Newman Yeilding

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BACKGROUND Interleukins 12 and 23 have important roles in the pathophysiology of psoriasis. We assessed ustekinumab, a human monoclonal antibody directed against these cytokines, for the treatment of psoriasis. METHODS In this phase III, parallel, double-blind, placebo-controlled study, 766 patients with moderate-to-severe psoriasis were randomly assigned(More)
BACKGROUND Ustekinumab, a human monoclonal antibody against interleukins 12 and 23, has shown therapeutic potential for psoriasis. This study assessed the efficacy and safety of ustekinumab in psoriasis patients and assessed dosing intensification in partial responders. METHODS In this multicentre, phase III, double-blind, placebo-controlled study, 1230(More)
BACKGROUND Skin-infiltrating lymphocytes expressing type 1 cytokines have been linked to the pathophysiology of psoriasis. We evaluated the safety and efficacy of a human interleukin-12/23 monoclonal antibody in treating psoriasis. METHODS In this double-blind, placebo-controlled trial, 320 patients with moderate-to-severe plaque psoriasis underwent(More)
BACKGROUND Biologic agents offer a range of new therapeutic options for patients with psoriasis; however, the relative benefit-risk profiles of such therapies are not well known. We compared two biologic agents, ustekinumab (an interleukin-12 and interleukin-23 blocker) and etanercept (an inhibitor of tumor necrosis factor alpha), for the treatment of(More)
OBJECTIVE To incorporate a new trial design to examine clinical response, cytokine expression and joint imaging in patients with rheumatoid arthritis (RA) switching from etanercept to infliximab treatment. METHODS A randomised, open-label, clinical trial of 28 patients with an inadequate response to etanercept was conducted. Eligible patients received(More)
The population pharmacokinetics of ustekinumab are characterized in patients with moderate to severe plaque psoriasis in 2 Phase 3 studies (PHOENIX 1 and PHOENIX 2). Serum concentration data from 1937 patients are analyzed to determine pharmacokinetic characteristics of ustekinumab and to assess factors that may contribute to their variability. The(More)
BACKGROUND An unmet need remains for safe and effective long-term treatments of psoriasis. OBJECTIVES To evaluate ustekinumab efficacy and safety for up to 3 years in the PHOENIX 1 trial. METHODS Patients (n = 766) with moderate-to-severe psoriasis were randomized to ustekinumab 45 mg or 90 mg at weeks 0 and 4, and then every 12 weeks, or placebo at(More)
BACKGROUND Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of moderate-to-severe psoriasis. OBJECTIVE To evaluate overall pooled study data to assess the safety profile of ustekinumab through 3 years of treatment. METHODS Cumulative safety data were pooled from studies in 3117 ustekinumab-treated patients. RESULTS During the(More)
Background PHOENIX 1 was a phase III, randomized, double-blind, placebo-controlled study that demonstrated the long-term efficacy and safety of ustekinumab in patients with moderate-to-severe psoriasis. Objectives To assess the effect of ustekinumab maintenance therapy on health-related quality of life (HRQoL) in PHOENIX 1 patients. Patients and methods(More)
BACKGROUND Cardiovascular diseases or risk factors (CVDR) seem to be more common in psoriasis patients than in the general population. OBJECTIVE We assessed the relationship of psoriasis with CVDR by analysis of healthcare claims data using a cross-sectional, prevalence-based study design. PATIENTS AND METHODS The IMS Health and MarketScan claims(More)