皮下注生物学的製剤の注射時痛の比較 ~アダリムマブ0.4 ml皮下注製剤の評価
目的:アダリムマブ皮下注製剤(ADAsc(0.8))は注射時痛が比較的強い製剤であったが,2016年11月に注射時痛軽減が期待できるADAsc(0.4)が発売された.今回ADAsc(0.4)を中心に,各種皮下注生物学的製剤の注射時痛の比較検討を行った. 対象・方法:当院通院中の皮下注生物学的製剤を使用中の関節リウマチ患者のうち同意が得られた423例(ADAsc群72例,他製剤351例)に対し注射時痛のアンケート調査を行った. 結果:ADAsc製剤変更前後で疾患活動性に統計学的有意な変化は認めなかった.注射時痛のShort-Form McGill Pain Questionnaire versi...
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Published in | 臨床リウマチ Vol. 29; no. 4; pp. 251 - 260 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | Japanese |
Published |
一般社団法人 日本臨床リウマチ学会
2017
The Japanese Society for Clinical Rheumatology and Related Research |
Subjects | |
Online Access | Get full text |
ISSN | 0914-8760 2189-0595 |
DOI | 10.14961/cra.29.251 |
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Abstract | 目的:アダリムマブ皮下注製剤(ADAsc(0.8))は注射時痛が比較的強い製剤であったが,2016年11月に注射時痛軽減が期待できるADAsc(0.4)が発売された.今回ADAsc(0.4)を中心に,各種皮下注生物学的製剤の注射時痛の比較検討を行った. 対象・方法:当院通院中の皮下注生物学的製剤を使用中の関節リウマチ患者のうち同意が得られた423例(ADAsc群72例,他製剤351例)に対し注射時痛のアンケート調査を行った. 結果:ADAsc製剤変更前後で疾患活動性に統計学的有意な変化は認めなかった.注射時痛のShort-Form McGill Pain Questionnaire version 2 (SF-MPQ-2)スコアは,4.50 (1.00-19.0)から1.00 (0.000-5.00)点(p<0.001)に改善した.穿刺時痛は55.4%,薬液注入時痛は78.6%の患者がADAsc(0.4)の方がとてもよいと回答した.重回帰分析で注射時痛が高値(SF-MPQ-2スコア3点以上)となる因子を検討したところ,ADAsc(0.4)と比較してADAsc(0.8),アバタセプト,エタネルセプト,セルトリズマブペゴルでオッズ比が高かった. 結論:注射時痛が改善したことにより,ADAscはさらに使用しやすい製剤となった. |
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AbstractList | Purposes : Subcutaneous injection of adalimumab (ADAsc(0.8)) was known to be painful, but an improved device (ADAsc(0.4)) was approved in November 2016. Here we compared the efficacy and pain level of injection among ADAsc(0.4), ADAsc(0.8), and other subcutaneous injection of biological disease-modifying anti-rheumatic drugs (sc-bDMARDs). Methods : Patients with rheumatoid arthritis (RA), who were treated by sc-bDMARDs in our hospital, and agreed to take part in this survey, were enrolled (ADAsc group, n=72; other sc-bDMARDs group, n=351). Results : The disease activity of RA did not change after switching from ADAsc(0.8) to ADAsc(0.4). Injection pain evaluated using the Short-Form McGill Pain Questionnaire version 2 (SF-MPQ-2) improved from 4.50 (1.00-19.0) to 1.00 (0.00-5.00), p<0.001. Furthermore, 55.4% and 78.6% of the patients expressed a marked preference for the ADAsc(0.4) in terms of needle-related pain, and the pain associated with infusion, respectively. Multivariate analysis indicated that more severe injection pain (SF-MPQ-2 score >2) was associated with use of the ADAsc(0.8), abatacept, etanercept, and certrilumab pegol, in comparison to the ADAsc(0.4). Conclusion : The ADAsc(0.4) has achieved a lower level of injection-related pain, and become more usable.
