Once weekly administration of etanercept 50 mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomized controlled trial with open-label extension.

BACKGROUND: In previous studies, etanercept 25 mg twice weekly (BIW) or 50 mg BIW significantly reduced disease severity in patients with plaque psoriasis and demonstrated a favourable safety profile. OBJECTIVES: To assess the efficacy and safety of etanercept 50 mg administered once weekly (QW) compared with placebo in patients with moderate-to-severe plaque psoriasis over 24 weeks. METHODS: This study was conducted in two parts: (i) a 12-week, double-blind, placebo-controlled phase, in which patients received etanercept 50 mg QW or placebo QW; and (ii) a 12-week, open-label extension phase, in which all patients received etanercept 50 mg QW. Primary endpoint was a 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at week 12. Secondary endpoints included percentage PASI improvement and Physician's Global Assessment (PGA). RESULTS: One hundred and forty-two patients were analysed in the double-blind phase; 126 patients entered the open-label phase. At week 12, significantly more patients receiving etanercept 50 mg QW (37.5%) achieved PASI 75 response than patients receiving placebo (2.2%; P < 0.0001). At week 24, 71.1% in the etanercept-etanercept group and 44.4% in the placebo-etanercept group achieved PASI 75. Mean percentage of PASI improvement from baseline was 55.4% with etanercept vs. 9.4% worsening with placebo at week 12 (P < 0.0001), with 77.4% and 57.7% improvement in the etanercept-etanercept and placebo-etanercept groups at week 24. A PGA score of 0-1 (clear-almost clear) was achieved by 64% and 42% in the etanercept-etanercept and placebo-etanercept groups at week 24, respectively. Etanercept 50 mg QW was well tolerated. No deaths, serious infections, opportunistic infections (including tuberculosis), demyelinating disorders, malignancies or new safety signals were reported. CONCLUSIONS: Nearly three-quarters of patients with moderate-to-severe psoriasis receiving etanercept 50 mg QW achieved significant improvement in disease severity over 24 weeks. This study also showed a favourable tolerability and safety profile with etanercept 50 mg QW.

Results of a randomised, multicentre study comparing a new water-based gel of clindamycin 1% versus clindamycin 1% topical solution in the treatment of acne vulgaris.

Several topical formulations of clindamycin phosphate are currently marketed for the treatment of acne vulgaris. This 12 week, multi-centre, investigator-blind, randomised, active and placebo-controlled, parallel group study assessed the clinical efficacy and safety of clindamycin 1% gel once-a-day vs clindamycin 1% solution twice-a-day, and to demonstrate its superiority vs its vehicle alone. A total of 592 subjects were included. After 12 weeks, a 65% reduction in inflammatory lesion count was observed with both active treatments. The gel was superior to its vehicle for total and inflammatory lesion reduction, Global Assessment of Improvement, and Global Severity Grade at final visit (all p < 0.01). No difference was found between the 2 active treatments for any of the evaluated criteria. Local tolerance in each active treatment group was slightly better with clindamycin gel (1.9% of subjects) relative to 3.1% in the topical solution group. In conclusion, the new water-based gel once-a-day formulation of clindamycin 1% is an effective, safe, and convenient alternative to the twice-a-day topical solution formulation in the treatment of acne vulgaris.

Community validation of the United Kingdom diagnostic criteria for atopic dermatitis in Romanian schoolchildren.

Although the U.K. modification of Hanifin and Rajka's diagnostic criteria for atopic dermatitis (AD) for use in epidemiological studies has demonstrated good validity and repeatability when previously tested in a U.K. community setting, little is known about its performance in other countries where different cultural, educational and linguistic factors could impair validity. We used a questionnaire to test the validity of the U.K. criteria as a point prevalence measure of AD in 1114 Romanian schoolchildren aged 6-12 years against the clinical diagnosis of a dermatologist with an interest in AD, who was unaware of the questionnaire content and responses. The sensitivity and specificity of the U.K. criteria for AD in this setting was 74% and 99%, respectively, an improvement rather than a deterioration in validity when compared with the previous U.K. study. Test-retest repeatability for all of the questions pertaining to the U.K. criteria using the chance-corrected kappa statistic was high, with values of 0.72 and over. The positive predictive value of the criteria was lower than in the U.K. study (63% compared with 80%, respectively) due to the very low prevalence of AD in this study (2.4%). The validity of a parental report of 'eczema' was poor, with a sensitivity of 22%, specificity of 97% and positive predictive value of 18%. This study suggests that the U.K. criteria perform well in settings outside the U.K., although care has to be taken when using the criteria to ascertain cases in settings where the prevalence of AD is very low.

The prevalence of skin conditions in Romanian school children.

Virtually nothing is known about the prevalence of skin conditions in children in the general population. Although we know something about the relative frequency of skin conditions seen by dermatologists, we do not know how such referrals are influenced by factors such as social class, accessibility to medical services or educational and cultural background. In order to estimate the burden and relative frequency of dermatological disease in children in the community, we measured the point prevalence of skin conditions in 1114 Romanian schoolchildren aged 6-12 years, using the British Association of Dermatologists diagnostic index. The overall point prevalence of children with one or more skin diseases was 22.8%, with no significant differences according to age group or sex, except for pityriasis alba which showed a male predominance (P = 0. 007). The most common diseases were infectious dermatoses such as viral warts and insect bites (6.3%), dermatitis/eczema (5.1%), pityriasis alba (5.1%), keratosis pilaris (4.0%) and urticaria (1. 9%). Together, these five groups accounted for more than 84% of the cases. Of the 1114 children, 213 (19.1%) had only one skin disease and 41 (3.7%) had two skin diseases. While acknowledging the limitations in defining which skin conditions can benefit from medical care, this study suggests that skin disorders are common in Romanian schoolchildren, affecting about one-quarter of 6-12 year olds. Such a point prevalence is likely to be conservative because of the tendency of prevalence estimates to exclude many other dermatoses of short duration. The finding that over 80% of the disorders can be grouped into fewer than six categories is important in informing training programmes and delivery of service for primary health care teams. This study provides a baseline for further studies into the morbidity and use of health care services by children with skin disease in the community.

The outpatient management of peripheral diabetic neuropathy.

Diabetic neuropathy is a common complication of diabetes. Its commonest form is the bilateral, distal sensorimotor neuropathy and this has been associated with increased risk of disability from foot ulceration, inadvertent injury leading to gangrene as well as to amputation. The economic implications of the treatment of diabetic neuropathy and its consequences are enormous. In spite of this, there is no universally accepted method of treating it and efforts are still underway to find an adequate form of therapy. The following is a review of the outpatient management of peripheral diabetic neuropathy.