IgG4関連疾患に対する治療：前方視的臨床研究を中心に
目的：IgG4関連疾患にはステロイドが有効だがエビデンスが無かったため，多施設共同前方視的治療研究にて検証した． 方法：12施設より症例登録を受け，初発IgG4関連疾患包括診断基準確診例を対象とした．中等量ステロイドprednisolone 0.6mg/kg/日を初期投与量とし，２週間毎に10%漸減，その後は各主治医判断で症状や臨床データの推移から維持量を決定した．１年後の完全寛解率を主要評価項目とし，副次評価項目としてはステロイド維持量，再発再燃率，有害事象を観察した． 結果：５年間で57例の登録予定であったが，４年間で61例の登録あり終了．臨床病理中央診断の結果，確診群は44例，準確診１例...
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| Published in | 臨床リウマチ Vol. 29; no. 2; pp. 140 - 146 |
|---|---|
| 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.29.140 |
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| Abstract | 目的：IgG4関連疾患にはステロイドが有効だがエビデンスが無かったため，多施設共同前方視的治療研究にて検証した． 方法：12施設より症例登録を受け，初発IgG4関連疾患包括診断基準確診例を対象とした．中等量ステロイドprednisolone 0.6mg/kg/日を初期投与量とし，２週間毎に10%漸減，その後は各主治医判断で症状や臨床データの推移から維持量を決定した．１年後の完全寛解率を主要評価項目とし，副次評価項目としてはステロイド維持量，再発再燃率，有害事象を観察した． 結果：５年間で57例の登録予定であったが，４年間で61例の登録あり終了．臨床病理中央診断の結果，確診群は44例，準確診１例，疑診13例，否定３例であった．３例の脱落例を認めた．確診群では完全寛解29例（65.9%），全奏功率93.2%で，脱落以外の全例にステロイドが奏功した．維持投与量中央値は７mg/dayで，維持投与量中に６例（14.6%）の再増悪を認めステロイド再増量又はその他の薬剤の追加投与を要した．主な有害事象は耐糖能異常（41%）であった． 結論：IgG4関連疾患の診断が確実であれば，初期のステロイドは有効である．ステロイド治療抵抗例に対する二次治療として，欧米ではrituximabが汎用されているが，ステロイド治療抵抗例には誤診例が多いため，画像検査や病理再生検など再評価が必要である． |
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| AbstractList | “Objective” Although glucocorticoids are effective for patients with IgG4-related disease, the treatment has not yet been standardized. Therefore, the treatment strategy should be established. “Patients and methods” Patients who fulfilled the comprehensive diagnostic criteria for definite IgG4-related disease were started on prednisolone (0.6mg/kg body weight) with the dose reduced every 2 weeks. The subsequent maintenance dose and need for prednisolone were determined for individual patients. The primary endpoint was the complete remission (CR) rate at 1 year. Secondary endpoints included overall response rate (ORR), the maintenance dose, the relapse rate and adverse events. “Results” This study enrolled 61 patients. After clinicopathological review, three patients were excluded, and one, 13, and 44 patients were diagnosed with probable, possible, and definite IgG4-related disease, respectively. Of the 44 patients with definite IgG4-related disease, 29 (65.9%) achieved CR, and the ORR was 93.2%. No patient was refractory to primary treatment. The most frequent adverse events were glucose intolerance. Six patients relapsed. “Conclusions” Glucocorticoid treatment is usually effective for patients with IgG4-related disease, and we should examine the possibility of other disorders when a patient is glucocorticoid refractory. Some patients are misdiagnosed, making central clinicopathological review of diagnosis very important in conducting clinical studies. Strict classification criteria will be necessary for conducting clinical study.