目的:アダリムマブ皮下注製剤(ADAsc(0.8))は注射時痛が比較的強い製剤であったが,2016年11月に注射時痛軽減が期待できるADAsc(0.4)が発売された.今回ADAsc(0.4)を中心に,各種皮下注生物学的製剤の注射時痛の比較検討を行った.対象・方法:当院通院中の皮下注生物学的製剤を使用中の関節リウマチ患者のうち同意が得られた423例(ADAsc群72例,他製剤351例)に対し注射時痛のアンケート調査を行った.結果:ADAsc製剤変更前後で疾患活動性に統計学的有意な変化は認めなかった.注射時痛のShort-Form McGill Pain Questionnaire version 2 (SF-MPQ-2)スコアは,4.50 (1.00-19.0)から1.00 (0.000-5.00)点(p<0.001)に改善した.穿刺時痛は55.4%,薬液注入時痛は78.6%の患者がADAsc(0.4)の方がとてもよいと回答した.重回帰分析で注射時痛が高値(SF-MPQ-2スコア3点以上)となる因子を検討したところ,ADAsc(0.4)と比較してADAsc(0.8),アバタセプト,エタネルセプト,セルトリズマブペゴルでオッズ比が高かった.結論:注射時痛が改善したことにより,ADAscはさらに使用しやすい製剤となった. 目的:アダリムマブ皮下注製剤(ADAsc(0.8))は注射時痛が比較的強い製剤であったが,2016年11月に注射時痛軽減が期待できるADAsc(0.4)が発売された.今回ADAsc(0.4)を中心に,各種皮下注生物学的製剤の注射時痛の比較検討を行った. 対象・方法:当院通院中の皮下注生物学的製剤を使用中の関節リウマチ患者のうち同意が得られた423例(ADAsc群72例,他製剤351例)に対し注射時痛のアンケート調査を行った. 結果:ADAsc製剤変更前後で疾患活動性に統計学的有意な変化は認めなかった.注射時痛のShort-Form McGill Pain Questionnaire version 2 (SF-MPQ-2)スコアは,4.50 (1.00-19.0)から1.00 (0.000-5.00)点(p<0.001)に改善した.穿刺時痛は55.4%,薬液注入時痛は78.6%の患者がADAsc(0.4)の方がとてもよいと回答した.重回帰分析で注射時痛が高値(SF-MPQ-2スコア3点以上)となる因子を検討したところ,ADAsc(0.4)と比較してADAsc(0.8),アバタセプト,エタネルセプト,セルトリズマブペゴルでオッズ比が高かった. 結論:注射時痛が改善したことにより,ADAscはさらに使用しやすい製剤となった. |
Author | 石川, 肇 村澤, 章 阿部, 麻美 成田, 一衛 中園, 清 小林, 大介 長谷川, 絵理子 伊藤, 聡 大谷, 博 野村, 優美 村松, 春菜 |
Author_FL | Hasegawa Eriko Abe Asami Nakazono Kiyoshi 小林 大介 Ishikawa Hajime 野村 優美 Narita Ichiei Ito Satoshi Murasawa Akira Otani Hiroshi Muramatsu Haruna |
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References | 14) Laursen T, Hansen B, Fisker S: Pain perception after subcutaneous injections of media containing different buffers. Basic Clin Pharmacol Toxicol, 98:218-221, 2006. 19) Lautenbacher S: Experimental approaches in the study of pain in the elderly. Pain Med, 13:S44-S50, 2012. 13) Veys N, Dhondt A, Lameire N: Pain at the injection site of subcutaneously administered erythropoietin: phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Clin Nephrol, 49:41-44, 1998. 15) Frenken LA, van Lier HJ, Koene RA: Analysis of the efficacy of measures to reduce pain after subcutaneous administration of epoetin alfa. Nephrol Dial Transplant, 9:1295-1298,1994. 16) Jørgensen JT, Rømsing J, Rasmussen M, et al: Pain assessment of subcutaneous injections. Ann Pharmacother, 729-732, 1996. 3) 佐藤正夫,竹村正男,四戸隆基:皮下注生物学的製剤の注射時痛に関する検討.臨床リウマチ,26: 121-125, 2014. 5) Nash P, Vanhoof J, Hall S, et al: Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis. Rheumatol Ther, 3:257-270, 2016. 21) Borrás-Blasco J, Gracia-Pérez A, Casterá MD, et al: Educational session as a tool to increase patient satisfaction of switching etanercept from the prefilled syringe to the autoinjection pen. Expert Opin Biol Ther, 13:1103-1108, 2013. 12) Frenken LA, van Lier HJ, Jordans JG, et al: Identification of the component part in an epoetin alfa preparation that causes pain after subcutaneous injection. Am J Kidney Dis, 22:553-556, 1993. 18) AbbVie GK. Product information for adalimumab. URL:www.abbvie.co.jp/content/ dam/abbviecorp/japan/docs/if_humira. pdf (accessed 2017-7-15) (in Japanese 1) Oh K, Ito S, Unno M, et al: The rate of decrease in disease activity of rheumatoid arthritis during treatment with adalimumab depends on the dose of methotrexate. Intern Med, 54:1035-1041, 2015. 10) Todd KH, Funk KG, Funk JP, et al: Clinical significance of reported changes in pain severity. Ann Emerg Med, 27:485-489, 1996. 4) 茂呂貴知:皮下注射生物学的製剤注射時の疼痛比較.臨床リウマチ,26:126-129, 2014. 20) 冨本和彦:予防接種時の疼痛軽減のために ―第1報:予防接種時の疼痛要因の検討―. 外来小児科,15:141-148, 2012. 11) Kelly AM: The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J, 18:205-207, 2001. 2) Ito S, Unno M, Kobayashi D, et al: Dose escalation of methotrexate in rheumatoid arthritis patients. J New Rem & Clin, 63:1302-1315, 2014. 8) Dworkin RH, Turk DC, Revicki DA, et al: Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain, 144:35-42, 2009. 17) Jaber A, Bozzato GB, Vedrine L, et al: A novel needle for subcutaneous injection of interferon beta-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurol, 8:38, 2008. 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. 6) Aletaha D, Neogi T, Silman AJ, et al: 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum, 62:2569-2581, 2010. 9) 圓尾知之,中江 文,前田 倫,他:痛みの評価尺度・日本語版Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2)の作成とその信頼性と妥当性の検討. Pain Research, 28:43-53, 2013. |
