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Clinical and therapeutic management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: RADAR study

Rheumatology International volume 39, pages 2015–2024 (2019)Cite this article

Abstract

To describe the clinical and therapeutic management of rheumatoid arthritis (RA) patients with biological disease-modifying antirheumatic drugs (bDMARDs), alone or in combination with conventional synthetic DMARDs (csDMARDs), as well as analysing changes over time in bDMARD use. An observational, retrospective, multicentre study was conducted in the rheumatology departments of 10 public Spanish hospitals. Patients with RA treated with bDMARDs at baseline who had medical records available in the data collection period 2013–2016 were included. All visits to rheumatology departments recording any type of bDMARD modification (dose, etc.) were collected. Clinical characteristics, concomitant treatment, resource use, work productivity and quality of life (QoL) were recorded. 128 patients were included: 81 received first-line bDMARD treatment, 28 second-line bDMARD treatment and 19 received third or later lines. Mean study follow-up was 4.1 years. Assessment of DAS28 was available in 54.6% of visits. At baseline, 48.7% of patients had moderate–high disease activity. At final observation, 69.5% of patients continued with the first bDMARD. Tumour necrosis factor blockers were administered to 85.2% of patients in first line, 45.7% in second line and 18.1% in third or later lines. At final observation, 80.2% of patients still felt pain/discomfort. As expected, those with higher disease activity had higher loss of work productivity and lower QoL, as assessed by DAS28, than patients with lower disease activity. Drugs represented 82.6% of the total cost. In this Spanish cohort of 128 patients, most patients remained on the first prescribed bDMARD, despite remaining signs and symptoms.

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References

  1. Fauci AS, Langford CA, Langford C (2013) Harrison’s rheumatology. McGraw-Hill Publishing, New York

    Google Scholar 

  2. O’Dell JR (2004) Therapeutic strategies for rheumatoid arthritis. N Engl J Med 350(25):2591–2602. https://doi.org/10.1056/NEJMra040226

    Article  PubMed  Google Scholar 

  3. Steiner M, Muñoz Fernández S (2010) Artritis reumatoide: fármacos modificadores de la enfermedad. Jano Med Humanid 1760:66

    Google Scholar 

  4. Carmona L, Villaverde V, Hernandez-Garcia C, Ballina J, Gabriel R, Laffon A (2002) The prevalence of rheumatoid arthritis in the general population of Spain. Rheumatol (Oxf Engl) 41(1):88–95. https://doi.org/10.1093/rheumatology/41.1.88

    CAS  Article  Google Scholar 

  5. Carbonell J, Cobo T, Balsa A, Descalzo MA, Carmona L (2008) The incidence of rheumatoid arthritis in Spain: results from a nationwide primary care registry. Rheumatol (Oxf Engl) 47(7):1088–1092. https://doi.org/10.1093/rheumatology/ken205

    CAS  Article  Google Scholar 

  6. Cross M, Smith E, Hoy D, Carmona L, Wolfe F, Vos T, Williams B, Gabriel S, Lassere M, Johns N, Buchbinder R, Woolf A, March L (2014) The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis 73(7):1316–1322. https://doi.org/10.1136/annrheumdis-2013-204627

    Article  PubMed  Google Scholar 

  7. Ruiz-Montesinos MD, Hernandez-Cruz B, Ariza-Ariza R, Carmona L, Ballina J, Navarro-Sarabia F (2005) Cost analysis in a cohort of rheumatoid arthritis patients managed in rheumatology units in Spain. Reumatol Clin 1(4):193–199. https://doi.org/10.1016/s1699-258x(05)72744-3

    CAS  Article  PubMed  Google Scholar 

  8. Mattila K, Buttgereit F, Tuominen R (2015) Influence of rheumatoid arthritis-related morning stiffness on productivity at work: results from a survey in 11 European countries. Rheumatol Int 35(11):1791–1797. https://doi.org/10.1007/s00296-015-3275-4

