AB0302 Influence of Tapering Biological Therapies in Immunogenicity in A Cohort of Rheumatoid Arthritis with Low Disease Activity
BackgroundRecent studies propose the use of a tapering strategy (dose reduction or discontinuation) of tumor necrosis factor inhibitors (TNFi) in rheumatoid arthritis (RA) patients (pts) in low disease activity (LDA) or clinical remission (R) without losing the disease control. One concern, when low...
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creator | Paredes, B. Plasencia, C. Balsa, A. Monjo, I. Pascual-Salcedo, D. Pieren, A. Moral, E. Tornero, C. Bogas, P. Bonilla, G. Nuño, L. Villalba, A. Peiteado, D. Ramiro, S. Jurado, T. Díez, J. Martin-Mola, E. |
description | BackgroundRecent studies propose the use of a tapering strategy (dose reduction or discontinuation) of tumor necrosis factor inhibitors (TNFi) in rheumatoid arthritis (RA) patients (pts) in low disease activity (LDA) or clinical remission (R) without losing the disease control. One concern, when lower doses are used, is the appearance of anti-drug antibodies (ADA) with the consequent loss of efficacy.ObjectivesTo evaluate the clinical influence of the tapering strategy of TNFi in a cohort of RA pts in LDA or R.MethodsOf a total of 283 RA pts under TNFi, 52 patients treated with Infliximab (Ifx), Adalimumab (Ada) or Etanercept (Etn) were selected. All pts were in LDA or R (DAS28 0.6). At flare, the biologic and non-biologic therapy could be intensified.ResultsIn our cohort of 52 pts, 26 (50%) pts were treated with Ada, 16 (31%) with Etn and 10 (19%) with Ifx. Forty one (79%) were women and 41 (79%) pts were ACPA+ and RF+. Most patients received methotrexate concomitantly (69%), 25 (48%) pts other DMARDs and 22 (42%) prednisone. The mean follow-up was 43.76±8months, without statistically significance among TNFi (p=0.595). At pre-visit, 40 (77%) pts were in R and 12 (33%) LDA. The majority of patients remained in LDA or R at final-visit: 26 (50%) in R, 14 (27%) in LDA, 12 (23%) with DAS28>3.2, p=0.97). When a subanalysis in each TNFi was performed, it was confirmed that most pts were in LDA or R at final-visit (p=0.59 in Ada, p=0.26 in Ifx and p=0.78 in Etn). No differences in CRP levels between visit-pre and final visit were seen. 25 patients (48%) had flares during follow-up (13 (52%) had 1 flare, 10 (40%) had 2 flares and 2 (8%) had 3 flares. Most patients with flares were in LDA or R at final-visit (R=9 (36%), LDA=5 (20%)). Only 2 pts with flares dropped out the TNFi and were ADA + at final visit. All patients were ADA negative at the pre-visit and only 6 (11%) were positive at final-visit, 4 of them withdrawed therapy for maintaining clinical remission. A statistically significant decrease was observed in drug levels between the pre-visit and post-visit (Ada: 5251.9±1205.9 vs 1507.2±322.7, p=0.001; Etn: 2735.2±347.4 vs 1114.9± |
doi_str_mv | 10.1136/annrheumdis-2016-eular.5481 |
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One concern, when lower doses are used, is the appearance of anti-drug antibodies (ADA) with the consequent loss of efficacy.ObjectivesTo evaluate the clinical influence of the tapering strategy of TNFi in a cohort of RA pts in LDA or R.MethodsOf a total of 283 RA pts under TNFi, 52 patients treated with Infliximab (Ifx), Adalimumab (Ada) or Etanercept (Etn) were selected. All pts were in LDA or R (DAS28 <3.2 or <2.6, respectively) for at least 6 months prior to start the tapering strategy. Clinical activity (DAS28), drug levels (DL) and ADA were evaluated at baseline before tapering (pre-visit) and at the last available