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Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis

Rudwaleit, M. ; Rosenbaum, J. T. ; Landewé, R. ; Marzo‐Ortega, H. ; Sieper, J. ; van der Heijde, D. ; Davies, O. ; Bartz, H. ; Hoepken, B. ; Nurminen, T. ; Deodhar, A.

Arthritis care & research (2010), 2016-06, Vol.68 (6), p.838-844 [Periódico revisado por pares]

United States: Wiley Subscription Services, Inc

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  • Título:
    Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis
  • Autor: Rudwaleit, M. ; Rosenbaum, J. T. ; Landewé, R. ; Marzo‐Ortega, H. ; Sieper, J. ; van der Heijde, D. ; Davies, O. ; Bartz, H. ; Hoepken, B. ; Nurminen, T. ; Deodhar, A.
  • Assuntos: Adult ; Ankylosing spondylitis ; Arthritis ; Certolizumab Pegol - therapeutic use ; Double-Blind Method ; Female ; Humans ; Immunosuppressive Agents - therapeutic use ; Immunotherapy ; Incidence ; Inflammatory diseases ; Joint diseases ; Male ; Middle Aged ; Monoclonal antibodies ; Patients ; Rheumatic diseases ; Spine ; Spondylarthritis - drug therapy ; Spondylitis ; Spondyloarthritis ; Tumor necrosis factor-α ; Uveitis ; Uveitis - epidemiology
  • É parte de: Arthritis care & research (2010), 2016-06, Vol.68 (6), p.838-844
  • Notas: Clinicaltrials.gov
    Supported by UCB Pharma.
    Dr. Marzo‐Ortega has received honoraria and/or grants (less than $10,000 each) from AbbVie, Janssen, MSD, Novartis, Pfizer, and UCB Pharma.
    Dr. Deodhar has received research grants, consulting fees, and/or speaking fees (less than $10,000 each) from Amgen, Janssen, Novartis, and Pfizer, and (more than $10,000 each) from AbbVie and UCB Pharma.
    Dr. van der Heijde has received consulting fees and/or research grants (less than $10,000 each) from AbbVie, Amgen, AstraZeneca, Augurex, Bristol‐Myers Squibb, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli‐Lilly, Galapagos, GlaxoSmithKline, Janssen Biologics, Merck, Novartis, Novo‐Nordisk, Otsuka, Pfizer, Roche, Sanofi‐Aventis, UCB Pharma, and Vertex, and is the director of Imaging Rheumatology BV.
    identifier: NCT01087762.
    Dr. Rosenbaum has received consulting fees (more than $10,000 each) from AbbVie, Allergan, Genentech, Novartis, Sanofi, Santen, Teva, UptoDate, and Xoma, and has received research grants (less than $10,000 each) from AbbVie, Avventy, Bristol‐Myers Squibb, Eyegate, and Genentech.
    Dr. Sieper has received speaking/consulting fees (less than $10,000 each) from Abbott, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB Pharma.
    Dr. Davies owns stock options in UCB Pharma.
    Dr. Rudwaleit has received consulting fees (less than $10,000 each) from AbbVie, Bristol‐Myers Squibb, MSD, Pfizer, Roche, and UCB Pharma.
    Dr. Hoepken owns stock options in UCB Pharma.
    Dr. Landewé has received research grants (less than $10,000 each) from Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering‐Plough, UCB Pharma, and Wyeth; speaking fees (less than $10,000 each) from Abbott, Amgen, Bristol‐Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering‐Plough, UCB Pharma, and Wyeth; and consulting fees (less than $10,000 each) from Abbott, Ablynx, Amgen, AstraZeneca, Bristol‐Myers Squibb, Centocor, GlaxoSmithKline, Novartis, Merck, Pfizer, Roche, Schering‐Plough, UCB Pharma, and Wyeth.
    ObjectType-Article-1
    SourceType-Scholarly Journals-1
    ObjectType-Feature-2
    ObjectType-News-3
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    Clinicaltrials.gov identifier: NCT01087762.
  • Descrição: Objective Axial spondyloarthritis (axial SpA) is characterized by inflammation of the spine and sacroiliac joints and can also affect extraarticular sites, with the most common manifestation being uveitis. Here we report the incidence of uveitis flares in axial SpA patients from the RAPID‐axSpA trial, including ankylosing spondylitis (AS) and nonradiographic (nr) axial SpA. Methods The RAPID‐axSpA (NCT01087762) trial is double‐blind and placebo‐controlled to week 24, dose‐blind to week 48, and open‐label to week 204. Patients were randomized to certolizumab pegol (CZP) or placebo. Placebo patients entering the dose‐blind phase were re‐randomized to CZP. Uveitis events were recorded on extraarticular manifestation or adverse event forms. Events were analyzed in patients with/without history of uveitis, and rates reported per 100 patient‐years. Results At baseline, 38 of 218 CZP‐randomized patients (17.4%) and 31 of 107 placebo‐randomized patients (29.0%) had past uveitis history. During the 24‐week double‐blind phase, the rate of uveitis flares was lower in CZP (3.0 [95% confidence interval (95% CI) 0.6–8.8] per 100 patient‐years) than in placebo (10.3 [95% CI 2.8–26.3] per 100 patient‐years). All cases observed during the 24‐week double‐blind phase were in patients with a history of uveitis; in these patients, rates were similarly lower for CZP (17.1 [95% CI 3.5–50.1] per 100 patient‐years) than placebo (38.5 [95% CI 10.5–98.5] per 100 patient‐years). Rates of uveitis flares remained low up to week 96 (4.9 [95% CI 3.2–7.4] per 100 patient‐years) and were similar between AS (4.4 [95% CI 2.3–7.7] per 100 patient‐years) and nr‐axial SpA (5.6 [95% CI 2.9–9.8] per 100 patient‐years). Conclusion The rate of uveitis flares was lower for axial SpA patients treated with CZP than placebo during the randomized controlled phase. Incidence of uveitis flares remained low to week 96 and was comparable to rates reported for AS patients receiving other anti–tumor necrosis factor antibodies.
  • Editor: United States: Wiley Subscription Services, Inc
  • Idioma: Inglês
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