Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis
ObjectiveCorticosteroid has been established as the standard therapy for autoimmune pancreatitis (AIP), but the requirement for maintenance corticosteroid therapy is controversial. We conducted a randomised controlled trial to clarify the efficacy of maintenance corticosteroid therapy in patients wi...
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| Veröffentlicht in: | Gut 2017-03, Vol.66 (3), p.487-494 |
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| creator | Masamune, Atsushi Nishimori, Isao Kikuta, Kazuhiro Tsuji, Ichiro Mizuno, Nobumasa Iiyama, Tatsuo Kanno, Atsushi Tachibana, Yuichi Ito, Tetsuhide Kamisawa, Terumi Uchida, Kazushige Hamano, Hideaki Yasuda, Hiroaki Sakagami, Junichi Mitoro, Akira Taguchi, Masashi Kihara, Yasuyuki Sugimoto, Hiroyuki Hirooka, Yoshiki Yamamoto, Satoshi Inui, Kazuo Inatomi, Osamu Andoh, Akira Nakahara, Kazuyuki Miyakawa, Hiroyuki Hamada, Shin Kawa, Shigeyuki Okazaki, Kazuichi Shimosegawa, Tooru |
| description | ObjectiveCorticosteroid has been established as the standard therapy for autoimmune pancreatitis (AIP), but the requirement for maintenance corticosteroid therapy is controversial. We conducted a randomised controlled trial to clarify the efficacy of maintenance corticosteroid therapy in patients with AIP.DesignWe conducted a multicentre, tertiary setting, randomised controlled trial. After the induction of remission with the initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5–7.5 mg/day was continued for 3 years or withdrawn at 26 weeks. The primary endpoint was relapse-free survival over 3 years and the secondary endpoint was serious corticosteroid-related complications. All analyses were performed on an intention-to-treat basis.ResultsBetween April 2009 and March 2012, 49 patients with AIP were randomly assigned to the maintenance therapy group (n=30) or the cessation group (n=19). Baseline characteristics were not different between the two groups. Relapses occurred within 3 years in 11 out of 19 (57.9%) patients assigned to the cessation group, and in 7 of 30 (23.3%) patients in the maintenance therapy group. The relapse rate over 3 years was significantly lower in the maintenance therapy group than that in the cessation group (p=0.011). The relapse-free survival was significantly longer in the maintenance therapy group than that in the cessation group (p=0.007). No serious corticosteroid-related complications requiring discontinuation of PSL were observed.ConclusionsMaintenance corticosteroid therapy for 3 years may decrease relapses in patients with AIP compared with those who discontinued the therapy at 26 weeks.Trial registration numberUMIN000001818; Results. |
| doi_str_mv | 10.1136/gutjnl-2016-312049 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1872841388</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1859728638</sourcerecordid><originalsourceid>FETCH-LOGICAL-b353t-ad28b71c35e21026ec4edb6d98a04df9cb6b1c0dd9b01323a2c53e5e144add3f3</originalsourceid><addsrcrecordid>eNqNkcFq3TAQRUVJaV7S_kAXxZBNN2oljWxLyxDSphAIhHZtZGmc6GFLL5JMyd9XD6dddJXVDNwzF4ZDyEfOvnAO3deHtezDTAXjHQUumNRvyI7LTlEQSp2QHWO8p20v9Sk5y3nPGFNK83fkVPStBAlsR8q9CS4uPqNrbAwlxXmua0nezE2cmjmGB1owLc1ifCgYTLBYyVS8jbkG0Vf6EZM5PDc-NAdTPIaSm9--PDZmLdEvyxqwBsEmrGnx-T15O5k544eXeU5-fbv-eXVDb---_7i6vKUjtFCocUKNPbfQouBMdGglurFzWhkm3aTt2I3cMuf0yDgIMMK2gC1yKY1zMME5-bz1HlJ8WjGXoT5qcZ5NwLjmgateKMlBqVegra5wB0f04j90H9cU6iPHQgBQGnSlxEbZFHNOOA2H5BeTngfOhqO-YdM3HPUNm7569Omleh0XdP9O_vqqAN2Acdm_pvAPNx2oZQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1873338939</pqid></control><display><type>article</type><title>Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis</title><source>MEDLINE</source><source>PubMed