Background The GO-PRACTICE study was initiated to describe the use of Golimumab (GLM), a human anti-TNFα monoclonal antibody, in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in French clinical practice.
Objectives The primary objective of this interim analysis was to assess the persistence of GLM at 1-year.
Methods Observational, multicenter, prospective, national study. Adult patients with RA, PsA and AS were included consecutively at GLM after the decision for GLM therapy has been taken or at least after GLM initiation, and followed-up for 2 years. We present here baseline characteristics for overall population (n=754) and interim results for patients with 1-year follow-up (n=228 patients with available data regarding persistence of GLM)
Results A total of 754 patients (134 sites) were included between January 2015 and March 2016. Most of them had AS (64%), and 22% and 13% had RA and PsA, respectively. Mean age was 46±13 years and 61% were female. Almost 37% had received prior biotherapy.
Nearly all patients (99%) were prescribed GLM as 50 mg-monthly injections. GLM was mostly co-prescribed with other antirheumatic treatments (84%).
Of the 163 patients with available data at strictly 1-year, 56.4% were still treated with GLM; (61.9% in biotherapy-naïve patients); the persistence rate was similar across the three groups. The Kaplan-Meier duration curves of GLM are presented in figure 1. The main reason for GLM discontinuation was primary non-response, reported in 42% of patients.
Among patients who continued GLM treatment, a meaningful improvement in disease activity was observed at 1-year in 71.9% of RA, 63.2% of PsA and 68.0% of AS patients. Patients-reported outcomes, including pain and functional disability, also showed improvement
Conclusions In real-life practice in France, GLM was prescribed according to recommendations in terms of dosage and therapeutic strategy. One-year interim analysis, performed in one third of the cohort, suggests that GLM treatment is associated with clinical improvements leading to persistence of treatment. These results need to be confirmed in the final overall analysis planned in 2018.
Disclosure of Interest R.-M. Flipo: None declared, F. Tubach: None declared, J. Ouaniche: None declared, P. Goupille: None declared, E. Lespesailles: None declared, N. Gouyette Employee of: MSD, P. Bertin: None declared, B. Fautrel: None declared
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