visit after 4 years follow-up (final-visit), this parameters were also evaluated at flares (DAS28>3,2 and ΔDAS28>0.6). At flare, the biologic and non-biologic therapy could be intensified.ResultsIn our cohort of 52 pts, 26 (50%) pts were treated with Ada, 16 (31%) with Etn and 10 (19%) with Ifx. Forty one (79%) were women and 41 (79%) pts were ACPA+ and RF+. Most patients received methotrexate concomitantly (69%), 25 (48%) pts other DMARDs and 22 (42%) prednisone. The mean follow-up was 43.76±8months, without statistically significance among TNFi (p=0.595). At pre-visit, 40 (77%) pts were in R and 12 (33%) LDA. The majority of patients remained in LDA or R at final-visit: 26 (50%) in R, 14 (27%) in LDA, 12 (23%) with DAS28>3.2, p=0.97). When a subanalysis in each TNFi was performed, it was confirmed that most pts were in LDA or R at final-visit (p=0.59 in Ada, p=0.26 in Ifx and p=0.78 in Etn). No differences in CRP levels between visit-pre and final visit were seen. 25 patients (48%) had flares during follow-up (13 (52%) had 1 flare, 10 (40%) had 2 flares and 2 (8%) had 3 flares. Most patients with flares were in LDA or R at final-visit (R=9 (36%), LDA=5 (20%)). Only 2 pts with flares dropped out the TNFi and were ADA + at final visit. All patients were ADA negative at the pre-visit and only 6 (11%) were positive at final-visit, 4 of them withdrawed therapy for maintaining clinical remission. A statistically significant decrease was observed in drug levels between the pre-visit and post-visit (Ada: 5251.9±1205.9 vs 1507.2±322.7, p=0.001; Etn: 2735.2±347.4 vs 1114.9±283.2, p=0.002; Ifx: 2358.4±728.5 vs 650.4±290.1, p=0.008).ConclusionsThe tapering strategy seems feasible in RA pts in LDA treated with TNFi, reducing the amount of drug administered with low incidence of ADA and without deterioration of disease activity. In most patients, flares appear to be controlled by changing the drug administration interval without the necessity of changing or stopping treatment.Disclosure of InterestB. Paredes Grant/research support from: This work was funded by an unrestricted research grant from Pfizer, C. Plasencia: None declared, A. Balsa: None declared, I. Monjo: None declared</description><identifier>ISSN: 0003-4967</identifier><identifier>EISSN: 1468-2060</identifier><identifier>DOI: 10.1136/annrheumdis-2016-eular.5481</identifier><identifier>CODEN: ARDIAO</identifier><language>eng</language><publisher>London: BMJ Publishing Group LTD</publisher><ispartof>Annals of the rheumatic diseases, 2016-06, Vol.75 (Suppl 2), p.1003-1003</ispartof><rights>2016, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Copyright: 2016 (c) 2016, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://ard.bmj.com/content/75/Suppl_2/1003.2.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://ard.bmj.com/content/75/Suppl_2/1003.2.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,314,780,784,3196,23571,27924,27925,77600,77631</link.rule.ids></links><search><creatorcontrib>Paredes, B.</creatorcontrib><creatorcontrib>Plasencia, C.</creatorcontrib><creatorcontrib>Balsa, A.</creatorcontrib><creatorcontrib>Monjo, I.</creatorcontrib><creatorcontrib>Pascual-Salcedo, D.</creatorcontrib><creatorcontrib>Pieren, A.</creatorcontrib><creatorcontrib>Moral, E.</creatorcontrib><creatorcontrib>Tornero, C.</creatorcontrib><creatorcontrib>Bogas, P.</creatorcontrib><creatorcontrib>Bonilla, G.</creatorcontrib><creatorcontrib>Nuño, L.</creatorcontrib><creatorcontrib>Villalba, A.</creatorcontrib><creatorcontrib>Peiteado, D.</creatorcontrib><creatorcontrib>Ramiro, S.</creatorcontrib><creatorcontrib>Jurado, T.