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Factors associated with long-term retention of treatment with golimumab in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis: an analysis of the Spanish BIOBADASER registry

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Abstract

Background

Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. Retention of golimumab was high in clinical trial extensions and real-world studies up to 5 years in patients with immune-mediated rheumatic diseases.

Objective

To assess the probability of real-world long-term retention of treatment with golimumab up to 7 years after treatment initiation.

Methods

This retrospective noninterventional study involved analysis of the Spanish biological drugs registry, BIOBADASER. Adults who had ever received golimumab for rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA), and had initiated it > 6 months before the analysis date, were included.

Results

Among 685 patients (28.5% RA, 42.9% SpA, 28.6% PsA), the overall probability of retention of golimumab treatment since initiation was 71.7% (95% confidence interval 68.1–74.9) at year 1, 60.5% (56.5–64.2%) at year 2, 55.6% (51.5–59.5%) at year 3, 50.6% (46.2–54.8%) at year 4, 45.1% (40.1–50.0%) at year 5, 44.2% (39.0–49.3) at year 6, and 39.5% (32.8–46.2) at year 7. Retention was greater in patients with axial SpA or PsA versus RA (p < 0.001) and when golimumab was used as first-line treatment versus third or later lines (p < 0.001). Factors associated with greater golimumab retention in Cox regression included use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy. Steroids were associated with lower retention.

Conclusion

In this real-world study of RA, axial SpA, and PsA patients, the retention rate of golimumab was 39.5% at year 7.

Key Points

• Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction.

• This real-world study of 685 patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA) showed that golimumab treatment had a retention rate up to 39.5% at year 7.

• Greater golimumab retention was associated with use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy

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Data availability

Additional information and data of this study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors thank Kathy Croom and David P. Figgitt, Ph.D., ISMPP CMPP™, Content Ed Net, for providing medical writing/editorial assistance in the preparation of the manuscript, with funding from MSD Spain.

Funding

BIOBADASER is the Spanish registry of biological drugs, which is owned by the Spanish Agency of Medicines (https://www.aemps.gob.es/en/home.htm) and the Spanish Society of Rheumatology (https://www.ser.es/), and has additional financial support from different pharmaceutical companies. This specific analysis was funded by MSD Spain.

Author information

Authors and Affiliations

  1. Department of Rheumatology, Hospital Universitario de Santiago de Compostela, Rúa da Choupana, s/n, 15706 Santiago de Compostela, A Coruña, Spain

    Manuel Pombo-Suarez & Juan J. Gómez-Reino

  2. Clinical Research Unit, Spanish Society of Rheumatology (SER), Madrid, Spain

    Carlos Sanchez-Piedra

  3. Department of Rheumatology, Hospital San Jorge, Huesca, Spain

    Blanca Garcia-Magallón

  4. Department of Rheumatology, Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain

    Ana Pérez-Gómez

  5. Department of Rheumatology, Hospital Carlos Haya, Málaga, Spain

    Sara Manrique-Arija

  6. Department of Rheumatology, Hospital de Elda, Alicante, Spain

    Raquel Martín-Doménech

  7. Department of Rheumatology, Hospital Universitario de Burgos, Burgos, Spain

    María Colazo

  8. Department of Rheumatology, Hospital General Universitario de Valencia, Valencia, Spain

    Cristina Campos

  9. Department of Rheumatology, Hospital Puerta de Hierro, Madrid, Spain

    José Campos

  10. Department of Rheumatology, Complejo Asistencial Universitario de Salamanca, Salamanca, Spain

    Javier del Pino-Montes

  11. Medical Affairs Department, MSD Spain, Madrid, Spain

    Maria J. Arteaga & Luis Cea-Calvo

  12. Department of Rheumatology, Hospital Universitario de Canarias, Sta Cruz de Tenerife, Spain

    Federico Díaz-González

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  1. Manuel Pombo-Suarez
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  2. Carlos Sanchez-Piedra
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  8. Cristina Campos
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Contributions

M P-S, CS-P, FD-G, MJA, LC-C, and JJG-R were involved in the design of the study. Statistical analysis was independently executed by CS-P and FD-G, with overview from the abovementioned authors. LC-C and MJA, employees of MSD Spain, were involved in the design of the study but were not involved in data collection and had no access to the data source. The rest of the authors are regular investigators of BIOBADASER, were involved in data collection, and made substantial contributions to the current work. All authors reviewed and approved the final version of the manuscript.

Corresponding author

Correspondence to Manuel Pombo-Suarez.

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Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institution and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflict of interest

Manuel Pombo-Suarez: consulting fee from MSD; Blanca Garcia-Magallón: payments for consultancy, lectures, presentations, or travel expenses by MSD, Pfizer, Bristol-Myers, Amgen, Celgene, and Menarini; Sara Manrique-Arija: payments for consultancy, lectures, presentations, or travel expenses by Abbvie, Janssen, Sanofi, Novartis, Pfizer, Lilly, MSD, and Menarini; José Campos: payments for consultancy, lectures, presentations, or travel expenses by Pfizer, MSD, Novartis, Lilly, Roche, and Sanofi; Maria J. Arteaga: full-time employee at Medical Affairs, MSD, Spain; Luis Cea-Calvo: full-time employee at Medical Affairs, MSD, Spain; Federico Díaz-González: grant from MSD; Juan J. Gómez-Reino: payments for consultancy, lectures, and grants from MSD. The rest of the authors declared no conflict of interest.

Informed consent

All patients signed informed consent to be included in the BIOBADASER registry. Informed consent included consent for subsequent analysis, such as in the present analysis. Patients’ information was managed as anonymized aggregated data, and as approved by the Clinical Research Committee, specific informed consent for this analysis was not required.

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Pombo-Suarez, M., Sanchez-Piedra, C., Garcia-Magallón, B. et al. Factors associated with long-term retention of treatment with golimumab in rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis: an analysis of the Spanish BIOBADASER registry. Clin Rheumatol 40, 3979–3988 (2021). https://doi.org/10.1007/s10067-021-05742-3

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