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 language | English |
|---|---|
| Pages (from-to) | 390-398 |
| Number of pages | 9 |
| Journal | Modern Rheumatology |
| Volume | 24 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2014 |
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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 journal › Article
}
TY - JOUR
T1 - Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients
T2 - Postmarketing surveillance report of 7740 patients
AU - Koike, Takao
AU - Harigai, Masayoshi
AU - Ishiguro, Naoki
AU - Inokuma, Shigeko
AU - Takei, Syuji
AU - Takeuchi, Tsutomu
AU - Yamanaka, Hisashi
AU - Haruna, Shigenori
AU - Ushida, Naoko
AU - Kawana, Katsuyoshi
AU - Tanaka, Yoshiya
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - Adalimumab
KW - Effectiveness
KW - Postmarketing surveillance
KW - Rheumatoid arthritis
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=84900435415&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84900435415&partnerID=8YFLogxK
U2 - 10.3109/14397595.2013.843760
DO - 10.3109/14397595.2013.843760
M3 - Article
VL - 24
SP - 390
EP - 398
JO - Modern Rheumatology
JF - Modern Rheumatology
SN - 1439-7595
IS - 3
ER -