Effectiveness of Adalimumab in Perianal Fistulas in Crohn’s Disease Patients Naive to Anti-TNF Therapy
BACKGROUND:Data regarding the effectiveness of adalimumab (ADA) in the treatment of perianal fistula in patients with Crohn’s disease (CD) naive to antitumor necrosis factor (TNF) therapy are scarce. AIM:To assess the effectiveness of ADA in the treatment of perianal fistulas in CD patients naive to...
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| Veröffentlicht in: | Journal of clinical gastroenterology 2015-01, Vol.49 (1), p.34-40 |
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| creator | Castaño-Milla, Carlos Chaparro, María Saro, Cristina Barreiro-de Acosta, Manuel García-Albert, Ana M Bujanda, Luis Martín-Arranz, María D Carpio, Daniel Muñoz, Fernando Manceñido, Noemí García-Planella, Esther Piqueras, Marta Calvet, Xavier Cabriada, José L Botella, Belén Bermejo, Fernando Gisbert, Javier P |
| description | BACKGROUND:Data regarding the effectiveness of adalimumab (ADA) in the treatment of perianal fistula in patients with Crohn’s disease (CD) naive to antitumor necrosis factor (TNF) therapy are scarce.
AIM:To assess the effectiveness of ADA in the treatment of perianal fistulas in CD patients naive to anti-TNF therapy.
METHODS:A retrospective multicenter study was designed. The Fistula Drainage Assessment Index was used to assess the clinical response, and the Van Assche and Ng indexes to classify radiologic response (magnetic resonance imaging).
RESULTS:A total of 46 patients (83% women, 83% complex fistula) were included. At 6 months, 72% of patients responded to ADA (54% remission, 18% partial response) and at 12 months 49% responded (41% remission, 8% partial response). Among patients with complex fistula, the response rate was 66% at 6 months and 39% at 12 months. Nine patients escalated the ADA dose to 40 mg weekly, 6 for partial response and 3 for absence of response. Thirty-three percent of these patients achieved remission after dose escalation. There was a good correlation between clinical and radiologic assessment of response (κ=0.68). In the multivariate analysis, complex fistula was the only predictor of a worse response (hazard ratio 0.083; 95% confidence interval, 0.0009-0.764; P=0.028). Adverse effects were recorded in 11% of patients.
CONCLUSIONS:ADA was effective for the treatment of perianal fistulas in CD patients naive to anti-TNF drugs. We found a good correlation between clinical and radiologic assessment of therapy response. |
| doi_str_mv | 10.1097/MCG.0000000000000169 |
| format | Article |
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AIM:To assess the effectiveness of ADA in the treatment of perianal fistulas in CD patients naive to anti-TNF therapy.
METHODS:A retrospective multicenter study was designed. The Fistula Drainage Assessment Index was used to assess the clinical response, and the Van Assche and Ng indexes to classify radiologic response (magnetic resonance imaging).
RESULTS:A total of 46 patients (83% women, 83% complex fistula) were included. At 6 months, 72% of patients responded to ADA (54% remission, 18% partial response) and at 12 months 49% responded (41% remission, 8% partial response). Among patients with complex fistula, the response rate was 66% at 6 months and 39% at 12 months. Nine patients escalated the ADA dose to 40 mg weekly, 6 for partial response and 3 for absence of response. Thirty-three percent of these patients achieved remission after dose escalation. There was a good correlation between clinical and radiologic assessment of response (κ=0.68). In the multivariate analysis, complex fistula was the only predictor of a worse response (hazard ratio 0.083; 95% confidence interval, 0.0009-0.764; P=0.028). Adverse effects were recorded in 11% of patients.
