Currents: Within Reach?
Unraveling Mysteries of Skin/Body Connections
Psoriasis Severity Linked to Increased Risk of Death
The more surface area of the body covered by psoriasis, the greater the risk of death, according to a new analysis by researchers at the Perelman School of Medicine at the University of Pennsylvania.
In fact, patients with psoriasis on 10 percent or more of their body are at almost double the risk of death, the study found.
The findings, which appear in the Journal of Investigative Dermatology, are the first to link psoriasis severity to an increased risk of death using an objective measure of disease severity—Body Surface Area (BSA)—rather than treatment patterns, such as whether or not a patient was receiving oral, injectable, or phototherapy treatment for the condition.
For this study, Joel M. Gelfand, MD, MSCE, a professor of Dermatology and Epidemiology at Penn and his team looked at 8,760 patients with psoriasis and 87,600 people without it via a database from the United Kingdom. They sent surveys to the patient’s general practitioners to determine the body surface area affected by psoriasis as this information is not routinely available in medical records. They then looked at the number of deaths in each group by person-years.
Dr. Gelfand and his team used an average follow-up time of about four years. In that time, there was an average of 6.39 deaths per 1,000 person years in patients with psoriasis on more than 10 percent of their bodies, compared to 3.24 deaths in patients without psoriasis. Even when researchers adjusted for other demographic factors, patients with a BSA greater than 10 percent were 1.79 times more likely to have died than other people their age and gender who do not have the condition. This risk held even after researchers controlled for other risk factors like smoking, obesity, and major medical conditions.
The study authors note more research is needed to better understand the specific causes of death in patients with extensive psoriasis and to see if and how treatment can impact the risk.
The study was supported by a medical dermatology fellowship from the National Psoriasis Foundation and the National Institutes for Health (T32-GM075766, K24-AR064310-36).
FDA Greenlights Humira Biosim Cyltezo for Multiple Inflammatory Diseases
The FDA approved Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo, a biosimilar to Humira (adalimumab), in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including:
• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Moderate to severe active rheumatoid arthritis
• Moderate to severe polyarticular juvenile idiopathic arthritis
• Active ankylosing spondylitis
• Moderate to severe active adult Crohn’s disease
• Moderate to severe active ulcerative colitis
Cyltezo is not commercially available at this time. Boehringer Ingelheim is currently engaged in patent litigation with Humira manufacturer AbbVie. Boehringer Ingelheim will also seek approval for an auto-injector of Cyltezo as another delivery option for patients.
The FDA approval is based on a comprehensive data package comprised of analytical, pharmacological, non-clinical, and clinical development studies demonstrating that Cyltezo is biosimilar to Humira. The European Medicines Agency is expected to provide an opinion on the marketing authorization application for our biosimilar candidate in 2017.
FDA Advisory Arm Backs Xeljanz for PsA
The FDA’s Arthritis Advisory Committee recommends the approval of Pfizer’s Xeljanz (tofacitinib) for the treatment of adults with active psoriatic arthritis (PsA).
Rash Decisions: How to Work-up the Patient with Granulomatous Reactions
Granulomatous conditions are usually a sign of systemic disease. Misha A. Rosenbach, MD says it’s important to get a full drug history and offers an overview of the tests to order. The work-up may not be as complex as some clinicians may think.
The Arthritis Advisory Committee voted 10 to one in favor of approving Xeljanz, a Janus kinase (JAK) inhibitor. The FDA is not obligated to follow the advice of their advisory panel, but they usually do. The FDA decision is anticipated by December 2017.
Pfizer submitted supplemental new drug applications for Xeljanz 5mg twice daily (BID) and Xeljanz XR extended release 11mg once daily (QD) for this pending indication.
PuraCap Pharmaceuticals Introduces EpiCeram Quad Pack
PuraCap Pharmaceutical introduced the EpiCeram Controlled Release Skin Barrier Emulsion Quad Pack, which contains four 100g airless pumps.
EpiCeram, an FDA-approved topical prescription emollient, is used to treat dry skin conditions and manage atopic dermatitis (AD). The new Quad Pack may mean fewer trips to the pharmacy and a better value for patients.
Epiceram ingredients include ceramides, free fatty acids, and cholesterol in a balanced ratio, which mimics the lipid concentration found in the skin. It is formulated to help keep the skin at a pH of 5 to keep moisture in and potential irritants out.
EpiCeram is also available in a 90g tube and 225g airless pump.
Glenmark Pharmaceuticals Reports Positive Phase 2a Data for GBR 830 for Atopic Dermatitis
Glenmark Pharmaceuticals shared positive data from a Phase 2a study of GBR 830, an investigational, anti-OX40 monoclonal antibody, for the treatment of atopic dermatitis (AD). The study evaluated the safety, biological and clinical activity, and pharmacokinetics of GBR 830, relative to placebo, in adults with moderate to severe AD with history of inadequate response to topical therapies. Based on the results of this Phase 2a study, Glenmark says it is firmly committed to advancing GBR 830 for patients with AD and plans to initiate a Phase 2b trial in the first half of calendar year 2018.
In this Phase 2a study, a total of 31 patients were evaluated following the last study visit. Patients were assessed on multiple endpoints after receiving two doses with two viable biopsies. In the GBR 830 cohort, 17 out of 23 patients experienced at least a 50 percent reduction in their Eczema Area and Severity Index (EASI) scores at day 57 compared to baseline, a key secondary endpoint of the study. Although not powered for statistical differences between GBR 830 versus placebo, data from this analysis suggest clinically meaningful improvement of symptoms that is continuous and sustained, with consistency observed between biological and clinical response.
“Atopic dermatitis can have a severe impact on quality of life. There is an unmet need for safe and more durable therapies for people suffering from atopic dermatitis,” said Dr. Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals. “GBR 830 is a novel, antagonistic monoclonal antibody that is designed to selectively target OX40 receptors to reduce inflammation in atopic dermatitis. We are pleased with the outcome of our Phase 2a study and look forward to rapidly advancing GBR 830.”