Patient-reported outcomes with golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: non-interventional study GO-NICE in Germany

Abstract

The TNF inhibitor golimumab (GLM) is a treatment option in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). The GO-NICE study assessed patient-reported outcomes (PRO) in patients newly treated with monthly GLM 50 mg subcutaneously (SC) under real-life conditions in Germany. A prospective non-interventional study with 24-month observation per patient was conducted at 158 sites. Available for analysis were 1,458 patients, 474 with rheumatoid arthritis (RA: 54.9 ± 13.4 years, 72.8% females, 60.4% biologic-naïve), 501 with psoriatic arthritis (PsA: 50.5 ± 12.1 years, 54.1% females; 47.5% biologic-naïve), and 483 with ankylosing spondylitis (AS: 43.6 ± 12.3 years, 66.5% males; 58.4% biologic-naïve). A total of 664 patients completed follow-up to month 24. An improvement of QoL by EuroQoL EQ-5D-3L was seen after 6 months and was maintained over 24 months. The patients’ health state today (EQ visual analog scale) improved statistically significantly (p < 0.0001 vs. BL) from 51.0 at baseline (BL) to 63.4 (RA), from 48.4 to 64.3 (PsA) and from 46.8 to 66.5 (AS). Functional ability (FFbH) improved significantly (p < 0.003 vs. BL) from BL 68.2 to 76.1 points (RA), from 69.0 to 76.8 points (PsA), and from 69.0 to 78.5 points (AS). The mean FACIT-Fatigue score increased significantly (p < 0.0001 vs. BL) from BL 32.4 to 38.3 points (RA), from 30.0 to 35.9 points (PsA), and from 29.9 to 37.9 points after 24 months (AS); p < 0.0001 vs. BL each. On treatment with GLM SC once monthly, significant improvements in patient-reported QoL parameters were noted in a very similar manner in all three diseases.Trial registration ClinTrials.gov Identifier: NCT01313858. Registered March 14, 2011; https://clinicaltrials.gov/ct2/show/record/NCT01313858.

Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry

“…Due to its long-term duration, BioTRAC offered a unique opportunity to evaluate the real-world effectiveness and safety of three anti-TNF agents in a community Canadian setting, while assessing regional variations due to differences in patient profiles, practice patterns and local reimbursement policies impacting access to care over 16 years. Although there has been extensive real-world evidence generated on the early anti-TNF agents such as IFX or etanercept, very little efficacy data has been published with other anti-TNF agents such as GLM, and most of those only presented persistence data (15,(29)(30)(31). One exception, however, is the GO NICE prospective non-interventional trial in Germany for inflammatory arthritis patients treated with GLM (15,32).…”

“…Although there has been extensive real-world evidence generated on the early anti-TNF agents such as IFX or etanercept, very little efficacy data has been published with other anti-TNF agents such as GLM, and most of those only presented persistence data (15,(29)(30)(31). One exception, however, is the GO NICE prospective non-interventional trial in Germany for inflammatory arthritis patients treated with GLM (15,32). This 2-year trial also found significant clinical effectiveness among RA patients (15), as well as improvements in patient-reported health status, physical function, and fatigue levels (32).…”

“…One exception, however, is the GO NICE prospective non-interventional trial in Germany for inflammatory arthritis patients treated with GLM (15,32). This 2-year trial also found significant clinical effectiveness among RA patients (15), as well as improvements in patient-reported health status, physical function, and fatigue levels (32).…”

Golimumab for Treating Chronic Inflammatory Joint Diseases in the Adult Population: Clinical Efficacy and Tolerability

“…Таблица 3. Динамика оцениваемых параметров в исследовании GO-NICE[21] Table 3. Dynamics of the assessed parameters in the GO-NICE study[21] Примечание.…”

“…Динамика оцениваемых параметров в исследовании GO-NICE[21] Table 3. Dynamics of the assessed parameters in the GO-NICE study[21] Примечание. DAS28 -индекс активности ревматоидного артрита по 28 суставам, ОСБ -общее состояние больных, PsARC -индекс Американского колледжа ревматологов для псориатического артрита, BASDAI -индекс активности анкилозирующего спондилита.…”