CONCLUSIONS:ADA was effective for the treatment of perianal fistulas in CD patients naive to anti-TNF drugs. We found a good correlation between clinical and radiologic assessment of therapy response.</description><identifier>ISSN: 0192-0790</identifier><identifier>EISSN: 1539-2031</identifier><identifier>DOI: 10.1097/MCG.0000000000000169</identifier><identifier>PMID: 25485513</identifier><language>eng</language><publisher>United States: by Lippincott Williams & Wilkins</publisher><subject>Adalimumab ; Adult ; Anti-Inflammatory Agents, Non-Steroidal - adverse effects ; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use ; Antibodies, Monoclonal, Humanized - adverse effects ; Antibodies, Monoclonal, Humanized - therapeutic use ; Crohn Disease - complications ; Crohn Disease - drug therapy ; Crohn Disease - surgery ; Cutaneous Fistula - drug therapy ; Cutaneous Fistula - etiology ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Rectal Fistula - drug therapy ; Rectal Fistula - etiology ; Retrospective Studies ; Severity of Illness Index ; Tumor Necrosis Factor-alpha - antagonists & inhibitors ; Young Adult</subject><ispartof>Journal of clinical gastroenterology, 2015-01, Vol.49 (1), p.34-40</ispartof><rights>2015 by Lippincott Williams & Wilkins</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4229-a1f5f6bf2a8efadf1004fef28c5e5557f4fc9a1b63adf8f7cf299f016fac022f3</citedby><cites>FETCH-LOGICAL-c4229-a1f5f6bf2a8efadf1004fef28c5e5557f4fc9a1b63adf8f7cf299f016fac022f3</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/25485513$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Castaño-Milla, Carlos</creatorcontrib><creatorcontrib>Chaparro, María</creatorcontrib><creatorcontrib>Saro, Cristina</creatorcontrib><creatorcontrib>Barreiro-de Acosta, Manuel</creatorcontrib><creatorcontrib>García-Albert, Ana M</creatorcontrib><creatorcontrib>Bujanda, Luis</creatorcontrib><creatorcontrib>Martín-Arranz, María D</creatorcontrib><creatorcontrib>Carpio, Daniel</creatorcontrib><creatorcontrib>Muñoz, Fernando</creatorcontrib><creatorcontrib>Manceñido, Noemí</creatorcontrib><creatorcontrib>García-Planella, Esther</creatorcontrib><creatorcontrib>Piqueras, Marta</creatorcontrib><creatorcontrib>Calvet, Xavier</creatorcontrib><creatorcontrib>Cabriada, José L</creatorcontrib><creatorcontrib>Botella, Belén</creatorcontrib><creatorcontrib>Bermejo, Fernando</creatorcontrib><creatorcontrib>Gisbert, Javier P</creatorcontrib><title>Effectiveness of Adalimumab in Perianal Fistulas in Crohn’s Disease Patients Naive to Anti-TNF Therapy</title><title>Journal of clinical gastroenterology</title><addtitle>J Clin Gastroenterol</addtitle><description>BACKGROUND:Data regarding the effectiveness of adalimumab (ADA) in the treatment of perianal fistula in patients with Crohn’s disease (CD) naive to antitumor necrosis factor (TNF) therapy are scarce.
AIM:To assess the effectiveness of ADA in the treatment of perianal fistulas in CD patients naive to anti-TNF therapy.
METHODS:A retrospective multicenter study was designed. The Fistula Drainage Assessment Index was used to assess the clinical response, and the Van Assche and Ng indexes to classify radiologic response (magnetic resonance imaging).
RESULTS:A total of 46 patients (83% women, 83% complex fistula) were included. At 6 months, 72% of patients responded to ADA (54% remission, 18% partial response) and at 12 months 49% responded (41% remission, 8% partial response). Among patients with complex fistula, the response rate was 66% at 6 months and 39% at 12 months. Nine patients escalated the ADA dose to 40 mg weekly, 6 for partial response and 3 for absence of response. Thirty-three percent of these patients achieved remission after dose escalation. There was a good correlation between clinical and radiologic assessment of response (κ=0.68). In the multivariate analysis, complex fistula was the only predictor of a worse response (hazard ratio 0.083; 95% confidence interval, 0.0009-0.764; P=0.028). Adverse effects were recorded in 11% of patients.