Central</source><creator>Masamune, Atsushi ; Nishimori, Isao ; Kikuta, Kazuhiro ; Tsuji, Ichiro ; Mizuno, Nobumasa ; Iiyama, Tatsuo ; Kanno, Atsushi ; Tachibana, Yuichi ; Ito, Tetsuhide ; Kamisawa, Terumi ; Uchida, Kazushige ; Hamano, Hideaki ; Yasuda, Hiroaki ; Sakagami, Junichi ; Mitoro, Akira ; Taguchi, Masashi ; Kihara, Yasuyuki ; Sugimoto, Hiroyuki ; Hirooka, Yoshiki ; Yamamoto, Satoshi ; Inui, Kazuo ; Inatomi, Osamu ; Andoh, Akira ; Nakahara, Kazuyuki ; Miyakawa, Hiroyuki ; Hamada, Shin ; Kawa, Shigeyuki ; Okazaki, Kazuichi ; Shimosegawa, Tooru</creator><creatorcontrib>Masamune, Atsushi ; Nishimori, Isao ; Kikuta, Kazuhiro ; Tsuji, Ichiro ; Mizuno, Nobumasa ; Iiyama, Tatsuo ; Kanno, Atsushi ; Tachibana, Yuichi ; Ito, Tetsuhide ; Kamisawa, Terumi ; Uchida, Kazushige ; Hamano, Hideaki ; Yasuda, Hiroaki ; Sakagami, Junichi ; Mitoro, Akira ; Taguchi, Masashi ; Kihara, Yasuyuki ; Sugimoto, Hiroyuki ; Hirooka, Yoshiki ; Yamamoto, Satoshi ; Inui, Kazuo ; Inatomi, Osamu ; Andoh, Akira ; Nakahara, Kazuyuki ; Miyakawa, Hiroyuki ; Hamada, Shin ; Kawa, Shigeyuki ; Okazaki, Kazuichi ; Shimosegawa, Tooru ; Research Committee of Intractable Pancreas Diseases in Japan</creatorcontrib><description>ObjectiveCorticosteroid has been established as the standard therapy for autoimmune pancreatitis (AIP), but the requirement for maintenance corticosteroid therapy is controversial. We conducted a randomised controlled trial to clarify the efficacy of maintenance corticosteroid therapy in patients with AIP.DesignWe conducted a multicentre, tertiary setting, randomised controlled trial. After the induction of remission with the initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5–7.5 mg/day was continued for 3 years or withdrawn at 26 weeks. The primary endpoint was relapse-free survival over 3 years and the secondary endpoint was serious corticosteroid-related complications. All analyses were performed on an intention-to-treat basis.ResultsBetween April 2009 and March 2012, 49 patients with AIP were randomly assigned to the maintenance therapy group (n=30) or the cessation group (n=19). Baseline characteristics were not different between the two groups. Relapses occurred within 3 years in 11 out of 19 (57.9%) patients assigned to the cessation group, and in 7 of 30 (23.3%) patients in the maintenance therapy group. The relapse rate over 3 years was significantly lower in the maintenance therapy group than that in the cessation group (p=0.011). The relapse-free survival was significantly longer in the maintenance therapy group than that in the cessation group (p=0.007). No serious corticosteroid-related complications requiring discontinuation of PSL were observed.ConclusionsMaintenance corticosteroid therapy for 3 years may decrease relapses in patients with AIP compared with those who discontinued the therapy at 26 weeks.Trial registration numberUMIN000001818; Results.