Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial.

BACKGROUND: CF101, an adenosine A3 receptor agonist, is an orally bioavailable small molecule drug presenting an anti-psoriatic effect demonstrated in a Phase 2 clinical trial in psoriasis patients.
OBJECTIVE: To evaluate the safety and efficacy of CF101 treatment in a Phase 2/3 study in patients with moderate to severe plaque-type psoriasis.
METHODS: This multicenter, double-blind, 2-segment, placebo-controlled study randomized subjects with moderate to severe plaque psoriasis to CF101 1 or 2 mg, or placebo twice daily. At either week 12 (Segment 1) or 16 (Segment 2), the placebo group crossed over to CF101 BID through week 32 in an open-label fashion. At week 12, following an interim analysis, the CF101 1mg group was discontinued due to futility. The primary endpoint was proportion of patients achieving ≥75% improvement in Psoriasis Area Severity Index (PASI 75). Efficacy testing was performed using the Cochran-Mantel Haenszel test, the primary analysis of PASI 75 was performed at the 0.035 significance level.
RESULTS: CF101 had an excellent safety profile at all tested dosages with a profile similar to the placebo group. The most common adverse events were infections and gastrointestinal events, and there was no cumulative intolerance over the 32-week dosing period. The study did not meet the primary endpoint of PASI 75 at week 12 (2 mg: 8.5% vs. placebo: 6.9%, P=0.621). However, at week 32, PASI mean percent improvement with CF101 2 mg was 57% (P<0.001) compared to baseline, with linear improvement in PASI 50 (63.5%), 75 (35.5%), 90 (24.7%), and 100 (10.6%).
CONCLUSIONS: Oral CF101 was found to be safe and very well tolerated, demonstrating evidence of efficacy in patients with moderate to severe plaque psoriasis through 32 weeks of treatment.

J Drugs Dermatol. 2016;15(8):931-938.

Toxic Epidermal Necrolysis - A Case Report.

Toxic epidermal necrolysis (TEN) is an acute, life-threatening muco-cutaneous disease, often induced by drugs. It is characterized by muco-cutaneous erythematous and purpuric lesions, flaccid blisters which erupt, causing large areas of denudation. The condition can involve the genitourinary, pulmonary and, gastrointestinal systems. Because of the associated high mortality rate early diagnosis and treatment are mandatory. This article presents the case of a sixty-six years old male patient, known to have cirrhosis, chronic kidney failure, and diabetes mellitus. His current treatment included haemodialysis. He was hospitalized as an emergency to the Dermatology Department for erythemato-violaceous, purpuric patches and papules, with acral disposition, associated with rapidly spreading erosions of the oral, nasal and genital mucosa and the emergence of flaccid blisters which erupted quickly leaving large areas of denudation. Based on the clinical examination and laboratory investigations the patient was diagnosed with TEN, secondary to carbamazepine intake for encephalopathic phenomena. The continuous alteration in both kidney and liver function and electrolyte imbalance, required him to be transferred to the intensive care unit. Following pulse therapy with systemic corticosteroids, hydro-electrolytic re-equilibration, topical corticosteroid and antibiotics, there was a favourable resolution of TEN. The case is of interest due to possible life-threatening cutaneous complications, including sepsis and significant fluid loss, in a patient with associated severe systemic pathology, highlighting the importance of early recognition of TEN, and the role of a multidisciplinary team in providing suitable treatment.

Epidemiological aspects of genital warts in romania - a 2012 retrospective survey.

OBJECTIVES: Genital infection with human papillomavirus (HPV) has become one of the most frequently viral sexually transmitted diseases. The infection may remain asymptomatic, may take the form of external genital warts and may give raise to cervical cancers. The aim of this study was to assess the frequency of the patients with genital warts addressing to five tertiary referral dermato-venereological units in Romania (where patients from several counties are referred) and to compare the results with the out-patient data reported by all Romanian hospitals. MATERIAL AND METHODS: Data regarding patients with external genital warts who addressed to the hospital emergency rooms, in five tertiary referral dermato-venerological units in Romania (Bucharest, Timisoara, Craiova, Constanta, Târgu-Mures) were collected for the year 2012. For comparison there have been used data collected by the National School of Public Health, Management and Professional Development, during the same year. OUTCOMES: Data reported at national level in 2012 included 952 patients (731 women and 221 men) with 26 males under 20 years of age and 251 female patients in the age group 0-20 years. In the overall population (males and females combined) the total number of genital warts cases registered at the hospital emergency rooms in the five centers, in the year 2012, was 266 patients (119 men and 147 women) with 4 girls under 14 years of age and 6 male patients in the age group 0-14 years. CONCLUSIONS: The high prevalence of the infection with HPV, the costs of treatment and the psychological impact prove that prevention of the disease is the most important step for decreasing the incidence of this disease. General measures for patients awareness regarding the disease and its complications need to be completed with the recommendation for vaccination. A closer monitoring of patients would provide information for a strategic national approach leading to a better outcome.

Recommended strategies for epidermolysis bullosa management in romania.

BACKGROUND: There are 72 families with epidermolysis bullosa (EB) in Romania. Since 2012 a National Program for the treatment of these patients is run by the Ministry of Health.The objectives of the strategies for EB patients are to optimize the management (diagnosis, treatment, monitoring) and to provide actual information on classification and patho-physiology which dictate the course of the disease. METHODS: An international expert panel of specialists produced by consensus the recommendations for the management of EB cases in Romania taking into account the local possibilities. Patient association proposals were included. A review of the literature was performed to up-date the information. OUTCOMES: A strategy for diagnosis, treatment and follow-up of the patients with EB was elaborated in clear steps. Pharmacological treatments and wound care indications are provided together with a useful score for patient evaluation. CONCLUSION: These recommended strategies are allowing dermatologists to generate an individualized care plan for patients with EB.