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Optimization of biological therapy in rheumatoid arthritis patients: outcomes from the CREATE registry after 2 years of follow-up

Rheumatology International volume 37, pages 1701–1708 (2017)Cite this article

Abstract

The current strategy for managing rheumatoid arthritis (RA) focuses on achieving clinical remission. Once remission is achieved and sustained over time, the most efficient strategy is dose optimization. This work describes the results of dose optimization after 2 years of follow-up in patients with RA treated with biological therapy and identifies predictive variables of response. Cohort: patients from the CREATE registry who, as of 1 November 2013, had been in clinical remission (DAS28 ≤2.6) for at least 6 months. Intervention: Dose optimization was 20–50% of the standard dose. Outcome measurement were effectiveness (percentage of patients who continued to meet criteria for clinical remission) and efficiency (dose reduction and mean savings). Sixty-eight patients with RA were optimized, with initial mean DAS28 of 2.2 ± 0.7. After 2 years of follow-up, the mean DAS28 was 2.4 ± 0.7, a non-statistically significant difference. Twenty-eight patients (41.2%) continued in clinical remission with dose optimization after 2 years. Mean survival time was 14.2 months (95% CI 12.0–16.5). Of the 40 patients who needed to return to a standard dose, 57.5% managed to achieve remission again at 2 years. Mean dose reduction at 2 years was 21.17%, reaching a mean saving of €5576 ± 5099 per patient. In actual clinical practice, over 40% of patients with established RA who had been in sustained clinical remission managed to continue in remission 2 years after receiving optimized doses. The savings achieved was about 21% of the actual direct health costs for patients in the CREATE registry.

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Acknowledgments

No funding has been received to carry out this study or for preparation of the manuscript. The authors thank Mª Dolores Aguilar-Conesa for technical assistance.

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Affiliations

  1. Pharmacy Department, Reina Sofía Universitary Hospital, IMIBIC/University of Córdoba, Av Menéndez Pidal s/n, 14004, Córdoba, Spain

    Manuel J. Cárdenas, Soraya de la Fuente & José R. del Prado

  2. Rheumatology Department, Reina Sofía Universitary Hospital, IMIBIC/University of Córdoba, Córdoba, Spain

    María C. Castro-Villegas, Montserrat Romero-Gómez, Desiré Ruiz-Vílchez, Jerusalem Calvo-Gutiérrez, Alejandro Escudero-Contreras, Eduardo Collantes-Estévez & Pilar Font

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  1. Manuel J. Cárdenas
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  2. Soraya de la Fuente
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  3. María C. Castro-Villegas
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  4. Montserrat Romero-Gómez
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  5. Desiré Ruiz-Vílchez
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  6. Jerusalem Calvo-Gutiérrez
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  7. Alejandro Escudero-Contreras
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  8. José R. del Prado
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  9. Eduardo Collantes-Estévez
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  10. Pilar Font
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Corresponding author

Correspondence to Manuel J. Cárdenas.

Ethics declarations

The study meets the standards of Good Clinical Practice, the principles of the Declaration of Helsinki and Order SAS 347/2009 of December 16, which develops guidelines on observational post-authorization studies for drugs used in humans in Spain. Patient data are coded to maintain anonymity in the study and to prevent their identification by third parties. The study was approved by the Ethical Committee of the Reina Sofia University Hospital of Cordoba.

Conflict of interest

Cárdenas M, Font P, Castro-Villegas and Collantes-Estévez E, report grants, consulting fees, or lecture fees from MSD, Pfizer or AbbVie, none of which were related to the present work. De la Fuente S, Romero-Alonso M, Calvo-Gutiérrez J, Escudero-Contreras A and Del Prado JR have no conflict of interest.

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Cárdenas, M.J., de la Fuente, S., Castro-Villegas, M.C. et al. Optimization of biological therapy in rheumatoid arthritis patients: outcomes from the CREATE registry after 2 years of follow-up. Rheumatol Int 37, 1701–1708 (2017). https://doi.org/10.1007/s00296-017-3757-7

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  • DOI: https://doi.org/10.1007/s00296-017-3757-7

Keywords

  • Rheumatoid arthritis
  • Clinical remission
  • Biological therapy
  • Optimization
  • Cost-effectiveness
  • Real clinical practice