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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

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Abstract

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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Data availability

Data are available from the corresponding author upon reasonable request. There are circumstances that may prevent MSD Greece from sharing the requested data.

Code availability

All data were analyzed using SAS v9.4 (SAS Institute, Cary, NC).

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Acknowledgements

The authors wish to thank Dimitrios Zisopoulos, Michail P. Migkos, Ilias Bournazos, Eleni Kteniadaki for their assistance and feedback.

Funding

This study was sponsored by Merck Sharp & Dohme (MSD) Greece. The sponsor did not have any involvement at all stage of the research and submission, except providing funding.

Author information

Authors and Affiliations

  1. Rheumatology Department, Aghios Pavlos” General Hospital of Thessaloniki, Thessaloniki, Greece

    Panagiotis Athanassiou

  2. Private Practice, Serres, Greece

    Dimitrios Psaltis

  3. Private Practice, Ioannina, Greece

    Athanasios Georgiadis

  4. Naval Hospital of Athens, Rheumatology Clinic, Athens, Greece

    Gkikas Katsifis

  5. Private Practice, Thessaloniki, Greece

    Athina Theodoridou, Periklis Vounotrypidis & Grigorios T. Sakellariou

  6. Rheumatology Unit, “KAT” Regional General Hospital, Athens, Greece

    Souzana Gazi

  7. Department of Rheumatology, Clinical Immunology and Allergy, University of Crete, Heraklion, Greece

    Prodromos Sidiropoulos

  8. Rheumatology Unit, 1st Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Joint Rheumatology Program, Laiko Hospital, Athens, Greece

    Maria G. Tektonidou

  9. “OLYMPION”, General Clinic of Patra, Patra, Greece

    Andreas Bounas

  10. Private Practice, Athens, Greece

    Anna Kandyli

  11. 2nd University Department of Internal Medicine, General Hospital of Athens “Ippokrateion”, Athens, Greece

    Dimitrios Vassilopoulos

  12. Epidemiology, Biostatistics and Research Decision Sciences (BARDS), Merck & Co., Inc., Kenilworth, NJ, 07033, USA

    Zhiping Huang

  13. MSD Pharmaceutical, Industrial and Commercial S.A, Athens, Medical Affairs, MSD Greece, 63 Agiou Dimitriou Street, 17456, Alimos, Greece

    Evangelia Petrikkou

  14. Rheumatology and Clinical Immunology, 4th Department of Internal Medicine, “Attikon” University Hospital, Rimini 1, 124 62, Athens, Greece

    Dimitrios Boumpas

Authors
  1. Panagiotis Athanassiou
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  2. Dimitrios Psaltis
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  3. Athanasios Georgiadis
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Contributions

Substantial contribution to the conception or design of the work; Drafting the work or revising it critically for important intellectual content: EP, DB; acquisition and interpretation of data and writing: PA, DP, AG, GK, AT, SG, PS, MT, AB, AK, PV, GS, DV; analysis of data: ZH. All authors were involved in drafting the article or revising it critically for important intellectual content, approved final version of manuscript to be published, and 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 all aspects of the work.

Corresponding author

Correspondence to Evangelia Petrikkou.

