Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease
Background The endoscopic substudy of the ACCENT I (•••) Crohn's disease trial examined the effects of infliximab on mucosal inflammation and mucosal healing, and assessed their impact on outcomes. Methods This study was a randomized, double-blind, parallel group study at multiple centers in No...
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| creator | Rutgeerts, Paul, MD, PhD Diamond, Robert H., MD Bala, Mohan, PhD Olson, Allan, MD Lichtenstein, Gary, MD Bao, Weihang, PhD Patel, Kamlesh, MS Wolf, Douglas C., MD Safdi, Michael, MD Colombel, Jean Frederic, MD Lashner, Bret, MD Hanauer, Stephen B., MD |
| description | Background The endoscopic substudy of the ACCENT I (•••) Crohn's disease trial examined the effects of infliximab on mucosal inflammation and mucosal healing, and assessed their impact on outcomes. Methods This study was a randomized, double-blind, parallel group study at multiple centers in North America, Europe, and Israel. Ileocolonoscopic examinations were performed at weeks 0, 10, and 54. Complete mucosal healing was defined as the absence of all mucosal ulcerations. The end point of principal interest was the proportion of patients randomized as responders with mucosal healing at week 10. The proportion of responders who demonstrated mucosal healing at week 54 or at both weeks 10 and 54 are also summarized. Changes in Crohn's disease endoscopic index of severity (CDEIS) scores from baseline to week 10 and 54 were calculated for all patients in this substudy. Results Complete mucosal healing by week 10 occurred in significantly more week 2 responders who had received 3 doses of infliximab compared with a single dose (31% vs. 0%, p = 0.010). A significantly higher proportion of week 2 responders in the combined scheduled maintenance group had complete mucosal healing at week 54 compared with the episodic group (50% vs. 7%, p = 0.007). The results for all patients are consistent with those for week 2 responders only. Significantly greater improvement in the CDEIS occurred with scheduled maintenance compared with episodic treatment at week 10 ( p ≤ 0.001) and week 54 ( p = 0.026). Notably, no strong relationship between clinical remission and complete mucosal healing was found. Overall, mucosal healing appeared to correlate with fewer hospitalizations, although these results were not statistically significant. Conclusions Scheduled infliximab maintenance therapy resulted in more improvement in mucosal ulceration and in higher rates of mucosal healing. There was a numerical trend for patients with better mucosal healing to have a lower rate of Crohn's disease-related hospitalizations. |
| doi_str_mv | 10.1016/j.gie.2005.08.011 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_67690134</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0016510705026489</els_id><sourcerecordid>67690134</sourcerecordid><originalsourceid>FETCH-LOGICAL-c436t-99e7833cc0a37f49468315c9f7b9af3ebd1f0e7aa66ee09c9c766f4419a6a2163</originalsourceid><addsrcrecordid>eNp9kk9vEzEQxVcIREPhA3BBvgCnhPF6114LqRKKyh-pEofC2XK848Zhdx08Xmg_CV8Xh0Qq4sDJh_m9edZ7U1XPOaw4cPlmt7oJuKoB2hV0K-D8QbXgoNVSKqUfVgso0LLloM6qJ0Q7AOhqwR9XZ1y2AELXi-rXtdtiPw_Ys9GGKeNkJ4csJ7R5xCmznyFvWZj8EG7DaDcsEKN5jynExHJkuA8U--D-UvjDZItsi3YI0w2Lno2zi2QHNg8Ok80hTswSRRdsLsZ_LNYpbqfXxPpAaAmfVo-8HQifnd7z6uv7yy_rj8urzx8-rd9dLV0jZF5qjaoTwjmwQvlGN7ITvHXaq422XuCm5x5QWSslIminnZLSNw3XVtqaS3FevTru3af4fUbKZgzkcBjshHEmI5XUwEVTQH4EXYpECb3ZpxJIujMczKENszOlDXNow0BnShtF8-K0fN6M2N8rTvEX4OUJsOTs4FMJP9A9p1rNW94V7u2RwxLFj4DJkAtYiupDQpdNH8N_v3Hxj9qVYkIx_IZ3SLs4p6lkbLih2oC5PpzN4WqghVo2nRa_AZKuv8s</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>67690134</pqid></control><display><type>article</type><title>Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Rutgeerts, Paul, MD, PhD ; Diamond, Robert H., MD ; Bala, Mohan, PhD ; Olson, Allan, MD ; Lichtenstein, Gary, MD ; Bao, Weihang, PhD ; Patel, Kamlesh, MS ; Wolf, Douglas C., MD ; Safdi, Michael, MD ; Colombel, Jean Frederic, MD ; Lashner, Bret, MD ; Hanauer, Stephen B., MD</creator><creatorcontrib>Rutgeerts, Paul, MD, PhD ; Diamond, Robert H., MD ; Bala, Mohan, PhD ; Olson, Allan, MD ; Lichtenstein, Gary, MD ; Bao, Weihang, PhD ; Patel, Kamlesh, MS ; Wolf, Douglas C., MD ; Safdi, Michael, MD ; Colombel, Jean Frederic, MD ; Lashner, Bret, MD ; Hanauer, Stephen B., MD</creatorcontrib><description>Background The endoscopic substudy of the ACCENT I (•••) Crohn's disease trial examined the effects of infliximab on mucosal inflammation and mucosal healing, and assessed their impact on outcomes. Methods This study was a randomized, double-blind, parallel group study at multiple centers in North America, Europe, and Israel. Ileocolonoscopic examinations were performed at weeks 0, 10, and 54. Complete mucosal healing was defined as the absence of all mucosal ulcerations. The end point of principal interest was the proportion of patients randomized as responders with mucosal healing at week 10. The proportion of responders who demonstrated mucosal healing at week 54 or at both weeks 10 and 54 are also summarized. Changes in Crohn's disease endoscopic index of severity (CDEIS) scores from baseline to week 10 and 54 were calculated for all patients in this substudy. Results Complete mucosal healing by week 10 occurred in significantly more week 2 responders who had received 3 doses of infliximab compared with a single dose (31% vs. 0%, p = 0.010). A significantly higher proportion of week 2 responders in the combined scheduled maintenance group had complete mucosal healing at week 54 compared with the episodic group (50% vs. 7%, p = 0.007). The results for all patients are consistent with those for week 2 responders only. Significantly greater improvement in the CDEIS occurred with scheduled maintenance compared with episodic treatment at week 10 ( p ≤ 0.001) and week 54 ( p = 0.026). Notably, no strong relationship between clinical remission and complete mucosal healing was found. Overall, mucosal healing appeared to correlate with fewer hospitalizations, although these results were not statistically significant. Conclusions Scheduled infliximab maintenance therapy resulted in more improvement in mucosal ulceration and in higher rates of mucosal healing. There was a numerical trend for patients with better mucosal healing to have a lower rate of Crohn's disease-related hospitalizations.</description><identifier>ISSN: 0016-5107</identifier><identifier>EISSN: 1097-6779</identifier><identifier>DOI: 10.1016/j.gie.2005.08.011</identifier><identifier>PMID: 16500392</identifier><identifier>CODEN: GAENBQ</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Adult ; Antibodies, Monoclonal - administration & dosage ; Biological and medical sciences ; Colon - pathology ; Crohn Disease - complications ; Crohn Disease - pathology ; Digestive system. Abdomen ; Drug Administration Schedule ; Endoscopy ; Endoscopy, Gastrointestinal ; Female ; Follow-Up Studies ; Gastroenterology and Hepatology ; Gastroenterology. Liver. Pancreas. Abdomen ; Gastrointestinal Agents - administration & dosage ; Humans ; Ileum - pathology ; Immunomodulators ; Infliximab ; Intestinal Mucosa - pathology ; Investigative techniques, diagnostic techniques (general aspects) ; Male ; Medical sciences ; Other diseases. Semiology ; Pharmacology. Drug treatments ; Severity of Illness Index ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Treatment Outcome ; Ulcer - drug therapy ; Ulcer - etiology ; Ulcer - pathology ; Wound Healing</subject><ispartof>Gastrointestinal endoscopy, 2006-03, Vol.63 (3), p.433-442</ispartof><rights>American Society for Gastrointestinal Endoscopy</rights><rights>2006 American Society for Gastrointestinal