OcrV1, Main, Exploration, bibRecord, 000297

Safety and efficacy of ocrelizumab in combination with methotrexate in MTX-naive subjects with rheumatoid arthritis: the phase III FILM trial

Identifieur interne : 000297 ( Main/Exploration ); précédent : 000296; suivant : 000298

Safety and efficacy of ocrelizumab in combination with methotrexate in MTX-naive subjects with rheumatoid arthritis: the phase III FILM trial

Auteurs : William Stohl [États-Unis] ; Juan Gomez-Reino [Espagne] ; Ewa Olech [États-Unis] ; Jean Dudler [Suisse] ; Roy M. Fleischmann [États-Unis] ; Cristiano A. F. Zerbini [Brésil] ; Ali Ashrafzadeh [États-Unis] ; Susanna Grzeschik [États-Unis] ; Rebecca Bieraugel [Royaume-Uni] ; Jennifer Green [Royaume-Uni] ; Steven Francom [États-Unis] ; Wolfgang Dummer [États-Unis]

Source :

Annals of the rheumatic diseases [ 0003-4967 ] ; 2012.

RBID : Pascal:12-0321593

Descripteurs français

Pascal (Inist)
- Polyarthrite rhumatoïde, Ocrélizumab, Chimiothérapie, Toxicité, Méthotrexate, Homme, Essai clinique phase III, Rhumatologie, Immunomodulateur, Antirhumatismal, Anticancéreux, Chronique.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Antineoplastic agent, Antirheumatic agent, Chemotherapy, Chronic, Human, Immunomodulator, Methotrexate, Ocrelizumab, Phase III trial, Rheumatoid arthritis, Rheumatology, Toxicity.

Abstract

Objective To determine the efficacy and safety of ocrelizumab (OCR) with methotrexate (MTX) in MTX-naive rheumatoid arthritis (RA) patients. Methods In a randomised, double-blind, controlled trial, patients received placebo+MTX (MTX; n=210), OCR 200 mg×2+MTX (OCR 200; n=200) or OCR 500 mg×2+MTX (OCR 500; n=203). OCR/placebo (two intravenous infusions) was given on days 1 and 15, with fixed re-treatment scheduled at weeks 24/26, 52/54 and 76/78. Due to early termination of OCR dosing, there was no formal primary end point analysis (change from baseline in modified total Sharp score (ΔmTSS) at week 104). Analyses are reported for week 52 outcomes. Results At week 52, treatment with OCR + MTX compared with MTX alone reduced progression of joint damage (mean (SD) change in ΔmTSS: OCR 200, 0.66 (4.51); OCR 500, 0.27 (2.91); MTX alone, 1.59 (4.82); p = 0.001 and p = 0.003, respectively vs MTX alone) and improved clinical signs and symptoms (American College of Rheumatology 20 response: OCR 200, 73.0%; OCR 500, 71.0%; MTX alone, 57.5%; p<0.005 for each OCR vs MTX alone). Serious infection rates per 100 patient-years were similar with OCR 200 and MTX alone (2.6 (95% CI 0.9 to 6.1 ) and 3.0 (1.1 to 6.5), respectively), but higher with OCR 500 (7.1 (3.9 to 11.9)). Conclusions OCR 200 mg and 500 mg with MTX in MTX-naive patients with RA were effective in inhibiting joint damage progression and improving RA signs and symptoms. OCR 500 mg with MTX was associated with an increased rate of serious infections.

Affiliations:

Brésil, Espagne, Royaume-Uni, Suisse, États-Unis
Californie, Oklahoma, Texas, État de São Paulo
São Paulo

Links toward previous steps (curation, corpus...)

to stream PascalFrancis, to step Corpus: 000084
to stream PascalFrancis, to step Curation: 000688
to stream PascalFrancis, to step Checkpoint: 000059
to stream Main, to step Merge: 000300
to stream Main, to step Curation: 000297

