Recent Developments

World Congress of Dermatology Research Highlights

Ustekinumab Four-year Safety Data

Rates of adverse events associated with ustekinumab (Stelara, Janssen Biotech, Inc.) remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment. The finding is based on analysis of pooled data from the clinical development program for the drug. Data were available for 3,117 patients who participated in the phase II trial and the phase III PHOENIX 1, PHOENIX 2, and ACCEPT studies. The most commonly reported AEs—more than five per 100 patient years—were nasopharyngitis, upper respiratory tract infection, arthralgia, sinusitis, headache and back pain, and influenza. Rates of serious infections, non-melanoma skin cancer, and major adverse cardiovascular events (MACE) remained generally stable during the time period evaluated. The rate of malignancies was consistent with that expected in the general population, the rate of non-fatal MI or stroke was consistent with or lower than expected in the general population.

A second data analysis showed that ustekinumab provides similar efficacy and safety in patients of Japanese and Korean-Taiwanese descent as it does in North American and European populations.

Clinical Application of OCT Scanner

A study performed on BCC patients describes the OCT morphology in Non-Melanoma Skin Cancer (NMSC) lesions during PDT treatment and assesses how OCT morphology before, during and after treatment reflects the treatment outcome at three months follow-up. Because no tissue is removed for analysis in the PDT procedure, the efficacy of treatment in eradicating tumors is difficult to assess. Use of the VivoSight OCT scanner (Michelson Diagnostics, Ltd.) to image skin before, during and after PDT treatment, appears to enable clinicians to monitor the lesion throughout the treatment process and ascertain the degree of clearance.

Etanercept Effects on Cardiometabolic Biomarkers

Data from an exploratory endpoint from the PRISTINE trial studying patients with moderate-to-severe plaque psoriasis treated with etanercept (Enbrel, Amgen/Pfizer) 50mg once or twice weekly suggest that 12 weeks of treatment did not negatively impact various biomarkers of cardiometabolic disease, including apolipoprotein B/apolipoprotein A1 ratio, hsCRP, and NT-proBNP. Increasing evidence indicates an increased incidence of comorbid conditions such as diabetes and cardiovascular disease in psoriasis patients. The clinical significance of the current findings requires further study, researchers say.

New Data for Blue Light for Acne

New clinical study results support the safety and efficacy of TRIA Beauty's acne-clearing blue light device. TRIA's clinical data proves the suitability of TRIA Blue Light for self-treatment of mild to moderate acne outside of a clinical setting, the company says. The device utilizes high intensity blue light to eliminate acne-causing bacteria and leave the skin healthier and more radiant-looking. In addition, TRIA Beauty also announced the results of their study, "Tolerability in Asian Skin of a New Blue Light Device for the Self-Treatment of Mild to Moderate Acne," which focuses on treatment of Asian skin with the Blue Light device.

European Beauty Attitudes Revealed

A survey of over 2,900 women in five European countries reveals what female patients across the pond think about beauty. All respondents to the “Face Value” Beauty Survey—hailing from France, Italy, Spain, Russia, and the United Kingdom—had experience with or interest in minimally invasive aesthetic procedures, including dermal fillers and/or botulinum toxins. The survey was sponsored by and reported by Merz Aesthetics.

Across all five countries surveyed, most women agree that healthy skin and/or an overall well-groomed appearance make a woman beautiful, while only 24 percent attribute beauty to youth. Confidence and charming personality were among the top five things cited as making a woman beautiful.

Pan-European women were most likely to describe their personal style as natural, feminine, and/or casual, and less likely to describe their style as classic, sexy or sophisticated. Women are twice as likely to say beauty stems from a natural appearance (57 percent), rather than a glamorous or made-up look (28 percent).

About 68 percent of women say they feel beautiful, and nearly nine in 10 say they feel more beautiful when they are happy. A majority (89 percent) say they are more confident when they feel beautiful.

Of note, nearly all (98 percent) survey respondents indicated that there are aspects of their body they would like to improve or change, including stomach or abdomen (56 percent), overall weight (44 percent), breasts (41 percent), face (38 percent), and buttocks (38 percent.)

Among respondents with wrinkles, 45 percent are concerned about them and 62 percent have looked for treatments. Of those who have undergone treatment with injectables for wrinkles, approximately three in five say they have experienced a positive life change as a result of facial injectable treatments and two in three have recommended them to a friend.

Overall, women say they want their facial injectable treatment(s) to deliver natural-looking, long-lasting results. Half of women say they want a facial injectable treatment to enhance their looks without changing their appearance too much. Almost as many (44 percent) want to look radiant and well-rested.