    Article  PubMed  Google Scholar 

  9. Ruiz-Montesinos MD, Hernandez-Cruz B, Ariza-Ariza R, Carmona L, Ballina J, Navarro-Sarabia F (2005) Resource utilization in a cohort of rheumatoid arthritis patients attended in rheumatology units in Spain. Reumatol Clin 1(3):142–149. https://doi.org/10.1016/s1699-258x(05)72733-9

    CAS  Article  PubMed  Google Scholar 

  10. Punzi L, Cimmino MA, Frizziero L, Gerloni V, Grassi W, Modena V, Montecucco C, Ramonda R, Schiavon F, Spadaro A, Trotta F (2007) Italian Society of Rheumatology (SIR) recommendations for performing arthrocentesis. Reumatismo 59(3):227–234

    CAS  PubMed  Google Scholar 

  11. van Aken J, Lard LR, le Cessie S, Hazes JM, Breedveld FC, Huizinga TW (2004) Radiological outcome after four years of early versus delayed treatment strategy in patients with recent onset rheumatoid arthritis. Ann Rheum Dis 63(3):274–279. https://doi.org/10.1136/ard.2003.010298

    Article  PubMed  PubMed Central  Google Scholar 

  12. Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D (2014) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 73(3):492–509. https://doi.org/10.1136/annrheumdis-2013-204573

    CAS  Article  PubMed  Google Scholar 

  13. Smolen JS, Aletaha D, McInnes IB (2016) Rheumatoid arthritis. Lancet (Lond Engl) 388(10055):2023–2038. https://doi.org/10.1016/s0140-6736(16)30173-8

    CAS  Article  Google Scholar 

  14. Sanmartí R, García-Rodríguez S, Álvaro-Gracia JM, Andreu JL, Balsa A, Cáliz R, Fernández-Nebro A, Ferraz-Amaro I, Gómez-Reino JJ, González-Álvaro I (2015) Actualización 2014 del Documento de Consenso de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en la artritis reumatoide. Reumatol Clin 11(5):279–294

    Article  Google Scholar 

  15. Smolen JS, Landewe R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, Nam J, Ramiro S, Voshaar M, van Vollenhoven R, Aletaha D, Aringer M, Boers M, Buckley CD, Buttgereit F, Bykerk V, Cardiel M, Combe B, Cutolo M, van Eijk-Hustings Y, Emery P, Finckh A, Gabay C, Gomez-Reino J, Gossec L, Gottenberg JE, Hazes JMW, Huizinga T, Jani M, Karateev D, Kouloumas M, Kvien T, Li Z, Mariette X, McInnes I, Mysler E, Nash P, Pavelka K, Poor G, Richez C, van Riel P, Rubbert-Roth A, Saag K, da Silva J, Stamm T, Takeuchi T, Westhovens R, de Wit M, van der Heijde D (2017) EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 76(6):960–977. https://doi.org/10.1136/annrheumdis-2016-210715

    Article  PubMed  Google Scholar 

  16. González-Álvaro I, Hernández-García C, Villaverde García V, Vargas E, Ortiz AM, emAR GdE (2002) Variabilidad en el tratamiento farmacológico de la artritis reumatoide en España. Med Clín 118(20):771–776

    Article  Google Scholar 

  17. Lopez-Longo FJ, Seoane-Mato D, Martin-Martinez MA, Sanchez-Alonso F (2018) Variability in the prescription of biological drugs in rheumatoid arthritis in Spain: a multilevel analysis. Rheumatol Int 38(4):589–598. https://doi.org/10.1007/s00296-018-3933-4

    CAS  Article  PubMed  Google Scholar 

  18. Gómez-Reino JJ, Rodríguez-Lozano C, Campos-Fernández C, Montoro M, Descalzo MÁ, Carmona L (2012) Change in the discontinuation pattern of tumour necrosis factor antagonists in rheumatoid arthritis over 10 years: data from the Spanish registry BIOBADASER 2.0. Ann Rheumat Dis 71(3):382–385