Endoscopy</rights><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c436t-99e7833cc0a37f49468315c9f7b9af3ebd1f0e7aa66ee09c9c766f4419a6a2163</citedby><cites>FETCH-LOGICAL-c436t-99e7833cc0a37f49468315c9f7b9af3ebd1f0e7aa66ee09c9c766f4419a6a2163</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0016510705026489$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17591518$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16500392$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rutgeerts, Paul, MD, PhD</creatorcontrib><creatorcontrib>Diamond, Robert H., MD</creatorcontrib><creatorcontrib>Bala, Mohan, PhD</creatorcontrib><creatorcontrib>Olson, Allan, MD</creatorcontrib><creatorcontrib>Lichtenstein, Gary, MD</creatorcontrib><creatorcontrib>Bao, Weihang, PhD</creatorcontrib><creatorcontrib>Patel, Kamlesh, MS</creatorcontrib><creatorcontrib>Wolf, Douglas C., MD</creatorcontrib><creatorcontrib>Safdi, Michael, MD</creatorcontrib><creatorcontrib>Colombel, Jean Frederic, MD</creatorcontrib><creatorcontrib>Lashner, Bret, MD</creatorcontrib><creatorcontrib>Hanauer, Stephen B., MD</creatorcontrib><title>Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease</title><title>Gastrointestinal endoscopy</title><addtitle>Gastrointest Endosc</addtitle><description>Background The endoscopic substudy of the ACCENT I (•••) Crohn's disease trial examined the effects of infliximab on mucosal inflammation and mucosal healing, and assessed their impact on outcomes. Methods This study was a randomized, double-blind, parallel group study at multiple centers in North America, Europe, and Israel. Ileocolonoscopic examinations were performed at weeks 0, 10, and 54. Complete mucosal healing was defined as the absence of all mucosal ulcerations. The end point of principal interest was the proportion of patients randomized as responders with mucosal healing at week 10. The proportion of responders who demonstrated mucosal healing at week 54 or at both weeks 10 and 54 are also summarized. Changes in Crohn's disease endoscopic index of severity (CDEIS) scores from baseline to week 10 and 54 were calculated for all patients in this substudy. Results Complete mucosal healing by week 10 occurred in significantly more week 2 responders who had received 3 doses of infliximab compared with a single dose (31% vs. 0%, p = 0.010). A significantly higher proportion of week 2 responders in the combined scheduled maintenance group had complete mucosal healing at week 54 compared with the episodic group (50% vs. 7%, p = 0.007). The results for all patients are consistent with those for week 2 responders only. Significantly greater improvement in the CDEIS occurred with scheduled maintenance compared with episodic treatment at week 10 ( p ≤ 0.001) and week 54 ( p = 0.026). Notably, no strong relationship between clinical remission and complete mucosal healing was found. Overall, mucosal healing appeared to correlate with fewer hospitalizations, although these results were not statistically significant. Conclusions Scheduled infliximab maintenance therapy resulted in more improvement in mucosal ulceration and in higher rates of mucosal healing. There was a numerical trend for patients with better mucosal healing to have a lower rate of Crohn's disease-related hospitalizations.</description><subject>Adult</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Biological and medical sciences</subject><subject>Colon - pathology</subject><subject>Crohn Disease - complications</subject><subject>Crohn Disease - pathology</subject><subject>Digestive system. Abdomen</subject><subject>Drug Administration Schedule</subject><subject>Endoscopy</subject><subject>Endoscopy, Gastrointestinal</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gastroenterology and Hepatology</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Gastrointestinal Agents - administration & dosage</subject><subject>Humans</subject><subject>Ileum - pathology</subject><subject>Immunomodulators</subject><subject>Infliximab</subject><subject>Intestinal Mucosa - pathology</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Other