Raptiva Under Fire
In a recent turn of events, the FDA has issued a Public Health Advisory regarding safety concerns for patients treated with efalizumab (Raptiva, Genentech). The advisory was issued primarily due to three reports of progressive multifocal leukoencephalopathy (PDL) in patients taking the drug. In October 2008, the labeling for Rapitiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva. The FDA is reviewing this latest information and will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML.
In related news, the European Medicines Agency recommended the suspension of marketing authorisation for Raptiva following the conclusion by the agency that the benefits of the drug no longer outweigh its risks.
Unexpected Adverse Events with TNF Therapy
Use of anti-TNF blockers for the treatment of rheumatoid arthritis appears to be associated with an increased risk of herpes zoster, according to a new report (JAMA February 18). Researchers analyzed data from patients who began treatment with adalimumab or infliximab, etanercept, or when patients changed conventional disease modifying anti-rheumatic drug. There were 86 cases of herpes zoster among 82 patients. Researchers found that 39 occurrences could be attributed to treatment with anti-TNF antibodies (23 to etanercept, 24 to conventional DMARDs). They also found a significant association between herpes zoster and treatment with monoclonal anti-TNF agents infliximab and adalimumab, although this risk was lower than the threshold of clinical significance.
Another recent study suggests that TNF-blocker therapy for the treatment of rheumatoid arthritis may also be associated with another somewhat unexpected adverse event. In the study (Ann Rheum Dis 2009; 68: 209-215.), researchers reported several cases of new-onset psoriasis in patients treated with TNF agents. The study evaluated nearly 10,000 patients with RA, and found 25 cases of psoriasis, an incidence rate of 1.04 per 1000 person years in the TNF-blocker cohort. Interestingly, the incidence was significantly higher in patients treated with adalimumab than in those who received etanercept or infliximab.
Triple Chemo
For patients with unresectable stage IV melanoma, triple therapy with monthly carboplatin, weekly paclitaxel and biweekly bevacizumab may deliver excellent results. In a phase II study (Cancer 2009; 115: 119-127), 53 patients were treated with triple chemotherapy; carboplatin was given on day one of a 28-day cycle; paclitaxel was given on days one, eight, and 15; and bevacizumab was given on days one and 15. Treatment was continued until patients achieved remission or experienced intolerable toxicity. Results showed that nine patients (17 percent) achieved partial remission, and 37 patients (57 percent) achieved stable disease for at least eight weeks. Median progression-free survival was six months, and the median overall survival was 12 months. One patient died after eight treatment cycles from intracranial hemorrhage at the site of undiagnosed brain metastases.
High Risk
Patients with epidermolysis bullosa (EB) are at great risk of developing squamous cell carcinoma by age 55, according to a new study (JAAD 2009; 60: 203-211). Researchers analyzed data on 3,280 EB patients to determine the cumulative and conditional risks for SCC, basal cell carcinoma and malignant melanoma in the various EB subtypes. SCC occurred primarily in recessive dystrophic EB, especially in the Hallopeau-Siemens subtype. Cumulative risk of SCC rose steeply in RDEB-HS, and risk of SCC was 7.5 percent by the age of 20, 67.8 percent by age 35, 80.2 percent by age 45, and 90.1 percent by age 55.
Cancer Detector
A non-invasive instrument designed to aid melanoma detection shows clinical benefit, according to results of a study recently reported. The MelaFind (Electro-Optical Sciences), detected 112 of 114 melanomas eligible and evaluable for primary sensitivity endpoint analysis and 125 of 127 melanomas overall, the manufacturer reports. The instrument had higher specificity than did clinical dermatologic evaluation. The company intends to apply to the FDA for marketing clearance soon.
High Brow
Open brow-lift procedures appear to be as effective as endoscopic procedures for upper-face rejuvenation, according to a new report (Arch Facial Plast Surg 2009; 11: 13-17). Reviewing the role of open forehead procedures in upper-face rejuvenation, researchers found that during follow-up ranging from two to 10 years, the revision rate after open brow-lift procedures was 0.57 percent. Complications were uncommon and included alopecia (0.70 percent), persistent dyesthesia (1.3 percent), ocular irritation (7.37 percent), and unsatisfactory scar formation (0.19 percent). When researchers questioned patients, none found their scar to be unacceptable, and 92.5 percent would recommend the procedure to a friend. Finally, 98.1 percent said they would undergo the procedure again knowing.
Favorable Data
Positive data continue to stack up in favor of ustekinumab (Centocor). A study published online at TheLancet.com found that ustekinumab may significantly reduce signs and symptoms of psoriatic arthritis, as well as diminish skin lesions in patients with psoriatic arthritis. Importantly, the study found that these reductions in PA symptoms included patients with psoriasis affecting three percent or more body surface area. Researchers also reported that the drug was well-tolerated, with a similar incidence of adverse events and infections compared with placebo up to week 12. Researchers concluded that a larger study for a longer period of time is warranted to evaluate safety and efficacy of ustekinumab in psoriatic arthritis.
Events: Rosacea Awareness Month
April Awareness. As research indicates that rosacea may be more prevalent than previously thought, it is important to spread awareness and alert the public to warning signs of the condition. The National Rosacea Society once again has designated April as Rosacea Awareness Month. The Society will conduct public education activities to increase awareness and understanding of this widespread disorder now estimated to affect more than 14 million people. The NRS will emphasize warning signs and urge those who suspect they may have the condition to see a dermatologist or other physician. Be sure to take this opportunity to spread awareness and educate the public about rosacea and its effects. For information, ideas, and resources, visit Rosacea.org.
Clarification
In the January 2009 article, "Novel Approaches for Soft Tissue Augmentation" (vol. 6, no. 1, p.42), Evolence (OrthoNeutrogena) was inaccurately described as a form of porcine collagen with lidocaine. Evolence does not contain lidocaine. It is a porcine collagen-based structural dermal filler indicated for correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. Because of purification processes used to derive porcine collagen, potentially allergenic molecules are removed; skin pre-tests are not required. The collagen in Evolence is cross-linked via Glymatrix technology. For more information, visit evolence.com/us.