Le document en format XML

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<author><name sortKey="Gomez Reino, Juan" sort="Gomez Reino, Juan" uniqKey="Gomez Reino J" first="Juan" last="Gomez-Reino">Juan Gomez-Reino</name>
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<author><name sortKey="Zerbini, Cristiano A F" sort="Zerbini, Cristiano A F" uniqKey="Zerbini C" first="Cristiano A. F." last="Zerbini">Cristiano A. F. Zerbini</name>
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<author><name sortKey="Ashrafzadeh, Ali" sort="Ashrafzadeh, Ali" uniqKey="Ashrafzadeh A" first="Ali" last="Ashrafzadeh">Ali Ashrafzadeh</name>
<affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Genentech Inc, South San Francisco</s1>
<s2>California</s2>
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<placeName><region type="state">Californie</region>
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<author><name sortKey="Grzeschik, Susanna" sort="Grzeschik, Susanna" uniqKey="Grzeschik S" first="Susanna" last="Grzeschik">Susanna Grzeschik</name>
<affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Genentech Inc, South San Francisco</s1>
<s2>California</s2>
<s3>USA</s3>
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<placeName><region type="state">Californie</region>
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<author><name sortKey="Bieraugel, Rebecca" sort="Bieraugel, Rebecca" uniqKey="Bieraugel R" first="Rebecca" last="Bieraugel">Rebecca Bieraugel</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Roche Products Ltd</s1>
<s2>Welwyn Garden City</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
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</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Roche Products Ltd</wicri:noRegion>
</affiliation>
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<author><name sortKey="Green, Jennifer" sort="Green, Jennifer" uniqKey="Green J" first="Jennifer" last="Green">Jennifer Green</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Roche Products Ltd</s1>
<s2>Welwyn Garden City</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Roche Products Ltd</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Francom, Steven" sort="Francom, Steven" uniqKey="Francom S" first="Steven" last="Francom">Steven Francom</name>
<affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Genentech Inc, South San Francisco</s1>
<s2>California</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dummer, Wolfgang" sort="Dummer, Wolfgang" uniqKey="Dummer W" first="Wolfgang" last="Dummer">Wolfgang Dummer</name>
<affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Genentech Inc, South San Francisco</s1>
<s2>California</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Annals of the rheumatic diseases</title>
<title level="j" type="abbreviated">Ann. rheum. dis.</title>
<idno type="ISSN">0003-4967</idno>
<imprint><date when="2012">2012</date>
</imprint>
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<seriesStmt><title level="j" type="main">Annals of the rheumatic diseases</title>
<title level="j" type="abbreviated">Ann. rheum. dis.</title>
<idno type="ISSN">0003-4967</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term>
<term>Antirheumatic agent</term>
<term>Chemotherapy</term>
<term>Chronic</term>
<term>Human</term>
<term>Immunomodulator</term>
<term>Methotrexate</term>
<term>Ocrelizumab</term>
<term>Phase III trial</term>
<term>Rheumatoid arthritis</term>
<term>Rheumatology</term>
<term>Toxicity</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Polyarthrite rhumatoïde</term>
<term>Ocrélizumab</term>
<term>Chimiothérapie</term>
<term>Toxicité</term>
<term>Méthotrexate</term>
<term>Homme</term>
<term>Essai clinique phase III</term>
<term>Rhumatologie</term>
<term>Immunomodulateur</term>
<term>Antirhumatismal</term>
<term>Anticancéreux</term>
<term>Chronique</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