diseases. Semiology</subject><subject>Pharmacology. Drug treatments</subject><subject>Severity of Illness Index</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Treatment Outcome</subject><subject>Ulcer - drug therapy</subject><subject>Ulcer - etiology</subject><subject>Ulcer - pathology</subject><subject>Wound Healing</subject><issn>0016-5107</issn><issn>1097-6779</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kk9vEzEQxVcIREPhA3BBvgCnhPF6114LqRKKyh-pEofC2XK848Zhdx08Xmg_CV8Xh0Qq4sDJh_m9edZ7U1XPOaw4cPlmt7oJuKoB2hV0K-D8QbXgoNVSKqUfVgso0LLloM6qJ0Q7AOhqwR9XZ1y2AELXi-rXtdtiPw_Ys9GGKeNkJ4csJ7R5xCmznyFvWZj8EG7DaDcsEKN5jynExHJkuA8U--D-UvjDZItsi3YI0w2Lno2zi2QHNg8Ok80hTswSRRdsLsZ_LNYpbqfXxPpAaAmfVo-8HQifnd7z6uv7yy_rj8urzx8-rd9dLV0jZF5qjaoTwjmwQvlGN7ITvHXaq422XuCm5x5QWSslIminnZLSNw3XVtqaS3FevTru3af4fUbKZgzkcBjshHEmI5XUwEVTQH4EXYpECb3ZpxJIujMczKENszOlDXNow0BnShtF8-K0fN6M2N8rTvEX4OUJsOTs4FMJP9A9p1rNW94V7u2RwxLFj4DJkAtYiupDQpdNH8N_v3Hxj9qVYkIx_IZ3SLs4p6lkbLih2oC5PpzN4WqghVo2nRa_AZKuv8s</recordid><startdate>20060301</startdate><enddate>20060301</enddate><creator>Rutgeerts, Paul, MD, PhD</creator><creator>Diamond, Robert H., MD</creator><creator>Bala, Mohan, PhD</creator><creator>Olson, Allan, MD</creator><creator>Lichtenstein, Gary, MD</creator><creator>Bao, Weihang, PhD</creator><creator>Patel, Kamlesh, MS</creator><creator>Wolf, Douglas C., MD</creator><creator>Safdi, Michael, MD</creator><creator>Colombel, Jean Frederic, MD</creator><creator>Lashner, Bret, MD</creator><creator>Hanauer, Stephen B., MD</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>IQODW</scope><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>7X8</scope></search><sort><creationdate>20060301</creationdate><title>Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease</title><author>Rutgeerts, Paul, MD, PhD ; Diamond, Robert H., MD ; Bala, Mohan, PhD ; Olson, Allan, MD ; Lichtenstein, Gary, MD ; Bao, Weihang, PhD ; Patel, Kamlesh, MS ; Wolf, Douglas C., MD ; Safdi, Michael, MD ; Colombel, Jean Frederic, MD ; Lashner, Bret, MD ; Hanauer, Stephen B., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c436t-99e7833cc0a37f49468315c9f7b9af3ebd1f0e7aa66ee09c9c766f4419a6a2163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adult</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Biological and medical sciences</topic><topic>Colon - pathology</topic><topic>Crohn Disease - complications</topic><topic>Crohn Disease - pathology</topic><topic>Digestive system. Abdomen</topic><topic>Drug Administration Schedule</topic><topic>Endoscopy</topic><topic>Endoscopy, Gastrointestinal</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gastroenterology and Hepatology</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Gastrointestinal Agents - administration & dosage</topic><topic>Humans</topic><topic>Ileum - pathology</topic><topic>Immunomodulators</topic><topic>Infliximab</topic><topic>Intestinal Mucosa - pathology</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Other diseases. Semiology</topic><topic>Pharmacology. Drug treatments</topic><topic>Severity of Illness Index</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Treatment Outcome</topic><topic>Ulcer - drug therapy</topic><topic>Ulcer - etiology</topic><topic>Ulcer - pathology</topic><topic>Wound Healing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rutgeerts, Paul, MD, PhD</creatorcontrib><creatorcontrib>Diamond, Robert H., MD</creatorcontrib><creatorcontrib>Bala, Mohan, PhD</creatorcontrib><creatorcontrib>Olson, Allan, MD</creatorcontrib><creatorcontrib>Lichtenstein, Gary, MD</creatorcontrib><creatorcontrib>Bao, Weihang, PhD</creatorcontrib><creatorcontrib>Patel, Kamlesh, MS</creatorcontrib><creatorcontrib>Wolf, Douglas C., MD</creatorcontrib><creatorcontrib>Safdi, Michael, MD</creatorcontrib><creatorcontrib>Colombel, Jean Frederic, MD</creatorcontrib><creatorcontrib>Lashner, Bret, MD</creatorcontrib><creatorcontrib>Hanauer, Stephen