TY - JOUR
T1 - 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
T2 - the GO-BEYOND prospective, observational study
AU - Athanassiou, Panagiotis
AU - Psaltis, Dimitrios
AU - Georgiadis, Athanasios
AU - Katsifis, Gkikas
AU - Theodoridou, Athina
AU - Gazi, Souzana
AU - Sidiropoulos, Prodromos
AU - Tektonidou, Maria G.
AU - Bounas, Andreas
AU - Kandyli, Anna
AU - Vounotrypidis, Periklis
AU - Sakellariou, Grigorios T.
AU - Vassilopoulos, Dimitrios
AU - Huang, Zhiping
AU - Petrikkou, Evangelia
AU - Boumpas, Dimitrios
N1 - Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2023/10
Y1 - 2023/10
N2 - 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 .
AB - 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 .
KW - Axial spondyloarthritis
KW - Disease activity
KW - Golimumab
KW - Psoriatic arthritis
KW - Quality of life
KW - Rheumatoid arthritis
UR - http://www.scopus.com/inward/record.url?scp=85163868455&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85163868455&partnerID=8YFLogxK
U2 - 10.1007/s00296-023-05376-5
DO - 10.1007/s00296-023-05376-5
M3 - Article
C2 - 37402886
AN - SCOPUS:85163868455
SN - 0172-8172
VL - 43
SP - 1871
EP - 1883
JO - Rheumatology International
JF - Rheumatology International
IS - 10
ER -