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Safety and Effectiveness of Biologic Disease-Modifying Antirheumatic Drugs in Older Patients with Rheumatoid Arthritis: A Prospective Cohort Study

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Abstract

Background and Objective

The number of older patients with rheumatoid arthritis is increasing, but data on drug effectiveness and safety in these patients are scarce. This study assessed the effectiveness and safety of biologic disease-modifying antirheumatic drugs in older patients with rheumatoid arthritis.

Methods

This prospective cohort study was based on data recorded in the Rheumatic Diseases Portuguese Register (Reuma.pt). Treatment persistence, European League Against Rheumatism response at 6 and 12 months, and adverse events were compared between adult (age < 65 years), old (age 65–74 years), and very old (age ≥ 75 years) patients.

Results

In total, 2401 patients were included, of which 379 were old and 83 were very old. Older patients had higher disease activity at baseline (Disease Activity Score 28: 5.5 in adults, 5.7 in old patients, and 6 in very old patients; p = 0.02) and more comorbidities, with patients aged 65–74 years beginning biologic disease-modifying antirheumatic drugs later in the course of rheumatoid arthritis. Treatment persistence was similar in the three patient groups (p = 0.07). The European League Against Rheumatism response rates were comparable in the three groups at 6 months (81.6% of adults, 75.2% of old patients, and 81.8% of very old patients; p = 0.19), and inferior in old patients at 12 months. The proportion of patients who experienced adverse events was also similar in the three groups (21% of adults, 22.5% of old patients, and 22.9% of very old patients; p = 0.76), but the rate of serious adverse events was higher in old patients (1.94/100 patient-years) and very old patients (4.29/100 patient-years) compared with 1.03/100 patient-years in adult patients with rheumatoid arthritis (p < 0.05).

Conclusions

Adults, old patients, and very old patients with rheumatoid arthritis benefit similarly from biologic disease-modifying antirheumatic drug treatments, although older patients have more active disease at baseline and more comorbidities. However, it is necessary to consider the risk of serious adverse events in older patients when prescribing a biologic.

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Author information

Authors and Affiliations

  1. Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal

    Raquel Freitas, Fátima Godinho & Maria José Santos

  2. Instituto Português Reumatologia, Lisboa, Portugal

    Nathalie Madeira & Luís Miranda

  3. Rheumatology Department, Centro Hospitalar e Universitário São João, Porto, Portugal

    Bruno Miguel Fernandes & Miguel Bernardes

  4. Rheumatology Department, Centro Hospitalar e Universitário Coimbra, Coimbra, Portugal

    Flávio Costa & Mariana Santiago

  5. Rheumatology Department, Centro Hospitalar Lisboa Ocidental, Lisboa, Portugal

    Agna Neto

  6. Rheumatology Department, ULSAM, Ponte de Lima, Portugal

    Soraia Azevedo

  7. Rheumatology Department, Hospital São Teotónio, Viseu, Portugal

    Maura Couto

  8. Rheumatology Department, Hospital Faro, Faro, Portugal

    Graça Sequeira

  9. Rheumatology Department, Centro Hospitalar Médio Tejo, Torres Novas, Portugal

    João Madruga Dias

  10. Nova Medical School, Lisboa, Portugal

    João Madruga Dias

  11. Faculty of Medicine, University of Porto, Porto, Portugal

    Miguel Bernardes

  12. Rheumatology Department, Centro Hospitalar e Universitário Santa Maria, Lisboa, Portugal

    Joaquim Polido Pereira & João Eurico Fonseca

  13. Instituto de Medicina Molecular, Lisboa, Portugal

    Joaquim Polido Pereira & João Eurico Fonseca

  14. Faculty of Medicine, University of Lisboa, Lisboa, Portugal

    Joaquim Polido Pereira, João Eurico Fonseca & Maria José Santos

Authors
  1. Raquel Freitas
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  2. Fátima Godinho
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  6. Mariana Santiago
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  7. Agna Neto
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  9. Maura Couto
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  10. Graça Sequeira
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  12. Miguel Bernardes
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  13. Luís Miranda
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  14. Joaquim Polido Pereira
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  15. João Eurico Fonseca
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  16. Maria José Santos
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Corresponding author

Correspondence to Raquel Freitas.

Ethics declarations

Funding

No funding was received for the conduct of this study or the preparation of this article.

Conflicts of interest/competing interests

Raquel Freitas, Fátima Godinho, Nathalie Madeira, Bruno Miguel Fernandes, Flávio Costa, Mariana Santiago, Agna Neto, Soraia Azevedo, Maura Couto, Graça Sequeira, João Madruga Dias, and Luís Miranda have no conflicts of interest that are directly relevant to the content of this study. Miguel Bernardes is on the advisory boards of Lilly, Biogen, and Abbvie (fees < $10,000). Joaquim Polido-Pereira is on the advisory boards of Pfizer, MSD, and Abbvie (fees < $10,000). João Eurico Fonseca receives consultancy and speaking fees for Pfizer, UCB, Jansen, Roche, MSD, Novartis, Abbvie, and Lilly (fees < $10,000). Maria José Santos receives consultancy and speaking fees for Pfizer and Abbvie (fees < $10,000).

Ethics approval

Reuma.pt was approved by the National Data Protection Authority and the ethics committee of each participating center. This study was approved by the Ethics Committee of Hospital Garcia de Orta, Almada, Portugal.

Consent to participate

All patients registered in the database Reuma.pt provided written informed consent for data collection and analysis.

Consent for publication

All patients registered in the database Reuma.pt provided written informed consent for publication.

Availability of data and material

The database generated and analyzed during the study is not publicly available due to ethical and law restrictions. The data that support the findings of this study are available on request from the corresponding author.

Code availability

Not applicable.

Authors’ contributions

The study protocol and analysis plan was drafted by R Freitas and MJ Santos and revised by all the authors. Data analyses and draft of the manuscript were done by R Freitas. All authors contributed substantially for study conception, data acquisition and interpretation, revised the final manuscript for important intellectual content and approved the final version submitted for publication.

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Freitas, R., Godinho, F., Madeira, N. et al. Safety and Effectiveness of Biologic Disease-Modifying Antirheumatic Drugs in Older Patients with Rheumatoid Arthritis: A Prospective Cohort Study. Drugs Aging 37, 899–907 (2020). https://doi.org/10.1007/s40266-020-00801-x

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  • DOI: https://doi.org/10.1007/s40266-020-00801-x

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