[ { "key": "JIAM6A2P", "version": 66, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/JIAM6A2P", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/JIAM6A2P", "type": "text/html" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "creatorSummary": "Desai et al.", "parsedDate": "2012-11-01", "numChildren": 4 }, "data": { "key": "JIAM6A2P", "version": 66, "itemType": "journalArticle", "title": "Mixed Treatment Comparison of the Treatment Discontinuations of Biologic Disease-Modifying Antirheumatic Drugs in Adults with Rheumatoid Arthritis", "creators": [ { "creatorType": "author", "firstName": "Rishi J.", "lastName": "Desai" }, { "creatorType": "author", "firstName": "Richard A.", "lastName": "Hansen" }, { "creatorType": "author", "firstName": "Jaya K.", "lastName": "Rao" }, { "creatorType": "author", "firstName": "Tania M.", "lastName": "Wilkins" }, { "creatorType": "author", "firstName": "Elizabeth A.", "lastName": "Harden" }, { "creatorType": "author", "firstName": "Andrea", "lastName": "Yuen" }, { "creatorType": "author", "firstName": "Daniel E.", "lastName": "Jonas" }, { "creatorType": "author", "firstName": "Robert", "lastName": "Roubey" }, { "creatorType": "author", "firstName": "Beth", "lastName": "Jonas" }, { "creatorType": "author", "firstName": "Gerald", "lastName": "Gartlehner" }, { "creatorType": "author", "firstName": "Linda", "lastName": "Lux" }, { "creatorType": "author", "firstName": "Katrina E.", "lastName": "Donahue" } ], "abstractNote": "BACKGROUND: Introduction of biologic disease-modifying antirheumatic drugs (DMARDs) has considerably changed treatment options for rheumatoid arthritis (RA) over the past decade. Very little information is available on comparative discontinuation rates of the biologics.\nOBJECTIVE: To compare treatment discontinuations for 9 biologic DMARDs in adults with RA.\nMETHODS: We searched electronic databases through May 2012 to retrieve randomized controlled trials (RCTs) of patients with RA that compared biologic DMARDs with placebo or another biologic DMARD. The primary outcome was treatment discontinuation during the blinded phase of the trials, measured as overall withdrawals, withdrawals resulting from lack of efficacy, and withdrawals resulting from adverse events. Random-effects meta-analysis estimated the effect size for individual agents, and adjusted indirect comparisons were made between biologics using mixed treatment comparisons (MTC) meta-analysis.\nRESULTS: Forty-four trials were included in the analysis. In comparison with placebo, biologics were less likely to be withdrawn because of lack of efficacy (OR 0.22, 95% CI 0.17 to 0.27) and more likely to be withdrawn because of an adverse event (OR 1.41, 95% CI 1.16 to 1.70). Based on the MTC, certolizumab had the most favorable overall withdrawal profile, followed by etanercept and rituximab. Certolizumab had lower relative withdrawal rates resulting from lack of efficacy than adalimumab, anakinra, and infliximab. Anakinra had higher relative withdrawal rates resulting from lack of efficacy than most other biologics. Certolizumab and infliximab had more, while etanercept had fewer, withdrawals because of adverse events than most other drugs.\nCONCLUSIONS: Based on MTC using data from RCTs, differences in discontinuation rates were observed, generally favoring certolizumab, etanercept, and rituximab over other biologic DMARDs. These potential differences need to be further explored in head-to-head trials or well-conducted observational studies.", "publicationTitle": "Annals of Pharmacotherapy", "publisher": "", "place": "", "date": "2012-11-01", "volume": "46", "issue": "11", "section": "", "partNumber": "", "partTitle": "", "pages": "1491-1505", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Ann Pharmacother", "DOI": "10.1345/aph.1R203", "citationKey": "", "url": "http://aop.sagepub.com/content/46/11/1491", "accessDate": "2016-03-17T19:37:02Z", "PMID": "23092868", "PMCID": "", "ISSN": "1060-0280, 1542-6270", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "en", "libraryCatalog": "aop.sagepub.com", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Adult" }, { "tag": "Antirheumatic Agents .administration & dosage" }, { "tag": "Arthritis,Rheumatoid .drug therapy" }, { "tag": "Comparative Effectiveness Research" }, { "tag": "Humans.checkword DOI: 10.1345.1R203" }, { "tag": "Rheumatoid Arthritis", "type": 1 }, { "tag": "Treatment Outcome" }, { "tag": "adalimumab" }, { "tag": "anakinra" }, { "tag": "arthritis" }, { "tag": "biologic DMARD", "type": 1 }, { "tag": "discontinuation rates", "type": 1 }, { "tag": "disease modifying antirheumatic drug" }, { "tag": "effect size" }, { "tag": "etanercept" }, { "tag": "infliximab" }, { "tag": "meta analysis" }, { "tag": "meta-analysis", "type": 1 }, { "tag": "mixed treatment comparisons", "type": 1 }, { "tag": "observational study" }, { "tag": "patient" }, { "tag": "placebo" }, { "tag": "randomized controlled trial" }, { "tag": "rheumatoid arthritis" }, { "tag": "rituximab" }, { "tag": "tolerability", "type": 1 } ], "collections": [ "97W7TVIZ" ], "relations": { "dc:replaces": "http://zotero.org/groups/529271/items/BWKMFCDG" }, "dateAdded": "2016-05-10T17:11:58Z", "dateModified": "2019-12-10T17:23:59Z" } }, { "key": "WTMRN4T5", "version": 62, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/WTMRN4T5", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/WTMRN4T5", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/GEKIFA6N", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "WTMRN4T5", "version": 62, "parentItem": "GEKIFA6N", "itemType": "note", "note": "