目的：IgG4関連疾患にはステロイドが有効だがエビデンスが無かったため，多施設共同前方視的治療研究にて検証した．方法：12施設より症例登録を受け，初発IgG4関連疾患包括診断基準確診例を対象とした．中等量ステロイドprednisolone 0.6mg/kg/日を初期投与量とし，２週間毎に10%漸減，その後は各主治医判断で症状や臨床データの推移から維持量を決定した．１年後の完全寛解率を主要評価項目とし，副次評価項目としてはステロイド維持量，再発再燃率，有害事象を観察した．結果：５年間で57例の登録予定であったが，４年間で61例の登録あり終了．臨床病理中央診断の結果，確診群は44例，準確診１例，疑診13例，否定３例であった．３例の脱落例を認めた．確診群では完全寛解29例（65.9%），全奏功率93.2%で，脱落以外の全例にステロイドが奏功した．維持投与量中央値は７mg/dayで，維持投与量中に６例（14.6%）の再増悪を認めステロイド再増量又はその他の薬剤の追加投与を要した．主な有害事象は耐糖能異常（41%）であった．結論：IgG4関連疾患の診断が確実であれば，初期のステロイドは有効である．ステロイド治療抵抗例に対する二次治療として，欧米ではrituximabが汎用されているが，ステロイド治療抵抗例には誤診例が多いため，画像検査や病理再生検など再評価が必要である． 目的：IgG4関連疾患にはステロイドが有効だがエビデンスが無かったため，多施設共同前方視的治療研究にて検証した． 方法：12施設より症例登録を受け，初発IgG4関連疾患包括診断基準確診例を対象とした．中等量ステロイドprednisolone 0.6mg/kg/日を初期投与量とし，２週間毎に10%漸減，その後は各主治医判断で症状や臨床データの推移から維持量を決定した．１年後の完全寛解率を主要評価項目とし，副次評価項目としてはステロイド維持量，再発再燃率，有害事象を観察した． 結果：５年間で57例の登録予定であったが，４年間で61例の登録あり終了．臨床病理中央診断の結果，確診群は44例，準確診１例，疑診13例，否定３例であった．３例の脱落例を認めた．確診群では完全寛解29例（65.9%），全奏功率93.2%で，脱落以外の全例にステロイドが奏功した．維持投与量中央値は７mg/dayで，維持投与量中に６例（14.6%）の再増悪を認めステロイド再増量又はその他の薬剤の追加投与を要した．主な有害事象は耐糖能異常（41%）であった． 結論：IgG4関連疾患の診断が確実であれば，初期のステロイドは有効である．ステロイド治療抵抗例に対する二次治療として，欧米ではrituximabが汎用されているが，ステロイド治療抵抗例には誤診例が多いため，画像検査や病理再生検など再評価が必要である． |
| Author | 坂井, 知之 藤本, 信乃 川端, 浩 河南, 崇典 正木, 康史 藤田, 義正 河南（岩男）, 悠 福島, 俊洋 |
| Author_FL | Kawanami (Iwao) Haruka Fukushima Toshihiro Fujita Yoshimasa Kawanami Takafumi Kawabata Hiroshi Sakai Tomoyuki Fujimoto Shino Masaki Yasufumi |
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| References | 11) Masaki Y, Shimizu H, Nakamura TS, et al; IgG4-related disease: Diagnostic methods and therapeutic strategies in Japan. J Clin Exp Hematop, 54:95-101, 2014. 7) Deshpande V, Zen Y, Chan JKC, et al: Consensus Statement on the Pathology of IgG4-Related Disease. Mod Pathol, 25: 1181-1192, 2012. 13) Khosroshahi A, Stone JH: Treatment approaches to IgG4-related systemic disease.Curr Opin Rheumatol, 23:67-71, 2011. 14) Topazian M, Witzig TE, Smyrk TC, et al: Rituximab therapy for refractory biliary strictures in immunoglobulin G4-associated cholangitis. Clin Gastroenterol Hepatol, 6:364-366, 2008. 16) Carruthers MN, Topazian MD, Khosroshahi A, et al: Rituximab for IgG4-related disease: a prospective, open-label trial. Ann Rheum Dis, 74:1171-1177, 2015. 17) Carruthers MN, Stone JH, Deshpande V, et al: Development of an IgG4-RD responder index. Int J Rheumatol, 2012: 259408. doi: 10.1155/2012/259408. Epub 2012 Apr 24, 2012. 5) Kawano M, Saeki T, Nakashima H, et al: Proposal for diagnostic criteria for IgG4-related kidney disease. Clin Exp Nephrol, 15:615-626, 2011. 10) Masaki Y, Kurose N, Umehara H: IgG4-related disease: a novel lymphoproliferative disorder discovered and established in Japan in the 21st century.J Clin Exp Hematop, 51:13-20, 2011. 4) Masaki Y, Sugai S, Umehara H: IgG4-related diseases including Mikulicz's disease and sclerosing pancreatitis: diagnostic insights. J Rheumatol, 37:1380-1385, 2010. 9) Masaki Y, Iwao H, Nakajima A, et al: IgG4-related disease (IgG4+MOLPS) – diagnostic criteria and diagnostic problems. Current Immunol Rev, 7:172-177, 2011. 