimumab for the Treatment of Axial Spondyloarthritis: Integrating Clinical Outcomes with Real-World Patient Benefits.Advances in therapy · 2026Review
- Efficacy and safety of subcutaneous golimumab in Syrian patients with ankylosing spondylitis: A cohort study.The Journal of international medical research · 2026Observational
- Golimumab for the Treatment of Rheumatoid Arthritis: A Narrative Review of Pivotal Randomized Trials and Real-World Studies.Rheumatology and therapy · 2026Review
- Safety of Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Axial Spondyloarthritis: Results from a Real-World Canadian Setting.Rheumatology and therapy · 2025Article
- Impact of comorbidities, diabetes, and smoking on sustained outcomes in rheumatoid arthritis: a retrospective study.Reumatologia · 2025Article
- A review of JAK-STAT signalling in the pathogenesis of spondyloarthritis and the role of JAK inhibition.Rheumatology (Oxford, England) · 2022Review
- The effects of golimumab on patient centric outcomes amongst rheumatoid arthritis patients in Greece. The GO-Q study.Rheumatology international · 2022Observational
- Effectiveness of Etanercept in Rheumatoid Arthritis: Real-World Data from the German Non-interventional Study ADEQUATE with Focus on Treat-to-Target and Patient-Reported Outcomes.Rheumatology and therapy · 2022Article
- Real-world effectiveness and safety of golimumab in rheumatoid arthritis treatment: A two-center study in Taiwan.Journal of the Chinese Medical Association : JCMA · 2022Article
- Article
- Effectiveness and safety of 12-month certolizumab pegol treatment for axial spondyloarthritis in real-world clinical practice in Europe.Rheumatology (Oxford, England) · 2021Observational
- The effect of electronic moxibustion combined with rehabilitation nursing on the lumbar pain and stiffness of ankylosing spondylitis patients.American journal of translational research · 2021Article
- Long-term effectiveness and safety of infliximab and golimumab in ankylosing spondylitis patients from a Canadian prospective observational registry.BMC rheumatology · 2020Article
- Observational
- Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany.Rheumatology and therapy · 2020Article
- Association Between Nursing Support Levels and Effectiveness of Golimumab in the Management of Patients with Rheumatologic Diseases.Rheumatology and therapy · 2020Article
- Safety Profile of Biologics Used in Rheumatology: An Italian Prospective Pharmacovigilance Study.Journal of clinical medicine · 2020Article
- Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry.BMC rheumatology · 2020Article
- Article
- Golimumab for Rheumatoid Arthritis.Journal of clinical medicine · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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<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.
conclusionsGLM 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.