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Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial

DC Field Value Language
dc.contributor.author박민찬-
dc.date.accessioned2014-12-18T08:36:33Z-
dc.date.available2014-12-18T08:36:33Z-
dc.date.issued2013-
dc.identifier.issn0140-6736-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/86624-
dc.description.abstractBACKGROUND: Clinical remission and low disease activity are essential treatment targets in patients with rheumatoid arthritis. Although moderately active rheumatoid arthritis is common, treatment effects in moderate disease have not been well studied. Additionally, optimum use of biologics needs further investigation, including the use of induction, maintenance, and withdrawal treatment strategies. The aim of the PRESERVE trial was to assess whether low disease activity would be sustained with reduced doses or withdrawal of etanercept in patients with moderately active disease. METHODS: In a randomised controlled trial, patients aged between 18 and 70 years with moderately active rheumatoid arthritis (disease activity score in 28 joints [DAS28] >3.2 and ≤5.1) despite treatment with methotrexate were enrolled at 80 centres in Europe, Latin America, Asia, and Australia between March 6, 2008, and Sept 9, 2009. To be eligible, patients had to have been receiving 15-25 mg of methotrexate every week for at least 8 weeks. In an open-label period of 36 weeks, all patients were given 50 mg etanercept plus methotrexate every week. To be eligible for a subsequent double-blind period of 52 weeks, participants had to have achieved sustained low disease activity. These patients were randomly assigned (1:1:1) by an interactive voice-response system to one of three treatment groups: 50 mg etanercept plus methotrexate, 25 mg etanercept plus methotrexate, or placebo plus methotrexate. Patients were stratified in blocks of three by DAS28 response (low disease activity or remission) at week 36. Patients, investigators, data analysts, and study staff were all masked to treatment allocation. The primary endpoint was the proportion of patients with low disease activity at week 88 in the groups given 50 mg etanercept or placebo in the double-blind period. A conditional primary endpoint was the proportion of patients receiving 25 mg etanercept who achieved low disease activity. Modified intention-to-treat populations were used for analyses. This trial is registered with ClinicalTrials.gov, number NCT00565409. FINDINGS: 604 (72.4%) of 834 enrolled patients were eligible for the double-blind period, of whom 202 were assigned to 50 mg etanercept plus methotrexate, 202 to 25 mg etanercept plus methotrexate, and 200 to placebo plus methotrexate. At week 88, 166 (82.6%) of 201 patients who had received at least one dose of 50 mg etanercept and one or more DAS28 evaluations had low disease activity, compared with 84 (42.6%) of 197 who had received placebo (mean difference 40.8%, 95% CI 32.5-49.1%; p<0.0001). Additionally, 159 (79.1%) of 201 patients given 25 mg etanercept had low disease activity at week 88 (mean difference from placebo 35.9%, 27.0-44.8%; p<0.0001). INTERPRETATION: Conventional or reduced doses of etanercept with methotrexate in patients with moderately active rheumatoid arthritis more effectively maintain low disease activity than does methotrexate alone after withdrawal of etanercept. FUNDING: Pfizer.-
dc.description.statementOfResponsibilityopen-
dc.relation.isPartOfLANCET-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAntirheumatic Agents/administration & dosage-
dc.subject.MESHAntirheumatic Agents/therapeutic use*-
dc.subject.MESHArthralgia/etiology-
dc.subject.MESHArthralgia/prevention & control*-
dc.subject.MESHArthritis, Rheumatoid/complications-
