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Biological and targeted-synthetic disease-modifying anti-rheumatic drugs with concomitant methotrexate or leflunomide in rheumatoid arthritis: real-life TReasure prospective data


1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22

 

  1. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Hatay, Hatay Mustafa Kemal University, Turkey.
  2. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey. umut.kalyoncu@yahoo.com
  3. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey.
  4. Division of Rheumatology, Department of Internal Medicine, University of Health Sciences, Bakırkoy Dr Sadi Konuk Training and Research Hospital, Istanbul, Turkey.
  5. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Uludag University, Bursa, Turkey.
  6. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Uludag University, Bursa, Turkey.
  7. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Yıldırım Beyazıt University, Ankara, Turkey.
  8. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Koc University, Istanbul, Turkey.
  9. Division of Rheumatology, Department of Internal Medicine, Ankara City Hospital, Ankara, Turkey.
  10. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey.
  11. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey.
  12. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Eskisehir Osmangazi University, Eskisehir, Turkey.
  13. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Trakya University, Edirne, Turkey.
  14. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Firat University, Elazig, Turkey.
  15. Division of Rheumatology, Department of Internal Medicine, Izmir Katip Celebi University School of Medicine, Izmir, Turkey.
  16. Division of Rheumatology, Department of Internal Medicine, Gulhane Faculty of Medicine, University of Health Sciences, Ankara, Turkey.
  17. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Akdeniz University, Antalya, Turkey.
  18. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Ankara University, Ankara, Turkey.
  19. Division of Rheumatology, Department of Internal Medicine, Ministry of Health Adana City Training and Research Hospital, Adana, Turkey.
  20. Division of Rheumatology, Department of Internal Medicine, Sakarya University, Sakarya, Turkey.
  21. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Tekirdag Namik Kemal University, Tekirdag, Turkey.
  22. Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey.

CER13375
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PMID: 32896266 [PubMed]

Received: 28/03/2020
Accepted : 27/07/2020
In Press: 04/09/2020

Abstract

OBJECTIVES:
To determine the real-life efficacy, safety, and drug-retention rates of leflunomide (LEF) or methotrexate (MTX) as a synthetic DMARD used in combination with biological DMARDs for rheumatoid arthritis (RA).
METHODS:
The TReasure database is a web-based, prospective, observational cohort of RA and spondyloarthritis patients from 17 centres in different regions of Turkey and data entry was enabled since December 2017. Until May 2019, 2556 RA patients on biologic treatment were recorded. Demographic and RA-related data of 1526 patient either received LEF or MTX were compared, efficacy of both drugs compared by RA-disease activity composite indices. Reasons fordrug discontinuation also recorded. Drug retention rates were compared with Kaplan-Meier curves (log-rank test).
RESULTS:
Of 2556 RA patients 1526 (59.7%) were receiving concomitant LEF (n=646, 42.3%; median follow up 35 months) or concomitant MTX (n=880, 57.3%; median follow-up 32 months) at the time of initiation to their first bDMARDs. The LEF group were older and had longer disease duration, proportion of females and seropositive patients was higher in this group. In the LEF group, non-anti-TNF agents were used in higher rate. Remission rates, changes in composite indices and rate of comorbidities and adverse events were similar in both groups. The retention rate of LEF + non-anti-TNF b/tsDMARDs was higher compared to MTX + anti–TNF bDMARDs (p=0.002, log-rank). Rates of adverse events were similar in both groups.
CONCLUSIONS:
LEF in combination with either anti-TNF or non-anti-TNF drugs appears as an effective and safe therapeutic option at least as MTX.

Rheumatology Article