    Article  Google Scholar 

  19. Lapadula G, Ferraccioli G, Ferri C, Punzi L, Trotta F (2011) GISEA: an Italian biological agents registry in rheumatology. Reumatismo 63(3):155–164. https://doi.org/10.4081/reumatismo.2011.155

    CAS  Article  PubMed  Google Scholar 

  20. Gonzalez VM, Stewart A, Ritter PL, Lorig K (1995) Translation and validation of arthritis outcome measures into Spanish. Arthritis Rheum 38(10):1429–1446

    CAS  Article  Google Scholar 

  21. Badia X, Roset M, Montserrat S, Herdman M, Segura A (1999) The Spanish version of EuroQol: a description and its applications. European Quality of Life Scale. Med Clin (Barc) 112(Suppl 1):79–85

    Google Scholar 

  22. Reilly MC, Zbrozek AS, Dukes EM (1993) The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics 4(5):353–365. https://doi.org/10.2165/00019053-199304050-00006

    CAS  Article  PubMed  Google Scholar 

  23. Oblikue consulting eSalud—Información económica del sector sanitario (2017) http://esalud.oblikue.com/. Accessed 10 Oct 2017

  24. Consejo General de Colegios Oficiales de Farmacéuticos Bot PLUS (2017) https://botplusweb.portalfarma.com/. Accessed 10 Oct 2017

  25. Instituto Nacional de Estadística (INE) (2017) Actualización de rentas con el IPC general (sistema IPC base 2016) para periodos anuales completos. http://www.ine.es/. Accessed 10 Oct 2017

  26. Grupo de trabajo de la GUIPCAR (2011) Actualización de la Guía de Práctica Clínica para el manejo de la artritis reumatoide en España. 2011. Sociedad Española de Reumatología, Doyma ed, Madrid

  27. Grupo de trabajo de la GUIPCAR (2018) Guía de práctica clínica para el manejo de pacientes con artritis reumatoide. Sociedad Española de Reumatología, Madrid

  28. Carmona L (2008) Cambios entre anti-TNF,¿ están siempre justificados? Reumatol Clin 4(3):87–89

    Article  Google Scholar 

  29. Balsa A (2011) Definiendo la remisión en la artritis reumatoide: nuevos criterios de la ACR/EULAR. Reumatol Clin 6:12–15

    Article  Google Scholar 

  30. Villaverde V, Hernandez-Garcia C, Gonzalez-Alvaro I, Vargas E, Abasolo L, Morado I, emAR gde (2005) Evaluación clínica de los pacientes con artritis reumatoide en España. Rev Esp Reumatol 32(3):112–120

    Google Scholar 

  31. Navarro Sarabia F, Ballina García F, Hernández Cruz B, Hernández Mejía R, Ruiz Montesinos M, Fernández López J, Ariza Ariza R, Martín Lascuevas P, Carmona Ortell L (2004) Costes calidad de vida-artritis reumatoide. Estudio económico y de la calidad de vida de los pacientes con artritis reumatoide en España. Resultados preliminares. Rev Españ Reumatol 31(4):184–189

    Google Scholar 

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Funding

This study was supported by Sanofi Genzyme Spain.