REALISTIC

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:57Z" } }, { "key": "2EJJS5HZ", "version": 62, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/2EJJS5HZ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/2EJJS5HZ", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/GEKIFA6N", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "2EJJS5HZ", "version": 62, "parentItem": "GEKIFA6N", "itemType": "note", "note": "

NCT00717236

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:57Z" } }, { "key": "N4VKVFWE", "version": 62, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/N4VKVFWE", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/N4VKVFWE", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/GEKIFA6N", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "N4VKVFWE", "version": 62, "parentItem": "GEKIFA6N", "itemType": "note", "note": "

Incluir

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:57Z" } }, { "key": "GEKIFA6N", "version": 60, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/GEKIFA6N", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/GEKIFA6N", "type": "text/html" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "creatorSummary": "Weinblatt et al.", "parsedDate": "2012", "numChildren": 3 }, "data": { "key": "GEKIFA6N", "version": 60, "itemType": "journalArticle", "title": "Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study", "creators": [ { "creatorType": "author", "firstName": "M.E.", "lastName": "Weinblatt" }, { "creatorType": "author", "firstName": "R.", "lastName": "Fleischmann" }, { "creatorType": "author", "firstName": "T.W.", "lastName": "Huizinga" }, { "creatorType": "author", "firstName": "P.", "lastName": "Emery" }, { "creatorType": "author", "firstName": "J.", "lastName": "Pope" }, { "creatorType": "author", "firstName": "E.M.", "lastName": "Massarotti" }, { "creatorType": "author", "firstName": "R.F.", "lastName": "Vollenhoven" }, { "creatorType": "author", "firstName": "J.", "lastName": "Wollenhaupt" }, { "creatorType": "author", "firstName": "C.O.", "lastName": "Bingham" }, { "creatorType": "author", "firstName": "B.", "lastName": "Duncan" }, { "creatorType": "author", "firstName": "N.", "lastName": "Goel" }, { "creatorType": "author", "firstName": "O.R.", "lastName": "Davies" }, { "creatorType": "author", "firstName": "M.", "lastName": "Dougados" } ], "abstractNote": "OBJECTIVE: To investigate the efficacy and safety of certolizumab pegol (CZP) in a broad population of patients with active RA. METHODS: In this 12-week, double-blind period of the phase IIIb trial, RA patients with inadequate response to at least one DMARD were randomized 4:1 to CZP (400 mg at weeks 0, 2 and 4, followed by 200 mg every 2 weeks) or placebo (every 2 weeks) plus current therapy stratified by previous TNF inhibitor use, concomitant methotrexate use and disease duration (<2 vs ?2 years). The primary outcome was ACR20 response rate at week 12. RESULTS: Of 1063 patients (CZP = 851; placebo = 212), 37.6% had previous TNF inhibitor use. Baseline mean HAQ Disability Index (HAQ-DI) and DAS 28-joint assessment-ESR [DAS28(ESR)] values were 1.5 and 6.4 in the CZP group, and 1.6 and 6.4 in the placebo group, respectively. The primary endpoint was significant (week 12 ACR20, CZP vs placebo: 51.1 vs 25.9%; P < 0.001); differences were noted at week 2 (31.8 vs 8.5%; P < 0.001). HAQ-DI and DAS28(ESR) change from baseline and ACR50 were significant from week 2. Week 12 ACR20 responses were similar across CZP patient subgroups regardless of concomitant DMARD use at baseline. Adverse and serious adverse events were comparable between CZP and placebo, with no new safety signals. CONCLUSION: CZP was associated with rapid and consistent clinical responses and improved physical function in a diverse group of RA patients, irrespective of concomitant or previous therapy. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00717236", "publicationTitle": "Rheumatology", "publisher": "", "place": "", "date": "2012", "volume": "51", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "2204-2214", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Rheumatology (Oxford).", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "ACR20 response" }, { "tag": "Antibodies,Monoclonal,Humanized .adverse effects .therapeutic use" }, { "tag": "Antirheumatic Agents .adverse effects .therapeutic use" }, { "tag": "Arthritis,Rheumatoid .drug therapy" }, { "tag": "Double-Blind Method" }, { "tag": "Female.checkword" }, { "tag": "Humans.checkword" }, { "tag": "Immunoglobulin Fab Fragments .adverse effects .therapeutic use" }, { "tag": "Male.checkword" }, { "tag": "Middle Aged.checkword DOI: 10.1093/rheumatology/kes150" }, { "tag": "Polyethylene Glycols .adverse effects .therapeutic use" }, { "tag": "Treatment Outcome" }, { "tag": "arthritis" }, { "tag": "certolizumab pegol" }, { "tag": "disability" }, { "tag": "disease duration" }, { "tag": "methotrexate" }, { "tag": "patient" }, { "tag": "placebo" }, { "tag": "population" }, { "tag": "registration" }, { "tag": "rheumatoid arthritis" }, { "tag": "safety" }, { "tag": "therapy" } ], "collections": [ "97W7TVIZ", "ZKS7SZW5" ], "relations": { "dc:replaces": "http://zotero.org/groups/529271/items/MTE2KABM" }, "dateAdded": "2016-05-10T17:11:58Z", "dateModified": "2019-12-10T17:23:57Z" } }, { "key": "SPQIAQKT", "version": 62, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/SPQIAQKT", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/SPQIAQKT", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/T9JBJAZF", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } } }, "data": { "key": "SPQIAQKT", "version": 62, "parentItem": "T9JBJAZF", "itemType": "attachment", "linkMode": "linked_url", "title": "PubMed entry", "accessDate": "2016-03-09T10:18:46Z", "url": "http://www.ncbi.nlm.nih.gov/pubmed/22344576", "note": "", "contentType": "text/html", "charset": "", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:56Z" } }, { "key": "QN2HHQRN", "version": 62, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/QN2HHQRN", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/QN2HHQRN", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/T9JBJAZF", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } } }, "data": { "key": "QN2HHQRN", "version": 62, "parentItem": "T9JBJAZF", "itemType": "attachment", "linkMode": "imported_url", "title": "Snapshot", "accessDate": "2016-03-09T10:18:46Z", "url": "http://rheumatology.oxfordjournals.org/content/51/7/1226", "note": "", "contentType": "text/html", "charset": "utf-8", "filename": "1226.html", "md5": "2c3c8aae5e69f9295bc297d599583a8f", "mtime": 1462900415000, "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:56Z" } }, { "key": "58KECV3S", "version": 62, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/58KECV3S", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/58KECV3S", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/T9JBJAZF", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "58KECV3S", "version": 62, "parentItem": "T9JBJAZF", "itemType": "attachment", "linkMode": "imported_url", "title": "Full Text PDF", "accessDate": "2016-03-09T10:18:46Z", "url": "http://rheumatology.oxfordjournals.org/content/51/7/1226.full.pdf", "note": "", "contentType": "application/pdf", "charset": "", "filename": "Choy et al. - 2012 - Certolizumab pegol plus MTX administered every 4 w.pdf", "md5": "b41703838ccc348d9c27ec8d9d173ac0", "mtime": 1462900415000, "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:56Z" } }, { "key": "7ZX9F7VS", "version": 61, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/7ZX9F7VS", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/7ZX9F7VS", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/T9JBJAZF", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "7ZX9F7VS", "version": 61, "parentItem": "T9JBJAZF", "itemType": "note", "note": "