</description><identifier>ISSN: 0017-5749</identifier><identifier>EISSN: 1468-3288</identifier><identifier>DOI: 10.1136/gutjnl-2016-312049</identifier><identifier>PMID: 27543430</identifier><identifier>CODEN: GUTTAK</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Aged ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - adverse effects ; Autoimmune Diseases - drug therapy ; Disease ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Maintenance Chemotherapy ; Male ; Middle Aged ; Pancreatic cancer ; Pancreatitis - drug therapy ; Patients ; Prednisolone - administration & dosage ; Prednisolone - adverse effects ; Recurrence ; Studies ; Time Factors ; Withholding Treatment</subject><ispartof>Gut, 2017-03, Vol.66 (3), p.487-494</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.</rights><rights>Copyright: 2016 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-b353t-ad28b71c35e21026ec4edb6d98a04df9cb6b1c0dd9b01323a2c53e5e144add3f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27543430$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Masamune, Atsushi</creatorcontrib><creatorcontrib>Nishimori, Isao</creatorcontrib><creatorcontrib>Kikuta, Kazuhiro</creatorcontrib><creatorcontrib>Tsuji, Ichiro</creatorcontrib><creatorcontrib>Mizuno, Nobumasa</creatorcontrib><creatorcontrib>Iiyama, Tatsuo</creatorcontrib><creatorcontrib>Kanno, Atsushi</creatorcontrib><creatorcontrib>Tachibana, Yuichi</creatorcontrib><creatorcontrib>Ito, Tetsuhide</creatorcontrib><creatorcontrib>Kamisawa, Terumi</creatorcontrib><creatorcontrib>Uchida, Kazushige</creatorcontrib><creatorcontrib>Hamano, Hideaki</creatorcontrib><creatorcontrib>Yasuda, Hiroaki</creatorcontrib><creatorcontrib>Sakagami, Junichi</creatorcontrib><creatorcontrib>Mitoro, Akira</creatorcontrib><creatorcontrib>Taguchi, Masashi</creatorcontrib><creatorcontrib>Kihara, Yasuyuki</creatorcontrib><creatorcontrib>Sugimoto, Hiroyuki</creatorcontrib><creatorcontrib>Hirooka, Yoshiki</creatorcontrib><creatorcontrib>Yamamoto, Satoshi</creatorcontrib><creatorcontrib>Inui, Kazuo</creatorcontrib><creatorcontrib>Inatomi, Osamu</creatorcontrib><creatorcontrib>Andoh, Akira</creatorcontrib><creatorcontrib>Nakahara, Kazuyuki</creatorcontrib><creatorcontrib>Miyakawa, Hiroyuki</creatorcontrib><creatorcontrib>Hamada, Shin</creatorcontrib><creatorcontrib>Kawa, Shigeyuki</creatorcontrib><creatorcontrib>Okazaki, Kazuichi</creatorcontrib><creatorcontrib>Shimosegawa, Tooru</creatorcontrib><creatorcontrib>Research Committee of Intractable Pancreas Diseases in Japan</creatorcontrib><title>Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis</title><title>Gut</title><addtitle>Gut</addtitle><description>ObjectiveCorticosteroid has been established as the standard therapy for autoimmune pancreatitis (AIP), but the requirement for maintenance corticosteroid therapy is controversial. We conducted a randomised controlled trial to clarify the efficacy of maintenance corticosteroid therapy in patients with AIP.DesignWe conducted a multicentre, tertiary setting, randomised controlled trial. After the induction of remission with the initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5–7.5 mg/day was continued for 3 years or withdrawn at 26 weeks. The primary endpoint was relapse-free survival over 3 years and the secondary endpoint was serious corticosteroid-related complications. All analyses were performed on an intention-to-treat basis.ResultsBetween April 2009 and March 2012, 49 patients with AIP were randomly assigned to the maintenance therapy group (n=30) or the cessation group (n=19). Baseline characteristics were not different between the two groups. Relapses occurred within 3 years in 11 out of 19 (57.9%) patients assigned to the cessation group, and in 7 of 30 (23.3%) patients in the maintenance therapy group. The relapse rate over 3 years was significantly lower in the maintenance therapy group than that in the cessation group (p=0.011). The relapse-free survival was significantly longer in the maintenance therapy group than that in the cessation group (p=0.007). No serious corticosteroid-related complications requiring discontinuation of PSL were observed.ConclusionsMaintenance corticosteroid therapy for 3 years may decrease relapses in patients with AIP compared with those who discontinued the therapy at 26 weeks.Trial registration numberUMIN000001818; Results.