Skip to main content

Advertisement

SpringerLink
Log in

Twenty-four-week clinical results of adalimumab therapy in Japanese patients with rheumatoid arthritis: retrospective analysis for the best use of adalimumab in daily practice

  • Original Article
  • Published:
Modern Rheumatology

Abstract

Objective

We evaluated patient drug adherence to and efficacy and safety of adalimumab (ADA) based on data collected from approximately 200 patients to retrospectively examine the best use of ADA in Japanese patients with longstanding rheumatoid arthritis (RA) managed in daily practice.

Methods

For explorative comparisons, patients were stratified by prior use or no use of biologics (Bio-naïve vs. Bio-switch) and concomitant use (+) or no use (−) of methotrexate (MTX) into four subgroups. The primary efficacy endpoint was extent of improvement in the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) from baseline to 24 weeks assessed as European League Against Rheumatism (EULAR) good response. Secondary endpoints included ADA treatment continuation as represented by Kaplan–Meier survival curves and percentages of patients achieving remission as defined by DAS28-ESR <2.6.

Results

Overall, mean DAS28-ESR significantly decreased from 5.6 ± 1.2 at baseline to 4.1 ± 1.7 at week 24 (p < 0.0001), and >30 % of patients achieved EULAR good response. Subgroup analyses indicated that patients in the Bio-naïve and MTX (+) subgroup showed the highest EULAR good response rate of 37.3 % at week 24. The three most commonly reported adverse events (AEs) were skin allergies such as injection-site reactions, infections, and respiratory disorders such as interstitial lung lesions and organizing pneumonia.

Conclusion

In conclusion, ADA therapy resulted in significant clinical response in established Japanese patients with RA treated in daily practice. It also demonstrated generally good safety and tolerability. It was suggested that the best use of ADA may be in biologically naïve patients with concomitant administration of MTX.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Hochberg MC, Lebwohl MG, Plevy SE, Hobbs KF, Yocum DE. The benefit/risk profile of TNF-blocking agents: findings of a consensus panel. Semin Arthritis Rheum. 2005;34:819–36.

    Article  PubMed  CAS  Google Scholar 

  2. Vultaggio A, Matucci A, Nencini F, Pratesi S, Parronchi P, Rossi O, et al. Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions. Allergy. 2010;65:657–61.

    Article  PubMed  CAS  Google Scholar 

  3. Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for treating rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48:35–45.

    Article  PubMed  CAS  Google Scholar 

  4. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, et al. Radiographic, clinical and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum. 2004;50:1400–11.

    Article  PubMed  CAS  Google Scholar 

  5. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26–37.

    Article  PubMed  CAS  Google Scholar 

  6. Weinblatt ME, Keystone EC, Furst DE, Kavanaugh AF, Chartash EK, Segurado OG. Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study. Ann Rheum Dis. 2006;65:753–9.

    Article  PubMed  CAS  Google Scholar 

  7. Bejarano V, Quinn M, Conaghan PG, Reece R, Keenan A-N, Walker D, et al. Effect of the early use of the anti-tumor necrosis factor adalimumab on the prevention of job loss in patients with early rheumatoid arthritis. Arthritis Rheum. 2008;59:1467–74.

    Article  PubMed  Google Scholar 

  8. Van Vollenhoven RF, Cifaldi MA, Ray S, Chen N, Weisman MH. Improvement in work place and household productivity for patients with early rheumatoid arthritis treated with adalimumab plus methotrexate: work outcomes and their correlations with clinical and radiographic measures from a randomized controlled trial comparison study. Arthritis Care Res. 2010;62:226–34.

    Article  Google Scholar 

  9. Kojima T, Kaneko A, Hirano Y, Ishikawa H, Miyake H, Oguchi T, et al. Study protocol of a multicenter registry of patients with rheumatoid arthritis starting biologic therapy in Japan: Tsurumai Biologics Communication Registry (TBCR) Study. Mod Rheumatol. 2011;. doi:10.1007/s10165-011-0518-4.

    Google Scholar 

  10. HUMIRA (adalimumab) (prescribing information) (in Japanese). Pharmaceuticals and medical devices agency web site. http://www.info.pmda.go.jp/go/pack/3999426G1024_1_12/.

  11. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31:315–24.

    Article  PubMed  CAS  Google Scholar 

  12. Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59:762–84.

    Article  PubMed  CAS  Google Scholar 

  13. Van Gestel AM, Haagsma CJ, van Riel PLCM. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998;41:1845–50.

    Article  PubMed  Google Scholar 

  14. Van Gestel AM, Anderson JJ, van Riel PL, Boers M, Haagsma CJ, Rich B, et al. ACR and EULAR improvement criteria have comparable validity in rheumatoid arthritis trials. American College of Rheumatology European League of Associations for Rheumatology. J Rheumatol. 1999;26:705–11.

    Google Scholar 

  15. Shinomiya F, Mima N, Nanba K, Tani K, Nakano S, Egawa H, et al. Life expectancies of Japanese patients with rheumatoid arthritis: a review of deaths over a 20-year period. Mod Rheumatol. 2008;18:165–9.