dc.subject.MESHArthritis, Rheumatoid/diagnostic imaging-
dc.subject.MESHArthritis, Rheumatoid/drug therapy*-
dc.subject.MESHArthritis, Rheumatoid/physiopathology-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Administration Schedule-
dc.subject.MESHDrug Therapy, Combination-
dc.subject.MESHEtanercept-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHImmunoglobulin G/administration & dosage-
dc.subject.MESHImmunoglobulin G/therapeutic use*-
dc.subject.MESHMaintenance Chemotherapy-
dc.subject.MESHMale-
dc.subject.MESHMethotrexate/administration & dosage-
dc.subject.MESHMethotrexate/therapeutic use*-
dc.subject.MESHMiddle Aged-
dc.subject.MESHRadiography-
dc.subject.MESHReceptors, Tumor Necrosis Factor/administration & dosage-
dc.subject.MESHReceptors, Tumor Necrosis Factor/therapeutic use*-
dc.subject.MESHSeverity of Illness Index-
dc.subject.MESHTime Factors-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHTumor Necrosis Factor-alpha/antagonists & inhibitors*-
dc.titleMaintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학)-
dc.contributor.googleauthorJosef S Smolen-
dc.contributor.googleauthorPeter Nash-
dc.contributor.googleauthorPatrick Durez-
dc.contributor.googleauthorStephen Hall-
dc.contributor.googleauthorElena Ilivanova-
dc.contributor.googleauthorFedra Irazoque-Palazuelos-
dc.contributor.googleauthorPedro Miranda-
dc.contributor.googleauthorMin-Chan Park-
dc.contributor.googleauthorKarel Pavelka-
dc.contributor.googleauthorRonald Pedersen-
dc.contributor.googleauthorAnnette Szumski-
dc.contributor.googleauthorConstance Hammond-
dc.contributor.googleauthorAndrew S Koenig-
dc.contributor.googleauthorBonnie Vlahos-
dc.identifier.doi10.1016/S0140-6736(12)61811-X-
dc.admin.authorfalse-
dc.admin.mappingfalse-
dc.contributor.localIdA01470-
dc.relation.journalcodeJ02152-
dc.identifier.eissn1474-547X-
dc.identifier.pmid23332236-
dc.identifier.urlhttp://www.sciencedirect.com/science/article/pii/S014067361261811X-
dc.subject.keywordAdult-
dc.subject.keywordAged-
dc.subject.keywordAntirheumatic Agents/administration & dosage-
dc.subject.keywordAntirheumatic Agents/therapeutic use*-
dc.subject.keywordArthralgia/etiology-
dc.subject.keywordArthralgia/prevention & control*-
dc.subject.keywordArthritis, Rheumatoid/complications-
dc.subject.keywordArthritis, Rheumatoid/diagnostic imaging-
dc.subject.keywordArthritis, Rheumatoid/drug therapy*-
dc.subject.keywordArthritis, Rheumatoid/physiopathology-
dc.subject.keywordDouble-Blind Method-
dc.subject.keywordDrug Administration Schedule-
dc.subject.keywordDrug Therapy, Combination-
dc.subject.keywordEtanercept-
dc.subject.keywordFemale-
dc.subject.keywordHumans-
dc.subject.keywordImmunoglobulin G/administration & dosage-
dc.subject.keywordImmunoglobulin G/therapeutic use*-
dc.subject.keywordMaintenance Chemotherapy-
dc.subject.keywordMale-
dc.subject.keywordMethotrexate/administration & dosage-
dc.subject.keywordMethotrexate/therapeutic use*-
dc.subject.keywordMiddle Aged-
dc.subject.keywordRadiography-
dc.subject.keywordReceptors, Tumor Necrosis Factor/administration & dosage-
dc.subject.keywordReceptors, Tumor Necrosis Factor/therapeutic use*-
dc.subject.keywordSeverity of Illness Index-
dc.subject.keywordTime Factors-
dc.subject.keywordTreatment Outcome-
dc.subject.keywordTumor Necrosis Factor-alpha/antagonists & inhibitors*-
dc.contributor.alternativeNamePark, Min Chan-
dc.contributor.affiliatedAuthorPark, Min Chan-
dc.rights.accessRightsnot free-
dc.citation.volume381-
dc.citation.number9870-
dc.citation.startPage918-
dc.citation.endPage929-
dc.identifier.bibliographicCitationLANCET, Vol.381(9870) : 918-929, 2013-
dc.identifier.rimsid29102-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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