</description><subject>Aged</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - adverse effects</subject><subject>Autoimmune Diseases - drug therapy</subject><subject>Disease</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Maintenance Chemotherapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pancreatic cancer</subject><subject>Pancreatitis - drug therapy</subject><subject>Patients</subject><subject>Prednisolone - administration & dosage</subject><subject>Prednisolone - adverse effects</subject><subject>Recurrence</subject><subject>Studies</subject><subject>Time Factors</subject><subject>Withholding Treatment</subject><issn>0017-5749</issn><issn>1468-3288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkcFq3TAQRUVJaV7S_kAXxZBNN2oljWxLyxDSphAIhHZtZGmc6GFLL5JMyd9XD6dddJXVDNwzF4ZDyEfOvnAO3deHtezDTAXjHQUumNRvyI7LTlEQSp2QHWO8p20v9Sk5y3nPGFNK83fkVPStBAlsR8q9CS4uPqNrbAwlxXmua0nezE2cmjmGB1owLc1ifCgYTLBYyVS8jbkG0Vf6EZM5PDc-NAdTPIaSm9--PDZmLdEvyxqwBsEmrGnx-T15O5k544eXeU5-fbv-eXVDb---_7i6vKUjtFCocUKNPbfQouBMdGglurFzWhkm3aTt2I3cMuf0yDgIMMK2gC1yKY1zMME5-bz1HlJ8WjGXoT5qcZ5NwLjmgateKMlBqVegra5wB0f04j90H9cU6iPHQgBQGnSlxEbZFHNOOA2H5BeTngfOhqO-YdM3HPUNm7569Omleh0XdP9O_vqqAN2Acdm_pvAPNx2oZQ</recordid><startdate>20170301</startdate><enddate>20170301</enddate><creator>Masamune, Atsushi</creator><creator>Nishimori, Isao</creator><creator>Kikuta, Kazuhiro</creator><creator>Tsuji, Ichiro</creator><creator>Mizuno, Nobumasa</creator><creator>Iiyama, Tatsuo</creator><creator>Kanno, Atsushi</creator><creator>Tachibana, Yuichi</creator><creator>Ito, Tetsuhide</creator><creator>Kamisawa, Terumi</creator><creator>Uchida, Kazushige</creator><creator>Hamano, Hideaki</creator><creator>Yasuda, Hiroaki</creator><creator>Sakagami, Junichi</creator><creator>Mitoro, Akira</creator><creator>Taguchi, Masashi</creator><creator>Kihara, Yasuyuki</creator><creator>Sugimoto, Hiroyuki</creator><creator>Hirooka, Yoshiki</creator><creator>Yamamoto, Satoshi</creator><creator>Inui, Kazuo</creator><creator>Inatomi, Osamu</creator><creator>Andoh, Akira</creator><creator>Nakahara, Kazuyuki</creator><creator>Miyakawa, Hiroyuki</creator><creator>Hamada, Shin</creator><creator>Kawa, Shigeyuki</creator><creator>Okazaki, Kazuichi</creator><creator>Shimosegawa, Tooru</creator><general>BMJ Publishing Group LTD</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20170301</creationdate><title>Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis</title><author>Masamune, Atsushi ; Nishimori, Isao ; Kikuta, Kazuhiro ; Tsuji, Ichiro ; Mizuno, Nobumasa ; Iiyama, Tatsuo ; Kanno, Atsushi ; Tachibana, Yuichi ; Ito, Tetsuhide ; Kamisawa, Terumi ; Uchida, Kazushige ; Hamano, Hideaki ; Yasuda, Hiroaki ; Sakagami, Junichi ; Mitoro, Akira ; Taguchi, Masashi ; Kihara, Yasuyuki ; Sugimoto, Hiroyuki ; Hirooka, Yoshiki ; Yamamoto, Satoshi ; Inui, Kazuo ; Inatomi, Osamu ; Andoh, Akira ; Nakahara, Kazuyuki ; Miyakawa, Hiroyuki ; Hamada, Shin ; Kawa, Shigeyuki ; Okazaki, Kazuichi ; Shimosegawa, Tooru</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b353t-ad28b71c35e21026ec4edb6d98a04df9cb6b1c0dd9b01323a2c53e5e144add3f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Aged</topic><topic>Anti-Inflammatory Agents - administration & dosage</topic><topic>Anti-Inflammatory Agents - adverse effects</topic><topic>Autoimmune Diseases - drug therapy</topic><topic>Disease</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Maintenance Chemotherapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pancreatic cancer</topic><topic>Pancreatitis - drug therapy</topic><topic>Patients</topic><topic>Prednisolone - administration & dosage</topic><topic>Prednisolone - adverse effects</topic><topic>Recurrence</topic><topic>Studies</topic><topic>Time Factors</topic><topic>Withholding Treatment</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Masamune, Atsushi</creatorcontrib><creatorcontrib>Nishimori, Isao</creatorcontrib><creatorcontrib>Kikuta, Kazuhiro</creatorcontrib><creatorcontrib>Tsuji, Ichiro</creatorcontrib><creatorcontrib>Mizuno, Nobumasa</creatorcontrib><creatorcontrib>Iiyama, Tatsuo</creatorcontrib><creatorcontrib>Kanno, Atsushi</creatorcontrib><creatorcontrib>Tachibana, Yuichi</creatorcontrib><creatorcontrib>Ito, Tetsuhide</creatorcontrib><creatorcontrib>Kamisawa, Terumi</creatorcontrib><creatorcontrib>Uchida, Kazushige</creatorcontrib><creatorcontrib>Hamano, Hideaki</creatorcontrib><creatorcontrib>Yasuda, Hiroaki</creatorcontrib><creatorcontrib>Sakagami, Junichi</creatorcontrib><creatorcontrib>Mitoro, Akira</creatorcontrib><creatorcontrib>Taguchi, Masashi</creatorcontrib><creatorcontrib>Kihara, Yasuyuki</creatorcontrib><creatorcontrib>Sugimoto, Hiroyuki</creatorcontrib><creatorcontrib>Hirooka, Yoshiki</creatorcontrib><creatorcontrib>Yamamoto, Satoshi</creatorcontrib><creatorcontrib>Inui, Kazuo</creatorcontrib><creatorcontrib>Inatomi, Osamu</creatorcontrib><creatorcontrib>Andoh, Akira</creatorcontrib><creatorcontrib>Nakahara, Kazuyuki</creatorcontrib><creatorcontrib>Miyakawa, Hiroyuki</creatorcontrib><creatorcontrib>Hamada, Shin</creatorcontrib><creatorcontrib>Kawa, Shigeyuki</creatorcontrib><creatorcontrib>Okazaki, Kazuichi</creatorcontrib><creatorcontrib>Shimosegawa, Tooru</creatorcontrib><creatorcontrib>Research Committee of Intractable Pancreas Diseases in Japan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest_Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>ProQuest Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biological Sciences</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest Science Journals</collection><collection>Biological Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Gut</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Masamune, Atsushi</au><au>Nishimori, Isao</au><au>Kikuta, Kazuhiro</au><au>Tsuji, Ichiro</au><au>Mizuno, Nobumasa</au><au>Iiyama, Tatsuo</au><au>Kanno, Atsushi</au><au>Tachibana, Yuichi</au><au>Ito, Tetsuhide</au><au>Kamisawa, Terumi</au><au>Uchida, Kazushige</au><au>Hamano, Hideaki</au><au>Yasuda, Hiroaki</au><au>Sakagami, Junichi</au><au>Mitoro, Akira</au><au>Taguchi, Masashi</au><au>Kihara, Yasuyuki</au><au>Sugimoto, Hiroyuki</au><au>Hirooka, Yoshiki</au><au>Yamamoto, Satoshi</au><au>Inui, Kazuo</au><au>Inatomi, Osamu</au><au>Andoh, Akira</au><au>Nakahara, Kazuyuki</au><au>Miyakawa, Hiroyuki</au><au>Hamada, Shin</au><au>Kawa, Shigeyuki</au><au>Okazaki, Kazuichi</au><au>Shimosegawa, Tooru</au><aucorp>Research Committee of Intractable Pancreas Diseases in