BACKGROUND: Long-term data are essential to assess the safety of biologic agents for the treatment of psoriasis.
OBJECTIVE: To evaluate the incidence of adverse events of interest (AEIs), including all-cause mortality, major adverse cardiovascular
events (MACE), malignancy (excluding nonmelanoma skin cancer), and serious infections (SI), in patients treated for psoriasis in
clinical practice settings.
METHODS: PSOLAR is a large, ongoing, observational study of patients receiving, or eligible to receive, biologic or systemic therapy
for psoriasis. Cumulative incidence rates of AEIs per 100 patient-years (PY) are reported across treatment cohorts: (1) infliximab, (2)
ustekinumab, (3) other biologics (eg, adalimumab and etanercept), and (4) non-biologic agents. Significant predictors of each AEI were
identified using Cox proportional hazards regression methodology.
RESULTS: PSOLAR is now fully enrolled at 12095 patients followed for 31818PY. The cumulative rate was 0.46/100PY for death,
0.36/100PY for MACE, 0.68/100PY for malignancy, and 1.50/100PY for SI. Increasing age was a significant predictor of all AEIs. A history
of cardiovascular disease, malignancy, and significant infection was associated with a higher risk of developing MACE, malignancy,
and SI, respectively. Exposure to infliximab (Hazard Ratio [HR]=3.101, P<0.001) and exposure to other biologics (HR=1.736, P<0.001)
were significant predictors of SI. Use of immunomodulators (HR=1.954, P=0.005) was a significant predictor of MACE. Compared with
non-biologic therapy, the use of biologic agents was not a significant predictor of death, MACE, or malignancy.
CONCLUSIONS: Based on PSOLAR data through 2013, no new safety concerns were observed with infliximab for all-cause mortality,
MACE, or malignancy; the data suggest that infliximab was associated with serious infections.
J Drugs Dermatol. 2014;13(12):1441-1448.
Adipocytolytic therapies have always raised the interest of aesthetic medicine physicians, mainly because of the great potential to achieve spectacular results in localized adiposities reduction. In the last few decades, these results have been severely compromised due to the improper or reckless injection of these products, to the extent of some of them being banned in many countries. Today, there is a new adipocytolytic solution that has been approved, is effective, and has theoretic and empiric consensus regarding its safety. The aim of this study for which 331 therapeutic sessions were retrospectively analyzed is to provide evidence of its safety and efficacy.
J Drugs Dermatol. 2014;13(12):1451-1455.
Onychomycosis is a very common nail disorder seen in dermatological practice. It is difficult to treat successfully for a multitude of
reasons, and although topical antifungal therapy might be considered ideal for mild to moderate onychomycosis, efficacy has been
limited by poor nail penetration of active ingredient through the nail plate into the nail bed and nail matrix to the site of infection. The
intrinsic properties of an antifungal and its vehicle formulation are both considered important contributors to effective treatment.
Here we review the formulation approach to efinaconazole topical solution, 10% an effective and well-tolerated treatment for onychomycosis.
We demonstrate that the low surface tension formulation affords better penetration of efinaconazole through the nail
plate, and also to the site of infection by spreading into the space between the nail and nail bed.
J Drugs Dermatol. 2014;13(12):1457-1461.
Microscopic frozen section interpretation is one of the cornerstones of Mohs surgery. The recent development of super wide field
(SWF) microscopy can improve accuracy and efficiency while reading microscope sections, and also decrease the physician’s musculoskeletal and ocular strain.1,2 Super wide field microscopy systems increase viewable field area (VA) by combining low magnification objectives, eg, 1x or 2x (Figure 1), with eyepieces that have a higher field number.2,3 This article reviews 3 SWF microscopy systems: Leica DM2000 (Leica Microsystems, Wetzlar, Germany), Nikon Eclipse Ni (Nikon Instruments Inc., Melville, NY), and Olympus BX43 (Olympus, Center Valley, PA). The Leica DM2000’s 1.25x objective results in a VA of 314.16 mm2. The Nikon Eclipse Ni’s 1x objective results in a VA of 490.87 mm2. The Olympus BX43’s 1.25x objective results in a VA of 352.99 mm2. The maximum VA at the lowest
objective for Nikon is nearly 40% greater than for the Olympus and over 50% greater than for the Leica. The Nikon Eclipse Ni has a
significantly higher maximum VA than the other 2 systems.