</creatorcontrib><creatorcontrib>Díez, J.</creatorcontrib><creatorcontrib>Martin-Mola, E.</creatorcontrib><title>AB0302 Influence of Tapering Biological Therapies in Immunogenicity in A Cohort of Rheumatoid Arthritis with Low Disease Activity</title><title>Annals of the rheumatic diseases</title><description>BackgroundRecent studies propose the use of a tapering strategy (dose reduction or discontinuation) of tumor necrosis factor inhibitors (TNFi) in rheumatoid arthritis (RA) patients (pts) in low disease activity (LDA) or clinical remission (R) without losing the disease control. One concern, when lower doses are used, is the appearance of anti-drug antibodies (ADA) with the consequent loss of efficacy.ObjectivesTo evaluate the clinical influence of the tapering strategy of TNFi in a cohort of RA pts in LDA or R.MethodsOf a total of 283 RA pts under TNFi, 52 patients treated with Infliximab (Ifx), Adalimumab (Ada) or Etanercept (Etn) were selected. All pts were in LDA or R (DAS28 <3.2 or <2.6, respectively) for at least 6 months prior to start the tapering strategy. Clinical activity (DAS28), drug levels (DL) and ADA were evaluated at baseline before tapering (pre-visit) and at the last available visit after 4 years follow-up (final-visit), this parameters were also evaluated at flares (DAS28>3,2 and ΔDAS28>0.6). At flare, the biologic and non-biologic therapy could be intensified.ResultsIn our cohort of 52 pts, 26 (50%) pts were treated with Ada, 16 (31%) with Etn and 10 (19%) with Ifx. Forty one (79%) were women and 41 (79%) pts were ACPA+ and RF+. Most patients received methotrexate concomitantly (69%), 25 (48%) pts other DMARDs and 22 (42%) prednisone. The mean follow-up was 43.76±8months, without statistically significance among TNFi (p=0.595). At pre-visit, 40 (77%) pts were in R and 12 (33%) LDA. The majority of patients remained in LDA or R at final-visit: 26 (50%) in R, 14 (27%) in LDA, 12 (23%) with DAS28>3.2, p=0.97). When a subanalysis in each TNFi was performed, it was confirmed that most pts were in LDA or R at final-visit (p=0.59 in Ada, p=0.26 in Ifx and p=0.78 in Etn). No differences in CRP levels between visit-pre and final visit were seen. 25 patients (48%) had flares during follow-up (13 (52%) had 1 flare, 10 (40%) had 2 flares and 2 (8%) had 3 flares. Most patients with flares were in LDA or R at final-visit (R=9 (36%), LDA=5 (20%)). Only 2 pts with flares dropped out the TNFi and were ADA + at final visit. All patients were ADA negative at the pre-visit and only 6 (11%) were positive at final-visit, 4 of them withdrawed therapy for maintaining clinical remission. A statistically significant decrease was observed in drug levels between the pre-visit and post-visit (Ada: 5251.9±1205.9 vs 1507.2±322.7, p=0.001; Etn: 2735.2±347.4 vs 1114.9±283.2, p=0.002; Ifx: 2358.4±728.5 vs 650.4±290.1, p=0.008).ConclusionsThe tapering strategy seems feasible in RA pts in LDA treated with TNFi, reducing the amount of drug administered with low incidence of ADA and without deterioration of disease activity. In most patients, flares appear to be controlled by changing the drug administration interval without the necessity of changing or stopping treatment.Disclosure of InterestB. Paredes Grant/research support from: This work was funded by an unrestricted research grant from Pfizer, C. Plasencia: None declared, A. Balsa: None declared, I. Monjo: None declared</description><issn>0003-4967</issn><issn>1468-2060</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqVkMFq3DAQhkVpINsk7yDYs9OZtS3L9OTdNO3CQiFszkKWpbUWW9pIdkNugZAX7ZPU7vbQa0_D_Mw3M3yELBFuEVP2WToXWj32jY3JCpAleuxkuM0zjh_IAjPGp5jBR7IAgDTJSlZckk8xHqcWOPIFeavWkMLq1-v71plu1E5p6g3dy5MO1h3o2vrOH6ySHd23OsiT1ZFaR7d9Pzp_0M4qO7zMSUU3vvVhmPGH-Sk5eNvQKgxtsION9NkOLd35Z3pno5ZR00oN9udEX5MLI7uob_7WK_J4_3W_-Z7sfnzbbqpdUuOqYAkrMFdmBaqWkCk0KA0vGoaKa16DBMhNk5XYAG_KrMllWXKVNjBFJkel6_SKLM97T8E_jToO4ujH4KaTAktAnpdFxqapL-cpFXyMQRtxCraX4UUgiNm6-Me6mK2LP9bFbH2i2Zmu--N_gb8BS2SQKQ</recordid><startdate>201606</startdate><enddate>201606</enddate><creator>Paredes, B.