Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis.

Background: Adalimumab is approved for the treatment of hidradenitis suppurativa (HS), plaque psoriasis, and other inflammatory conditions.

Objective: Our objective was to examine the safety of adalimumab administered every other week (EOW) and every week (EW) in patients with HS and psoriasis and to investigate informative data from non-dermatologic indications.

Methods: The safety of adalimumab 40-mg EOW versus EW dosing was examined during placebo-controlled and open-label study periods in patients with HS (three studies), psoriasis (two studies), Crohn's disease (six studies), ulcerative colitis (three studies), and rheumatoid arthritis (one study).

Update on TNF Inhibitors in Dermatology.

Emerging data describe new potential indications for tumor necrosis factor (TNF) inhibitors in dermatology, including pediatric psoriasis and hidradenitis suppurativa. New biosimilar TNF agents are in late stages of development and may be available in the United States in the near future. Biosimilar agents are similar but not identical to available TNF inhibitors, and approval requires extensive analytic, toxicity, pharmacokinetic, pharmacodynamic, and clinical testing.

Effects of Apremilast on Pruritus and Skin Discomfort/Pain Correlate With Improvements in Quality of Life in Patients With Moderate to Severe Plaque Psoriasis.

Pruritus and skin discomfort/pain negatively impact health-related quality of life (HRQoL). The effects of apremilast, an oral phosphodiesterase inhibitor, on pruritus, skin discomfort/pain, and patient global assessment of psoriasis disease activity (PgAPDA) were assessed in moderate/severe chronic plaque psoriasis patients in the phase 3 ESTEEM trials. Significant improvements in pruritus and skin discomfort/pain observed at Week 2 with apremilast versus placebo (both studies, p < 0.

Therapeutic development in psoriasis.

Advances in molecular biology have provided the basis for development of new therapeutic approaches to psoriasis. New, more effective therapies target specific molecules in the inflammatory cascade involved in the pathogenesis of psoriasis.The biologic era of psoriasis therapy began with inhibitors of T-cell activation, tumor necrosis factor-α, and interleukin (IL)-12/23.

The role of TNF inhibitors in psoriatic disease.

In contrast to many other diseases, modern psoriasis therapy has a fairly brief history. Until about 15 years ago, clinicians and their patients had few options, with limited ability to rein in the disease process.The success of antifolate methotrexate in the treatment of rheumatoid arthritis (RA) led to clinical evaluation and adoption of the agent, a principal form of treatment for psoriasis, which, like RA, has its origin based in inflammation.

A Delphi Consensus Approach to Challenging Case Scenarios in Moderate-to-Severe Psoriasis: Part 2.

Introduction: Clinicians may be confronted with difficult-to-treat psoriasis cases for which there are scant data to rely upon for guidance. To assist in managing such patients, who are typically excluded from clinical trials, a consensus panel of 14 experts in the field of psoriasis was formed to conduct a Delphi method exercise.

Methods: The exercise consisted of both survey questionnaires and a live meeting to review and discuss current data (as of 2009, when the exercise was conducted) and arrive at a consensus for optimal treatment options.

A Delphi Consensus Approach to Challenging Case Scenarios in Moderate-to-Severe Psoriasis: Part 1.

Introduction: Traditional clinical trials in psoriasis exclude a significant proportion of patients with complex disease and comorbidities. A consensus panel of 14 experts in the field of psoriasis was formed to conduct a Delphi method exercise to identify difficult-to-treat psoriasis clinical scenarios and to rank treatment approaches.

Methods: The exercise consisted of both survey questionnaires and a live meeting to review and discuss current data (as of 2009, when the exercise was conducted) and arrive at a consensus for optimal treatment options.

Management of moderate to severe plaque psoriasis (part 2): clinical update on T-cell modulators and investigational agents.

This second part of a 2-part review on the use of biologics for treatment of patients with psoriasis is focused on currently approved therapies that work through modulation of T cells: alefacept, a leukocyte function-associated antigen 3-immunoglobulin G fusion molecule; and efalizumab, an anti-CD11 humanized antibody. Efficacy and safety data from pivotal clinical trials are summarized and new data are presented for these biological agents, and considerations for optimal therapeutic selection are discussed. Clinical data from investigational agents currently in development are also reviewed.

Management of moderate to severe plaque psoriasis (part I): clinical update on antitumor necrosis factor agents.

Psoriasis is an immunologic disorder mediated by T cells and proinflammatory cytokines. Novel biologic therapies, targeted at key pathogenic steps, have been developed and provide efficacy without the potential end-organ toxicity induced by traditional therapies. The biologic therapies currently approved for treatment of psoriasis are classified into 2 categories, as defined by their mechanism of action: inhibition of tumor necrosis factor (TNF) (etanercept, infliximab, adalimumab) and modulation of pathogenic activated T cells (alefacept, efalizumab).

Reductions in healthcare resource utilization in psoriatic arthritis patients receiving etanercept therapy: results from the educate trial.

The Experience Diagnosing, Understanding Care, and Treatment with Enbrel (EDUCATE) trial is a phase IV, 24-week, multicenter, open-label study of etanercept 50 mg weekly in the treatment of psoriatic arthritis (PsA) in community dermatology clinics. In this study, patients with active PsA and moderate to severe plaque psoriasis have measurable uses of healthcare resources at baseline, reflecting a burden of illness. Etanercept significantly reduced healthcare resource utilization, absenteeism, and caregiver assistance in PsA patients after 24 weeks of treatment.

Overview of biologic agents in medicine and dermatology.

Three agents have recently been approved by the Food and Drug Administration for the treatment of chronic plaque psoriasis: alefacept, efalizumab, and etanercept. The field of dermatology has now entered a new era, joining other disciplines of medicine that have been using biologic agents for decades. These new therapies offer psoriatic patients the potential for safe and effective long-term management of this disease.

Systemic therapies for psoriasis: understanding current and newly emerging therapies.

The treatment of moderate to severe psoriasis is a rapidly expanding area. Recent insights into the pathogenesis of this disease as a T-cell mediated process has led to a greater understanding of the mechanisms of action of conventional FDA-approved systemic therapies such as methotrexate, cyclosporine, acitretin, and psoralen with ultraviolet A phototherapy. It has also led to the development of rationally targeted therapies against key components of the immune process critical in the generation of the psoriatic plaque.