Abstract
This study aimed at assessing the impact of golimumab on health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) in real-world settings. GO-Q was an observational, prospective, 12-month study, which recruited patients with moderate-to-severely active RA initiating golimumab treatment per label in rheumatology clinics and private practices. Primary endpoint was the change in PROs [EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire, Health Assessment Questionnaire Disease Index (HAQ-DI), and Work Productivity and Activity Index for RA (WPAI:RA)] after 12 months of treatment. Other endpoints included Disease Activity Score for 28 joints with erythrocyte sedimentation rate (DAS28-ESR), healthcare resource utilization, and golimumab adherence. Changes in continuous variables from baseline were evaluated with the paired t test. One hundred forty-five patients were recruited. The mean [standard deviation (SD)] EQ-5D-3L index increased significantly at 12 months versus baseline [from 0.427 (0.206) to 0.801 (0.229); p < 0.0001], with changes as early as 3 and 6 months (both p < 0.0001). Accordingly, there were statistically significant changes in all WPAI:RA domains from baseline to 3, 6, and 12 months (p < 0.0001). Patients’ function improved gradually from the third month until the end of follow-up (p < 0.0001 for all time-points). Thirty (27.3%) and 60 (54.6%) patients achieved remission (DAS28-ESR < 2.6) and low disease activity (DAS28-ESR ≤ 3.2), respectively, at 12 months. Adherence rate to golimumab was high (mean [SD] 90.3% (7.5) at 12 months). In patients with moderate-to-severely active RA, golimumab significantly improved HRQoL, physical function, and work productivity and activity, with improvements in disease activity over 12 months in real-world settings.
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Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA’s data sharing policy, including restrictions, is available at http://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study can be submitted through the EngageZone site or via to dataaccess@merck.com.
Code availability
All data were analyzed using SAS v9.4 (SAS Institute, Cary, NC).
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Acknowledgements
Authors: All authors are responsible for the work described in this paper; they were involved in at least one of the following: conception, design of work or acquisition, analysis, interpretation of data and drafting the manuscript and/or revising/reviewing the manuscript for important intellectual content. They provided final approval of the version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All co-authors take full responsibility for the integrity and accuracy of all aspects of the work. The funding sponsor participated in the study design, collection analysis, data interpretation, and reporting the study results. Investigators: The authors wish to thank the following GO-Q investigators; Alexandros Andrianakos, Dimitrios Tseronis, Athanasios Georgountzos, Maria Tektonidou, Emmanouil Dermitzakis, Vasiliki Galanopoulou, Nikolaos Michas, Panagiotis Bozios, Anna Kandyli, Stamatis-Nikos Liossis, Foteini Lada, Magdalini Patriki, Panayiotis Vlachoyiannopoulos, Athanasios Koutroumpas, Suzana Gazi.
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Funding for this research and article processing charges was provided by MSD Greece.
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Dr Dimitrios Vassilopoulos has received honoraria from Abbvie, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. Dr Prodromos Sidiropoulos has received honoraria from AbbVie, Amgen, MSD, Novartis, Pfizer, Roche, and UCB. Dr Evangelia Petrikkou and Dr Achilleas Livieratos are employees of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA, who may own stock and/or hold stock options in Merck & Co., Inc., Kenilworth, NJ, USA. For the remaining authors none were declared.
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The study was designed and conducted in accordance with the guidelines for Good Pharmacoepidemiology Practice of the International Society for Pharmacoepidemiology, the ethical principles laid down in the Declaration of Helsinki, and all applicable local rules and regulations. The study was approved by the competent Institutional Review Boards of all participating hospital sites. Participation of private practice investigators was approved by the Institutional Review Board of a participating hospital located in the same geographic region as the Private Practice.
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Psaltis, D., Settas, L., Georgiadis, A. et al. The effects of golimumab on patient centric outcomes amongst rheumatoid arthritis patients in Greece. The GO-Q study. Rheumatol Int 42, 639–650 (2022). https://doi.org/10.1007/s00296-021-05073-1
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DOI: https://doi.org/10.1007/s00296-021-05073-1