Dupilumab Harvests Positive Phase 3 Results in Patients with Severe Atopic Dermatitis in Adolescents
May 17, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On May 16, Regeneration and Sanofi Pharmaceuticals announced that DUPIXENT® (dupilumab) has reached the primary and critical secondary endpoints in a pivotal phase 3 trial of adolescents (12-17 years) with moderate to severe atopic dermatitis. . In the trial, DUPIXENT monotherapy significantly improved overall disease severity, skin cleanliness, itching, and certain health-related quality of life indicators. DUPIXENT is the first and only biological product to show positive results in this patient population.
George D. Yancopoulos, president and chief scientific officer of Renaissance Pharmaceuticals, said: “Moderate to severe atopic dermatitis poses a particularly severe burden on adolescents. During their years of growth, they have to face persistent intense itching. Exudative lesions. DUPIXENT blocks the IL-4/IL-13 pathway, which is a central driver of type 2 allergic inflammation. We are committed to studying DUPIXENT for type 2 inflammation with highly unmet needs. Therapeutic potential of the disease, including atopic dermatitis, asthma, eosinophilic esophagitis, nasal polyps, chronic obstructive pulmonary disease and food allergies."
At 16 weeks, the severity of the condition in patients treated with DUPIXENT was significantly improved. The primary endpoint of the trial was the proportion of patients who achieved a 75% improvement in the Global Assessment of Investigators (IGA) score of 0 (clear) or 1 (almost cleared) and the Eczema Area and Severity Index (EASI-75) at 16 weeks. The findings include:
1. 24% of patients taking DUPIXENT (200 mg or 300 mg) every two weeks and 18% of patients receiving a fixed dose of DUPIXENT (300 mg) every 4 weeks achieved the primary IGA endpoint, while the placebo group 2% (p<0.0001, p=0.0007).
2. 41.5% of patients who received DUPIXENT treatment every two weeks and 38% of patients who received DUPIXENT every 4 weeks had a skin improvement rate of 75% or higher compared with 8% in the placebo group (p<0.0001). ).
3. For the average percentage change in EASI scores compared to baseline levels, the improvement rate for DUPIXENT patients was 66% every two weeks, with an average improvement of 65% in the 4 weeks and 24% in the placebo group (p<0.0001). .
4. For the average percentage change in the pruritus numerical rating scale (NRS) compared to baseline, DUPIXENT achieved a 48% improvement every two weeks, and a 45.5% improvement in the four-week medication group, while the placebo group improved. 19% (p < 0.0001).
Elias Zerhouni, president of Sanofi Global R&D, said: "The current treatment options for these adolescents include topical steroids, oral steroids and non-steroidal immunosuppressants, but these drugs have significant side effects. We will continue to explore DUPIXENT in the United States. The role of patients with dermatitis provides a treatment option for adolescent patients that is not just a symptom of improvement."
The security of DUPIXENT is consistent with that of adults.
During the 16-week treatment period, the overall adverse event rate was comparable in the DUPIXENT and placebo groups (72% in the DUPIXENT group every two weeks, 64% in the DUPIXENT group every four weeks, and 69% in the placebo group). There were no serious adverse events or events leading to discontinuation of treatment in the treatment group. Higher adverse events were observed in the DUPIXENT group including injection site response (8.5% in the biweekly group, 6% in the four-week group, 3.5% in the placebo group), conjunctivitis (10% per biweekly group, per 11% in the four-week group and 5% in the placebo group. The number of skin infections in the DUPIXENT group was lower (11% in the biweekly group, 13% in the four-week group, and 20% in the placebo group).
The detailed results of this trial will be announced at future medical conferences and the data will be submitted to the regulatory authorities later. In 2016, the US FDA granted DUPIXENT a breakthrough therapeutic status for patients with moderate to severe (12-17 years old) and severe (6 months-11 years old) atopic dermatitis. (Sina Pharmaceutical Compilation / David)
Article Reference Source: Positive Phase 3 Trial of DUPIXENT® (dupilumab) in Adolescents with Inadequately Controlled Moderate-to-severe Atopic Dermatitis
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