Emollient Foam Wins Over Patients with AD

A non-steroidal, ceramide-hyaluronic acid emollient foam may provide better results than a topical calcineurin inhibitor for the management of atopic dermatitis, results of a 30-patient, open-label, investigator- blinded, bilateral comparison study show (J Drugs Dermatol, E-pub June). Patients treated with Hylatopic Plus (Onset Dermatologics) had a 67.9 percent overall improvement in IGA scores, compared to 63.1 percent improvement with pimecrolimus cream 1%. At the conclusion of the study, 82 percent of foam-treated patients were clear or almost clear, compared to 71 percent of creamtreated patients. Sixty-eight percent of patients reported that they preferred the foam formulation over the cream.

DMARDS Drop Diabetes Risk

Though it's not clear why, treatment with disease modifying antirheumatic drugs (DMARDS) appears to reduce the risk of diabetes in patients with rheumatoid arthritis (RA) or psoriasis (JAMA 305(24)). The retrospective review of records for 13,906 patients with RA or psoriasis found that over the 12-year study period the rate of diabetes was 19.7 per 1,000 person years (PY) among patients taking TNF-inhibitors and no other DMRADS, 22.2 per 1,000 PY for those taking hydroxychloroquine without TNF inhibitors or methotrexate, 23.8 per 1,000 PY among those taking methotrexate alone; and 50.2 percent for those taking other DMARDS without any of the above-named agents. TNF inhibitors were shown to reduce diabetes risk by 38 percent, methotrexate by 23 percent, and hydroxychloroquine by 46 percent.

National Adverse Drug Event Network Launched

A new online network to collect and distribute adverse event information was recently launched. The new service, called RxEvent, is now available to all US prescribers via integration into EHR platforms and other online services, including directly at www.rxevent.org.

New Name for Biotech Firm

Janssen Biotech, Inc. is the new name for Centocor Ortho Biotech, Inc. The name change, announced last month, is intended to unite Janssen companies around the world under a common identity, the company said.

Rosacea Impacts the Workplace

New data from the National Rosacea Society indicate rosacea can have a strong impact on a patient's workplace interaction and productivity. In a survey of 1,134 patients, 60 percent of all respondents and 88 percent of those reporting severe symptoms said the disorder had negatively affected their interactions with others in the workplace. Among those with severe symptoms, 51 percent said they had even missed work because of their condition. In addition, 69 percent of all respondents and 87 percent of those with severe symptoms said they had noticed others staring at their face when they were experiencing a flare-up. Some respondents (19 percent) also reported that they felt they did not receive a job offer or were denied a job promotion because of their condition.

Supreme Court Rules in Favor of Generics

The US Supreme Court says makers of generic drugs cannot be held responsible for warning consumers of the dangers of their drugs on the package's label when the brand-name equivalent does not. The high court ruled in a 5-4 decision against Gladys Mensing, who had sued Croatia-based PLIVA, Inc. and other generic drug manufacturers. She alleges that taking metoclopramide gave her a severe neurological movement disorder, but none of the generic drug's manufacturers and distributors made any effort to include warnings on the label. Generic drug makers say US government regulations require them to have the same label on metoclopramide as is on its brand-name equivalent, Reglan, which did not have a warning about tardive dyskinesia.

Abbott Strikes Deal for Investigational Psoriasis Agent

Abbott and Biotest AG announced a global agreement to develop and commercialize BT-061, a novel anti-CD4 antibody for the treatment of rheumatoid arthritis and psoriasis. BT-061 is currently in Phase II clinical trials for RA and psoriasis, with preclinical studies underway to study its potential use in other immune-related diseases. CD4 is expressed on T-cells and is involved in T-cell mediated modulation of immune responses. BT-061 is a humanized monoclonal antibody that works by activating the body's T-regulatory cells, a subset of T-cells, strengthening a natural function of the body that prevents excessive immune reactions. Unlike other anti-CD4 antibodies that have been in development, BT-061 does not cause depletion of CD4 positive T-cells that would give rise to weakened immune responses.

AK Treatment Approved in UK

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK granted a marketing authorization for Actikerall® (5mg/g fluorouracil and 100mg/g salicylic acid) cutaneous solution for the treatment of palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in adult patients, Almirall, S.A. announced. In a 12-week Phase III trial, which enrolled 470 patients with four to 10 AK lesions, complete clearance of a representative lesion was confirmed, by histology, in 72 percent of patients. This benefit was sustained, as 85.8 percent of lesions clinically assessed as cleared after initial treatment were still clear 12 months post treatment. Actikerall was well tolerated during the study with less than four percent of patients withdrawing from the study due to adverse reactions reported on application sites. Actikerall is supplied in a 25ml bottle. The solution is applied by an integral brush that allows for more precise application and may reduce the risk of affecting normal skin.

Savings Card Released

A new $0 co-pay card from Promius Pharma, LLC is applicable to the full range of Cloderm Cream sizes and forms, including the 45 and 90 gram tube and the and 75 gram pump. The $0 co-pay card is good for the first purchase and two subsequent refills of Cloderm. There are some restrictions and limitations to use of the card, printed on each card so individual patients can review and fully understand them. The rebate cards are available through local Promius sales representatives or by calling (800) 429-4500. Patients can download the card at www.cloderm.com.