FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2323642502> ?p ?o ?g. }

• W2323642502 endingPage "484" @default.
• W2323642502 startingPage "484.1" @default.
• W2323642502 abstract "<h3>Background</h3> Assessment of structural damage progression, clinical efficacy and safety in patients with early-stage rheumatoid arthritis (RA) naïve to methotrexate (MTX) and with poor prognostic factors with certolizumab pegol (CZP) has not been performed so far. <h3>Objectives</h3> To report the efficacy and safety of using CZP in combination with MTX compared to MTX alone, in early Japanese RA patients who were MTX-naïve with poor prognostic factors. <h3>Methods</h3> Patients with early RA (<12 months from onset of persistent RA symptoms) fulfilling the 2010 ACR/EULAR Classification Criteria were enrolled in this multicenter, double-blind, randomized study (NCT01451203). Patients were included if they had poor prognostic factors: high-positive anti-CCP (>3xULN), and either positive rheumatoid factor or erosion on radiographs; were naïve to MTX, and had at least moderate disease activity (DAS28≥3.2). Patients were randomized 1:1 to either CZP+MTX or placebo (PBO)+MTX with oral MTX escalated to 16mg by Week (Wk) 8 unless safety issues and tolerability precluded further dose increase. The primary endpoint was inhibition of radiographic progression (change from baseline in modified total Sharp score [ΔmTSS]) at Wk52. Secondary endpoints were ΔmTSS at Wk24, and clinical remission rates by DAS28, ACR/EULAR (SDAI), and ACR/EULAR (Boolean) at Wks24 and 52. <h3>Results</h3> The FAS population consisted of 316 patients with mean age 49.2±10.5yrs, symptoms duration 4.1±2.9 months, DAS28: 5.45±1.15 and mTSS: 5.55±12.43 at baseline, with the groups well-balanced. The average dose of concomitant MTX throughout the study was 11.61±2.8mg/wk. The CZP+MTX group (n=159) showed significantly greater inhibition of radiographic progression relative to the PBO+MTX group (n=157) at Wk52 (p<0.001) and at Wk24 (p=0.003) in the primary analyses of ANCOVA on the ranks. Similar results were obtained in the sensitivity analyses using ANCOVA at Wk52 (ΔmTSS=0.36 vs 1.58; p<0.001) and at Wk24 (ΔmTSS=0.26 vs 0.86; p=0.003). Clinical remission rates of the CZP+MTX group were significantly higher compared to those of the PBO+MTX group at Wk24 (DAS28: 52.8% vs 30.6% [p<0.001]; SDAI: 48.4% vs 29.3% [p<0.001]; Boolean: 36.5% vs 22.3% [p=0.007]) and at Wk52 (DAS28: 57.2% vs 36.9% [p<0.001]; SDAI: 57.9% vs 33.8% [p<0.001]; Boolean: 45.3% vs 28.0% [p=0.002]) (Figure). The combination therapy was well tolerated, with no new or unexpected safety signals observed. <h3>Conclusions</h3> Combination of CZP with MTX was significantly more effective than PBO with MTX in inhibiting structural disease progression, as well as in achieving clinical remission in Japanese patients with early RA with poor prognostic factors. <h3>Acknowledgements</h3> The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma. <h3>Disclosure of Interest</h3> T. Atsumi Grant/research support: Kyowa Hakko Kirin, Chugai, Novartis, Mitsubishi Tanabe, Teijin, MSD, Astellas, Sanofi, Takeda, Novo Nordisk, Otsuka, Boehringer Ingelheim, AbbVie, Kissei, Pfizer, Astellas, Shionogi, Dainippon, Taisho-Toyama, Bristol-Myers Squibb, GlaxoSmithKline, Acterion, Paid instructor for: Astellas, Acterion, AbbVie, Eisai, MSD, Asahikasei, Otsuka, Daiichi-Sankyo, Mitsubishi Tanabe, Takeda, Chugai, Pfizer, Bristol-Myers Squibb, K. Yamamoto Grant/research support: UCB Pharma, Pfizer, Abbott, Santen, Mitsubishi-Tanabe, Eisai, Consultant for: UCB Pharma, Pfizer, Abbott, Bristol-Myers Squibb, Roche, Chugai, Mitsubishi-Tanabe, Eisai, T. Takeuchi Grant/research support: Abbott Japan, Astellas