Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients

Postmarketing surveillance report of 7740 patients

Takao Koike, Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Syuji Takei, Tsutomu Takeuchi, Hisashi Yamanaka, Shigenori Haruna, Naoko Ushida, Katsuyoshi Kawana, Yoshiya Tanaka

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Objectives. To confirm the safety and effectiveness of adalimumab and to evaluate the influence of the concomitant use of methotrexate (MTX). Methods. Postmarketing surveillance of 7740 Japanese rheumatoid arthritis (RA) patients was performed. All patients who received adalimumab in the registration period were followed for 28 weeks after starting treatment for safety and 24 weeks for effectiveness. Effectiveness was measured by duration of morning stiffness, swollen and tender joint counts (28 joints), patient global assessment of disease activity, erythrocyte sedimentation rate and serum C-reactive protein. Results. Comparable rates of adverse drug reactions (ADRs) were reported in this study and in the interim analysis. Age, pulmonary disease history or comorbidity, co-existing diabetes mellitus, concomitant MTX at doses of > 8 mg/week and concomitant glucocorticoids at doses of > 5 mg/day were risk factors for infections. All mean values of effectiveness measurements improved. Relatively lower disease activity at baseline, biologic-naïve, concomitant MTX use and early RA stage/low functional class were background factors contributing to the effectiveness. The combination of adalimumab with MTX improved the response to adalimumab treatment. Conclusion. Adalimumab, especially with concomitant use of MTX, provided significant improvement in disease activity, without any unexpected ADRs in Japanese RA patients.

Original languageEnglish
Pages (from-to)390-398
Number of pages9
JournalModern Rheumatology
Volume24
Issue number3
DOIs
Publication statusPublished - 2014

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Methotrexate
Rheumatoid Arthritis
Safety
Drug-Related Side Effects and Adverse Reactions
Joints
Blood Sedimentation
Biological Products
C-Reactive Protein
Glucocorticoids
Lung Diseases
Comorbidity
Blood Proteins
Diabetes Mellitus
Adalimumab
Therapeutics
Infection

Keywords

  • Adalimumab
  • Effectiveness
  • Postmarketing surveillance
  • Rheumatoid arthritis
  • Safety

ASJC Scopus subject areas

  • Rheumatology
  • Medicine(all)

Cite this

Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients : Postmarketing surveillance report of 7740 patients. / Koike, Takao; Harigai, Masayoshi; Ishiguro, Naoki; Inokuma, Shigeko; Takei, Syuji; Takeuchi, Tsutomu; Yamanaka, Hisashi; Haruna, Shigenori; Ushida, Naoko; Kawana, Katsuyoshi; Tanaka, Yoshiya.

In: Modern Rheumatology, Vol. 24, No. 3, 2014, p. 390-398.

Research output: Contribution to journalArticle

Koike, T, Harigai, M, Ishiguro, N, Inokuma, S, Takei, S, Takeuchi, T, Yamanaka, H, Haruna, S, Ushida, N, Kawana, K & Tanaka, Y 2014, 'Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: Postmarketing surveillance report of 7740 patients', Modern Rheumatology, vol. 24, no. 3, pp. 390-398. https://doi.org/10.3109/14397595.2013.843760
Koike, Takao ; Harigai, Masayoshi ; Ishiguro, Naoki ; Inokuma, Shigeko ; Takei, Syuji ; Takeuchi, Tsutomu ; Yamanaka, Hisashi ; Haruna, Shigenori ; Ushida, Naoko ; Kawana, Katsuyoshi ; Tanaka, Yoshiya. / Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients : Postmarketing surveillance report of 7740 patients. In: Modern Rheumatology. 2014 ; Vol. 24, No. 3. pp. 390-398.
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