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<front><div type="abstract" xml:lang="en">Objective To determine the efficacy and safety of ocrelizumab (OCR) with methotrexate (MTX) in MTX-naive rheumatoid arthritis (RA) patients. Methods In a randomised, double-blind, controlled trial, patients received placebo+MTX (MTX; n=210), OCR 200 mg×2+MTX (OCR 200; n=200) or OCR 500 mg×2+MTX (OCR 500; n=203). OCR/placebo (two intravenous infusions) was given on days 1 and 15, with fixed re-treatment scheduled at weeks 24/26, 52/54 and 76/78. Due to early termination of OCR dosing, there was no formal primary end point analysis (change from baseline in modified total Sharp score (ΔmTSS) at week 104). Analyses are reported for week 52 outcomes. Results At week 52, treatment with OCR + MTX compared with MTX alone reduced progression of joint damage (mean (SD) change in ΔmTSS: OCR 200, 0.66 (4.51); OCR 500, 0.27 (2.91); MTX alone, 1.59 (4.82); p = 0.001 and p = 0.003, respectively vs MTX alone) and improved clinical signs and symptoms (American College of Rheumatology 20 response: OCR 200, 73.0%; OCR 500, 71.0%; MTX alone, 57.5%; p<0.005 for each OCR vs MTX alone). Serious infection rates per 100 patient-years were similar with OCR 200 and MTX alone (2.6 (95% CI 0.9 to 6.1 ) and 3.0 (1.1 to 6.5), respectively), but higher with OCR 500 (7.1 (3.9 to 11.9)). Conclusions OCR 200 mg and 500 mg with MTX in MTX-naive patients with RA were effective in inhibiting joint damage progression and improving RA signs and symptoms. OCR 500 mg with MTX was associated with an increased rate of serious infections.</div>
</front>
</TEI>
<affiliations><list><country><li>Brésil</li>
<li>Espagne</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Oklahoma</li>
<li>Texas</li>
<li>État de São Paulo</li>
</region>
<settlement><li>São Paulo</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="Californie"><name sortKey="Stohl, William" sort="Stohl, William" uniqKey="Stohl W" first="William" last="Stohl">William Stohl</name>
</region>
<name sortKey="Ashrafzadeh, Ali" sort="Ashrafzadeh, Ali" uniqKey="Ashrafzadeh A" first="Ali" last="Ashrafzadeh">Ali Ashrafzadeh</name>
<name sortKey="Dummer, Wolfgang" sort="Dummer, Wolfgang" uniqKey="Dummer W" first="Wolfgang" last="Dummer">Wolfgang Dummer</name>
<name sortKey="Fleischmann, Roy M" sort="Fleischmann, Roy M" uniqKey="Fleischmann R" first="Roy M." last="Fleischmann">Roy M. Fleischmann</name>
<name sortKey="Francom, Steven" sort="Francom, Steven" uniqKey="Francom S" first="Steven" last="Francom">Steven Francom</name>
<name sortKey="Grzeschik, Susanna" sort="Grzeschik, Susanna" uniqKey="Grzeschik S" first="Susanna" last="Grzeschik">Susanna Grzeschik</name>
<name sortKey="Olech, Ewa" sort="Olech, Ewa" uniqKey="Olech E" first="Ewa" last="Olech">Ewa Olech</name>
</country>
<country name="Espagne"><noRegion><name sortKey="Gomez Reino, Juan" sort="Gomez Reino, Juan" uniqKey="Gomez Reino J" first="Juan" last="Gomez-Reino">Juan Gomez-Reino</name>
</noRegion>
</country>
<country name="Suisse"><noRegion><name sortKey="Dudler, Jean" sort="Dudler, Jean" uniqKey="Dudler J" first="Jean" last="Dudler">Jean Dudler</name>
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<country name="Royaume-Uni"><noRegion><name sortKey="Bieraugel, Rebecca" sort="Bieraugel, Rebecca" uniqKey="Bieraugel R" first="Rebecca" last="Bieraugel">Rebecca Bieraugel</name>
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<name sortKey="Green, Jennifer" sort="Green, Jennifer" uniqKey="Green J" first="Jennifer" last="Green">Jennifer Green</name>
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{{Explor lien
   |wiki=    Ticri/CIDE
   |area=    OcrV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     Pascal:12-0321593
   |texte=   Safety and efficacy of ocrelizumab in combination with methotrexate in MTX-naive subjects with rheumatoid arthritis: the phase III FILM trial
}}

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Safety and efficacy of ocrelizumab in combination with methotrexate in MTX-naive subjects with rheumatoid arthritis: the phase III FILM trial

Safety and efficacy of ocrelizumab in combination with methotrexate in MTX-naive subjects with rheumatoid arthritis: the phase III FILM trial

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