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Academic Medical Center Amsterdam and... 1 Department of Medicine Memorial Unive... 1 Department of Rheumatology St Vincent... 1 Division of Rheumatology and Osteopor... 1 Leiden University Medical Centre Leid... 1 Oregon Health and Science University ... 1 PV MEDICAL Revmavita Centre Zlin Czec... 1 Poznan Medical University Poznan Poland 1 Rheumatology Associates Clinical Rese... 1 Schoen Klinik Hamburg Germany 1 Swedish Medical Center and University... 1 Toronto Western Research Institute To... 1 UCB Pharma Brussels Belgium 1 UCB Pharma Monheim Germany 1 UCB Pharma Raleigh North Carolina USA 1 University of Texas SW Medical Center... 1
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Academic Medical Center Amsterdam and... 1 Department of Medicine Memorial Unive... 1 Department of Rheumatology St Vincent... 1 Division of Rheumatology and Osteopor... 1 Leiden University Medical Centre Leid... 1 Oregon Health and Science University ... 1 PV MEDICAL Revmavita Centre Zlin Czec... 1 Poznan Medical University Poznan Poland 1 Rheumatology Associates Clinical Rese... 1 Schoen Klinik Hamburg Germany 1 Swedish Medical Center and University... 1 Toronto Western Research Institute To... 1 UCB Pharma Brussels Belgium 1 UCB Pharma Monheim Germany 1 UCB Pharma Raleigh North Carolina USA 1 University of Texas SW Medical Center... 1
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NLK
Directory of Open Access Journals
od 2015
Free Medical Journals
od 2015
PubMed Central
od 2015
Europe PubMed Central
od 2015
ProQuest Central
od 2015-01-01
Open Access Digital Library
od 2015-01-01
Open Access Digital Library
od 2015-01-01
Health & Medicine (ProQuest)
od 2015-01-01
ROAD: Directory of Open Access Scholarly Resources
od 2015
PubMed
26509074
DOI
10.1136/rmdopen-2015-000119
Knihovny.cz E-zdroje
OBJECTIVE: Previous reports of RAPID-PsA (NCT01087788) demonstrated efficacy and safety of certolizumab pegol (CZP) over 24 weeks in patients with psoriatic arthritis (PsA), including patients with prior antitumour necrosis factor (TNF) therapy. We report efficacy and safety data from a 96-week data cut of RAPID-PsA. METHODS: RAPID-PsA was placebo-controlled to week 24, dose-blind to week 48 and open-label to week 216. We present efficacy data including American College of Rheumatology (ACR)/Psoriasis Area and Severity Index (PASI) responses, HAQ-DI, pain, minimal disease activity (MDA), modified total Sharp score (mTSS) and ACR responses in patients with/without prior anti-TNF exposure, in addition to safety data. RESULTS: Of 409 patients randomised, 273 received CZP from week 0. 54 (19.8%) CZP patients had prior anti-TNF exposure. Of patients randomised to CZP, 91% completed week 24, 87% week 48 and 80% week 96. ACR responses were maintained to week 96: 60% of patients achieved ACR20 at week 24, and 64% at week 96. Improvements were observed with both CZP dose regimens. ACR20 responses were similar in patients with (week 24: 59%; week 96: 63%) and without (week 24: 60%; week 96: 64%) prior anti-TNF exposure. Placebo patients switching to CZP displayed rapid clinical improvements, maintained to week 96. In patients with ≥3% baseline skin involvement (60.8% week 0 CZP patients), PASI responses were maintained to week 96. No progression of structural damage was observed over the 96-week period. In the Safety Set (n=393), adverse events occurred in 345 patients (87.8%) and serious adverse events in 67 (17.0%), including 6 fatal events. CONCLUSIONS: CZP efficacy was maintained to week 96 with both dose regimens and in patients with/without prior anti-TNF exposure. The safety profile was in line with that previously reported from RAPID-PsA, with no new safety signals observed with increased exposure. TRIAL REGISTRATION NUMBER: NCT01087788.
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