Muy antiguo debe estar

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:56Z" } }, { "key": "X8GQVVBM", "version": 61, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/X8GQVVBM", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/X8GQVVBM", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/T9JBJAZF", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "X8GQVVBM", "version": 61, "parentItem": "T9JBJAZF", "itemType": "note", "note": "
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CDP870-014 2009

\n
\n
\n
\n
", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:56Z" } }, { "key": "5P5PAUMR", "version": 61, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/5P5PAUMR", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/5P5PAUMR", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/T9JBJAZF", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "5P5PAUMR", "version": 61, "parentItem": "T9JBJAZF", "itemType": "note", "note": "

NCT00544154

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:56Z" } }, { "key": "T9JBJAZF", "version": 60, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/T9JBJAZF", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/T9JBJAZF", "type": "text/html" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "creatorSummary": "Choy et al.", "parsedDate": "2012", "numChildren": 6 }, "data": { "key": "T9JBJAZF", "version": 60, "itemType": "journalArticle", "title": "Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX", "creators": [ { "creatorType": "author", "firstName": "E.", "lastName": "Choy" }, { "creatorType": "author", "firstName": "F.", "lastName": "McKenna" }, { "creatorType": "author", "firstName": "J.", "lastName": "Vencovsky" }, { "creatorType": "author", "firstName": "R.", "lastName": "Valente" }, { "creatorType": "author", "firstName": "N.", "lastName": "Goel" }, { "creatorType": "author", "firstName": "B.", "lastName": "VanLunen" }, { "creatorType": "author", "firstName": "O.", "lastName": "Davies" }, { "creatorType": "author", "firstName": "H.D.", "lastName": "Stahl" }, { "creatorType": "author", "firstName": "R.", "lastName": "Alten" } ], "abstractNote": "OBJECTIVE: Certolizumab pegol (CZP) is known to be effective as monotherapy at a dosage of 400 ?mg every 4 weeks in patients with active RA who have failed DMARDs. The aim of this study was to investigate every 4-week CZP in addition to continued MTX therapy in patients with an inadequate response to MTX alone. METHODS: Patients with active RA with inadequate response to MTX, on background MTX, were randomized to double-blind treatment with CZP 400 ?mg or placebo every 4 weeks for 24 weeks (NCT00544154). The primary efficacy end-point was the ACR 20% improvement criteria (ACR20) response rate at Week 24. Other end-points included ACR50 and ACR70 response rates, ACR core components, 28-joint DAS (ESR) with three variables (DAS28-3) and health-related quality-of-life outcomes in addition to safety. RESULTS: Of 247 randomized patients, 126 received CZP and 121 received placebo, in addition to MTX. ACR20 response rates were 45.9 vs 22.9%, respectively [P?", "publicationTitle": "Rheumatology", "publisher": "", "place": "", "date": "2012", "volume": "51", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "1226-1234", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Rheumatology (Oxford).", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "ACR20", "type": 1 }, { "tag": "ACR20 response" }, { "tag": "ACR70 response" }, { "tag": "Adolescent" }, { "tag": "Adult.checkword" }, { "tag": "Aged.checkword" }, { "tag": "Anti-TNF", "type": 1 }, { "tag": "Antibodies,Monoclonal,Humanized .administration & dosage" }, { "tag": "Antirheumatic Agents .administration & dosage" }, { "tag": "Arthritis,Rheumatoid .diagnosis .drug therapy" }, { "tag": "Certolizumab pegol", "type": 1 }, { "tag": "DAS28-3", "type": 1 }, { "tag": "Disease Progression" }, { "tag": "Dose-Response Relationship,Drug" }, { "tag": "Double-Blind Method" }, { "tag": "Drug Administration Schedule" }, { "tag": "Drug Therapy,Combination" }, { "tag": "Female.checkword" }, { "tag": "Follow-Up Studies" }, { "tag": "Humans.checkword" }, { "tag": "Immunoglobulin Fab Fragments .administration & dosage" }, { "tag": "Immunologic Factors .administration & dosage" }, { "tag": "Male.checkword" }, { "tag": "Methotrexate", "type": 1 }, { "tag": "Methotrexate .administration & dosage" }, { "tag": "Middle Aged.checkword" }, { "tag": "Polyethylene Glycols .administration & dosage" }, { "tag": "Retrospective Studies" }, { "tag": "Rheumatoid Arthritis", "type": 1 }, { "tag": "Time Factors" }, { "tag": "Treatment Outcome" }, { "tag": "Young Adult.checkword DOI: 10.1093/rheumatology/ker519" }, { "tag": "certolizumab pegol" }, { "tag": "death" }, { "tag": "infection" }, { "tag": "monotherapy" }, { "tag": "opportunistic infection" }, { "tag": "patient" }, { "tag": "placebo" }, { "tag": "quality of life" }, { "tag": "safety" }, { "tag": "therapy" } ], "collections": [ "97W7TVIZ", "ZKS7SZW5" ], "relations": { "dc:replaces": "http://zotero.org/groups/529271/items/MCD6SKHM" }, "dateAdded": "2016-05-10T17:11:58Z", "dateModified": "2019-12-10T17:23:56Z" } }, { "key": "GC8W6J9V", "version": 63, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/GC8W6J9V", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/GC8W6J9V", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/GCHSH7CZ", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "GC8W6J9V", "version": 63, "parentItem": "GCHSH7CZ", "itemType": "note", "note": "

Study Results

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NCT00791921

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:52Z" } }, { "key": "IRURCC7F", "version": 63, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/IRURCC7F", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/IRURCC7F", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/GCHSH7CZ", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "IRURCC7F", "version": 63, "parentItem": "GCHSH7CZ", "itemType": "note", "note": "

HIKARI

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:52Z" } }, { "key": "JPBWTEA3", "version": 62, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/JPBWTEA3", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/JPBWTEA3", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/GCHSH7CZ", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "JPBWTEA3", "version": 62, "parentItem": "GCHSH7CZ", "itemType": "note", "note": "