    Article  PubMed  Google Scholar 

  16. Van der Heijde D, Breedveld FC, Kavanaugh A, Keystone EC, Landewe R, Patra K, et al. Disease activity, physical function, and radiographic progression after long-term therapy with adalimumab plus methotrexate: 5-year results of PREMIER. J Rheumatol. 2010;37:2237–46.

    Article  PubMed  Google Scholar 

  17. Keystone EC, Kavanaugh A, Weinblatt ME, Patra K, Pangan AL. Clinical consequences of delayed addition of adalimumab to methotrexate therapy over 5 years in patients with rheumatoid arthritis. 2011. doi:10.3899/jrheum.100752.

  18. Miyasaka N, the CHANGE study Investigators. Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE study. Mod Rheumatol. 2008;18:252–62.

    Article  PubMed  CAS  Google Scholar 

  19. Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007;66:921–6.

    Article  PubMed  CAS  Google Scholar 

  20. Radstake TRDJ, Svenson M, Eijsbouts AM, van den Hoogen FHJ, Enevold C, van Riel PLCM, et al. Formation of antibodies against infliximab and adalimumab strongly correlated with functional drug levels and clinical response in rheumatoid arthritis. Ann Rheum Dis. 2009;68:1739–45.

    Article  PubMed  CAS  Google Scholar 

  21. Kaneko A. Case reports of biological products: D. Adalimumab. In: Abe C, Kondo M, Matsubara T, Yamasaki K. Nihon Igakukan, editors. The manual of rheumatoid arthritis therapy with biologics. 2010; 69–77.

  22. Kievit W, Adang EM, Fransen J, Kuper HH, van de Laar MAFJ, Jansen TL, et al. The effectiveness and medication costs of three anti-tumor necrosis factor agents in treating rheumatoid arthritis from prospective clinical practice data. Ann Rheum Dis. 2008;67:1229–34.

    Article  PubMed  CAS  Google Scholar 

  23. Hetland ML, Christensen IJ, Tarp U, Dreyer L, Hansen A, Hansen IT, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum. 2010;62:22–32.

    Article  PubMed  CAS  Google Scholar 

  24. Du Pan SM, Dehler S, Ciurea A, Ziswiler H-R, Gabay C, Finckh A. Comparison of drug retention rates and causes of drug discontinuation between anti-tumor necrosis factor agents in rheumatoid arthritis. Arthritis Rheum. 2009;61:560–8.

    Article  PubMed  Google Scholar 

  25. Gomez-Reino JJ, Garmona L. Switching TNF antagonists in patients with chronic arthritis: an observational study of 488 patients over a four-year period. Arthritis Res Ther. 2006;8:R29–35.

    Article  PubMed  Google Scholar 

  26. Smolen JS, Landewé R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69:964–75.

    Article  PubMed  CAS  Google Scholar 

  27. Humira® (adalimumab) (prescribing information). Abbott Laboratories. North Chicago; 2010.

  28. Paltiel M, Gober LM, Deng A, Mikdashi J, Alexeeva I, Saini SS, et al. Immediate type I hypersensitivity response implicated in worsening injection site reactions to adalimumab. Arch Dermatol. 2008;144:1190–4.

    Article  PubMed  CAS  Google Scholar 

  29. Benucci M, Manfredi M, Demoly P, Campi P. Injection site reactions to TNF-α blocking agents with positive skin tests. Allergy. 2008;63:138–9.

    Article  PubMed  CAS  Google Scholar 

  30. Smolen JS, Aletaha D, Koeller M, Weisman MH, Emery P. New therapies for treatment of rheumatoid arthritis. Lancet. 2007;370:1861–74.

    Article  PubMed  CAS  Google Scholar 

Download references

Conflict of interest

N. Ishiguro, T. Kojima, Y. Hirano, and A. Kaneko have received speaking fees (<US$5,000) from Abbott Japan Co. Ltd.; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Corporation; Pfizer Co. Ltd; Chugai Pharmaceutical Co. Ltd.; and Bristol-Myers Squibb Co. Ltd. The other authors declare no conflicts of interest.

Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery and Rheumatology, National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001, Japan

    Atsushi Kaneko

  2. Department of Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan

    Yuji Hirano

  3. Department of Orthopedic Surgery, Kounan Kosei Hospital, Kounan, Japan

    Takayoshi Fujibayashi

  4. Department of Orthopedic Surgery, Nagoya University School of Medicine, Nagoya, Japan

    Yosuke Hattori, Kenya Terabe, Toshihisa Kojima & Naoki Ishiguro

Authors
  1. Atsushi Kaneko
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yuji Hirano
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Takayoshi Fujibayashi
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yosuke Hattori
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Kenya Terabe
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Toshihisa Kojima
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Naoki Ishiguro
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Atsushi Kaneko.

About this article

Cite this article

Kaneko, A., Hirano, Y., Fujibayashi, T. et al. Twenty-four-week clinical results of adalimumab therapy in Japanese patients with rheumatoid arthritis: retrospective analysis for the best use of adalimumab in daily practice. Mod Rheumatol 23, 466–477 (2013). https://doi.org/10.1007/s10165-012-0705-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10165-012-0705-y

Keywords

Search

Navigation