</creator><creator>Plasencia, C.</creator><creator>Balsa, A.</creator><creator>Monjo, I.</creator><creator>Pascual-Salcedo, D.</creator><creator>Pieren, A.</creator><creator>Moral, E.</creator><creator>Tornero, C.</creator><creator>Bogas, P.</creator><creator>Bonilla, G.</creator><creator>Nuño, L.</creator><creator>Villalba, A.</creator><creator>Peiteado, D.</creator><creator>Ramiro, S.</creator><creator>Jurado, T.</creator><creator>Díez, J.</creator><creator>Martin-Mola, E.</creator><general>BMJ Publishing Group LTD</general><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>K9.</scope><scope>LK8</scope><scope>M0R</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></search><sort><creationdate>201606</creationdate><title>AB0302 Influence of Tapering Biological Therapies in Immunogenicity in A Cohort of Rheumatoid Arthritis with Low Disease Activity</title><author>Paredes, B. ; Plasencia, C. ; Balsa, A. ; Monjo, I. ; Pascual-Salcedo, D. ; Pieren, A. ; Moral, E. ; Tornero, C. ; Bogas, P. ; Bonilla, G. ; Nuño, L. ; Villalba, A. ; Peiteado, D. ; Ramiro, S. ; Jurado, T. ; Díez, J. ; Martin-Mola, E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b1276-6715cf20cba04c1f1af87d61c8e8b0a005fd491d08d94d5a998c3d0491f51ceb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Paredes, B.</creatorcontrib><creatorcontrib>Plasencia, C.</creatorcontrib><creatorcontrib>Balsa, A.</creatorcontrib><creatorcontrib>Monjo, I.</creatorcontrib><creatorcontrib>Pascual-Salcedo, D.</creatorcontrib><creatorcontrib>Pieren, A.</creatorcontrib><creatorcontrib>Moral, E.</creatorcontrib><creatorcontrib>Tornero, C.</creatorcontrib><creatorcontrib>Bogas, P.</creatorcontrib><creatorcontrib>Bonilla, G.</creatorcontrib><creatorcontrib>Nuño, L.</creatorcontrib><creatorcontrib>Villalba, A.</creatorcontrib><creatorcontrib>Peiteado, D.</creatorcontrib><creatorcontrib>Ramiro, S.</creatorcontrib><creatorcontrib>Jurado, T.</creatorcontrib><creatorcontrib>Díez, J.</creatorcontrib><creatorcontrib>Martin-Mola, E.</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>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 Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</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>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</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><jtitle>Annals of the rheumatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Paredes, B.</au><au>Plasencia, C.</au><au>Balsa, A.</au><au>Monjo, I.</au><au>Pascual-Salcedo, D.</au><au>Pieren, A.</au><au>Moral, E.</au><au>Tornero, C.</au><au>Bogas, P.</au><au>Bonilla, G.</au><au>Nuño, L.</au><au>Villalba, A.</au><au>Peiteado, D.</au><au>Ramiro, S.</au><au>Jurado, T.</au><au>Díez, J.