2) 厚生労働省難治性疾患克服研究事業奨励研究分野 IgG4関連全身性硬化性疾患の診断法の確立と治療研究の開発に関する研究班/新規疾患，IgG4関連多臓器リンパ増殖性疾患（IgG4 + MOLPS）の確立のための研究班：IgG4関連疾患包括診断基準2011．日内会誌，101:795-804, 2012 3) Okazaki K, Kawa S, Kamisawa T, et al: Research committee for intractable pancreatic disease and Japan pancreas society. Japanese consensus guidelines for management of autoimmune pancreatitis: I. Concept and diagnosis of autoimmune pancreatitis. J Gastroenterol, 45:249-265, 2010. 12) Khosroshahi A, Bloch DB, Deshpande V, et al: Rituximab therapy leads to rapid decline of serum IgG4 level and prompt clinical improvement in IgG4-related systemic disease. Arthritis Rheum, 62:1755-1762, 2010. 19) Masamune A, Nishimori I, Kikuta K, et al. Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis. Gut, 66:487-494, 2017. 1) Umehara H, Okazaki K, Masaki Y, et al: Comprehensive diagnostic criteria (CDC) for IgG4-related disease (IgG4RD), 2011. Mod Rheumatol, 22:21-30, 2012. 6) Ohara H, Okazaki K, Tsubouchi H, et al: Research committee of IgG4-related diseases; Research committee of intractable diseases of liver and biliary tract; Ministry of health, labor and welfare, Japan; Japan biliary association. Clinical diagnostic criteria of IgG4-related sclerosing cholangitis 2012. J Hepatobiliary Pancreat Sci, 19:536-542, 2012. 8) Masaki Y, Dong L, Kurose N, et al: Proposal for a new clinical entity, IgG4-positive multi-organ lymphoproliferative syndrome: Analysis of 64 cases of IgG4-related disorders. Ann Rheum Dis, 68:1310-1315, 2009. 15) Khosroshahi A, Carruthers MN, Deshpande V, et al: Rituximab for the treatment of IgG4-related disease: lessons from 10 consective patients. Medicine (Baltimore), 91:57-66, 2012. 18) Masaki Y, Matsui S, Saeki T, et al: A multicenter phase II prospective clinical trial of glucocorticoid for patients with untreated IgG4-related disease. Mod Rheumatol, 15:1-6, 2016. |
| References_xml | – reference: 12) Khosroshahi A, Bloch DB, Deshpande V, et al: Rituximab therapy leads to rapid decline of serum IgG4 level and prompt clinical improvement in IgG4-related systemic disease. Arthritis Rheum, 62:1755-1762, 2010. – reference: 15) Khosroshahi A, Carruthers MN, Deshpande V, et al: Rituximab for the treatment of IgG4-related disease: lessons from 10 consective patients. Medicine (Baltimore), 91:57-66, 2012. – reference: 18) Masaki Y, Matsui S, Saeki T, et al: A multicenter phase II prospective clinical trial of glucocorticoid for patients with untreated IgG4-related disease. Mod Rheumatol, 15:1-6, 2016. – reference: 10) Masaki Y, Kurose N, Umehara H: IgG4-related disease: a novel lymphoproliferative disorder discovered and established in Japan in the 21st century.J Clin Exp Hematop, 51:13-20, 2011. – reference: 17) Carruthers MN, Stone JH, Deshpande V, et al: Development of an IgG4-RD responder index. Int J Rheumatol, 2012: 259408. doi: 10.1155/2012/259408. Epub 2012 Apr 24, 2012. – reference: 7) Deshpande V, Zen Y, Chan JKC, et al: Consensus Statement on the Pathology of IgG4-Related Disease. Mod Pathol, 25: 1181-1192, 2012. – reference: 9) Masaki Y, Iwao H, Nakajima A, et al: IgG4-related