Añadir ACR20, ACR50 y casar los datos

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:52Z" } }, { "key": "GCHSH7CZ", "version": 60, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/GCHSH7CZ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/GCHSH7CZ", "type": "text/html" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "creatorSummary": "Yamamoto et al.", "parsedDate": "2014", "numChildren": 12 }, "data": { "key": "GCHSH7CZ", "version": 60, "itemType": "journalArticle", "title": "Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: The HIKARI randomized, placebo-controlled trial", "creators": [ { "creatorType": "author", "firstName": "K.", "lastName": "Yamamoto" }, { "creatorType": "author", "firstName": "T.", "lastName": "Takeuchi" }, { "creatorType": "author", "firstName": "H.", "lastName": "Yamanaka" }, { "creatorType": "author", "firstName": "N.", "lastName": "Ishiguro" }, { "creatorType": "author", "firstName": "Y.", "lastName": "Tanaka" }, { "creatorType": "author", "firstName": "K.", "lastName": "Eguchi" }, { "creatorType": "author", "firstName": "A.", "lastName": "Watanabe" }, { "creatorType": "author", "firstName": "H.", "lastName": "Origasa" }, { "creatorType": "author", "firstName": "K.", "lastName": "Iwai" }, { "creatorType": "author", "firstName": "Y.", "lastName": "Sakamaki" }, { "creatorType": "author", "firstName": "D.", "lastName": "Van Der Heijde" }, { "creatorType": "author", "firstName": "N.", "lastName": "Miyasaka" }, { "creatorType": "author", "firstName": "T.", "lastName": "Koike" } ], "abstractNote": "Objective. This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis (RA) patients in whom methotrexate (MTX) cannot be administered. Methods. A total of 230 patients were randomized to subcutaneous CZP 200 mg (induction dosing: 400 mg at Weeks 0, 2 and 4) or placebo every 2 weeks. Results. ACR20 responses with CZP were rapid and significant versus placebo at Week 1, sustained to Week 12 (67.2% vs. 14.9%) and Week 24 (63.8% vs. 11.4%). Week 24-modified Total Sharp Score (mTSS) change from baseline (CFB) was 0.48 (CZP) versus 2.45 (placebo). CZP treatment was associated with higher Week 12 ACR20 responses versus placebo (with non-MTX disease modifying antirheumatic drugs [DMARDs], 74.2% vs. 20.0%; without [monotherapy], 59.3% vs. 8.2%) and inhibition of radiographic progression at Week 24 (mTSS CFB; with non-MTX DMARDs, 0.24 vs. 1.61; monotherapy, 0.68 vs. 3.65). Incidences of serious adverse events were 11.2% (CZP) and 2.6% (placebo); one CZP patient died of dissecting aortic aneurysm. Conclusion. CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX cannot be administered resulted in rapid, sustained reductions in RA signs and symptoms. Notably, CZP monotherapy showed significant inhibition of radiographic progression. �� 2014 The Authors", "publicationTitle": "Modern Rheumatology", "publisher": "", "place": "", "date": "2014", "volume": "24", "issue": "4", "section": "", "partNumber": "", "partTitle": "", "pages": "July", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.3109/14397595.2013.843764", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "1439-7595", "archive": "", "archiveLocation": "(Yamamoto) Department of Allergy and Rheumatology, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo 113-8655, Japan (Takeuchi) Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan (Yamanaka) Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan (Ishiguro) Department of Orthopedic Surgery, Nagoya University Graduate School, Faculty of Medicine, Nagoya, Aichi, Japan (Tanaka) First Department of Internal Medicine, University of Occupational and Environmental Health, Fukuoka, Japan (Eguchi) Sasebo City General