Japan</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis</atitle><jtitle>Gut</jtitle><addtitle>Gut</addtitle><date>2017-03-01</date><risdate>2017</risdate><volume>66</volume><issue>3</issue><spage>487</spage><epage>494</epage><pages>487-494</pages><issn>0017-5749</issn><eissn>1468-3288</eissn><coden>GUTTAK</coden><abstract>ObjectiveCorticosteroid has been established as the standard therapy for autoimmune pancreatitis (AIP), but the requirement for maintenance corticosteroid therapy is controversial. We conducted a randomised controlled trial to clarify the efficacy of maintenance corticosteroid therapy in patients with AIP.DesignWe conducted a multicentre, tertiary setting, randomised controlled trial. After the induction of remission with the initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5–7.5 mg/day was continued for 3 years or withdrawn at 26 weeks. The primary endpoint was relapse-free survival over 3 years and the secondary endpoint was serious corticosteroid-related complications. All analyses were performed on an intention-to-treat basis.ResultsBetween April 2009 and March 2012, 49 patients with AIP were randomly assigned to the maintenance therapy group (n=30) or the cessation group (n=19). Baseline characteristics were not different between the two groups. Relapses occurred within 3 years in 11 out of 19 (57.9%) patients assigned to the cessation group, and in 7 of 30 (23.3%) patients in the maintenance therapy group. The relapse rate over 3 years was significantly lower in the maintenance therapy group than that in the cessation group (p=0.011). The relapse-free survival was significantly longer in the maintenance therapy group than that in the cessation group (p=0.007). No serious corticosteroid-related complications requiring discontinuation of PSL were observed.ConclusionsMaintenance corticosteroid therapy for 3 years may decrease relapses in patients with AIP compared with those who discontinued the therapy at 26 weeks.Trial registration numberUMIN000001818; Results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>27543430</pmid><doi>10.1136/gutjnl-2016-312049</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0017-5749 |
| ispartof | Gut, 2017-03, Vol.66 (3), p.487-494 |
| issn | 0017-5749 1468-3288 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1872841388 |
| source | MEDLINE; PubMed Central |
| subjects | Aged Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - adverse effects Autoimmune Diseases - drug therapy Disease Disease-Free Survival Female Follow-Up Studies Humans Maintenance Chemotherapy Male Middle Aged Pancreatic cancer Pancreatitis - drug therapy Patients Prednisolone - administration & dosage Prednisolone - adverse effects Recurrence Studies Time Factors Withholding Treatment |
| title | Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-12T02%3A10%3A16IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Randomised%20controlled%20trial%20of%20long-term%20maintenance%20corticosteroid%20therapy%20in%20patients%20with%20autoimmune%20pancreatitis&rft.jtitle=Gut&rft.au=Masamune,%20Atsushi&rft.aucorp=Research%20Committee%20of%20Intractable%20Pancreas%20Diseases%20in%20Japan&rft.date=2017-03-01&rft.volume=66&rft.issue=3&rft.spage=487&rft.epage=494&rft.pages=487-494&rft.issn=0017-5749&rft.eissn=1468-3288&rft.coden=GUTTAK&rft_id=info:doi/10.1136/gutjnl-2016-312049&rft_dat=%3Cproquest_cross%3E1859728638%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1873338939&rft_id=info:pmid/27543430&rfr_iscdi=true |