Efficacy of Adalimumab for Nail Psoriasis During 24 Months of Continuous Therapy.

Psoriatic nail symptoms are frequent in psoriasis, affecting up to 80% of patients. Therapy responses to nail symptoms are often limited. In this multicentre non-interventional prospective study, 267 patients with nail involvement were treated with adalimumab for a period of 24 months. The efficacy of adalimumab for nail psoriasis was evaluated and predictors for better response were identified. For statistical analysis Kolmogorov-Smirnoff, Mann-Whitney U, Wilcoxon, χ2 and two-tailed Spearman's rank correlation tests were applied. After 3 and 6 months, reductions in Nail Psoriasis Severity Index (NAPSI) of 32.8% (p < 0.001) and almost 50% (p < 0.001), respectively, were observed, compared with baseline scores (mean NAPSI score, 34.2 ± 1.3). In 6 months, 60.0% of patients achieved NAPSI50, 36.4% NAPSI75, and 21.7% NAPSI90. Approximately 42% and 60% of patients achieved NAPSI90 after 12 and 24 months, respectively. At month 12, reduction in NAPSI significantly correlated with improvement in Dermatological Life Quality Index. Stratification by age, sex, and body mass index indicated that treatment was more effective in younger patients and those with higher body mass index. Adalimumab is an effective long-term therapy for nail psoriasis. The amelioration of nail symptoms correlates with an improvements in the skin disease and quality of life.

Efficacy and durability of two hyaluronic acid-based fillers in the correction of nasolabial folds: results of a prospective, randomized, double-blind, actively controlled clinical pilot study.

BACKGROUND: This pilot study compared a monophasic hyaluronic acid dermal filler with a biphasic filler for the correction of nasolabial folds. METHODS: Participant- and assessor-blinded, randomized clinical trial involving participants with moderate to severe nasolabial folds. Split-face design comparing a monophase hyaluronic acid (HA) filler (mono-HA) with a biphasic HA filler (bi-HA). Injection with touch-up after 1 month. Wrinkle improvement was measured before and after injection and after 1, 2, 4, and 7 months, using the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale as outcome criteria. An optional treatment was offered at the end of the study, with participants allowed to choose one of the products. OBJECTIVE: Evaluation of efficacy and safety of both products. RESULTS: Both products showed immediate, good results after injection and touch-up and demonstrated good durability over time. Participant preference for optional treatment at the end of the study favoured mono-HA. Both products were well tolerated, without serious adverse events. CONCLUSION: The effect after injection of mono-HA and bi-HA is generally comparable, although there was a trend in favor of mono-HA. Materials and funding for this study were provided by Teoxane, Geneva, Switzerland.

The current state of treatment of adverse reactions to injectable fillers.

BACKGROUND: Adverse reactions to injectable filler may be challenging to treat. The spectrum of treatment options ranges from immunomodulatory drugs (e.g., glucocorticosteroids) to antibiotics to laser therapy and surgery. OBJECTIVES: To assess how adverse reactions were treated and how they processed over time. MATERIALS AND METHODS: Participants from the Injectable Filler Safety (IFS) Study were reinterviewed to obtain data on the course of adverse reactions and the therapy. RESULTS: Forty-one participants from the IFS Study were reinterviewed; 35 (85%) received treatment, 17 (41%) with a combination of drug therapy and surgery, 14 (34%) with drug therapy only, and four (10%) with a surgical intervention. Six (15%) did not receive any treatment. Fifty-one percent of all of the treated participants reported treatment-related adverse reactions. Participants with more severe adverse reactions were more likely to be treated with a combination of drugs and surgery. In all participants, adverse reactions improved. CONCLUSION: We certainly need more evidence. Reporting positive and negative treatment outcomes is important to improve our knowledge regarding these reactions. Therefore, registries focusing on adverse reactions to injectable fillers and their treatment should be encouraged. The authors have indicated no significant interest with commercial supporters.

Hand augmentation with stabilized hyaluronic acid (Macrolane VRF20 and Restylane Vital, Restylane Vital Light).

