Sarilumab is effective rapidly in ultrasound for patients with rheumatoid arthritis
Objective: The purpose of this study was to examine short-term efficacy of sarilumab therapy in patients with rheumatoid arthritis（RA）. Subjects and methods: Five patients with RA who underwent sarilumab treatment were assessed. 200 mg of sarilumab was administered SC by subcutaneous injection ev...
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| Published in | Clinical Rheumatology and Related Research Vol. 31; no. 1; pp. 41 - 47 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | Japanese |
| Published |
The Japanese Society for Clinical Rheumatology and Related Research
30.03.2019
一般社団法人 日本臨床リウマチ学会 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0914-8760 2189-0595 |
| DOI | 10.14961/cra.31.41 |
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| Abstract | Objective: The purpose of this study was to examine short-term efficacy of sarilumab therapy in patients with rheumatoid arthritis（RA）. Subjects and methods: Five patients with RA who underwent sarilumab treatment were assessed. 200 mg of sarilumab was administered SC by subcutaneous injection every 2 weeks for 12 weeks to patients with RA. Disease activity of RA was examined by DAS28-ESR and ultrasonography. Results: All patients were women（mean age 64.0 ± 17.8, mean disease duration 16.5 ± 14.0 years）. DAS28-ESR was significantly improved（4.58 ± 0.65 at baseline to 2.90 ± 0.76 at 12 weeks p= 0.03）. Total power Doppler score was also significantly improved（10.6 ± 2.2 at baseline to 2.0 ± 1.9 at 12 weeks p= 0.0067）. Conclusions: These findings suggested that sarilumab may lead to rapid improvement assessed by DAS28-ESR and ultrasound in patients with rheumatoid arthritis. |
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| AbstractList | Objective: The purpose of this study was to examine short-term efficacy of sarilumab therapy in patients with rheumatoid arthritis（RA）. Subjects and methods: Five patients with RA who underwent sarilumab treatment were assessed. 200 mg of sarilumab was administered SC by subcutaneous injection every 2 weeks for 12 weeks to patients with RA. Disease activity of RA was examined by DAS28-ESR and ultrasonography. Results: All patients were women（mean age 64.0 ± 17.8, mean disease duration 16.5 ± 14.0 years）. DAS28-ESR was significantly improved（4.58 ± 0.65 at baseline to 2.90 ± 0.76 at 12 weeks p= 0.03）. Total power Doppler score was also significantly improved（10.6 ± 2.2 at baseline to 2.0 ± 1.9 at 12 weeks p= 0.0067）. Conclusions: These findings suggested that sarilumab may lead to rapid improvement assessed by DAS28-ESR and ultrasound in patients with rheumatoid arthritis.
目的：関節リウマチ（RA）患者に対するサリルマブの短期的治療効果について臨床的評価項目と，関節エコーを用いて評価した．対象・方法：サリルマブ治療を導入したRA患者５例を対象とした．サリルマブは，２週間に１回，200㎎の皮下注射を行った．12週までの治療効果を後ろ向きに評価した．治療効果判定は，DAS28-ESRと関節エコーを用いて評価した．関節エコーは，28関節（両PIP関節，MP関節，手関節，肘関節，肩関節，膝関節）で評価し，半定量法（0-3）を用いてGrey scale（GS）とpower Doppler（PD）scoreを評価した．28関節の合計をそれぞれTotal GS score, Total PD scoreとした．結果：サリルマブ開始時の患者背景は，平均年齢64.0±17.8歳，全例が女性で，罹病期間は，16.5±14.0年であった．全例，サリルマブ治療前に２剤の生物学的製剤を使用していた．平均のDAS28-ESRは，4.58± 0.65で，Total GS score 16.8±4.7，Total PD scoreは10.6±2.2であった．サリルマブ投与12週後に，平均DAS28-ESRは2.90±0.76と有意に改善し（p= 0.03），Total PD scoreは2.0±1.9（p= 0.0067）で有意に改善を認めた．結論：サリルマブ治療は，早期に疾患活動性を低下させる可能性がある． Objective: The purpose of this study was to examine short-term efficacy of sarilumab therapy in patients with rheumatoid arthritis（RA）. Subjects and methods: Five patients with RA who underwent sarilumab treatment were assessed. 200 mg of sarilumab was administered SC by subcutaneous injection every 2 weeks for 12 weeks to patients with RA. Disease activity of RA was examined by DAS28-ESR and ultrasonography. Results: All patients were women（mean age 64.0 ± 17.8, mean disease duration 16.5 ± 14.0 years）. DAS28-ESR was significantly improved（4.58 ± 0.65 at baseline to 2.90 ± 0.76 at 12 weeks p= 0.03）. Total power Doppler score was also significantly improved（10.6 ± 2.2 at baseline to 2.0 ± 1.9 at 12 weeks p= 0.0067）. Conclusions: These findings suggested that sarilumab may lead to rapid improvement assessed by DAS28-ESR and ultrasound in patients with rheumatoid arthritis. |
| Author | Kimura, Yuko Yoshida, Shuzo |
| Author_FL | 吉田 周造 木村 侑子 |
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| References | 16） Kim GW, Lee NR, Pi RH, et al. IL-6 inhibitors for treatment of rheumatoid arthritis: past, present, and future. Arch Pharm Res, 38: 575-584, 2015. 1） Smolen JS, Aletaha D, Mclnnes IB, et al. Rheumatoid arthritis. Lancet, 22: 2023-2038, 2016. 3） Strand V, Gossec L, Proudfoot C.W.J, et al: Patient-reported outcomes from a randomized phase 3 trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis. Arthritis Res Ther 20: 129, 2018. 10） Kojima M, Nakayama T, Kawahito Y, et al. The process of collecting and evaluating evidences for the development of Guidelines for the management of rheumatoid arthritis, Japan College of Rheumatology 2014: Utilization of GRADE approach. Mod Rheumatol, 26: 175-179, 2016. 14） Foltz V, Gandjbakhch F, Etchepare F, et al. Power Doppler ultrasound, but not low-field magnetic resonance imaging, predicts relapse and radiographic disease progression in rheumatoid arthritis patients with low levels of disease activity. Arthritis Rheum, 64: 67-76, 2012. 