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Conflict of interest

Dr Prodromos Sidiropoulos has received support for the present manuscript from MSD, in addition to research grants from Pfizer, Genesis, UCB, GSK, MSD, Abbvie, Novartis, Roche, Eli Lilly and Amgen. He has also received consultation payments from Pfizer, Abbvie and Eli Lilly, and honoraria from Pfizer, UCB, Abbvie, Novartis and Eli Lilly. He has received support for attending a Data Safety Monitoring Board or Advisory Board from Pfizer, Abbvie, Novartis and Eli Lilly. Dr Dimitrios Vassilopoulos has received support for the present manuscript from MSD. Dr Periklis Vounotrypidis has received support for the present manuscript from MSD, in addition to research grants from Abbvie, Genesis pharma and Novartis. Dr Andreas Bounas has received support for the present manuscript from MSD, in addition to grants or contracts from Abbvie, Amgen, Genesis, MSD, Novartis and Pfizer. He has also received honoraria from Abbvie, Aeonorasis, Amgen, Bausch Health, Faran, Genesis, GSK, Janssen, MSD, Novartis, Pfizer and UCB, as well as for participation on a Data Safety Monitoring Board or Advisory Board from Abbvie, Aeonorasis, Amgen, Bausch Health, Faran, Genesis, GSK, Janssen, MSD, Novartis, Pfizer and UCB. Dr Anna Kandyli has received consultation payments from Abbvie, Mylan and Genesis, as well as honoraria from Abbvie and Novartis. She has received support for attending meetings and/or travel from UCB, and for participating on a Data Safety Monitoring Board or Advisory Board from Genesis and Amgen. Dr Gkikas Katsifis has received honoraria from Abbvie, Aenorasis, Amgen, Janssen, Jenessis, Lilly, MSD, Novartis, Sobi, Roche, Pfizer and UCB. Also, the author has received support for attending meetings from AbbVie, Sandoz, Roche, UCB, and Lilly, and for his participation on a Data Safety Monitoring Board or Advisory Board from ELPEN. Dr Grigorios Sakellariou has received support for the present manuscript from MSD, as well as research grants for education activities from Pfizer, Genesis, UCB, GSK, and MSD, and support for attending meetings and/or travel from Abbvie and MSD. Dr Maria Tektonidou has received support for the present manuscript from MSD, as well as research grants from Genesis, UCB, GSK, MSD, and Amgen, and consultation payments from Genesis, GSK, Novartis and EI Lilly. Zhiping Huang is an employee of Merck & Co., Inc., Rahway, NJ, USA, and Evangelia Petrikkou is an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, who owns stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. Drs Panagiotis Athanassiou, Dimitrios Psaltis, Athanasios Georgiadis, Athina Theodoridou, Souzana Gazi, and Dimitrios Bounas have declared no conflicts of interest.

Ethical approval

The study was conducted in accordance with the EU Directive 2001/20/EC section for non-interventional studies and the applicable laws and regulations of Greece. All included patients provided written informed consent before study entry. The present study was performed in accordance with the Helsinki declaration of 1964, and its later amendments. The study was approved by the competent Institutional Review Boards (IRBs) of all participating hospital sites. Participation of private practice investigators was approved by the IRB of a participating hospital located in the same geographic region as the Private Practice. Specifically, the IRBs that reviewed and approved the study, and corresponding ethical review reference numbers include IRB of “Laiko” General Hospital (reference number: 6046/24-Apr-2018), IRB of “KAT” Regional General Hospital (reference number: 188/14-Jun-2018), IRB of Private Practice under “Laiko” General Hospital (reference number: 59/15-Feb-2018), IRB of University General Hospital of Heraklion, Crete (reference number: 17991/22-Nov-2018), IRB of “Olympion”Rehabilitation Center of Patras (reference number: 14-Mar-2018), IRB of Private Practice under University General Hospital of Ioannina (reference number: 5th/08-Apr-2018), IRB of Private Practice under European Interbalkan Medical Center (reference number 17-Jan-2018), IRB of Private Practice under European Interbalkan Medical Center (reference number 22-Jan-2019), IRB of “Attikon” University General Hospital (reference number 5th/29-May-2018), IRB of “Ag. Pavlos” of Thessaloniki (reference number: 123/08-Mar-2018), IRB of “Ippokrateio”General Hospital of Athens (reference number: 4552/19-Mar-2018), IRB of Naval Hospital of Athens (reference number: 3/18/02-Apr-2018).

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Athanassiou, P., Psaltis, D., Georgiadis, A. et al. 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. Rheumatol Int 43, 1871–1883 (2023). https://doi.org/10.1007/s00296-023-05376-5

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