Volume augmentation of the back of the hand is a new technique which is not yet often employed. We describe the treatment of two patients who received hyaluronic acid products produced by Q-Med (Macrolane VRF20, Restylane Vital and Vital Light). The injections of Macrolane VRF 20 were done by feathering technique using a long and blunt 18 gauge canula while Restylane was injected by tunneling or tenting technique with a 30 gauge needle. Significant adverse events did not occur. After injection of the hyaluronic acid fillers, the appearance of the back of the hands was improved. Both patients were very satisfied with the result.

Risk of severe adverse reactions to an injectable filler based on a fixed combination of hydroxyethylmethacrylate and ethylmethacrylate with hyaluronic acid.

BACKGROUND: Hydroxyethylmethacrylate and ethylmethacrylate in a fixed combination with hyaluronic acid has been used as an injectable filler for nearly a decade. Severe adverse reactions have been associated with this filler. OBJECTIVE: To characterize the adverse reactions to this filler. METHODS: Data from the Berlin registry for adverse reactions to injectable fillers were analyzed. The registry is a partially population-based registry with the aim of collecting adverse reactions to injectable fillers. Patients were interviewed based on a standardized questionnaire. RESULTS: Thirty-four of 118 (28.8%) registered patients were treated with this filler. Of 95 treated areas, 87 responded with a reaction (91.6%). The most frequently observed adverse events were the development of nodules (n=85) in 87 affected areas, discoloration (n=39), erythema or inflammation (n=32), and swelling (n=24). Most nodular reactions were rated as severe. The mean time after the last treatment until appearance of an adverse reaction was 23.1+/-22.8 months. CONCLUSION: Adverse reactions to this methacrylate filler are common. The mean latency period for these mostly severe rated reactions was nearly 2 years. Based on the frequency and severity of these reactions, the use of this filler does not seem to be advisable.

The spectrum of adverse reactions after treatment with injectable fillers in the glabellar region: results from the Injectable Filler Safety Study.

BACKGROUND: For the glabellar region, severe partly vascular adverse events have been reported after treatment with injectable fillers. METHODS AND MATERIALS: For this study, data from the Injectable Filler Safety Study, a German-based registry for those reactions, was analyzed to characterize adverse events seen in the glabellar region. Patients were analyzed descriptively. RESULTS: Forty of 139 registered patients reported adverse events in the glabellar region. All patients were female, with an average age of 52.3. Nineteen patients with adverse reactions to hydroxyethylmethacrylate (HEMA) and ethylmethacrylate (EMA) in a fixed combination with hyaluronic acid (HA) and 10 patients with adverse reactions to different hyaluronic acid products were reported; five patients reacted to poly-L-lactic acid (PLA). The most common adverse reactions to HEMA/EMA in HA and PLA were nodules and hardening. In HA-treated patients, erythema and inflammation, swelling, and pain were most frequent. The adverse reactions to HEMA/EMA in HA were severe in 50% of the patients. Severe adverse reactions were found to a lesser extent in patients treated with HA and PLA. Potential vascular complications were documented in only two patients. CONCLUSION: Adverse reactions seen in the glabella are overwhelmingly product associated and to a lesser extent location associated. Vascular complications with necrosis and ulceration were rare.

Hyaluronidase in the correction of hyaluronic acid-based fillers: a review and a recommendation for use.

BACKGROUND: Hyaluronic acid (HA) preparations are the most commonly used injectable fillers in esthetic medicine. In contrast to other injectable fillers with hyaluronidase, there is a tool available to reduce unwanted depots of this filler. AIMS: The aim of this paper is to give an overview on the present literature and in addition to give some recommendations for use based on the experience of the authors. METHODS: The overview is based on a literature search. RESULTS: There is some evidence from two smaller clinical trials that hyaluronidase will effectively decrease injected depots of HA. It has further been shown from case series and case reports that this reduction is clinically relevant. There is less evidence that hyaluronidase is also helpful in adverse reactions to HA-based fillers. CONCLUSIONS: The reports suggest that the treatment is safe. However, adverse reactions to hyaluronidase such as allergic reactions have been reported. Patient should be informed about that before treatment.