Eczema (Atopic Dermatitis)

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. 

July 20, 2015

Anacor Pharmaceuticals reported results of two phase III studies of Crisaborole Topical Ointment, 2% (formerly AN2728) in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. The studies were multicenter, double-blind, vehicle-controlled studies of over 750 patients each, aged 2 years and older with mild-to-moderate atopic dermatitis (defined as an Investigator’s Static Global Assessment (ISGA) score of two (mild) or three (moderate)). The ISGA is a five-point scale ranging from zero (clear) to four (severe). Patients were randomized in a 2:1 ratio (crisaborole:vehicle). Crisaborole or vehicle was applied twice daily for 28 days. Time to Success in ISGA: Time course to success in ISGA between crisaborole and vehicle was statistically significantly different (p<0.001) in each study, with patients treated with crisaborole achieving success earlier than vehicle-treated patients. Percent of patients who achieved success in the ISGA: study AD-301, (crisaborole/vehicle), N=503/256, 32.8%/25.4% (p=0.038); study AD-302, (crisaborole/vehicle), N=513/250 31.4%/18% (p<0.001). In addition to the phase III pivotal studies, the company is conducting an open-label long-term safety study to evaluate the safety of intermittent use of crisaborole for up to 12 months.

July 9, 2007

Cytos issued mixed results from a phase IIa trial of CYT-003-QbG10 for the treatment of atopic dermatitis (AD). This randomized, double-blind and placebo-controlled trial enrolled 36 subjects withmild to moderate AD, as assessed by the Eczema Area Severity Index (EASI). Subjectswere randomized to two treatment groups and received 6 weekly subcutaneous injectionsof either 300 micrograms CYT003-QbG10 or placebo. Two weeks after the last dose,the disease status of the patients was again assessed by the EASI. Treatment wassafe and well tolerated. However, both the CYT003-QbG10 and placebo treatmentgroups showed a similar reduction of the EASI scores as measured over the studyperiod, indicating no treatment effect for CYT003-QbG10 in atopic dermatitis atthe dose level tested in this trial. Based on the results, Cytos is planning toconduct trials testing higher dose levels of CYT-003-QbG10 in order to determinea future path for this compound.

April 30, 2007

Basilea reported positive results from a phase III re-treatment trial of alitretinoin for severe chronic hand eczema. This trial enrolled 117 subjects who eventually had disease recurrence, and 243 subjects who had incomplete response after the initial treatment trial. The trial was designed to evaluate the safety and efficacy of a second treatment course of alitretinoin (30mg or 10mg) in subjects who achieved clear or almost clear hands after a previous initial treatment course. Subjects who had disease recurrence were randomized in double blind manner to receive another 12 to 24 weeks treatment with either placebo or their previous dose of alitretinoin. Response rates were 80% for the alitretinoin 30 mg group versus 8.3% for placebo and 48% for the 10 mg group versus 10% for placebo. The subjects who had either no or an incomplete response received 30 mg alitretinoin in an open-label fashion for another 12 to 24 weeks. The response rate was 47%. Based on these and other phase III results, Basilea plans to file an NDA before the end of 2007.

August 22, 2005

Connetics has issued positive results of a phase III trial of Desilux (desonide), their low-potency topical steroid in a foam formulation for the treatment of atopic dermatitis (eczema). Data for the drug achieved statistical superiority to placebo in the portion of patients achieving complete or near complete symptom amelioration on the Investigator's Static Global Assessment with no or minimal erythema and induration (39% vs. 8%; p<0.0001). This randomized, blinded, placebo-controlled study enrolled 581 patients, who received the drug or placebo twice daily for 4 weeks, followed by a 3-week observational follow-up. Based on these results, the company announced plans to submit and NDA for Desilux before the end of 2005.

September 13, 2004

NUCRYST Pharmaceuticals reported mixed results from a phase IIa trial investigating NPI 32101, a topical cream form of silver Rx nanocrystals for the treatment of atopic dermatitis. Results showed that statistical significance was not met, in the intent-to-treat analysis, in the overall investigator assessment of disease improvement. However, statistical significance was achieved with 1.0% NPI 32101 compared to vehicle using intent-to-treat patients who completed six weeks of treatment method. NPI 32101 was well tolerated with no serious adverse events reported. The double-blind, randomized, placebo-controlled study enrolled 224 subjects with mild to moderate atopic dermatitis at 23 sites across the U.S. Subjects were treated twice daily for a six-week period with one of two concentrations of NPI 32101, 0.5% and 1.0%, in a cream formulation or with the vehicle alone. The study was designed to evaluate the safety and efficacy of topical NPI 32101 in improving the signs and symptoms of atopic dermatitis. The company plans initiate additional phase II studies in order to prepare for the larger phase III trials of NPI 32101.

August 19, 2002

In a 12-month, double-blind controlled trial involving 251 infants (3-23 months old), a treatment regimen with Elidel (pimecrolimus) Cream 1% was compared to the conventional therapy regimen for the treatment of atopic dermatitis (eczema). Results showed that treatment with Elidel significantly reduced the incidence of flares over 6 and 12-month periods. In addition, 56.9% of subjects treated with Elidel experienced no flares over 12 months, while 28.3% of the control group experienced similar improvement during that time. Since topical corticosteroids were permitted in both treatment groups to treat severe flares, the analysis also compared corticosteroid use between the two groups. 63.7% of the Elidel group versus 34.8% of the control group used no corticosteroids. Elidel, which is currently approved for the treatment of eczema in subjects 2 years old and older, was developed by Novartis.

March 5, 2002

Phase III trial results suggest that Novartis' Elidel (pimecrolimus) cream 1% is more effective than a conventional treatment in reducing the incidence of disease flares. The 12-month, multicenter, double-blind study included 713 pediatric eczema subjects ages two to 17 years. The trial compared a long-term Elidel treatment regimen with a current conventional therapy regimen. Subjects applied either treatment at the earliest signs or symptoms of the disease. Both groups also used topical corticosteroids to treat any severe flares. At both six and 12 months, results showed that Elidel significantly reduced flare incidence compared to the conventional therapy. Additionally, 57% of subjects treated with Elidel had no flares that required corticosteroid treatment, compared to 32% in the control group.

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