Eczema (Atopic Dermatitis - Pediatric)
March 13, 2017
Regeneron Pharmaceuticals and Sanofi reported results of a phase III study of DUPIXENT with topical corticosteroids (TCS) for uncontrolled moderate to severe atopic dermatitis (AD). In the one year study, patients were randomized to receive DUPIXENT 300mg weekly with TCS, DUPIXENT 300mg every two weeks with TCS or placebo with TCS. DUPIXENT with TCS significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with TCS. At 52 weeks, 40% of patients who received DUPIXENT 300mg weekly with TCS, and 36% of patients who received DUPIXENT 300mg every two weeks with TCS achieved clear or almost clear skin (IGA zero or one), compared to 12.5% of patients receiving placebo with TCS (p<0.0001). At 52 weeks, 64% of patients who received DUPIXENT 300mg weekly with TCS, and 65% of patients who received DUPIXENT 300mg every two weeks with TCS achieved EASI-75, a 75% reduction on an index measuring eczema severity, compared to 22% with placebo with TCS (p<0.0001). At 52 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), was 54% for patients who received DUPIXENT weekly with TCS and 56% for patients who received DUPIXENT every two weeks with TCS, compared to 27% for patients receiving placebo with TCS (p<0.0001).At 52 weeks, the mean percent improvement in EASI from baseline was 80% for patients who received DUPIXENT weekly with TCS and 78% for patients who received DUPIXENT every two weeks with TCS, compared to 46% for patients receiving placebo with TCS (p<0.0001). The DUPIXENT Biologics License Application (BLA) was accepted for Priority Review by the FDA with a target action date of March 29, 2017. The FDA granted DUPIXENT Breakthrough Therapy designation in uncontrolled moderate to severe AD in 2014. The EMA accepted for review the Marketing Authorization Application (MAA) on December 8, 2016.The EMA and FDA have conditionally accepted DUPIXENT as the trade name for dupilumab.
March 7, 2016
Santalis Pharmaceuticals has released results of Santalia AD product regimen in a single-center, open-label study enrolling 25 patients, ages 3 months to 12 years with mild, moderate or severe atopic dermatitis with a mean beginning Eczema Area and Severity Index (EASI) score of 11.1 (moderate). Treatable atopic dermatitis, for this study, was defined as an EASI score ≥5 but ≤52. The EASI scoring system is a validated investigator-assessed instrument, which measures the severity of clinical attributes of atopic dermatitis in patients. Patients (or their caregivers) were instructed to apply the Santalia AD Regimen cleanser and cream twice daily for 60 days and bubble bath at least three times weekly. 22 out of 25 patients completed the study. 82% (18/22) of patients met the primary efficacy endpoint (a 25% reduction in their EASI score). 91% (20/22) of patients experienced a reduction in their EASI score. 68% of patients achieved an IGA score of “much improved” or “very much improved” with a minimum two-grade improvement after eight weeks of treatment. 61.9% of patients achieved an IGA score of “much improved” or “very much improved” with a minimum two-grade improvement after four weeks of treatment. Patients demonstrated an average 60% reduction in EASI score over baseline. In patient diary responses, the aggregate score for all diary responses went from zero at study commencement to 3.1 (much improvement) in eight weeks. 74.7% of respondents reported an aggregate score of three (much improvement) or four (very much improved) at study end. 78.9% reported a reduction in both redness and an improvement in skin texture of the treated area and 73.7% reported an improvement in pain or irritation of the treatment area.
August 16, 2004
Barrier Therapeutics reported results from a phase III trial investigating Zimycan, a topical antifungal ointment for the treatment of Candida-associated diaper dermatitis. Results showed that Zimycan achieved statistical significance versus vehicle ointment for all endpoints. Data showed that the average reduction in the signs and symptoms score, was 72% with Zimycan versus 25% with the vehicle ointment. More than twice the subjects treated with Zimycan reached the primary endpoint, overall cure at day 14, as compared with vehicle. The double-blind, vehicle-controlled study enrolled 236 infants at 20 sites in the U.S. and Latin America. Subjects were given Zimycan or vehicle for seven days. The study will form the basis of the filing of an amendment to Barrier's pending NDA.
March 4, 2003
Novartis reported positive results from a late phase trial investigating Elidel (pimecrolimus), a previously approved ascomycin derivative for the treatment of eczema in infants. Results indicated that more than twice the subjects treated with Elidel (54.4%) were clear or almost clear of eczema compared to those treated with inactive cream (23.8%). In addition, subjects in the vehicle groups who transferred to the treatment group achieved similar disease control. Less than 5% of subjects experienced site reactions or skin infections and these events were similar in both the treatment and placebo groups. The randomized, double blind, vehicle controlled study enrolled 186 infants aged 3 to 23 months. The initial double blind portion of the trial lasted for six weeks followed by a 20-week open labeled stage.