J Drugs Dermatol. 2014;13(12):1463-1465.
Resveratrol is an effective anti-aging molecule with diverse biologic activity. It functions as a dual antioxidant that can neutralize free
radicals and increase intrinsic antioxidant capacity. Additionally resveratrol increases mitochondrial biogenesis and has anti-inflammatory,
anti-diabetic, and anti-cancer activity. In this paper we will focus on the use of topically applied resveratrol using a proprietary blend
containing 1% resveratrol, 0.5% baicalin, and 1% vitamin E. This stabilized high concentration formulation demonstrates percutaneous
absorption and alterations in gene expression such as hemoxygenase-1 (HO-1), vascular endothelial growth factor (VEGFA), and collagen
3 (COL3A1). Clinical assessment showed a statistically significant improvement in fine lines and wrinkles, skin firmness, skin elasticity,
skin laxity, hyperpigmentation, radiance, and skin roughness over baseline in 12 weeks. Ultrasound measurements in the periorbital area
showed an average improvement of 18.9% in dermal thickness suggesting significant dermal remodeling. These studies confirm that
topical resveratrol, baicalin, and vitamin E are valuable ingredient that can be used for skin rejuvenation.
J Drugs Dermatol. 2014;13(12):1467-1472.
Dermatofibrosarcoma protuberans is a rare, slow growing tumor. This growth occurs most frequently in males from ages 20 to 50. The
most common area on which DFSP originates is the trunk. DFSP presents clinically as a pink nodule or as a firm, flesh-colored to brown,
indurated and exophytic plaque. Pathology shows atypical spindle cells of fibroblast origin surrounding a core of collagen. The definitive
treatment of DFSP is surgical excision. Imatinib is a tyrosine kinase inhibitor that has been approved for use in DFSP refractory to surgery.
J Drugs Dermatol. 2014;13(12):1474-1477.
The repair and maintenance of the epidermal barrier is of the utmost importance in the treatment of atopic dermatitis (AD). While barrier
creams and emollients are considered to be a foundation of AD therapy, there is little comparative data between various product options.
This was a pilot study with a small sample size to investigate the use of skin barrier emulsion cream vs a commonly used moisturizing
lotion to improve the epidermal barrier in subjects with atopic dermatitis.
J Drugs Dermatol. 2014;13(12):1482-1484.
INTRODUCTION: Radiofrequency has remained a staple procedure for the treatment of skin laxity as therapeutic heat thresholds effectively
promote collagen remodeling. Nevertheless, comprehensive skin tightening involves both dermal and hypodermal collagen
remodeling. However, transcutaneous radiofrequency is unable to deliver consistent and measurable temperatures to the hypodermal
layers. Herein, we evaluated a newly emerging approach that provides precise and controlled subdermal heating is thermistor-controlled
subdermal skin tightening (ThermiTight) using a percutaneous radiofrequency treatment probe.
METHODS: A retrospective analysis of 35 patients was completed on patients having undergone ThermiTight for submental skin
tightening. Treated sites included under-chin and under-chin and jowls. The ThermiTight probe temperature was set between 50 to
60oC and was maintained using the thermistor integrated electrode. The probe was guided at a deliberate pace, treating a surface
area of 3.0 cm2 every two minutes. The clinical endpoint was an epidermal temperature of 42oC. Two blinded reviewers assessed
photographs taken at baseline and 30 days post-procedure. They were randomly presented with a photograph and asked to rate the
photograph using a 4.0 skin laxity scale.
RESULTS: The combined mean change comparing baseline and post-procedure skin laxity scores was -0.78, which was statistically significant (Table 2; P<0.0001). Each blinded reviewer correctly categorized photographs as either being “baseline” or “post-procedure” 89% of the time. No adverse events were reported.
DISCUSSION: These data demonstrate the safety and efficacy of the ThermiTIght procedure for the treatment of skin laxity.
J Drugs Dermatol. 2014;13(12):1485-1489.