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Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: a pooled analysis of European prospective observational studie
M. Govoni1, A. Batalov2, D.T. Boumpas3, S. D’angelo4, F. De Keyser5, R.-M. Flipo6, H. Kellner7, H. Leroi8, A. Khalifa9
- Merck Sharp & Dohme, Rome, Italy. marinella.govoni@msd.com
- Rheumatology Clinic, Department of Internal Medicine, Medical University of Plovdiv, Bulgaria.
- Joint Academic Rheumatology Program, Medical School, National and Kapodestrian University of Athens, Greece, and Medical School, University of Cyprus, Nicosia, Cyprus.
- Rheumatology Department of Lucania, San Carlo Hospital, Potenza, Italy.
- Department of Rheumatology, Ghent University Hospital, Ghent, Belgium, and private practice, Maldegem, Belgium.
- Department of Rheumatology, CHU Lille, Université de Lille, France.
- Rheumatology and Gastroenterology Specialty Practice, Munich, Germany.
- Merck Sharp & Dohme, Belgium.
- Merck Sharp & Dohme, Germany.
CER16798
2024 Vol.42, N°3
PI 0642, PF 0650
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PMID: 37976120 [PubMed]
Received: 26/04/2023
Accepted : 04/09/2023
In Press: 15/11/2023
Published: 27/03/2024
Abstract
OBJECTIVES:
Rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) patients often experience secondary non-response to a first-line tumour necrosis factor alpha inhibitor (TNFαi). This pooled analysis of six observational studies in Europe (GO-BEYOND program) provides an estimate of second-line golimumab (GLM) effectiveness for these rheumatic diseases.
METHODS:
The GO-BEYOND studies included common disease-specific endpoints allowing for a pooled analysis. Patients had discontinued one prior TNFαi (due to loss of efficacy, tolerability, or inconvenience) and were followed for 12 months after GLM initiation. Primary endpoints included the proportion of patients achieving low disease activity (LDA, DAS28-CRP<3.2) in RA, minimal disease activity (MDA, fulfilment of 5 of 7 outcome measures) in PsA, or low disease activity (ASDAS<2.1) in axSpA at 6 months. Disease activity at 3 and 12 months and quality of life (QoL; EQ-5D-3L) were also assessed. Adverse events were monitored. Protocol-specified analyses were based on observed data.
RESULTS:
In 712 patients, (n=325, RA; 186, PsA; 201, axSpA), mean age was 54 years, 64% were female, and median disease duration was 5 years. Primary endpoints were achieved in 58.3% (RA), 45.5% (PsA), and 45.4% (axSpA) of patients; disease activity improvements were observed at 3 and 12 months and EQ-5D-3L results showed improved QoL over time. The treatment persistence rate at 12 months was 67.8% of patients. No new safety signals were observed.
CONCLUSIONS:
This pooled analysis of the GO-BEYOND studies showed that treatment with GLM was effective and represented a valid second-line option for RA, PsA, and axSpA patients.