CONCLUSIONS:ADA was effective for the treatment of perianal fistulas in CD patients naive to anti-TNF drugs. We found a good correlation between clinical and radiologic assessment of therapy response.</description><subject>Adalimumab</subject><subject>Adult</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - adverse effects</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Crohn Disease - complications</subject><subject>Crohn Disease - drug therapy</subject><subject>Crohn Disease - surgery</subject><subject>Cutaneous Fistula - drug therapy</subject><subject>Cutaneous Fistula - etiology</subject><subject>Female</subject><subject>Humans</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Rectal Fistula - drug therapy</subject><subject>Rectal Fistula - etiology</subject><subject>Retrospective Studies</subject><subject>Severity of Illness Index</subject><subject>Tumor Necrosis Factor-alpha - antagonists & inhibitors</subject><subject>Young Adult</subject><issn>0192-0790</issn><issn>1539-2031</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMFO3DAQhi3UCra0b4CQj70EbCfexMfVlqVIlHLYnqPZ7Izi4iRbj1PEra_R1-uTNGihQhw6l5Fmvv8fzS_EiVZnWrny_Mvy8ky9LD13B2Kmbe4yo3L9RsyUdiZTpVNH4h3z9wkp81wfiiNji8panc9Ee0GETfI_sUdmOZBcbCH4buxgI30vbzF66CHIlec0BuDH4TIObf_n12-WnzwjMMpbSB77xPIGJiuZBrnok8_WNyu5bjHC7uG9eEsQGD889WPxbXWxXn7Orr9eXi0X11lTGOMy0GRpviEDFRJsSStVEJKpGovW2pIKahzozTyflhWVDRnnaPqdoFHGUH4sPu59d3H4MSKnuvPcYAjQ4zByree5VcpYpye02KNNHJgjUr2LvoP4UGtVP2ZcTxnXrzOeZKdPF8ZNh9t_oudQJ6DaA_dDSBj5Loz3GOsWIaT2_95_AZT2ieI</recordid><startdate>201501</startdate><enddate>201501</enddate><creator>Castaño-Milla, Carlos</creator><creator>Chaparro, María</creator><creator>Saro, Cristina</creator><creator>Barreiro-de Acosta, Manuel</creator><creator>García-Albert, Ana M</creator><creator>Bujanda, Luis</creator><creator>Martín-Arranz, María D</creator><creator>Carpio, Daniel</creator><creator>Muñoz, Fernando</creator><creator>Manceñido, Noemí</creator><creator>García-Planella, Esther</creator><creator>Piqueras, Marta</creator><creator>Calvet, Xavier</creator><creator>Cabriada, José L</creator><creator>Botella, Belén</creator><creator>Bermejo, Fernando</creator><creator>Gisbert, Javier P</creator><general>by Lippincott Williams & Wilkins</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>7X8</scope></search><sort><creationdate>201501</creationdate><title>Effectiveness of Adalimumab in Perianal Fistulas in Crohn’s Disease Patients Naive to Anti-TNF Therapy</title><author>Castaño-Milla, Carlos ; Chaparro, María ; Saro, Cristina ; Barreiro-de Acosta, Manuel ; García-Albert, Ana M ; Bujanda, Luis ; Martín-Arranz, María D ; Carpio, Daniel ; Muñoz, Fernando ; Manceñido, Noemí ; García-Planella, Esther ; Piqueras, Marta ; Calvet, Xavier ; Cabriada, José L ; Botella, Belén ; Bermejo, Fernando ; Gisbert, Javier P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4229-a1f5f6bf2a8efadf1004fef28c5e5557f4fc9a1b63adf8f7cf299f016fac022f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adalimumab</topic><topic>Adult</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - adverse effects</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - therapeutic use</topic><topic>Antibodies, Monoclonal, Humanized - adverse effects</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Crohn Disease - complications</topic><topic>Crohn Disease - drug therapy</topic><topic>Crohn Disease - surgery</topic><topic>Cutaneous Fistula - drug therapy</topic><topic>Cutaneous Fistula - etiology</topic><topic>Female</topic><topic>Humans</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Rectal Fistula - drug therapy</topic><topic>Rectal Fistula - etiology</topic><topic>Retrospective Studies</topic><topic>Severity of Illness Index</topic><topic>Tumor Necrosis Factor-alpha - antagonists & inhibitors</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Castaño-Milla, Carlos</creatorcontrib><creatorcontrib>Chaparro, María</creatorcontrib><creatorcontrib>Saro, Cristina</creatorcontrib><creatorcontrib>Barreiro-de Acosta, Manuel</creatorcontrib><creatorcontrib>García-Albert, Ana