disease (IgG4+MOLPS) – diagnostic criteria and diagnostic problems. Current Immunol Rev, 7:172-177, 2011. – reference: 1) Umehara H, Okazaki K, Masaki Y, et al: Comprehensive diagnostic criteria (CDC) for IgG4-related disease (IgG4RD), 2011. Mod Rheumatol, 22:21-30, 2012. – reference: 16) Carruthers MN, Topazian MD, Khosroshahi A, et al: Rituximab for IgG4-related disease: a prospective, open-label trial. Ann Rheum Dis, 74:1171-1177, 2015. – reference: 14) Topazian M, Witzig TE, Smyrk TC, et al: Rituximab therapy for refractory biliary strictures in immunoglobulin G4-associated cholangitis. Clin Gastroenterol Hepatol, 6:364-366, 2008. – reference: 6) Ohara H, Okazaki K, Tsubouchi H, et al: Research committee of IgG4-related diseases; Research committee of intractable diseases of liver and biliary tract; Ministry of health, labor and welfare, Japan; Japan biliary association. Clinical diagnostic criteria of IgG4-related sclerosing cholangitis 2012. J Hepatobiliary Pancreat Sci, 19:536-542, 2012. – reference: 13) Khosroshahi A, Stone JH: Treatment approaches to IgG4-related systemic disease.Curr Opin Rheumatol, 23:67-71, 2011. – reference: 8) Masaki Y, Dong L, Kurose N, et al: Proposal for a new clinical entity, IgG4-positive multi-organ lymphoproliferative syndrome: Analysis of 64 cases of IgG4-related disorders. Ann Rheum Dis, 68:1310-1315, 2009. – reference: 5) Kawano M, Saeki T, Nakashima H, et al: Proposal for diagnostic criteria for IgG4-related kidney disease. Clin Exp Nephrol, 15:615-626, 2011. – reference: 2) 厚生労働省難治性疾患克服研究事業奨励研究分野 IgG4関連全身性硬化性疾患の診断法の確立と治療研究の開発に関する研究班/新規疾患，IgG4関連多臓器リンパ増殖性疾患（IgG4 + MOLPS）の確立のための研究班：IgG4関連疾患包括診断基準2011．日内会誌，101:795-804, 2012． – reference: 3) Okazaki K, Kawa S, Kamisawa T, et al: Research committee for intractable pancreatic disease and Japan pancreas society. Japanese consensus guidelines for management of autoimmune pancreatitis: I. Concept and diagnosis of autoimmune pancreatitis. J Gastroenterol, 45:249-265, 2010. – reference: 19) Masamune A, Nishimori I, Kikuta K, et al. Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis. Gut, 66:487-494, 2017. – reference: 11) Masaki Y, Shimizu H, Nakamura TS, et al; IgG4-related disease: Diagnostic methods and therapeutic strategies in Japan. J Clin Exp Hematop, 54:95-101, 2014. – reference: 4) Masaki Y, Sugai S, Umehara H: IgG4-related diseases including Mikulicz's disease and sclerosing pancreatitis: diagnostic insights. J Rheumatol, 37:1380-1385, 2010. |
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| Snippet | 目的：IgG4関連疾患にはステロイドが有効だがエビデンスが無かったため，多施設共同前方視的治療研究にて検証した． 方法：12施設より症例登録を受け，初発IgG4関連疾患包括診断基準確診例を対象とした．中等量ステロイドprednisolone... “Objective” Although glucocorticoids are effective for patients with IgG4-related disease, the treatment has not yet been standardized. Therefore, the... |
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| Title | IgG4関連疾患に対する治療：前方視的臨床研究を中心に |
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| ispartofPNX | 臨床リウマチ, 2017/06/30, Vol.29(2), pp.140-146 |
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