関節リウマチ患者におけるアダリムマブの長期使用成績

目的:アダリムマブ(ADA)の長期成績をX線学的評価も含めて検討した. 対象・方法:対象はADAを投与開始後2年以上経過したRA患者56例(男性14例,女性42例,平均年齢61.4歳)で,他の抗TNF製剤からのスイッチングは39例,抗TNF製剤未投与例は17例であった.ADAを2週間に1回皮下注射し,臨床評価は投与開始4,8,12,16,24,52,104週後にEULAR改善基準(DAS28CRP)を用いて行い,投与開始2年後にMHAQおよびシャープ法を用いて機能的評価,画像的評価を行った. 結果:56例中2年間ADAを投与継続し得たのは22例で,DAS28CRPおよび血中MMP-3濃度ともに...

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Published in臨床リウマチ Vol. 23; no. 4; pp. 305 - 310
Main Authors 三橋, 尚志, 万波, 健二
Format Journal Article
LanguageJapanese
Published 一般社団法人 日本臨床リウマチ学会 2011
The Japanese Society for Clinical Rheumatology and Related Research
Subjects
Online AccessGet full text
ISSN0914-8760
2189-0595
DOI10.14961/cra.23.305

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Abstract 目的:アダリムマブ(ADA)の長期成績をX線学的評価も含めて検討した. 対象・方法:対象はADAを投与開始後2年以上経過したRA患者56例(男性14例,女性42例,平均年齢61.4歳)で,他の抗TNF製剤からのスイッチングは39例,抗TNF製剤未投与例は17例であった.ADAを2週間に1回皮下注射し,臨床評価は投与開始4,8,12,16,24,52,104週後にEULAR改善基準(DAS28CRP)を用いて行い,投与開始2年後にMHAQおよびシャープ法を用いて機能的評価,画像的評価を行った. 結果:56例中2年間ADAを投与継続し得たのは22例で,DAS28CRPおよび血中MMP-3濃度ともに2年間有意な減少を認めた.効果不十分あるいは2次性無効による中止は25例であり,副作用による中止は5例,自己の都合による中止は4例であった.2年間継続し得た22例においてMHAQを用いた機能的評価では有意な改善が得られ,画像的評価でも特にgood response群(14例)において骨関節破壊抑制効果が認められた. 結論:ADAにより疾患活動性が抑制された例では,2年後の機能および画像評価において明らかな改善効果が得られた.
AbstractList Objective: Results of long-term adalimumab (ADA) treatment were investigated including a radiologic evaluation. Subject and methods: The subjects were 56 RA patients (14 males and 42 females with a mean age of 61.4 years) that had received ADA treatment for at least 2 years after the initiation of treatment, and 39 of whom had switched from other anti-TNF drugs while 17 did not administer any anti-TNF drug. ADA was subcutaneously administered for two weeks. The clinical evaluation was performed at 4,8,12,16,24,52, and 104 weeks after the initiation of treatment using the EULAR improvement standards (DAS28CRP). At 2 years after the initiation of treatment, functional and radiographic evaluations were performed using the MHAQ and sharp score methods. Results: Of the 56 patients, 22 continued ADA treatment for 2 years, and both DAS28CRP and plasma MMP-3 concentrations decreased significantly in 2 years. The discontinued cases were 25 patients due to poor response or secondary failure,5 due to adverse drug reactions, and 4 due to their personal circumstances.     In the functional evaluation of the 22 patients that continued the treatment for 2 years, using MHAQ, significant improvement was obtained and even the radiographic evaluation revealed inhibition of bone joint degeneration particularly in the good response group (14 patients).Conclusion: Among the patients whose disease activity was inhibited by ADA, clear improvement was seen in the functional and radiologic evaluations after two years. 目的:アダリムマブ(ADA)の長期成績をX線学的評価も含めて検討した. 対象・方法:対象はADAを投与開始後2年以上経過したRA患者56例(男性14例,女性42例,平均年齢61.4歳)で,他の抗TNF製剤からのスイッチングは39例,抗TNF製剤未投与例は17例であった.ADAを2週間に1回皮下注射し,臨床評価は投与開始4,8,12,16,24,52,104週後にEULAR改善基準(DAS28CRP)を用いて行い,投与開始2年後にMHAQおよびシャープ法を用いて機能的評価,画像的評価を行った. 結果:56例中2年間ADAを投与継続し得たのは22例で,DAS28CRPおよび血中MMP-3濃度ともに2年間有意な減少を認めた.効果不十分あるいは2次性無効による中止は25例であり,副作用による中止は5例,自己の都合による中止は4例であった.2年間継続し得た22例においてMHAQを用いた機能的評価では有意な改善が得られ,画像的評価でも特にgood response群(14例)において骨関節破壊抑制効果が認められた. 結論:ADAにより疾患活動性が抑制された例では,2年後の機能および画像評価において明らかな改善効果が得られた.
目的:アダリムマブ(ADA)の長期成績をX線学的評価も含めて検討した. 対象・方法:対象はADAを投与開始後2年以上経過したRA患者56例(男性14例,女性42例,平均年齢61.4歳)で,他の抗TNF製剤からのスイッチングは39例,抗TNF製剤未投与例は17例であった.ADAを2週間に1回皮下注射し,臨床評価は投与開始4,8,12,16,24,52,104週後にEULAR改善基準(DAS28CRP)を用いて行い,投与開始2年後にMHAQおよびシャープ法を用いて機能的評価,画像的評価を行った. 結果:56例中2年間ADAを投与継続し得たのは22例で,DAS28CRPおよび血中MMP-3濃度ともに2年間有意な減少を認めた.効果不十分あるいは2次性無効による中止は25例であり,副作用による中止は5例,自己の都合による中止は4例であった.2年間継続し得た22例においてMHAQを用いた機能的評価では有意な改善が得られ,画像的評価でも特にgood response群(14例)において骨関節破壊抑制効果が認められた. 結論:ADAにより疾患活動性が抑制された例では,2年後の機能および画像評価において明らかな改善効果が得られた.
Author 万波, 健二
三橋, 尚志
Author_FL Mitsuhashi Takashi
Mannami Kenji