2） Genovese MC, Fleischmann R, Kivitz AJ, et al: Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase Ⅲ study. Arthritis Rheumatol, 67: 1424-1437, 2015. 4） D’Agostino MA, Wakefield RJ, Berner-Hammer H et al. Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study. Ann Rheum Dis, 75: 1763-1769, 2016. 6） Chiu WC, Lai HM, Ko CH, et al. Ultrasound is more reliable than inflammatory parameters to evaluate disease activity in patients with RA receiving tocilizumab therapy. J Investig Med, 66: 1015-1018, 2018. 7） Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism Collaborative initiative. Ann Rheum Dis, 69: 1580-1588, 2010. 9） Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis, 76: 960-977, 2017. 5） Yoshida S, Kotani T, Kimura Y, et al. Efficacy of abatacept tapering therapy for sustained remission in patients with rheumatoid arthritis: Prospective single-centre study. Int J Rheum Dis, 2018 [Epub ahead of print]. 8） Wakefield RJ, Balint PV, Szkudlarek M, et al. Musculoskeletal ultrasound including definitions for ultrasonographic pathology. J Rheumatol, 32: 2485-2487, 2005. 11） Genovese MC, Fleischmann R, Kivitz AJ, et al: Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase 3 study. Arthritis Rheumatol, 67: 1100-1104, 2015. 12） Huizinga TW, Fleischmann RM, Jasson M, et al. Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomized SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis, 73: 1626-1634, 2014. 13） Brown AK, Conaghan PG, Karim Z, et al. An Explanation for the apparent dissociation between clinical remission and continued structural deterioration in rheumatoid arthritis. Arthritis Rheum, 58: 2958-2967, 2008. 15） Chen YC, Chiu WC, Su FM, et al. Generalized estimating equation model to compare drug effects on synovitis of the dominant wrist in severe rheumatoid arthritis between tocilizumab versus adalimumab versus abatacept using high-resolution ultrasound, Int J Rheum Dis, 21: 1695-1700, 2018. |
| References_xml | – reference: 3） Strand V, Gossec L, Proudfoot C.W.J, et al: Patient-reported outcomes from a randomized phase 3 trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis. Arthritis Res Ther 20: 129, 2018. – reference: 13） Brown AK, Conaghan PG, Karim Z, et al. An Explanation for the apparent dissociation between clinical remission and continued structural deterioration in rheumatoid arthritis. Arthritis Rheum, 58: 2958-2967, 2008. – reference: 9） Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis, 76: 960-977, 2017. – reference: 16） Kim GW, Lee NR, Pi RH, et al. IL-6 inhibitors for treatment of rheumatoid arthritis: past, present, and future. Arch Pharm Res, 38: 575-584, 2015. – reference: 1） Smolen JS, Aletaha D, Mclnnes IB, et al. Rheumatoid arthritis. Lancet, 22: 2023-2038, 2016. – reference: 6） Chiu WC, Lai HM, Ko CH, et al. Ultrasound is more reliable than inflammatory parameters to evaluate disease activity in patients with RA receiving tocilizumab therapy. J Investig Med, 66: 1015-1018, 2018. – reference: 11） Genovese MC, Fleischmann R, Kivitz AJ, et al: Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase 3 study. Arthritis Rheumatol, 67: 1100-1104, 2015. – reference: 10） Kojima M, Nakayama T, Kawahito Y, et al. The process of collecting and evaluating evidences for the development of Guidelines for the management of rheumatoid arthritis, Japan College of Rheumatology 2014: Utilization of GRADE approach. Mod Rheumatol, 26: 175-179, 2016. – reference: 14） Foltz V, Gandjbakhch F, Etchepare F, et al. Power Doppler ultrasound, but not low-field magnetic resonance imaging, predicts relapse and radiographic disease progression in rheumatoid arthritis patients with low levels of disease activity. Arthritis Rheum, 64: 67-76, 2012. – reference: 5） Yoshida S, Kotani T, Kimura Y, et al. Efficacy of abatacept tapering therapy for sustained remission in patients with rheumatoid arthritis: Prospective single-centre study. Int J Rheum Dis, 2018 [Epub ahead of print]. – reference: 15） Chen YC, Chiu WC, Su FM, et al. Generalized estimating equation model to compare drug effects on synovitis of the dominant wrist in severe rheumatoid arthritis between tocilizumab versus adalimumab versus abatacept using high-resolution ultrasound, Int J Rheum Dis, 21: 1695-1700, 2018. – reference: 2） Genovese MC, Fleischmann R, Kivitz AJ, et al: Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase Ⅲ study. Arthritis Rheumatol, 67: 1424-1437, 2015. – reference: 4） D’Agostino MA, Wakefield RJ, Berner-Hammer H et al. Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study. Ann Rheum Dis, 75: 1763-1769, 2016. – reference: 7） Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism Collaborative initiative. Ann Rheum Dis, 69: 1580-1588, 2010. – reference: 12） Huizinga TW, Fleischmann RM, Jasson M, et al. Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomized SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis, 73: 1626-1634, 2014. – reference: 8） Wakefield RJ, Balint PV, Szkudlarek M, et al. Musculoskeletal ultrasound including definitions for ultrasonographic pathology. J Rheumatol, 32: 2485-2487, 2005. |
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