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.

Life events involvement in psoriasis onset/recurrence.

BACKGROUND: The purpose of the study was to evaluate the possible role of stress before the onset/extension/recurrence of psoriasis. PATIENTS AND METHOD: One hundred and sixty-nine outpatients with psoriasis and 169 age and gender matched controls were enrolled. The design was a case-control study (controls had skin diseases with low psychosomatic component). Stressful life events were evaluated using Holmes and Rahe's Social Readjustment Rating Scale. RESULTS: In the psoriatic group, there was a female predominance (66%) and a median age 47.55 years (SD = 20.32). In all, 10.65% of patients had family history of psoriasis. More than 54% of cases experienced at least one stressful event (47.36% for onset, 63.51% for recurrence/extension), compared with 19.52% of controls (chi(2) = 42.71, P < 0.0001). The odds ratio was 4.92. There was a significant difference in the mean number of stressful events between patients and controls (P < 0.0001). Women with psoriasis vulgaris and men with guttate psoriasis seemed to be more sensitive to stressful events. We divided the events described by Holmes and Rahe into three categories: family, personal, and job/financial problems. Family matters were mentioned by 42.7% of psoriatic patients, statistically significant compared with controls (P < 0.0001). In 35% of psoriatic cases, "the stressful event" was represented by the illness/death of someone dear. Both "personal" (25.6%; P = 0.02) and "job/financial problems" (31.6%; P < 0.0001) were significantly different compared with controls. CONCLUSIONS: Stressful events could be highly related to psoriasis (especially in recurrences/extensions). Problems related to family are the most often involved with counseling being suggested.

Multiple glomus tumors.

BACKGROUND: Solitary and multiple glomus tumors are vascular tumors arising from glomus cells. These two forms have distinct clinical and histopathological features, suggesting that they might have a different pathogenesis. The multiple form is less frequent than the solitary form. Its diagnosis and treatment are more problematic and often delayed. MAIN OBSERVATION: We present the case of a 40-year-old patient, with a 20-year history of numerous non-tender disseminated blue papules. At the age of 30 years one of the lesions was excised and than regrew and became painful. The histological exam of the lesions was consistent with glomangioma, also known as glomus tumor. We performed surgical resection of the nodular and painful lesions. CONCLUSION: The diagnosis of glomus tumor is easily suspected when the lesion is painful located in the subungual region. However, if the lesions are multiple and extradigitally located, the clinical diagnosis may be difficult and requires having in mind this differential diagnosis. Our case also shows that glomus tumors may regrow after excision in the same location.

Stress in patients with alopecia areata and vitiligo.

OBJECTIVE: To study the involvement of stress before the onset/development of alopecia areata and vitiligo. PATIENTS AND METHOD: Forty-five outpatients with alopecia areata and 32 outpatients with vitiligo were enrolled. The design was a case-control study (controls had skin diseases unrelated to stress). Stressful events were evaluated using Holmes and Rahe's social readjustment rating scale. RESULTS: Mean age was around 30 years in both conditions. More than 65% of cases (both alopecia areata and vitiligo) experienced stressful events compared to 22% of controls. The odds ratio was 7.75 for alopecia areata and 6.81 for vitiligo. There was a significant difference in the mean number of stressful events between alopecia areata patients and controls (P = 0.005), and also a significant difference in the number of stressful events between men (P = 0.05) and women (P = 0.001) across these two groups. In the vitiligo group there was a significant difference in the mean number of stressful events between patients and controls only in women (P = 0.02). A potential stressful situation occurred more often in both patient groups. Alopecia areata patients described family problems in 45.6% of patients (especially women), which was statistically significant when compared to controls (P = 0.0004). Personal problems were reported by 35.7% of alopecia areata patients (P = 0.04 compared to controls). Vitiligo patients mentioned personal problems in 47% of cases (one-third were related to exams) and 31% of cases were related to job/financial problems. Again, this was statistically significant when compared to controls (P = 0.0002). CONCLUSIONS: Stress seems to play an important role in the onset and aggravation of both alopecia areata and vitiligo, mostly with one stressful event before disease onset.

Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study.

This randomised, double-blind, placebo-controlled, parallel-group, international, dose-ranging study investigated the effect of treatment with rupatadine 5, 10 and 20 mg once daily for 4 weeks on symptoms and interference with daily activities and sleep in 12-65 years-old patients with moderate-to-severe chronic idiopathic urticaria (CIU). Rupatadine 10 and 20 mg significantly reduced pruritus severity by 62.05% and 71.87% respectively, from baseline, over a period of 4 weeks compared to reduction with placebo by 46.59% (p < 0.05). Linear trends were noted for reductions in mean number of wheals and interference with daily activities and sleep with rupatadine 10 and 20 mg over the 4-week treatment period. The two most frequently reported AEs were somnolence (2.90% for placebo, 4.29% for 5 mg-, 5.41% for 10 mg- and 21.43% for 20 mg-rupatadine-treated group) and headache (4.35% for placebo, 2.86% for 5 mg-, 4.05% for 10 mg- and 4.29% for 20 mg-rupatadine-treated group). These findings suggest that rupatadine 10 and 20 mg is a fast-acting, efficacious and safe treatment for the management of patients with moderate-to-severe CIU. Rupatadine decreased pruritus severity, in a dose- and time-dependent manner.