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The effects of golimumab on work productivity and quality of life among work-active axial spondyloarthritis and psoriatic arthritis patients treated in the routine care in Greece: the ‘GO-UP’ study

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Abstract

Purpose

To examine the impact of golimumab, on work productivity, activity limitation, and quality of life (QoL) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).

Methods

This real-world, multicenter, prospective study consecutively enrolled adult consented work-active patients with axSpA or PsA, newly initiated on golimumab as per the approved label. Prior receipt of > 1 prior biologic, or switching from another tumor-necrosis factor inhibitor due to primary non-response or safety reasons was not allowed. The Work Productivity and Activity Impairment-Specific Health Problem and the EuroQol 5-Dimensions (EQ-5D)-5-Level instruments were completed by the patients to assess the impact of golimumab on work productivity and activity impairment, and generic QoL, respectively.

Results

Overall, 121 eligible patients (mean age: 45.4 years; median disease duration: 11.3 months), 51 diagnosed with PsA and 70 with axSpA, were enrolled by 19 rheumatologists. Over a 11.9-month median observation period, < 1% of injections were missed (as collected by patient diaries), and the 12-month golimumab retention rate was 91.7%. At 3, 6, and 12 months post baseline, in the overall population, work productivity loss improved by a median of 31.4%, 44.2%, and 50.0%; activity impairment improved by 40.0%, 40.0%, and 50.0%; and the EQ-5D UK-weighted utility index improved by 0.24, 0.32, and 0.36 points, respectively (p < 0.001 for all). Statistically significant improvements in these measures were also noted in the PsA and axSpA subpopulations.

Conclusion

In the routine care in Greece, golimumab displays beneficial effects on work productivity, daily activities, and QoL in work-active patients with axSpA and PsA.

Trial registration

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=MK8259-6083.

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Data availability

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

The authors wish to thank the following GO-UP investigators: Efstathios Ampatziadis, Alexandros Andrianakos, Parakevi Voulgari, Souzana Gazi, Panagiotis Georgiou, Athanasios Georgountzos, Dimitrios Karokis, Lazaros Sakkas, Prodromos Sidiropoulos, Vassileios Mpotzoris, Dimitrios Vassilopoulos, and Elias Mpournazos

Funding

Funding for this research and article processing charges was provided by MSD Greece.

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Authors and Affiliations

  1. “Agios Pavlos” General Hospital of Thessaloniki, Thessaloniki, Greece

    Panagiotis Athanassiou

  2. Private Practice, Karditsa, Greece

    Anastasios Kotrotsios

  3. Private Practice, Chania, Greece

    Ioannis Kallitsakis

  4. “Olympion”—General clinic of Patra, Patra, Greece

    Andreas Bounas

  5. 4th Department of Internal Medicine, Aristotle University of Thessaloniki, “Ippokrateio” General Hospital of Thessaloniki, Thessaloniki, Greece

    Theodoros Dimitroulas & Alexandros Garyfallos

  6. “Laiko” General Hospital of Athens, Athens, Greece

    Maria G. Tektonidou

  7. Euromedica General Clinic of Thessaloniki, Thessaloniki, Greece

    Giorgos Vosvotekas

  8. Merck Sharp & Dohme Pharmaceutical, Industrial and Commercial S.A., Medical Affairs, Athens, Greece

    Achilleas Livieratos & Evangelia Petrikkou

  9. Naval Hospital of Athens, Dinokratous 70, 115 21, Athens, Greece

    Gkikas Katsifis

Authors
  1. Panagiotis Athanassiou
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  2. Anastasios Kotrotsios
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  3. Ioannis Kallitsakis
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  4. Andreas Bounas
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  5. Theodoros Dimitroulas
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  6. Alexandros Garyfallos
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  7. Maria G. Tektonidou
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  8. Giorgos Vosvotekas
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  9. Achilleas Livieratos
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  10. Evangelia Petrikkou
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  11. Gkikas Katsifis
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Contributions

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.

Corresponding author

Correspondence to Gkikas Katsifis.

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Conflict of interest

Dr Giorgios Vosvotekas has received honoraria from Abbvie, MSD, Novartis, Pfizer, Genesis, and Roche. Dr Gkikas Katsifis has received honoraria from Abbvie, Aenorasis, Amgen, Bausch Health, BMS, Celgene, Janssen, MSD, Novartis, Roche, Pfizer, and UCB. Dr Maria G. Tektonidou has received honoraria from Abbvie, Genesis, GSK, MSD, Novartis, Pfizer, 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.

Ethical approval

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 (IRBs) 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. Specifically, the institutional ethics committees (Institutional Review Boards) that reviewed and approved the study, and corresponding ethical review reference numbers include IRB of 251 Air Force General Hospital (reference number: 862/03-Mar-2017), IRB of Iaso General Clinic (reference number: 79/05-Apr-2017), IRB of “Ag. Pavlos” General Hospital of Thessaloniki (reference number: 19/16-Feb-2017), IRB of “Olympion” Rehabilitation Center of Patras, IRB of University General Hospital of Ioannina (reference number: 13/19-Jun-2019), IRB of “Ippokrateio” General Hospital of Thessaloniki (reference number: 248/19-Jun-2017), IRB of “KAT” Hospital (reference number: 266/01-Aug-2017), IRB of “Ag. Andreas” General Hospital of Patras (reference number: 11/10-Mar-2017), IRB of “G. Gennimatas” General Hospital of Athens (reference number: 7856/07-Mar-2017), IRB of Private Practice under University General Hospital of Heraklion (reference number: 1261/08-Mar-2017), IRB of Naval Hospital of Athens (reference number: 2/1721-Feb-2017), IRB of University General Hospital of Larissa (reference number: 4829/17-Mar-2017), IRB of University General Hospital of Heraklion (reference number: 1261/08-Mar-2017), IRB of “Laiko” General Hospital (reference number: 386/06-Apr-2017), IRB of “Ippokrateio” General Hospital of Athens (reference number: 7396/18-May-2017), Private Practice under IRB of Iaso General Clinic (reference number: 278/08-Nov-2017), Private Practice under IRB of Euromedica Clinic Thessaloniki (reference number: 520/17-Mar-2017), Private Practice under IRB of “Ag. Pavlos” of Thessaloniki (reference number: 19/16-Feb-2017), and IRB of Private Practice under University General Hospital of Heraklion (reference number: 1261/08-Mar-2017).

Consent to participate

All persons gave their informed consent prior to their inclusion in the study.

Consent for publication

All participants provided consent for publication of the material collected in the context of this study in a non-identifiable manner.

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Athanassiou, P., Kotrotsios, A., Kallitsakis, I. et al. The effects of golimumab on work productivity and quality of life among work-active axial spondyloarthritis and psoriatic arthritis patients treated in the routine care in Greece: the ‘GO-UP’ study. Qual Life Res 31, 1385–1399 (2022). https://doi.org/10.1007/s11136-021-03044-4

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