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Certolizumab pegol ...
Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study
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Emery, P (författare)
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Bingham, CO (författare)
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Burmester, GR (författare)
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Bykerk, VP (författare)
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Furst, DE (författare)
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Mariette, X (författare)
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van der Heijde, D (författare)
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- van Vollenhoven, R (författare)
- Karolinska Institutet
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Arendt, C (författare)
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Mountian, I (författare)
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Purcaru, O (författare)
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Tatla, D (författare)
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VanLunen, B (författare)
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Weinblatt, ME (författare)
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(creator_code:org_t)
- 2016-05-10
- 2017
- Engelska.
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Ingår i: Annals of the rheumatic diseases. - : BMJ. - 1468-2060 .- 0003-4967. ; 76:1, s. 96-104
- Relaterad länk:
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https://ard.bmj.com/...
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http://kipublication...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- To assess the efficacy and safety of certolizumab pegol (CZP)+dose-optimised methotrexate (MTX) versus placebo (PBO)+dose-optimised MTX in inducing and sustaining clinical remission in DMARD-naïve patients with moderate-to-severe, active, progressive rheumatoid arthritis (RA), with poor prognostic factors over 52 weeks.MethodsDMARD-naïve patients with ≤1 year of active RA were randomised (3:1) in a double-blind manner to CZP (400 mg Weeks 0, 2, 4, then 200 mg Q2W to Week 52)+MTX or PBO+MTX (the mean optimised-MTX dose=21 and 22 mg/week, respectively). Sustained remission (sREM) and sustained low disease activity (sLDA; DAS28(ESR)<2.6 and DAS28(ESR)≤3.2, respectively, at both Weeks 40 and 52) were the primary and secondary endpoints.ResultsPatients were randomised to CZP+MTX (n=660) and PBO+MTX (n=219). At Week 52, significantly more patients assigned to CZP+MTX compared with PBO+MTX achieved sREM (28.9% vs 15.0%, p<0.001) and sLDA (43.8% vs 28.6%, p<0.001). Inhibition of radiographic progression and improvements in physical functioning were significantly greater for CZP+MTX versus PBO+MTX (van der Heijde modified total Sharp score (mTSS) mean absolute change from baseline (CFB): 0.2 vs 1.8, p<0.001, rate of mTSS non-progressors: 70.3% vs 49.7%, p<0.001; least squares (LS) mean CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI): −1.00 vs −0.82, p<0.001). Incidence of adverse events (AEs) and serious AEs was similar between treatment groups. Infection was the most frequent AE, with higher incidence for CZP+MTX (71.8/100 patient-years (PY)) versus PBO+MTX (52.7/100 PY); the rate of serious infection was similar between CZP+MTX (3.3/100 PY) and PBO+MTX (3.7/100 PY).ConclusionsCZP+dose-optimised MTX treatment of DMARD-naïve early RA resulted in significantly more patients achieving sREM and sLDA, improved physical function and inhibited structural damage compared with PBO+dose-optimised MTX.Trial registration numberNCT01519791.
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Emery, P
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Bingham, CO
-
Burmester, GR
-
Bykerk, VP
-
Furst, DE
-
Mariette, X
-
visa fler...
-
van der Heijde, ...
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van Vollenhoven, ...
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Arendt, C
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Mountian, I
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Purcaru, O
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Tatla, D
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VanLunen, B
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Weinblatt, ME
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visa färre...
- Artiklar i publikationen
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Annals of the rh ...
- Av lärosätet
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Karolinska Institutet