Hospital, Sasebo, Nagasaki, Japan (Watanabe) Research Division for Development of Anti-Infectious Agents, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Miyagi, Japan (Origasa) Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Japan (Iwai) Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan (Sakamaki) Development-Japan, UCB Pharma, Tokyo, Japan (Van Der Heijde) Department of Rheumatology, Leiden University Medical Centre, Leiden, Netherlands (Miyasaka) Department of Medicine and Rheumatology, Graduate School of Medicine and Dentistry, Tokyo Medical and Dental University, Tokyo, Japan (Koike) Department of Medicine II, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "NCT00791921/ClinicalTrials.gov", "rights": "", "extra": "", "tags": [ { "tag": "*certolizumab pegol/ae [Adverse Drug Reaction]" }, { "tag": "*certolizumab pegol/cr [Drug Concentration]" }, { "tag": "*certolizumab pegol/dt [Drug Therapy]" }, { "tag": "*certolizumab pegol/pk [Pharmacokinetics]" }, { "tag": "*certolizumab pegol/sc [Subcutaneous Drug Administration]" }, { "tag": "*drug efficacy" }, { "tag": "*drug safety" }, { "tag": "*rheumatoid arthritis/dt [Drug Therapy]" }, { "tag": "12244-57-4 (aurothiomalate)" }, { "tag": "15475-56-6 (methotrexate)" }, { "tag": "18699-02-0 (actarit)" }, { "tag": "34031-32-8 (auranofin)" }, { "tag": "428863-50-7 (certolizumab pegol)" }, { "tag": "50924-49-7 (mizoribine)" }, { "tag": "59-05-2 (methotrexate)" }, { "tag": "599-79-1 (salazosu" }, { "tag": "65002-17-7 (bucillamine)" }, { "tag": "7413-34-5 (methotrexate)" }, { "tag": "Adult" }, { "tag": "Embase" }, { "tag": "Japan" }, { "tag": "Japanese (people)" }, { "tag": "Male" }, { "tag": "Pneumococcus vaccine" }, { "tag": "Pneumocystis pneumonia/si [Side Effect]" }, { "tag": "Streptococcus pneumonia/si [Side Effect]" }, { "tag": "actarit" }, { "tag": "aged" }, { "tag": "aorta dissecting aneurysm/si [Side Effect]" }, { "tag": "arthritis" }, { "tag": "article" }, { "tag": "auranofin" }, { "tag": "aurothiomalate" }, { "tag": "bacterial arthritis/si [Side Effect]" }, { "tag": "bucillamine" }, { "tag": "certolizumab pegol" }, { "tag": "constipation/si [Side Effect]" }, { "tag": "controlled study" }, { "tag": "corticosteroid" }, { "tag": "disease course" }, { "tag": "disease modifying antirheumatic drug" }, { "tag": "double blind procedure" }, { "tag": "drug blood level" }, { "tag": "eczema/si [Side Effect]" }, { "tag": "female" }, { "tag": "foot radiography" }, { "tag": "hand radiography" }, { "tag": "hematoma/si [Side Effect]" }, { "tag": "herpes zoster/si [Side Effect]" }, { "tag": "human" }, { "tag": "hypertension/si [Side Effect]" }, { "tag": "incidence" }, { "tag": "injection site erythema/si [Side Effect]" }, { "tag": "injection site reaction/si [Side Effect]" }, { "tag": "major clinical study" }, { "tag": "methotrexate" }, { "tag": "mizoribine" }, { "tag": "monotherapy" }, { "tag": "multicenter study" }, { "tag": "nonsteroid antiinflammatory agent" }, { "tag": "patient" }, { "tag": "pharyngitis/si [Side Effect]" }, { "tag": "placebo" }, { "tag": "priority journal" }, { "tag": "randomized controlled trial" }, { "tag": "rash/si [Side Effect]" }, { "tag": "remission" }, { "tag": "rheumatoid arthritis" }, { "tag": "rhinopharyngitis/si [Side Effect]" }, { "tag": "safety" }, { "tag": "salazosulfapyridine" }, { "tag": "sodium chloride" }, { "tag": "tacrolimus" }, { "tag": "upper respiratory tract infection/si [Side Effect]" } ], "collections": [ "IXV75ZCJ", "ZKS7SZW5" ], "relations": { "dc:replaces": "http://zotero.org/groups/529271/items/Q765PK8C" }, "dateAdded": "2016-05-10T17:12:24Z", "dateModified": "2019-12-10T17:23:52Z" } 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Study Results