Pharma, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Janssen, Mitsubishi Tanabe, Pfizer Japan, Sanofi-Aventis, Santen, Takeda, Teijin Pharma, Abbvie, Asahikasei, Taisho-Toyama, Consultant for: Astra Zeneca, Eli Lilly Japan, Novartis, Mitsubishi Tanabe, Asahi Kasei Medical, Abbvie, Daiichi Sankyo, Speakers bureau: Abbott Japan, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi Tanabe, Pfizer Japan, Takeda, Astellas Pharma, Diaichi Sankyo, H. Yamanaka Grant/research support: AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin Pharma, Speakers bureau: AbbVie, Chugai, Daiichi Sankyo, Eisai, Mitsubishi Tanabe, Pfizer, Takeda, Teijin Pharma, N. Ishiguro Grant/research support: Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, BMS, Eisai, Janssen, Kaken and Pfizer, Daiichi Sankyo, Speakers bureau: Daiichi Sankyo, Takeda, Hisamitsu, Otsuka, Taisho-Toyama, Kaken, Eisai, Janssen, Bristol-Myers Squibb, Abbott Japan, Chugai, Mitsubishi Tanabe, UCB Japan, Astellas Pharma, Pfizer Japan, Y. Tanaka Grant/research support: Bristol-Myers Squibb, Mitsubishi-Tanabe, Abbvie, MSD, Chugai, Astellas, Daiichi-Sankyo, Consultant for: Mitsubishi-Tanabe, Eisai, Chugai, Abbott Japan, Astellas, Daiichi-Sankyo, Abbvie, Janssen, Pfizer, Takeda, Astra-Zeneca, Eli Lilly Japan, GlaxoSmithKline, Quintiles, MSD, Asahi-Kasei, Speakers bureau: Mitsubishi-Tanabe, Eisai, Chugai, Abbott Japan, Astellas, Daiichi-Sankyo, Abbvie, Janssen, Pfizer, Takeda, Astra-Zeneca, Eli Lilly Japan, GlaxoSmithKline, Quintiles, MSD, Asahi-Kasei, K. Eguchi Consultant for: UCB Pharma, A. Watanabe Grant/research support: Daiichi-Sankyo, Kyorin, Shionogi, Taisho, Dainippon-Sumitomo, Taiho, Toyama Chemical and Meiji Seika, Speakers bureau: MSD, GlaxoSmithKline, Shionogi, Daiichi-Sankyo, Taisho-Toyama, Dainippon-Sumitomo, Mitsubishi-Tanabe, Pfizer, H. Origasa Consultant for: UCB Pharma and Astellas, T. Shoji Employee of: UCB Pharma, T. Okada Employee of: Astellas Pharma, D. van der Heijde Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, Bristol-Myers Squibb, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, GlaxoSmithKline, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex, N. Miyasaka Grant/research support: Pfizer, Takeda, Mitsubishi-Tanabe, Chugai, Abbott, Eisai and Astellas, T. Koike Speakers bureau: UCB Pharma, Pfizer, Chugai, Abbott, Mitsubishi-Tanabe, Takeda, Eisai, Santen, Astellas, Taisho-Toyama, Bristol-Myers Squibb, Teijin Pharma, Daiichi-Sankyo <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.1448" @default.
• W2323642502 created "2016-06-24" @default.
• W2323642502 creator A5009147715 @default.
• W2323642502 creator A5015953107 @default.
• W2323642502 creator A5044442302 @default.
• W2323642502 creator A5053803963 @default.
• W2323642502 creator A5058359227 @default.
• W2323642502 creator A5063192431 @default.
• W2323642502 creator A5069911688 @default.
• W2323642502 creator A5075284186 @default.
• W2323642502 creator A5079071350 @default.
• W2323642502 creator A5082654587 @default.
• W2323642502 creator A5083044716 @default.
• W2323642502 creator A5083314956 @default.
• W2323642502 creator A5089158758 @default.
• W2323642502 creator A5089659933 @default.
• W2323642502 date "2014-06-01" @default.
• W2323642502 modified "2023-10-17" @default.
• W2323642502 title "FRI0278 The First Early Rheumatoid Arthritis, Certolizumab Pegol, Multicenter, Double-Blind, Randomized, Parallel-Group Study: C-Opera, in Patients Fulfilling the 2010 Acr/Eular Classification Criteria, Demonstrates Inhibition of Joint Damage Progression" @default.
• W2323642502 doi "https://doi.org/10.1136/annrheumdis-2014-eular.1448" @default.
• W2323642502 hasPublicationYear "2014" @default.
• W2323642502 type Work @default.
• W2323642502 sameAs 2323642502 @default.
