Recent Developments

Study: IL-12/23 Agents Do Not Increase Risk of CV Events

A recently published analysis suggests that anti-IL- 12/23 agents do not raise the risk of cardiovascular side effects (JAMA). Researchers examined data from 22 studies involving 10,183 patients that compared anti-IL-12/23 agents ustekinumab (Stelara, Janssen Biotech) and briakinumab (Ozespa, Abbott) and TNF inhibitors adalimumab (Humira, Abbott), etanercept (Enbrel, Pfizer) and infliximab (Remicade, Janssen) with placebo. Over the course of the trials, 10 patients out of 3,179 taking ustekinumab or briakinumab had a heart attack or stroke or died of heart-related causes, as compared to none of the 1,474 patients given placebo, which did not reach statistical significance. One subject among the 3,858 given TNF inhibitors and one among the 1,812 given placebo had a cardiovascular event. The authors noted that more data and longer studies are needed because drugmakers wouldn't release patient-level data associated with the drugs, including patient demographics and prior known cardiac risk factors. They concluded that "until more definitive data become available, we believe that dermatologists should exercise heightened vigilance for cardiovascular risk factors when initiating anti-IL-12/23 agents in psoriasis patients."

New Referral Program for Blue Light Device

The new TRIA |MD referral program enhances patient access to physicians who prescribe treatment with the blue light device. A new study supports the efficacy of the TRIA Skin Perfecting System for acne (Journal of Drugs in Dermatology). Researchers evaluated the system, which includes the blue light device, a proprietary salicylic acidbased cleanser and serum, for the self-treatment of mild to moderate acne. They found a statistically significant reduction in lesions as early as one week, which continued through the eight weeks of treatment. In addition, a majority of patients agreed that the system cleared and prevented their acne flares better than any other skin care products, and 90 percent of patients reported improvements in their skin's overall appearance, tone, texture and radiance.

FDA Advertisement Guidelines Rarely Followed

New research suggests that advertising from the pharmaceutical industry may not comply with FDA guidelines. A study of 192 pharmaceutical advertisements in biomedical journals found that only 18 percent were compliant with FDA guidelines, and over half failed to quantify serious risks including death (Public Library of Science One). Researchers performed a cross-sectional analysis of prescription pharmaceutical advertisements published in nine journals in November 2008. They evaluated adherence to FDA standards and the presence of content that is important for physicians to use when safely prescribing the drugs. Of the 192 advertisements for 82 unique products, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines. In addition, 57.8 percent of the advertisements did not quantify serious risks, 48.2 percent lacked verifiable references, and 28.9 percent failed to present adequate efficacy quantification.

OCT Beneficial for Diagnosis and Prognosis of Nail Disease

Optical Coherence Tomography may have considerable potential for the evaluation of psoriatic nail disease, a case study suggests (Dermatology). Researchers compared nail bed images produced by the VivoSight OCT scanner (Michelson Diagnostics) with those produced using high-resolution ultrasound. The OCT images showed much higher resolution changes than ultrasound, correlating with clinical observation of subungual hyperkeratosis. The findings were also presented at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis meeting. The authors note that the study could have implications for diagnosis, prognosis, and monitoring of therapies and for a better understanding of nail disease pathogenesis.

Hair Restoration Procedures Increase Worldwide

As hair restoration procedures increase, people are more willing to own up to having sought treatment, survey data show. According to data from the International Society of Hair Restoration Surgery, an estimated 279,381 surgical hair restoration procedures were performed worldwide in 2010, an increase of 11 percent from 2008. More than half (56.4 percent) of Society members reported that their patients would be more likely to discuss hair restoration than they were in 2008. In addition, 36.2 percent of members said their patients would be just as likely to discuss and only 7.4 percent responded that they would be less likely to discuss their hair restoration procedures.

Peels Aid Acne

Superficial chemical peels appear to be a worthwhile adjunct in the treatment of acne, a review of the literature concludes (Journal of the European Academy of Dermatology & Venereology). The paper reviewed 13 trials, most of which evaluated small numbers of patients. These studies, mainly open label, were not placebo-controlled. Nonetheless, all showed generally favorable results and suggested that chemical peeling provides benefits in the management of acne vulgaris. The authors urge further study to define the best use of chemical peels in active acne care.

Favorable Benefit/Risk for UStekinumab

A new data analysis presented at Academy '11 in New York last month (P2401), suggests a favorable benefitrisk profile for Stelara (ustekinumab, Janssen Biotech) in the treatment of moderate-to-severe psoriasis. Analyzed data were drawn from 12-week placebo-controlled periods of the phase III ustekinumab trials PHOENIX 1 and 2. Benefit was assessed based on number needed to treat (NNT, the number of subjects needed to be treated with ustekinumab versus placebo in order to observe one beneficial event). Risk was assessed based on number needed to harm (NNH, the number of subjects needed to be treated with ustekinumab versus placebo in order to observe one adverse event). NNT values were low, suggesting a significant treatment benefit, while NNH values were at least two orders of magnitude greater than NNT estimates. In patients treated with ustekinumab 90mg, the NNT to achieve a 75 percent reduction in PASI was 1.46; the NNH for any serious adverse event was 648. Another poster (P2402) showed that a majority of patients who resumed ustekinumab therapy after a period of therapeutic withdrawal were able to reachieve levels of clearance attained in the initial treatment period. Data come from the phase III PHOENIX 1 and ACCEPT trials, designed with treatment arms in which treatment was interrupted and reinstated. Among 260 patients retreated in PHOENIX 1, 83.7 percent of those retreated with ustekinumab 45mg and 85.4 percent of those retreated with ustekinumab 90mg achieved PASI 75 at week 12 of retreatment, results similar to those observed during the initial treatment course. Among 375 patients retreated in ACCEPT, 84.6 percent of those retreated with ustekinumab 45mg and 89.2 percent of those retreated with ustekinumab 90mg re-achieved a PGA

Patient Assistance Center

Drug costs can be high—even for patients with prescription drug coverage as part of their insurance plans. Each month, we'll highlight current promotions you can share with your patients to help them save money and increase the likelihood they'll fill their prescriptions and adhere to the treatment plan. Look for a compilation of programs listed at PracticalDermatology.com.

The Desonate (desonide) Gel 0.05% Zero Copay Card, now available from Intendis provides insured patients up to $200 toward their initial prescription fill for Desonate Gel and then provides a co-pay of no more than $10 on three subsequent refills. Patients can download cards at Desonate.com.

The Zyclara (imiquimod) Cream 3.75% Instant Savings Card from Graceway Pharmaceuticals allows most patients to pay $0 copays with a benefit up to $300 per prescription. The card is accessible online at http://www.gracewaypharma.com/products/ zyclara.

XTRAC Laser Treatment for children with psoriasis is now available with no co-pay. PhotoMedex has launched the co-pay reimbursement offer in conjunction with National Psoriasis Awareness Month. More information is online at XTRACLaser.com.