Steven Fakharzadeh

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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)
IMPORTANCE The efficacy of treatment for psoriasis must be balanced against potential adverse events. OBJECTIVE To determine the effect of treatment on the risk of serious infections in patients with psoriasis. DESIGN, SETTING, AND PARTICIPANTS A multicenter, longitudinal, disease-based registry (Psoriasis Longitudinal Assessment and Registry [PSOLAR])(More)
BACKGROUND Long-term data are essential to assess the safety of biologic agents for the treatment of psoriasis. OBJECTIVE To evaluate the incidence of adverse events of interest (AEIs), including all-cause mortality, major adverse cardiovascular events (MACE), malignancy (excluding nonmelanoma skin cancer), and serious infections (SI), in patients treated(More)
BACKGROUND Safety surveillance is needed for biologic therapies for psoriasis. OBJECTIVE To assess the risk of adverse events of special interest (AEoSIs) with ustekinumab and other psoriasis treatments in a real-world setting using 2014 Psoriasis Longitudinal Assessment and Registry (PSOLAR) data. AEoSIs included malignancy (excluding nonmelanoma skin(More)
BACKGROUND Most patients with psoriasis have nail changes, and treating nail psoriasis is challenging. OBJECTIVES To assess improvement in fingernail psoriasis with ustekinumab treatment in the PHOENIX 1 trial. METHODS Patients received ustekinumab 45 mg or 90 mg, or placebo at weeks 0 and 4. Ustekinumab-randomized patients continued maintenance dosing(More)
BACKGROUND Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of moderate to severe psoriasis. OBJECTIVE We sought to evaluate the impact of ustekinumab on infections and malignancies, both theoretical risks of blocking IL-12 and IL-23, in patients exposed up to 3 years. METHODS Rates of infections and malignancies were evaluated in(More)
BACKGROUND Psoriasis is associated with several comorbidities and behavioural risk factors. OBJECTIVES To evaluate demographic and disease characteristics in patients enrolled in the Psoriasis Longitudinal Assessment and Registry (PSOLAR). METHODS PSOLAR is a global, prospective, longitudinal, disease-based registry that includes a postmarketing(More)
BACKGROUND Reversible posterior leukoencephalopathy syndrome (RPLS) is a rare, generally reversible neurologic syndrome that is diagnosed based on characteristic clinical and radiologic findings. OBSERVATIONS We describe the first case of RPLS in a 65-year-old woman who underwent ustekinumab therapy for psoriasis. Approximately 2½ years after the(More)
A recently published report by Florek et al.1 associates malignancies with ustekinumab (STELARA® ) treatment. Janssen emphasizes patient safety and welcomes rigorous safety analyses from other parties. However, it is unclear how this report adds to the understanding of ustekinumab's safety profile. This article is protected by copyright. All rights reserved.