Author information

Affiliations

  1. Rheumatology Department, Parc Taulí Hospital Universitari, Parc Tauli 1, 08208, Sabadell, Barcelona, Spain

    Antonio Gomez-Centeno

  2. Hospital Universitario Virgen del Rocío, Sevilla, Spain

    Esteban Rubio-Romero

  3. Hospital General Universitario Gregorio Marañón, Madrid, Spain

    Juan Gabriel Ovalles

  4. Hospital Regional Universitario Carlos Haya, Malaga, Spain

    Sara Manrique-Arija

  5. Hospital Universitario Vall d’Hebron, Barcelona, Spain

    Sara Marsal-Barril

  6. Hospital Clínico Universitario Santiago de Compostela, Santiago de Compostela, La Coruña, Spain

    Juan Amarelo-Ramos

  7. Hospital Universitario de Salamanca, Salamanca, Spain

    Javier del Pino-Montes

  8. Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain

    Santiago Muñoz-Fernández

  9. Hospital Universitario Canarias, Santa Cruz de Tenerife, Spain

    Sagrario Bustabad

  10. Hospital Meixoeiro, Vigo, Pontevedra, Spain

    Ceferino Barbazán-Álvarez

Authors
  1. Antonio Gomez-Centeno
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  2. Esteban Rubio-Romero
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  3. Juan Gabriel Ovalles
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  4. Sara Manrique-Arija
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  5. Sara Marsal-Barril
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  6. Juan Amarelo-Ramos
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  7. Javier del Pino-Montes
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  8. Santiago Muñoz-Fernández
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  9. Sagrario Bustabad
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  10. Ceferino Barbazán-Álvarez
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Contributions

All the authors participated actively in the design of the work, the field work recruiting and collecting patient’s data, the analysis and later interpretation of data and in the writing of the present manuscript. In the same way, the final version of the manuscript has been reviewed and approved by all the authors. Also, this manuscript reflects honest, accurate and transparent information of the study and it has not been omitted key aspects of it.

Corresponding author

Correspondence to Antonio Gomez-Centeno.

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Conflict of interest

Dr Rubio reports speaker contributions for Lilly, Pfizer, Abbvie, Novartis, MSD, Celltrion, Sanofi, Roche, Gebro, Nordic, Grunenthal and UCB and was an advisor for Lilly, Sanofi, Biogen and Novartis. Dr Gómez-Centeno reportsspeaking fees from Pfizer, Lilly, Rubió, Abbvie, Sanofi, Roche, Janssen, travel expenses covered from Pfizer, Abbvie, Lilly, and was an advisor for Pfizer, Abbvie,Lilly, Sanofi, Rubió, Sandoz, Biogen and Gilead. Dr Gabriel Ovalles reports consultation and speaking fees from Abbvie, BMS, Celgene, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi and UCB Pharma. Dr Manrique Arija reports speaking fees from Pfizer, Abbvie, MSD, UCB, Lilly, Novartis and Roche. Dr Marsal Barril was an advisor for Pfizer, Celgene, MSD, BMS, Abbvie, Sandoz, Novartis, Roche, UCB, Lilly, Sanofi and Janssen. Dr Amarelo Ramos reports speaking fees and consultancy from Sanofi and was an advisor for Novartis. Dr del Pino Montes reports consultancy from Amgen, Lilly, Pfizer, MSD, Abbvie, BMS, Novartis, Janssen and Sanofi. Dr Muñoz-Fernández reports speaking fees or was an advisor for MSD, Pfizer, Abbvie, Novartis, Janssen, UCB, Sanofi, Roche, Celgene and Gebro. Dr Bustabad was an advisor for Pfizer, AbbVie, Novartis, Sanofi, Roche, UCB and Janssen. Dr Barbazán Álvarez reports consultancy and expert testimony for Sanofi, Celgene, Novartis, Pfizer, Abbvie, Lilly, a grant from Janssen, speaker fees from Celgene, Sanofi, Novartis, Pfizer, Abbvie, Lilly and Roche, travel expenses covered from MSD, Abbvie, Lilly, Sanofi and Pfizer.

Ethical approval

The Ethics Committee of Hospital Parc Taulí, Sabadell, approved the study protocol (study code DIREGL08326) and allowed the retrospective analysis of available records of the patients between 2013 and 2016. The study was conducted in accordance with the principles of the Declaration of Helsinki of 1975/83.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Gomez-Centeno, A., Rubio-Romero, E., Ovalles, J.G. et al. Clinical and therapeutic management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: RADAR study. Rheumatol Int 39, 2015–2024 (2019). https://doi.org/10.1007/s00296-019-04378-6

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  • DOI: https://doi.org/10.1007/s00296-019-04378-6

Keywords

  • Biological disease-modifying antirheumatic drugs
  • Management
  • Rheumatoid arthritis
  • Spain