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NCT00791999

", "tags": [], "relations": {}, "dateAdded": "2016-05-10T17:13:31Z", "dateModified": "2019-12-10T17:23:50Z" } }, { "key": "MPHA3EFB", "version": 60, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/MPHA3EFB", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/MPHA3EFB", "type": "text/html" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "creatorSummary": "Yamamoto et al.", "parsedDate": "2014", "numChildren": 7 }, "data": { "key": "MPHA3EFB", "version": 60, "itemType": "journalArticle", "title": "Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial", "creators": [ { "creatorType": "author", "firstName": "K.", "lastName": "Yamamoto" }, { "creatorType": "author", "firstName": "T.", "lastName": "Takeuchi" }, { "creatorType": "author", "firstName": "H.", "lastName": "Yamanaka" }, { "creatorType": "author", "firstName": "N.", "lastName": "Ishiguro" }, { "creatorType": "author", "firstName": "Y.", "lastName": "Tanaka" }, { "creatorType": "author", "firstName": "K.", "lastName": "Eguchi" }, { "creatorType": "author", "firstName": "A.", "lastName": "Watanabe" }, { "creatorType": "author", "firstName": "H.", "lastName": "Origasa" }, { "creatorType": "author", "firstName": "T.", "lastName": "Shoji" }, { "creatorType": "author", "firstName": "Y.", "lastName": "Sakamaki" }, { "creatorType": "author", "firstName": "D.", "lastName": "Van Der Heijde" }, { "creatorType": "author", "firstName": "N.", "lastName": "Miyasaka" }, { "creatorType": "author", "firstName": "T.", "lastName": "Koike" } ], "abstractNote": "Objectives. This 24-week, multicenter, double-blind, randomized, placebo-controlled study (NCT00791999) compared efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) vs placebo plus MTX in Japanese rheumatoid arthritis (RA) patients with inadequate response to MTX. Methods. In total, 316 patients were randomized 1:1:1:1 to subcutaneous CZP 100, 200, or 400 mg (induction dose: 200 mg or 400 mg CZP at Weeks 0, 2, and 4) plus MTX or placebo plus MTX every 2 weeks. Primary endpoint was ACR20 response at Week 12. Results. ACR20 response rates were 62.5%, 76.8%, 77.6%, and 28.6% at Week 12, and 61.1%, 73.2%, 71.8%, and 24.7% at Week 24 for CZP 100, 200, and 400 mg, and placebo groups, respectively, with statistical significance between each CZP group and placebo. Change in Total Sharp Score over 24 weeks was significantly smaller in CZP 200 and 400 mg groups vs placebo. Improvements in health-related quality of life (HRQoL) were observed in all three CZP groups vs placebo. Incidence of adverse events was similar between CZP groups. Conclusions. CZP plus MTX resulted in rapid, sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX, with significant inhibition of radiographic progression and improved HRQoL. �� 2014 The Authors", "publicationTitle": "Modern Rheumatology", "publisher": "", "place": "", "date": "2014", "volume": "24", "issue": "5", "section": "", "partNumber": "", "partTitle": "", "pages": "September", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.3109/14397595.2013.864224", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "1439-7595", "archive": "", "archiveLocation": "(Yamamoto) Department of Allergy and Rheumatology, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, Japan (Takeuchi) Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan (Yamanaka) Institute of Rheumatology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan (Ishiguro) Department of Orthopedic Surgery, Nagoya University Graduate School and Faculty of Medicine, Nagoya, Aichi, Japan (Tanaka) First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Fukuoka, Japan (Eguchi) Sasebo City General Hospital, Sasebo, Nagasaki, Japan (Watanabe) Research Division for Development of Anti-Infectious Agents, Institute of Development, Aging and Cancer, Tohoku University, Sendai, Miyagi, Japan (Origasa) Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Toyama, Japan (Shoji) Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd, Shinagawa-ku, Tokyo, Japan (Sakamaki) UCB Japan, Shinjuku-ku, Tokyo, Japan (Van Der Heijde) Department of Rheumatology, Leiden University Medical Centre, Leiden, Netherlands (Miyasaka) Department of Medicine and Rheumatology, Graduate School of Medicine and Dentistry, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan (Koike) Department of Medicine II, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "NCT00791999/ClinicalTrials.gov", "rights": "", "extra": "", "tags": [ { "tag": "*certolizumab pegol/ae [Adverse Drug Reaction]" }, { "tag": "*certolizumab pegol/cb [Drug Combination]" }, { "tag": "*certolizumab pegol/cr [Drug Concentration]" }, { "tag": "*certolizumab pegol/dt [Drug Therapy]" }, { "tag": "*certolizumab pegol/pd [Pharmacology]" }, { "tag": "*certolizumab pegol/pk [Pharmacokinetics]" }, { "tag": "*certolizumab pegol/sc [Subcutaneous