• W2323642502 citedByCount "3" @default.
• W2323642502 countsByYear W23236425022016 @default.
• W2323642502 countsByYear W23236425022017 @default.
• W2323642502 crossrefType "journal-article" @default.
• W2323642502 hasAuthorship W2323642502A5009147715 @default.
• W2323642502 hasAuthorship W2323642502A5015953107 @default.
• W2323642502 hasAuthorship W2323642502A5044442302 @default.
• W2323642502 hasAuthorship W2323642502A5053803963 @default.
• W2323642502 hasAuthorship W2323642502A5058359227 @default.
• W2323642502 hasAuthorship W2323642502A5063192431 @default.
• W2323642502 hasAuthorship W2323642502A5069911688 @default.
• W2323642502 hasAuthorship W2323642502A5075284186 @default.
• W2323642502 hasAuthorship W2323642502A5079071350 @default.
• W2323642502 hasAuthorship W2323642502A5082654587 @default.
• W2323642502 hasAuthorship W2323642502A5083044716 @default.
• W2323642502 hasAuthorship W2323642502A5083314956 @default.
• W2323642502 hasAuthorship W2323642502A5089158758 @default.
• W2323642502 hasAuthorship W2323642502A5089659933 @default.
• W2323642502 hasBestOaLocation W23236425021 @default.
• W2323642502 hasConcept C126322002 @default.
• W2323642502 hasConcept C141071460 @default.
• W2323642502 hasConcept C142724271 @default.
• W2323642502 hasConcept C168563851 @default.
• W2323642502 hasConcept C197934379 @default.
• W2323642502 hasConcept C203092338 @default.
• W2323642502 hasConcept C204787440 @default.
• W2323642502 hasConcept C27081682 @default.
• W2323642502 hasConcept C2776215756 @default.
• W2323642502 hasConcept C2777575956 @default.
• W2323642502 hasConcept C2778375690 @default.
• W2323642502 hasConcept C2780132546 @default.
• W2323642502 hasConcept C2781059491 @default.
• W2323642502 hasConcept C2908647359 @default.
• W2323642502 hasConcept C71924100 @default.
• W2323642502 hasConcept C90924648 @default.
• W2323642502 hasConcept C99454951 @default.
• W2323642502 hasConceptScore W2323642502C126322002 @default.
• W2323642502 hasConceptScore W2323642502C141071460 @default.
• W2323642502 hasConceptScore W2323642502C142724271 @default.
• W2323642502 hasConceptScore W2323642502C168563851 @default.
• W2323642502 hasConceptScore W2323642502C197934379 @default.
• W2323642502 hasConceptScore W2323642502C203092338 @default.
• W2323642502 hasConceptScore W2323642502C204787440 @default.
• W2323642502 hasConceptScore W2323642502C27081682 @default.
• W2323642502 hasConceptScore W2323642502C2776215756 @default.
• W2323642502 hasConceptScore W2323642502C2777575956 @default.
• W2323642502 hasConceptScore W2323642502C2778375690 @default.
• W2323642502 hasConceptScore W2323642502C2780132546 @default.
• W2323642502 hasConceptScore W2323642502C2781059491 @default.
• W2323642502 hasConceptScore W2323642502C2908647359 @default.
• W2323642502 hasConceptScore W2323642502C71924100 @default.
• W2323642502 hasConceptScore W2323642502C90924648 @default.
• W2323642502 hasConceptScore W2323642502C99454951 @default.
• W2323642502 hasIssue "Suppl 2" @default.
• W2323642502 hasLocation W23236425021 @default.
• W2323642502 hasOpenAccess W2323642502 @default.
• W2323642502 hasPrimaryLocation W23236425021 @default.
• W2323642502 hasRelatedWork W2100063456 @default.
• W2323642502 hasRelatedWork W2118084423 @default.
• W2323642502 hasRelatedWork W2414220780 @default.
• W2323642502 hasRelatedWork W2783466784 @default.
• W2323642502 hasRelatedWork W3130793960 @default.
• W2323642502 hasRelatedWork W3176947508 @default.
• W2323642502 hasRelatedWork W3212096909 @default.
• W2323642502 hasRelatedWork W4224437443 @default.
• W2323642502 hasRelatedWork W4283269884 @default.
• W2323642502 hasRelatedWork W4294301186 @default.
• W2323642502 hasVolume "73" @default.
• W2323642502 isParatext "false" @default.
• W2323642502 isRetracted "false" @default.
• W2323642502 magId "2323642502" @default.
• W2323642502 workType "article" @default.