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://ichgcp.net/clinical-trials-registry/NCT01313858 .

Keywords: Ankylosing spondylitis; Golimumab; Non-interventional study; Patient reported outcomes; Psoriatic arthritis; Rheumatoid arthritis.

Conflict of interest statement

Ethics approval and consent to participate

The study was performed in accordance with the Declaration of Helsinki and standards of Good Clinical Practice. The primary ethics approval was obtained from the Ethics Committee of the Ludwig-Maximilian University in Munich on 17 February 2010 (number 008–10). All patients provided written informed consent prior to participation.

Consent for publication

Not applicable.

Availability of data and materials

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.

Role of the sponsor

The sponsor MSD Sharp & Dohme GmbH funded this observational study and had a role in the design of the study and critical revision of the manuscript, in close collaboration with the scientific advisors of this study (co-authors). The authors confirm that there was on influence of the funding on the results and the conclusion.

Figures

Fig. 1

The flow chart shows the patient disposition and flow during the study. Of the 1613 documented patients (safety set), 1458 were eligible for the efficacy analysis (efficacy set), and 664 completed the study (completer set). AS ankylosing spondylitis, BL baseline, PsA psoriatic arthritis, RA rheumatoid arthritis

Fig. 2

Physician Global Assessment (PhGA) of patient’s health status. The PhGA is a non-disease-specific evaluation of participants’ overall health status assessed on a 10-mm visual analogue scale (VAS) ranging from “0” (free of complaints) to “10” (strong discomfort). The closer the score is to 0, the better is the health status

Fig. 3

EQ visual analogue scale (EQ VAS) from 0 = ‘worst imaginable health state’ to 100 = ‘best imaginable health state’. BL baseline

Fig. 4

EQ-5D-3L: Euro-QoL descriptive system of health-related quality of life states consisting of five dimensions and three levels. The figure shows the proportion of patients reporting some or extreme problems, by visit

Fig. 5

FFbH: Funktionsfragebogen Hannover. 0 represents minimal function, 100 optimal function

Fig. 6

FACIT-Fatigue: functional assessment of chronic illness therapy-fatigue. On the FACIT-F, 0 points represent the worst and 52 the highest possible state with regard to fatigue