</au><au>Martin-Mola, E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>AB0302 Influence of Tapering Biological Therapies in Immunogenicity in A Cohort of Rheumatoid Arthritis with Low Disease Activity</atitle><jtitle>Annals of the rheumatic diseases</jtitle><date>2016-06</date><risdate>2016</risdate><volume>75</volume><issue>Suppl 2</issue><spage>1003</spage><epage>1003</epage><pages>1003-1003</pages><issn>0003-4967</issn><eissn>1468-2060</eissn><coden>ARDIAO</coden><abstract>BackgroundRecent studies propose the use of a tapering strategy (dose reduction or discontinuation) of tumor necrosis factor inhibitors (TNFi) in rheumatoid arthritis (RA) patients (pts) in low disease activity (LDA) or clinical remission (R) without losing the disease control. One concern, when lower doses are used, is the appearance of anti-drug antibodies (ADA) with the consequent loss of efficacy.ObjectivesTo evaluate the clinical influence of the tapering strategy of TNFi in a cohort of RA pts in LDA or R.MethodsOf a total of 283 RA pts under TNFi, 52 patients treated with Infliximab (Ifx), Adalimumab (Ada) or Etanercept (Etn) were selected. All pts were in LDA or R (DAS28 <3.2 or <2.6, respectively) for at least 6 months prior to start the tapering strategy. Clinical activity (DAS28), drug levels (DL) and ADA were evaluated at baseline before tapering (pre-visit) and at the last available visit after 4 years follow-up (final-visit), this parameters were also evaluated at flares (DAS28>3,2 and ΔDAS28>0.6). At flare, the biologic and non-biologic therapy could be intensified.ResultsIn our cohort of 52 pts, 26 (50%) pts were treated with Ada, 16 (31%) with Etn and 10 (19%) with Ifx. Forty one (79%) were women and 41 (79%) pts were ACPA+ and RF+. Most patients received methotrexate concomitantly (69%), 25 (48%) pts other DMARDs and 22 (42%) prednisone. The mean follow-up was 43.76±8months, without statistically significance among TNFi (p=0.595). At pre-visit, 40 (77%) pts were in R and 12 (33%) LDA. The majority of patients remained in LDA or R at final-visit: 26 (50%) in R, 14 (27%) in LDA, 12 (23%) with DAS28>3.2, p=0.97). When a subanalysis in each TNFi was performed, it was confirmed that most pts were in LDA or R at final-visit (p=0.59 in Ada, p=0.26 in Ifx and p=0.78 in Etn). No differences in CRP levels between visit-pre and final visit were seen. 25 patients (48%) had flares during follow-up (13 (52%) had 1 flare, 10 (40%) had 2 flares and 2 (8%) had 3 flares. Most patients with flares were in LDA or R at final-visit (R=9 (36%), LDA=5 (20%)). Only 2 pts with flares dropped out the TNFi and were ADA + at final visit. All patients were ADA negative at the pre-visit and only 6 (11%) were positive at final-visit, 4 of them withdrawed therapy for maintaining clinical remission. A statistically significant decrease was observed in drug levels between the pre-visit and post-visit (Ada: 5251.9±1205.9 vs 1507.2±322.7, p=0.001; Etn: 2735.2±347.4 vs 1114.9±283.2, p=0.002; Ifx: 2358.4±728.5 vs 650.4±290.1, p=0.008).ConclusionsThe tapering strategy seems feasible in RA pts in LDA treated with TNFi, reducing the amount of drug administered with low incidence of ADA and without deterioration of disease activity. In most patients, flares appear to be controlled by changing the drug administration interval without the necessity of changing or stopping treatment.Disclosure of InterestB. Paredes Grant/research support from: This work was funded by an unrestricted research grant from Pfizer, C. Plasencia: None declared, A. Balsa: None declared, I. Monjo: None declared</abstract><cop>London</cop><pub>BMJ Publishing Group LTD</pub><doi>10.1136/annrheumdis-2016-eular.5481</doi><tpages>1</tpages></addata></record> |
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source | BMJ Journals - NESLi2 |
title | AB0302 Influence of Tapering Biological Therapies in Immunogenicity in A Cohort of Rheumatoid Arthritis with Low Disease Activity |
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