Drug Administration]" }, { "tag": "*drug efficacy" }, { "tag": "*drug safety" }, { "tag": "*methotrexate/ae [Adverse Drug Reaction]" }, { "tag": "*methotrexate/cb [Drug Combination]" }, { "tag": "*methotrexate/dt [Drug Therapy]" }, { "tag": "*rheumatoid arthritis/dt [Drug Therapy]" }, { "tag": "15475-56-6 (methotrexate)" }, { "tag": "428863-50-7 (certolizumab pegol)" }, { "tag": "53-03-2 (prednisone)" }, { "tag": "59-05-2 (methotrexate)" }, { "tag": "7413-34-5 (methotrexate)" }, { "tag": "9000-86-6 (alanine aminotransferase)" }, { "tag": "9000-97-9 (aspartate aminotransferase)" }, { "tag": "9014-30-6 (alanine aminotransferase)" }, { "tag": "Adult" }, { "tag": "Embase" }, { "tag": "Japan" }, { "tag": "Japanese (people)" }, { "tag": "Male" }, { "tag": "Short Form 36" }, { "tag": "acute heart infarction/si [Side Effect]" }, { "tag": "aged" }, { "tag": "alanine aminotransferase blood level" }, { "tag": "alanine aminotransferase/ec [Endogenous Compound]" }, { "tag": "allergic conjunctivitis/si [Side Effect]" }, { "tag": "anus fistula/si [Side Effect]" }, { "tag": "arthritis" }, { "tag": "article" }, { "tag": "aspartate aminotransferase blood level" }, { "tag": "aspartate aminotransferase/ec [Endogenous Compound]" }, { "tag": "bone marrow depression/si [Side Effect]" }, { "tag": "bronchitis/si [Side Effect]" }, { "tag": "certolizumab pegol" }, { "tag": "compression fracture/si [Side Effect]" }, { "tag": "controlled study" }, { "tag": "cornea perforation/si [Side Effect]" }, { "tag": "cyclooxygenase 2 inhibitor" }, { "tag": "disease course" }, { "tag": "disease exacerbation/si [Side Effect]" }, { "tag": "disease severity" }, { "tag": "double blind procedure" }, { "tag": "drug blood level" }, { "tag": "drug dose comparison" }, { "tag": "eczema/si [Side Effect]" }, { "tag": "female" }, { "tag": "hematoma/si [Side Effect]" }, { "tag": "human" }, { "tag": "incidence" }, { "tag": "infection/si [Side Effect]" }, { "tag": "infestation/si [Side Effect]" }, { "tag": "injection site bleeding/si [Side Effect]" }, { "tag": "injection site erythema/si [Side Effect]" }, { "tag": "injection site mass/si [Side Effect]" }, { "tag": "injection site reaction/si [Side Effect]" }, { "tag": "interstitial lung disease/si [Side Effect]" }, { "tag": "major clinical study" }, { "tag": "methotrexate" }, { "tag": "multicenter study" }, { "tag": "nonsteroid antiinflammatory agent" }, { "tag": "patient" }, { "tag": "pharyngitis/si [Side Effect]" }, { "tag": "placebo" }, { "tag": "pneumonia/si [Side Effect]" }, { "tag": "prednisone" }, { "tag": "priority journal" }, { "tag": "pyelonephritis/si [Side Effect]" }, { "tag": "pyomyositis/si [Side Effect]" }, { "tag": "quality of life" }, { "tag": "randomized controlled trial" }, { "tag": "rheumatoid arthritis" }, { "tag": "safety" }, { "tag": "treatment duration" }, { "tag": "treatment response" }, { "tag": "upper respiratory tract infection/si [Side Effect]" } ], "collections": [ "IXV75ZCJ", "ZKS7SZW5" ], "relations": { "dc:replaces": "http://zotero.org/groups/529271/items/FZVFNAIN" }, "dateAdded": "2016-05-10T17:12:24Z", "dateModified": "2019-12-10T17:23:50Z" } }, { "key": "MWP8N6GQ", "version": 60, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/MWP8N6GQ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/MWP8N6GQ", "type": "text/html" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "creatorSummary": "Landewe et al.", "parsedDate": "2013", "numChildren": 0 }, "data": { "key": "MWP8N6GQ", "version": 60, "itemType": "journalArticle", "title": "Effect of certolizumab pegol over 48 weeks in patients with axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis", "creators": [ { "creatorType": "author", "firstName": "R.B.M.", "lastName": "Landewe" }, { "creatorType": "author", "firstName": "M.", "lastName": "Rudwaleit" }, { "creatorType": "author", "firstName": "D.M.", "lastName": "Heijde" }, { "creatorType": "author", "firstName": "M.", "lastName": "Dougados" }, { "creatorType": "author", "firstName": "P.J.", "lastName": "Mease" }, { "creatorType": "author", "firstName": "J.D.", "lastName": "Reveille" }, { "creatorType": "author", "firstName": "J.", "lastName": "Walsh" }, { "creatorType": "author", "firstName": "A.J.", "lastName": "Kivitz" }, { "creatorType": "author", "firstName": "W.P.", "lastName": "Maksymowych" }, { "creatorType": "author", "firstName": "J.", "lastName": "Braun" }, { "creatorType": "author", "firstName": "A.A.", "lastName": "Deodhar" }, { "creatorType": "author", "firstName": "C.", "lastName": "Stach" }, { "creatorType": "author", "firstName": "B.", "lastName": "Hoepken" }, { "creatorType": "author", "firstName": "P.", "lastName": "Singh" }, { "creatorType": "author", "firstName": "J.", "lastName": "Sieper" } ], "abstractNote": "Background/Purpose: Previous reports of RAPID-axSpA have demonstrated the efficacy and safety of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, in patients (pts) with axial spondyloarthritis (axSpA) including pts with ankylosing spondylitis (AS, meeting modified New York criteria) and pts with no sacroiliitis on X-ray (non-radiographic axSpA, nr-axSpA), to Week (Wk) 24.1 We report clinical efficacy and safety of CZP in axSpA pts to Wk48. Methods: The ongoing RAPID-axSpA trial (NCT01087762) is doubleblind and placebo (PBO) controlled to Wk24 and dose-blind to Wk48.1 Pts fulfilled ASAS criteria2 and had active axSpA, including both AS pts and nr-axSpA pts. