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Regeneron (REGN) and Sanofi (SNY) Announce Positive Dupixent (dupilumab) Phase 3 Atopic Dermatitis Data Published in the New England Journal of Medicine

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Additional Relevant Details The NEJM paper provides data on key endpoints including: Š At 16 weeks for SOLO 1 and SOLO 2, respectively, 37 and 36 percent of adult patients who received Dupixent 300 mg weekly, and 38 and 36 percent of patients who received Dupixent 300 mg every two weeks, achieved clearing or near-clearing of skin lesions as measured by the 5-point Investigator's Global Assessment (IGA) scale, compared to 10 and 8 percent with placebo (p less than 0.001). This was the primary endpoint of the study in the U.S. and one of the primary endpoints in the EU. Š At 16 weeks for SOLO 1 and SOLO 2, respectively, 52 and 48 percent of adult patients who received Dupixent 300 mg weekly, and 51 and 44 percent of patients who received Dupixent 300 mg every two weeks, achieved a 75 percent or greater reduction in their Eczema Area and Severity Index score (EASI-75) compared to 15 and 12 percent with placebo (p less than 0.001). This was the key secondary endpoint in the U.S. and one of the primary endpoints in the EU. Š At 16 weeks for SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received Dupixent 300 mg every two weeks, compared to 38 and 31 percent for placebo (p less than 0.001). Š The reduction in the daily intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), was a secondary endpoint that was met at 2 weeks, 4 weeks and 16 weeks. The Pruritus NRS ranges from 0 (no itch) to 10 (worst itch imaginable). At 16 weeks, for SOLO 1 and SOLO 2, respectively, 40 and 39 percent of patients who received Dupixent 300 mg weekly and 41 and 36 percent of patients who received Dupixent 300 mg every two weeks achieved a four-point or greater reduction in their NRS score compared to 12 and 10 percent with placebo (p less than 0.001). 
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Occurred on:
Oct 01, 2016
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Related Keywords Dupixent, Dupilumab, Atopic Dermatitis