Efficacy of Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis in the North American Subgroup of Patients: Pooled Analysis of Four Phase 3 Studies.

Introduction: Demographic and disease characteristics may impact response to psoriasis therapies. The objective of this study is to explore the safety and efficacy profile of secukinumab in North American (NA) versus non-NA patients with moderate to severe psoriasis.

Methods: Data were pooled from four phase 3 studies of secukinumab.

Apremilast for the treatment of moderate-to-severe palmoplantar psoriasis: results from a double-blind, placebo-controlled, randomized study.

Background: Palmoplantar psoriasis is a variant of psoriasis vulgaris which can severely impair quality of life.

Objectives: The main objectives of this double-blind, placebo-controlled, randomized study were to assess the efficacy and impact on quality of life and work productivity of apremilast for the treatment of moderate-to-severe palmoplantar psoriasis.

Methods: A total of 100 patients with moderate-to-severe palmoplantar psoriasis were randomized to either apremilast 30 mg bid or placebo for 16 weeks.

Expert Perspectives on Management of Moderate-to-Severe Atopic Dermatitis: A Multidisciplinary Consensus Addressing Current and Emerging Therapies.

Atopic dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease that affects children and adults. Until recently, the only Food and Drug Administration-approved systemic treatment option for patients with moderate-to-severe AD was systemic steroids, which are not recommended by current guidelines and are commonly associated with disease rebound. Instead, clinicians choose from several off-label immunosuppressants, which can have serious adverse effects.

Efficacy and safety of the Janus kinase 1 inhibitor PF-04965842 in patients with moderate-to-severe psoriasis: phase II, randomized, double-blind, placebo-controlled study.

Background: PF-04965842 is an oral Janus kinase 1 inhibitor being investigated for the treatment of plaque psoriasis.

Objectives: To evaluate the efficacy, safety and tolerability of PF-04965842 in patients with moderate-to-severe plaque psoriasis.

Methods: Patients in this phase II, placebo-controlled study (NCT02201524) were randomized to receive placebo, 200 mg once daily (OD), 400 mg OD or 200 mg twice daily (TD) PF-04965842 for 4 weeks.

Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial.

Background: Dupilumab (an anti-interleukin-4-receptor-α monoclonal antibody) blocks signalling of interleukin 4 and interleukin 13, type 2/Th2 cytokines implicated in numerous allergic diseases ranging from asthma to atopic dermatitis. Previous 16-week monotherapy studies showed that dupilumab substantially improved signs and symptoms of moderate-to-severe atopic dermatitis with acceptable safety, validating the crucial role of interleukin 4 and interleukin 13 in atopic dermatitis pathogenesis. We aimed to evaluate the long-term efficacy and safety of dupilumab with medium-potency topical corticosteroids versus placebo with topical corticosteroids in adults with moderate-to-severe atopic dermatitis.

From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis.

Background: An urgent need exists in the United States to establish treatment goals in psoriasis.

Objective: We aim to establish defined treatment targets toward which clinicians and patients with psoriasis can strive to inform treatment decisions, reduce disease burden, and improve outcomes in practice.

Methods: The National Psoriasis Foundation conducted a consensus-building study among psoriasis experts using the Delphi method.

Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

Background: Drug survival is a marker for treatment sustainability in chronic diseases such as psoriasis.

Objective: The aim of these analyses was to assess survival of biologic treatments in the PSOriasis Longitudinal Assessment and Registry (PSOLAR).

Methods: PSOLAR is a large, prospective, international, disease-based registry of patients with psoriasis receiving (or eligible for) systemic therapy in a real-world setting.

Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) clinical trials in patients with moderate to severe psoriasis.

Background: Difficult-to-treat palmoplantar psoriasis has a disproportionately negative impact on quality of life.

Objective: We evaluated the efficacy and safety of apremilast in palmoplantar psoriasis.

Methods: A post hoc analysis of data pooled from phase IIb (PSOR-005) and phase III (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1 and 2) clinical studies was conducted to determine the effect of apremilast 30 mg twice daily versus placebo at week 16 in a subset of patients with moderate to severe plaque psoriasis with active palmoplantar psoriasis (baseline Palmoplantar Psoriasis Physician Global Assessment [PPPGA] score ≥1).

Randomized Vehicle-Controlled Study of Short Drug Incubation Aminolevulinic Acid Photodynamic Therapy for Actinic Keratoses of the Face or Scalp.

Background: Aminolevulinic acid photodynamic therapy (ALA-PDT) can be effective and well tolerated when applied over a broad area and for short drug incubation times.

Objective: To evaluate the effect of short-incubation time and application method on the safety and efficacy of ALA-PDT versus vehicle (VEH-PDT) in the treatment of actinic keratoses (AKs) of the face or scalp.

Methods: Aminolevulinic acid or VEH was applied to face or scalp as a broad area application for 1, 2, or 3 hours or as a spot application for 2 hours before blue light activation.

Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis.

Background: There are no systemic therapies approved in the United States to treat pediatric psoriasis.

Objective: We sought to evaluate long-term safety and efficacy of etanercept in children and adolescents with moderate to severe plaque psoriasis.

Methods: This 5-year, open-label extension study enrolled patients aged 4 to 17 years who had participated in a 48-week parent study.

Photodynamic therapy with methyl aminolaevulinate 80 mg g(-1) for severe facial acne vulgaris: a randomized vehicle-controlled study.

Background: Severe acne vulgaris has limited therapeutic options.

Objectives: To evaluate photodynamic therapy (PDT) using topical methyl aminolaevulinate (MAL, 80 mg g(-1) ) as the photosensitizer in severe facial acne.