M</creatorcontrib><creatorcontrib>Bujanda, Luis</creatorcontrib><creatorcontrib>Martín-Arranz, María D</creatorcontrib><creatorcontrib>Carpio, Daniel</creatorcontrib><creatorcontrib>Muñoz, Fernando</creatorcontrib><creatorcontrib>Manceñido, Noemí</creatorcontrib><creatorcontrib>García-Planella, Esther</creatorcontrib><creatorcontrib>Piqueras, Marta</creatorcontrib><creatorcontrib>Calvet, Xavier</creatorcontrib><creatorcontrib>Cabriada, José L</creatorcontrib><creatorcontrib>Botella, Belén</creatorcontrib><creatorcontrib>Bermejo, Fernando</creatorcontrib><creatorcontrib>Gisbert, Javier P</creatorcontrib><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>Journal of clinical gastroenterology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Castaño-Milla, Carlos</au><au>Chaparro, María</au><au>Saro, Cristina</au><au>Barreiro-de Acosta, Manuel</au><au>García-Albert, Ana M</au><au>Bujanda, Luis</au><au>Martín-Arranz, María D</au><au>Carpio, Daniel</au><au>Muñoz, Fernando</au><au>Manceñido, Noemí</au><au>García-Planella, Esther</au><au>Piqueras, Marta</au><au>Calvet, Xavier</au><au>Cabriada, José L</au><au>Botella, Belén</au><au>Bermejo, Fernando</au><au>Gisbert, Javier P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of Adalimumab in Perianal Fistulas in Crohn’s Disease Patients Naive to Anti-TNF Therapy</atitle><jtitle>Journal of clinical gastroenterology</jtitle><addtitle>J Clin Gastroenterol</addtitle><date>2015-01</date><risdate>2015</risdate><volume>49</volume><issue>1</issue><spage>34</spage><epage>40</epage><pages>34-40</pages><issn>0192-0790</issn><eissn>1539-2031</eissn><abstract>BACKGROUND:Data regarding the effectiveness of adalimumab (ADA) in the treatment of perianal fistula in patients with Crohn’s disease (CD) naive to antitumor necrosis factor (TNF) therapy are scarce.
AIM:To assess the effectiveness of ADA in the treatment of perianal fistulas in CD patients naive to anti-TNF therapy.
METHODS:A retrospective multicenter study was designed. The Fistula Drainage Assessment Index was used to assess the clinical response, and the Van Assche and Ng indexes to classify radiologic response (magnetic resonance imaging).
RESULTS:A total of 46 patients (83% women, 83% complex fistula) were included. At 6 months, 72% of patients responded to ADA (54% remission, 18% partial response) and at 12 months 49% responded (41% remission, 8% partial response). Among patients with complex fistula, the response rate was 66% at 6 months and 39% at 12 months. Nine patients escalated the ADA dose to 40 mg weekly, 6 for partial response and 3 for absence of response. Thirty-three percent of these patients achieved remission after dose escalation. There was a good correlation between clinical and radiologic assessment of response (κ=0.68). In the multivariate analysis, complex fistula was the only predictor of a worse response (hazard ratio 0.083; 95% confidence interval, 0.0009-0.764; P=0.028). Adverse effects were recorded in 11% of patients.
CONCLUSIONS:ADA was effective for the treatment of perianal fistulas in CD patients naive to anti-TNF drugs. We found a good correlation between clinical and radiologic assessment of therapy response.</abstract><cop>United States</cop><pub>by Lippincott Williams & Wilkins</pub><pmid>25485513</pmid><doi>10.1097/MCG.0000000000000169</doi><tpages>7</tpages></addata></record> |
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| subjects | Adalimumab Adult Anti-Inflammatory Agents, Non-Steroidal - adverse effects Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Crohn Disease - complications Crohn Disease - drug therapy Crohn Disease - surgery Cutaneous Fistula - drug therapy Cutaneous Fistula - etiology Female Humans Magnetic Resonance Imaging Male Middle Aged Rectal Fistula - drug therapy Rectal Fistula - etiology Retrospective Studies Severity of Illness Index Tumor Necrosis Factor-alpha - antagonists & inhibitors Young Adult |
| title | Effectiveness of Adalimumab in Perianal Fistulas in Crohn’s Disease Patients Naive to Anti-TNF Therapy |
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