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in dose-blind phase; PBO pts entering dose-blind phase were re-randomized to CZP loading dose followed by CZP 200mg Q2W or CZP 400mg Q4W after Wk24 or, for non-responders Wk16. We present efficacy data for all pts originally randomized to CZP and imaging outcomes for all pts included in the imaging sub-study (MRI set). Endpoints included ASAS20 and ASAS40 responses, ASAS PR and ASDAS outcomes. Also included were BASDAI, BASFI, BASMI-linear, total spine pain, fatigue, ASQoL, SPARCC and ASspiMRI-a. Outcomes are presented at Wk24 and Wk48. NRI was used for categorical measures and LOCF for quantitative measures. Safety sets consists of all pts treated with CZP at any stage of the 48-wk trial. Results: 325 pts were randomized, of which 218 received CZP from Wk0. Of pts randomized to CZP at baseline (BL), 93% completed Wk24 and 88% Wk48. ASAS20, ASAS40 and ASAS PR were maintained from Wk24 to 48 (Table) and improvements from BL in BASDAI, BASFI, BASMIlinear, ASDAS and ASDAS-ID were also maintained to Wk48 (Table). Reductions in pain, fatigue and ASQoL were also observed between Wk24 and Wk48 (Table). In the MRI sub-study (CZP N=104), reduction of inflammation, as measured by SPARCC and ASspiMRI-a, was maintained to Wk48. Similar improvements were seen with both dosing regimens and in both AS and nr-axSpA subpopulations (Table). In the safety set (N=315), adverse events (AEs) occurred in 248 pts (78.7%; event rate per 100 pt-yrs=419.5), serious AEs in 25 (7.9%). Serious infections occurred in 10 (3.2%) pts, including suspected tuberculosis in 3 (1.0%) of which 1 was confirmed (from Mexico). No deaths or malignancies were reported. (Table Presented) Conclusion: In the RAPID-axSpA trial, improvements observed over 24 wks in clinical efficacy, patient-reported and MRI outcomes were sustained over 48 wks in both CZP dosing regimens. Similar sustained improvements in clinical, patient-reported and MRI outcomes were observed in both AS and nr-axSpA subpopulations. The safety profile was in line with that observed for CZP in RA", "publicationTitle": "Arthritis and Rheumatism", "publisher": "", "place": "", "date": "2013", "volume": "65", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "S767", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Arthritis Rheum.", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Ankylosing Spondylitis Disease Activity Score" }, { "tag": "Bath ankylosing spondylitis disease activity index" }, { "tag": "Bath ankylosing spondylitis functional index" }, { "tag": "Mexico" }, { "tag": "United States" }, { "tag": "X ray" }, { "tag": "ankylosing spondylitis" }, { "tag": "certolizumab pegol" }, { "tag": "college" }, { "tag": "death" }, { "tag": "fatigue" }, { "tag": "health practitioner" }, { "tag": "human" }, { "tag": "imaging" }, { "tag": "infection" }, { "tag": "inflammation" }, { "tag": "loading drug dose" }, { "tag": "nuclear magnetic resonance imaging" }, { "tag": "pain" }, { "tag": "patient" }, { "tag": "placebo" }, { "tag": "placebo DOI: 10.1002.38216" }, { "tag": "placebo DOI: 10.3899.140420" }, { "tag": "rheumatology" }, { "tag": "sacroiliitis" }, { "tag": "safety" }, { "tag": "spine" }, { "tag": "spondylarthritis" }, { "tag": "spondylitis" }, { "tag": "tuberculosis" } ], "collections": [ "97W7TVIZ", "IXV75ZCJ" ], "relations": { "dc:replaces": "http://zotero.org/groups/529271/items/QXSHT3QR" }, "dateAdded": "2016-05-10T17:11:58Z", "dateModified": "2019-12-10T17:23:36Z" } }, { "key": "2X3Q9JNH", "version": 63, "library": { "type": "group", "id": 529271, "name": "CZP 2016", "links": { "alternate": { "href": "https://www.zotero.org/groups/czp_2016", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/529271/items/2X3Q9JNH", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/czp_2016/items/2X3Q9JNH", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/529271/items/W5U347HT", "type": "application/json" } }, "meta": { "createdByUser": { "id": 190164, "username": "vicente ruiz", "name": "Vicente ruiz", "links": { "alternate": { "href": "https://www.zotero.org/vicente_ruiz", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "2X3Q9JNH", "version": 63, "parentItem": "W5U347HT", "itemType": "note", "note": "

OLE

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DB - Ovid MEDLINE(R)

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