References_xml | – reference: 13) Veys N, Dhondt A, Lameire N: Pain at the injection site of subcutaneously administered erythropoietin: phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Clin Nephrol, 49:41-44, 1998. – reference: 4) 茂呂貴知:皮下注射生物学的製剤注射時の疼痛比較.臨床リウマチ,26:126-129, 2014. – 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: 15) Frenken LA, van Lier HJ, Koene RA: Analysis of the efficacy of measures to reduce pain after subcutaneous administration of epoetin alfa. Nephrol Dial Transplant, 9:1295-1298,1994. – reference: 16) Jørgensen JT, Rømsing J, Rasmussen M, et al: Pain assessment of subcutaneous injections. Ann Pharmacother, 729-732, 1996. – reference: 14) Laursen T, Hansen B, Fisker S: Pain perception after subcutaneous injections of media containing different buffers. Basic Clin Pharmacol Toxicol, 98:218-221, 2006. – reference: 18) AbbVie GK. Product information for adalimumab. URL:www.abbvie.co.jp/content/ dam/abbviecorp/japan/docs/if_humira. pdf (accessed 2017-7-15) (in Japanese) – reference: 11) Kelly AM: The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J, 18:205-207, 2001. – reference: 3) 佐藤正夫,竹村正男,四戸隆基:皮下注生物学的製剤の注射時痛に関する検討.臨床リウマチ,26: 121-125, 2014. – reference: 19) Lautenbacher S: Experimental approaches in the study of pain in the elderly. Pain Med, 13:S44-S50, 2012. – reference: 8) Dworkin RH, Turk DC, Revicki DA, et al: Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain, 144:35-42, 2009. – reference: 10) Todd KH, Funk KG, Funk JP, et al: Clinical significance of reported changes in pain severity. Ann Emerg Med, 27:485-489, 1996. – reference: 2) Ito S, Unno M, Kobayashi D, et al: Dose escalation of methotrexate in rheumatoid arthritis patients. J New Rem & Clin, 63:1302-1315, 2014. – reference: 9) 圓尾知之,中江 文,前田 倫,他:痛みの評価尺度・日本語版Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2)の作成とその信頼性と妥当性の検討. Pain Research, 28:43-53, 2013. – reference: 5) Nash P, Vanhoof J, Hall S, et al: Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis. Rheumatol Ther, 3:257-270, 2016. – reference: 6) Aletaha D, Neogi T, Silman AJ, et al: 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum, 62:2569-2581, 2010. – reference: 21) Borrás-Blasco J, Gracia-Pérez A, Casterá MD, et al: Educational session as a tool to increase patient satisfaction of switching etanercept from the prefilled syringe to the autoinjection pen. Expert Opin Biol Ther, 13:1103-1108, 2013. – reference: 12) Frenken LA, van Lier HJ, Jordans JG, et al: Identification of the component part in an epoetin alfa preparation that causes pain after subcutaneous injection. Am J Kidney Dis, 22:553-556, 1993. – reference: 20) 冨本和彦:予防接種時の疼痛軽減のために ―第1報:予防接種時の疼痛要因の検討―. 外来小児科,15:141-148, 2012. – reference: 1) Oh K, Ito S, Unno M, et al: The rate of decrease in disease activity of rheumatoid arthritis during treatment with adalimumab depends on the dose of methotrexate. Intern Med, 54:1035-1041, 2015. – reference: 17) Jaber A, Bozzato GB, Vedrine L, et al: A novel needle for subcutaneous injection of interferon beta-1a: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurol, 8:38, 2008. |
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Snippet | 目的:アダリムマブ皮下注製剤(ADAsc(0.8))は注射時痛が比較的強い製剤であったが,2016年11月に注射時痛軽減が期待できるADAsc(0.4)が発売された.今回ADAsc(0.4)を中心に,各種皮下注生物学的製剤の注射時痛の比較検討を行った.... Purposes : Subcutaneous injection of adalimumab (ADAsc(0.8)) was known to be painful, but an improved device (ADAsc(0.4)) was approved in November 2016. Here... |
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StartPage | 251 |
SubjectTerms | pain Questionnaire version 2 (SF-MPQ-2) rheumatoid arthritis Short-Form McGill Pain subcutaneous injection |
Title | 皮下注生物学的製剤の注射時痛の比較 ~アダリムマブ0.4 ml皮下注製剤の評価 |
URI | https://www.jstage.jst.go.jp/article/cra/29/4/29_251/_article/-char/ja https://cir.nii.ac.jp/crid/1390282679319679232 |
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ispartofPNX | 臨床リウマチ, 2017/12/30, Vol.29(4), pp.251-260 |
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