B., MD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gastrointestinal endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rutgeerts, Paul, MD, PhD</au><au>Diamond, Robert H., MD</au><au>Bala, Mohan, PhD</au><au>Olson, Allan, MD</au><au>Lichtenstein, Gary, MD</au><au>Bao, Weihang, PhD</au><au>Patel, Kamlesh, MS</au><au>Wolf, Douglas C., MD</au><au>Safdi, Michael, MD</au><au>Colombel, Jean Frederic, MD</au><au>Lashner, Bret, MD</au><au>Hanauer, Stephen B., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease</atitle><jtitle>Gastrointestinal endoscopy</jtitle><addtitle>Gastrointest Endosc</addtitle><date>2006-03-01</date><risdate>2006</risdate><volume>63</volume><issue>3</issue><spage>433</spage><epage>442</epage><pages>433-442</pages><issn>0016-5107</issn><eissn>1097-6779</eissn><coden>GAENBQ</coden><abstract>Background The endoscopic substudy of the ACCENT I (•••) Crohn's disease trial examined the effects of infliximab on mucosal inflammation and mucosal healing, and assessed their impact on outcomes. Methods This study was a randomized, double-blind, parallel group study at multiple centers in North America, Europe, and Israel. Ileocolonoscopic examinations were performed at weeks 0, 10, and 54. Complete mucosal healing was defined as the absence of all mucosal ulcerations. The end point of principal interest was the proportion of patients randomized as responders with mucosal healing at week 10. The proportion of responders who demonstrated mucosal healing at week 54 or at both weeks 10 and 54 are also summarized. Changes in Crohn's disease endoscopic index of severity (CDEIS) scores from baseline to week 10 and 54 were calculated for all patients in this substudy. Results Complete mucosal healing by week 10 occurred in significantly more week 2 responders who had received 3 doses of infliximab compared with a single dose (31% vs. 0%, p = 0.010). A significantly higher proportion of week 2 responders in the combined scheduled maintenance group had complete mucosal healing at week 54 compared with the episodic group (50% vs. 7%, p = 0.007). The results for all patients are consistent with those for week 2 responders only. Significantly greater improvement in the CDEIS occurred with scheduled maintenance compared with episodic treatment at week 10 ( p ≤ 0.001) and week 54 ( p = 0.026). Notably, no strong relationship between clinical remission and complete mucosal healing was found. Overall, mucosal healing appeared to correlate with fewer hospitalizations, although these results were not statistically significant. Conclusions Scheduled infliximab maintenance therapy resulted in more improvement in mucosal ulceration and in higher rates of mucosal healing. There was a numerical trend for patients with better mucosal healing to have a lower rate of Crohn's disease-related hospitalizations.</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>16500392</pmid><doi>10.1016/j.gie.2005.08.011</doi><tpages>10</tpages></addata></record> |
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| subjects | Adult Antibodies, Monoclonal - administration & dosage Biological and medical sciences Colon - pathology Crohn Disease - complications Crohn Disease - pathology Digestive system. Abdomen Drug Administration Schedule Endoscopy Endoscopy, Gastrointestinal Female Follow-Up Studies Gastroenterology and Hepatology Gastroenterology. Liver. Pancreas. Abdomen Gastrointestinal Agents - administration & dosage Humans Ileum - pathology Immunomodulators Infliximab Intestinal Mucosa - pathology Investigative techniques, diagnostic techniques (general aspects) Male Medical sciences Other diseases. Semiology Pharmacology. Drug treatments Severity of Illness Index Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Treatment Outcome Ulcer - drug therapy Ulcer - etiology Ulcer - pathology Wound Healing |
| title | Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease |
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