Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial
Identifieur interne : 000382 ( Main/Exploration ); précédent : 000381; suivant : 000383Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial
Auteurs : Michael E. Weinblatt [États-Unis] ; Clifton O. Bingham [États-Unis] ; Alan M. Mendelsohn [États-Unis] ; Lilianne Kim [États-Unis] ; Michael Mack [États-Unis] ; Jiandong Lu [États-Unis] ; Daniel Baker [États-Unis] ; Rene Westhovens [Belgique]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013-03.
Abstract
Objectives Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX. Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24. Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.
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DOI: 10.1136/annrheumdis-2012-201411
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Weinblatt</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Bingham, Clifton O" sort="Bingham, Clifton O" uniqKey="Bingham C" first="Clifton O" last="Bingham">Clifton O. Bingham</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Rheumatology, Johns Hopkins, Baltimore, Maryland</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Mendelsohn, Alan M" sort="Mendelsohn, Alan M" uniqKey="Mendelsohn A" first="Alan M" last="Mendelsohn">Alan M. 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Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24. Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.</div></front></TEI><affiliations><list><country><li>Belgique</li><li>États-Unis</li></country><region><li>Maryland</li><li>Massachusetts</li><li>Pennsylvanie</li></region></list><tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Weinblatt, Michael E" sort="Weinblatt, Michael E" uniqKey="Weinblatt M" first="Michael E" last="Weinblatt">Michael E. Weinblatt</name></region><name sortKey="Baker, Daniel" sort="Baker, Daniel" uniqKey="Baker D" first="Daniel" last="Baker">Daniel Baker</name><name sortKey="Bingham, Clifton O" sort="Bingham, Clifton O" uniqKey="Bingham C" first="Clifton O" last="Bingham">Clifton O. Bingham</name><name sortKey="Kim, Lilianne" sort="Kim, Lilianne" uniqKey="Kim L" first="Lilianne" last="Kim">Lilianne Kim</name><name sortKey="Lu, Jiandong" sort="Lu, Jiandong" uniqKey="Lu J" first="Jiandong" last="Lu">Jiandong Lu</name><name sortKey="Mack, Michael" sort="Mack, Michael" uniqKey="Mack M" first="Michael" last="Mack">Michael Mack</name><name sortKey="Mendelsohn, Alan M" sort="Mendelsohn, Alan M" uniqKey="Mendelsohn A" first="Alan M" last="Mendelsohn">Alan M. Mendelsohn</name></country><country name="Belgique"><noRegion><name sortKey="Westhovens, Rene" sort="Westhovens, Rene" uniqKey="Westhovens R" first="Rene" last="Westhovens">Rene Westhovens</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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