Advertisement

Clinical Rheumatology

, Volume 31, Issue 2, pp 251–257 | Cite as

Single-center, retrospective analysis of efficacy and safety of tacrolimus as a second-line DMARD in combination therapy and the risk factors contributing to adverse events in 115 patients with rheumatoid arthritis

  • Michihiro Ogasawara
  • Naoto Tamura
  • Michiaki Kageyama
  • Shin Onuma
  • Makio Kusaoi
  • Shoko Toyama
  • Fumio Sekiya
  • Ran Matsudaira
  • Masuyuki Nawata
  • Kurisu Tada
  • Masakazu Matsushita
  • Kazuo Kempe
  • Hirofumi Amano
  • Shinji Morimoto
  • Ken Yamaji
  • Yoshinari Takasaki
Original Article

Abstract

To retrospectively evaluate the efficacy and safety of combination therapy with tacrolimus (TAC) and other disease-modifying antirheumatic drugs (DMARDs). One hundred fifteen rheumatoid arthritis (RA) patients treated with tacrolimus were enrolled in this retrospective analysis. We collected clinical information, including patient background, treatment efficacy (evaluated using the DAS score), and adverse events observed. Multiple logistic regression analysis was conducted to analyze factors contributing to clinical response and adverse effects. The disease activity score of 28 joints (DAS28) improved significantly at 24 weeks, and continuation rate at 1 year was 57.9%. There was no difference in continuation rate between different DMARD combinations, and not only methotrexate (MTX) but also bucillamine (BUC) and salazosulfapyridine (SSZ) were effective combination partners with TAC. No serious adverse events were observed, and no different inefficacy or safety was observed between non-elderly (<65 years old) and elderly (≥65 years old) RA patients. By conducting multiple logistic regression analysis, combination therapy with MTX and TAC, the number of baseline DMARDs (specifically, ≥3), and old age were identified as risk factors for adverse events. Our findings indicate that TAC is a valuable DMARD for second-line combination therapy in RA.

Keywords

Combination therapy Rheumatoid arthritis Second-line DMARDs Tacrolimus 

Notes

Disclosures

None.

References

  1. 1.
    Furst D, Saag K, Fleischmann M, Sherrer Y, Block J, Schnitzer T et al (2002) Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with methotrexate: a six-month, double-blind, randomized, dose-ranging study. Arthritis Rheum 46:2020–2028PubMedCrossRefGoogle Scholar
  2. 2.
    Yocum D, Furst D, Kaine J, Baldassare A, Stevenson J, Borton M et al (2003) Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial. Arthritis Rheum 48:3328–3337PubMedCrossRefGoogle Scholar
  3. 3.
    Yocum D, Furst D, Bensen W, Burch F, Borton M, Mengle-Gaw L et al (2004) Safety of tacrolimus in patients with rheumatoid arthritis: long-term experience. Rheumatology (Oxford) 43:992–999CrossRefGoogle Scholar
  4. 4.
    Kawai S, Hashimoto H, Kondo H, Murayama T, Kiuchi T, Abe T (2006) Comparison of tacrolimus and mizoribine in a randomized, double-blind controlled study in patients with rheumatoid arthritis. J Rheumatol 33:2153–2161PubMedGoogle Scholar
  5. 5.
    Kawai S, Yamamoto K (2006) Safety of tacrolimus, an immunosuppressive agent, in the treatment of rheumatoid arthritis in elderly patients. Rheumatology (Oxford) 45:441–444CrossRefGoogle Scholar
  6. 6.
    Kawai S, Tanaka K, Ohno I, Utsunomiya K, Seino Y (2008) Safety of long-term tacrolimus therapy for rheumatoid arthritis: an open-label, uncontrolled study in non-elderly patients. Mod Rheumatol 18:345–353PubMedCrossRefGoogle Scholar
  7. 7.
    Kondo H, Abe T, Hashimoto H, Uchida S, Irimajiri S, Hara M et al (2004) Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo controlled dose-finding study. J Rheumatol 31:243–251PubMedGoogle Scholar
  8. 8.
    Suzuki K, Kameda H, Amano K, Nagasawa H, Takei H, Sekiguchi N et al (2009) Single center prospective study of tacrolimus efficacy and safety in treatment of rheumatoid arthritis. Rheumatol Int 29:431–436PubMedCrossRefGoogle Scholar
  9. 9.
    Kremer J, Habros J, Kolba K, Kaine J, Borton M, Mengle-Gaw L et al (2003) Tacrolimus in rheumatoid arthritis patients receiving concomitant methotrexate: a six-month, open-label study. Arthritis Rheum 48:2763–2768PubMedCrossRefGoogle Scholar
  10. 10.
    Morita Y, Sasae Y, Sakuta T, Satoh M, Sasaki T, Kashihara N (2008) Efficacy of low-dose tacrolimus added to methotrexate in patients with rheumatoid arthritis in Japan: a retrospective study. Mod Rheumatol 18:379–384PubMedCrossRefGoogle Scholar
  11. 11.
    Arnett F, Edworthy S, Bloch D, McShane D, Fries J, Cooper N et al (1988) The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 31:315–324PubMedCrossRefGoogle Scholar
  12. 12.
    Steinbrocker O, Traeger CH, Batterman RC (1949) Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc 140:659–662PubMedCrossRefGoogle Scholar
  13. 13.
    O'Dell J, Leff R, Paulsen G, Haire C, Mallek J, Eckhoff P et al (2002) Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: results of a two-year, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 46:1164–1170PubMedCrossRefGoogle Scholar

Copyright information

© Clinical Rheumatology 2011

Authors and Affiliations

  • Michihiro Ogasawara
    • 1
  • Naoto Tamura
    • 1
  • Michiaki Kageyama
    • 1
  • Shin Onuma
    • 1
  • Makio Kusaoi
    • 1
  • Shoko Toyama
    • 1
  • Fumio Sekiya
    • 1
  • Ran Matsudaira
    • 1
  • Masuyuki Nawata
    • 1
  • Kurisu Tada
    • 1
  • Masakazu Matsushita
    • 1
  • Kazuo Kempe
    • 1
  • Hirofumi Amano
    • 1
  • Shinji Morimoto
    • 1
  • Ken Yamaji
    • 1
  • Yoshinari Takasaki
    • 1
  1. 1.Department of Internal Medicine and RheumatologyJuntendo University School of MedicineTokyoJapan

Personalised recommendations