Methods: A double-blind, randomized, vehicle-controlled multicentre trial in 153 patients (aged 12-35 years) with severe facial acne [Investigator's Global Assessment (IGA) score 4; 25-75 inflammatory lesions with ≤ 3 nodules; 20-100 noninflammatory lesions].

Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - Short version.

Background: Actinic keratosis (AK) is a frequent health condition attributable to chronic exposure to ultraviolet radiation. Several treatment options are available and evidence based guidelines are missing.

Objectives: The goal of these evidence- and consensus-based guidelines was the development of treatment recommendations appropriate for different subgroups of patients presenting with AK.

Cohort study of malignancies and hospitalized infectious events in treated and untreated patients with psoriasis and a general population in the United States.

Background: Psoriasis is associated with risk of malignancy. Some psoriasis treatments may increase the risk of hospitalized infectious events (HIEs).

Objectives: To evaluate rates of malignancies and HIEs in patients with psoriasis.

Bimatoprost 0.03% for the Treatment of Eyelash Hypotrichosis: A Pooled Safety Analysis of Six Randomized, Double-masked Clinical Trials.

Objective: Describe the safety profile of bimatoprost 0.03% ophthalmic solution as once-daily topical treatment for idiopathic or chemotherapy-induced eyelash hypotrichosis.

Design: Pooled data from six randomized, multicenter, double-masked, parallel-group clinical studies of at least three-months' duration with at least one bimatoprost treatment group.

A multicenter, non-interventional study to evaluate patient-reported experiences of living with psoriasis.

Background: Moderate to severe plaque psoriasis (with or without psoriatic arthritis) places significant burden on patients' lives.

Objective: Explore and document patients' experiences of living with psoriasis, including symptoms, treatments, impact on daily lives and patient-reported functioning.

Methods: In a US-based, non-interventional study, narrative interviews were conducted at baseline and again within 16 weeks.

A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis.

Objective: To evaluate the efficacy and safety of onabotulinumtoxinA in adolescents with primary axillary hyperhidrosis.

Methods: This 52-week, multicenter, nonrandomized, open-label study was conducted in 141 adolescents ages 12 to 17 years with severe primary axillary hyperhidrosis. Patients could receive up to six treatments with onabotulinumtoxinA (50 U per axilla), with re-treatment occurring no sooner than 8 weeks after the prior treatment cycle and no later than 44 weeks after the initial treatment cycle.

Effects of tofacitinib on lymphocyte sub-populations, CMV and EBV viral load in patients with plaque psoriasis.

Background: Plaque psoriasis is a debilitating skin condition that affects approximately 2% of the adult population and for which there is currently no cure. Tofacitinib is an oral Janus kinase inhibitor that is being investigated for psoriasis.

Methods: The design of this study has been reported previously (NCT00678210).

A phase 2a randomized, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the efficacy and safety of ASP015K, a novel Janus kinase inhibitor, in patients with moderate-to-severe psoriasis.

Background: Many immune-mediated disorders, including psoriasis, involve cytokine signalling via Janus kinase (JAK) enzymes. ASP015K (also designated JNJ-54781532), a novel oral JAK inhibitor, has shown moderate selectivity for JAK3 over JAK1 and JAK2 in enzyme assays.

Objectives: The objective of this study was to evaluate the efficacy and safety of escalating, sequentially grouped, doses of ASP015K vs.

WITHDRAWN: Experience with ustekinumab in patients with psoriasis enrolled in a large, multicenter, prospective, disease-based registry (Psoriasis Longitudinal Assessment and Registry [PSOLAR]).

The above-referenced article has been voluntarily withdrawn by the authors in order to present more updated data in a subsequent manuscript. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.

OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.

Background: OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of patients with psoriasis.

Objective: We sought to assess long-term etanercept safety and effectiveness.

Methods: Patients with moderate to severe psoriasis enrolled; a single baseline dose of etanercept was required.

An open-label pilot study of apremilast for the treatment of moderate to severe lichen planus: a case series.

Background: Current treatments for chronic lichen planus (LP) are often ineffective and may have significant adverse side effects. An alternative safe and effective treatment for recalcitrant LP is needed.

Objectives: We sought to study the safety and efficacy of apremilast in the treatment of moderate to severe LP.

Integrated safety analysis: short- and long-term safety profiles of etanercept in patients with psoriasis.

Background: Multiple trials demonstrate the tolerability and safety of etanercept. However, there are limited data on etanercept tolerability in large populations of patients with psoriasis or with extended therapy.

Objectives: We sought to determine whether there is an increased safety risk associated with higher etanercept doses or with extended exposure in patients with psoriasis.

Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen.

Topical tretinoin and benzoyl peroxide (BPO) are often prescribed in combination for the treatment of acne vulgaris; however, these products have not traditionally been administered simultaneously because of the potential for tretinoin degradation by BPO as well as the instability of tretinoin in daylight. The primary objective of this randomized, investigator-blinded, 12-week, phase 4 trial was to determine non-inferiority of a once-daily morning combination regimen of 5% BPO wash + tretinoin gel microsphere (TGM) 0.04% pump versus a sequential regimen (BPO in the morning/TGM in the evening) in patients > or = 12 years old with moderate facial acne vulgaris.

Using a Hydroquinone/Tretinoin-based Skin Care System Before and After Electrodesiccation and Curettage of Superficial Truncal Basal Cell Carcinoma: A Multicenter, Randomized, Investigator-blind, Controlled Study of Short-term Healing.

Objective: To evaluate the efficacy and tolerability of using a 4% hydroquinone/0.05% tretinoin skin care system compared with standard treatment of cleanser plus healing ointment to enhance aesthetic outcomes resulting from electrodesiccation and curettage treatment for superficial truncal basal cell carcinomas.

Design: Multicenter, investigator-masked, randomized, parallel-group study.