Real-world effectiveness of golimumab in adult patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis and an inadequate response to initial TNFi therapy in Greece: the GO-BEYOND prospective, observational study.
Panagiotis Athanassiou, Dimitrios Psaltis, Athanasios Georgiadis, Gkikas Katsifis, Athina Theodoridou, Souzana Gazi, Prodromos Sidiropoulos, Maria G Tektonidou, Andreas Bounas, Anna Kandyli, Periklis Vounotrypidis, Grigorios T Sakellariou, Dimitrios Vassilopoulos, Zhiping Huang, Evangelia Petrikkou, Dimitrios Boumpas
Author Information
Panagiotis Athanassiou: Rheumatology Department, Aghios Pavlos" General Hospital of Thessaloniki, Thessaloniki, Greece.
Souzana Gazi: Rheumatology Unit, "KAT" Regional General Hospital, Athens, Greece.
Prodromos Sidiropoulos: Department of Rheumatology, Clinical Immunology and Allergy, University of Crete, Heraklion, Greece.
Maria G Tektonidou: Rheumatology Unit, 1st Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Joint Rheumatology Program, Laiko Hospital, Athens, Greece.
Andreas Bounas: "OLYMPION", General Clinic of Patra, Patra, Greece.
Dimitrios Boumpas: Rheumatology and Clinical Immunology, 4th Department of Internal Medicine, "Attikon" University Hospital, Rimini 1, 124 62, Athens, Greece.
The impact of golimumab (GLM) on remission or low disease activity (LDA) was evaluated in patients with moderate-to-severe rheumatoid arthritis (RA), progressive psoriatic arthritis (PsA), or severe axial spondyloarthritis (axSpA), who failed previous treatment for their rheumatic disease with one initial tumor necrosis factor α inhibitor (TNFi). This is a multicenter, prospective, real-world observational 18-month study, conducted in Greece. The primary endpoint, assessed at 6 months, included the proportion of patients attaining LDA and/or remission (Disease Activity Score for 28 joints based on C-reactive protein [DAS28-CRP] ≤ 3.2), minimal disease activity (MDA; MDA criteria), and moderate disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score 4-7), respectively. Other endpoints evaluated the persistence to GLM treatment and its impact on patients' work productivity (Work Productivity and Activity Impairment [WPAI] instrument) and quality of life (QoL; EuroQoL5 dimensions 3 levels [EQ-5D-3L] questionnaire). Descriptive statistics, the Wilcoxon signed-rank test, and Kaplan-Meier method were used for analyses. At 6 months, LDA was achieved by 46.4% of patients with RA, MDA by 57.1% of patients with PsA, and BASDAI 4-7 by 24.1% of patients with axSpA. For all study patients, persistence rates on GLM were high (85.1-93.7%) over 18 months; all WPAI domain scores and the EQ-5D-3L index score improved significantly (p < 0.001) from baseline to 18 months. GLM treatment was effective in patients with RA, PsA, or axSpA who had failed previous treatment with one TNFi and led to significant WPAI and QoL improvements. Persistence rates were high. Trial registration number and date of registration: As per the local regulations the study has been registered at the national registry for non-interventional studies https://www.dilon.sfee.gr/studiesp_d.php?meleti_id=MK8259-6995 .
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