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References 8) Miyasaka, N., The CHANGE studyinvestigators: Clinical Investigation in highly disease-affected rheumatoid arthritis patients in Japan with adlimumab applying standard and general evaluation: The CHANGE study. Mod. Rheumatol., 18: 252-262, 2008.
10) 田中良哉:関節リウマチの寛解:クライテリアによってどのように違うのか?.リウマチ科,42:329-336,2009
7) 三橋尚志,万波健二:抗TNF製剤スイッチング療法におけるアダリムマブ投与の臨床成績.臨床リウマチ,22:180-186,2010
4) Burmester, G.R., Mariette, X., Montecucco, C., et al.: Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial, Ann. Rheum. Dis., 66: 732-739, 2007.
3) Breedveld, F.C., Weisman, M.H., Kavanaugh, A.F., et al.: The PREMIER study: 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., 54: 26-37, 2006.
5) Sharp, J.T., Lidsky, M.D., Collins, L.C., et al.: Methods of Scoring the Progression of Radiologic Changes in Rheumatoid Arthritis. Arthritis Rheum., 14: 706-720, 1971.
6) Weinblatt, M.E., Keystone, E.C., Furst, D.E., et al.: Adalimumab, a fully human anti-tumor necrosis factorαmonoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial. Arthritis Rheum., 48: 35-45, 2007.
1) van der Bijl, A.E., Breedveld, F.C., Antoni, C.E., et al.: An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and antiinfliximab antibody status. Clin. Rheumatol., 27: 1021-1028, 2008.
2) Bejarano, V., Quinn, M., Conaghan, G.P., 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., 59: 1467-1474, 2008.
9) van Vollenhoven, R.F., Cifaldi, M.A., Ray, S., et al.: 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 companion study. Arthritis Care Res., 62: 226-234, 2010.
References_xml – reference: 4) Burmester, G.R., Mariette, X., Montecucco, C., et al.: Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial, Ann. Rheum. Dis., 66: 732-739, 2007.
– reference: 7) 三橋尚志,万波健二:抗TNF製剤スイッチング療法におけるアダリムマブ投与の臨床成績.臨床リウマチ,22:180-186,2010.
– reference: 5) Sharp, J.T., Lidsky, M.D., Collins, L.C., et al.: Methods of Scoring the Progression of Radiologic Changes in Rheumatoid Arthritis. Arthritis Rheum., 14: 706-720, 1971.
– reference: 1) van der Bijl, A.E., Breedveld, F.C., Antoni, C.E., et al.: An open-label pilot study of the effectiveness of adalimumab in patients with rheumatoid arthritis and previous infliximab treatment: relationship to reasons for failure and antiinfliximab antibody status. Clin. Rheumatol., 27: 1021-1028, 2008.
– reference: 3) Breedveld, F.C., Weisman, M.H., Kavanaugh, A.F., et al.: The PREMIER study: 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., 54: 26-37, 2006.
– reference: 9) van Vollenhoven, R.F., Cifaldi, M.A., Ray, S., et al.: 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 companion study. Arthritis Care Res., 62: 226-234, 2010.
– reference: 6) Weinblatt, M.E., Keystone, E.C., Furst, D.E., et al.: Adalimumab, a fully human anti-tumor necrosis factorαmonoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial. Arthritis Rheum., 48: 35-45, 2007.
– reference: 2) Bejarano, V., Quinn, M., Conaghan, G.P., 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., 59: 1467-1474, 2008.
– reference: 10) 田中良哉:関節リウマチの寛解:クライテリアによってどのように違うのか?.リウマチ科,42:329-336,2009.
– reference: 8) Miyasaka, N., The CHANGE studyinvestigators: Clinical Investigation in highly disease-affected rheumatoid arthritis patients in Japan with adlimumab applying standard and general evaluation: The CHANGE study. Mod. Rheumatol., 18: 252-262, 2008.
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Snippet 目的:アダリムマブ(ADA)の長期成績をX線学的評価も含めて検討した....
Objective: Results of long-term adalimumab (ADA) treatment were investigated including a radiologic evaluation. Subject and methods: The subjects were 56 RA...
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SubjectTerms adalimumab
radiographic progression
remission
rheumatoid arthritis
Title 関節リウマチ患者におけるアダリムマブの長期使用成績
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