Dupilumab in Moderate-to-Severe Atopic Dermatitis: Pooled Efficacy Results From Two Identically Designed Randomized Phase 3 Trials (SOLO 1 & 2) Presented at the 2017 Fall Clinical Dermatology Conference; Las Vegas, NV, USA; October 12-15, 2017. Carlos Ferrándiz1, Pablo de la Cueva Dobao2, Eric L. Simpson3, Rick Zhang4, Abhijit Gadkari5, Laurent Eckert6, Bolanle Akinlade5, Marius Ardeleanu5 1Hospital Universitario Germans Trias i Pujol, Barcelona, Spain; 2Hospital Universitario Infanta Leonor, Madrid, Spain; 3Oregon Health & Science University, Portland, OR, USA; 4Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA; 5Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; 6Sanofi, Chilly-Mazarin, France B A C K G R O U N D O B J E C T I V E S C O N C L U S I O N S 4–7 M E T H O D S Study design Treatments Outcomes R E S U LT S Baseline demographics and disease characteristics Patient-reported symptoms and quality of life P Safety References Acknowledgments Disclosures Ferrándiz C: de la Cueva Dobao P: Simpson EL: Zhu X, Gadkari A, Akinlade B, Ardeleanu M: Eckert L: Dupilumab 300 mg SC qw Placebo SC qw Maintenance study Open-label extension Post-treatment options: Safety follow-up through Week 28 Screening Dupilumab 300 mg SC q2w Treatment period (16 weeks) Follow-up period (12 weeks) Loading dose on Day 1a Day –35 to –1 Baseline Week 28Week 16 R Figure 1. SOLO 1 and SOLO 2: pivotal phase 3 studies with identical study design. Table 1. Baseline disease characteristics. 0 10 20 30 40 50 60 70 80 90 100 P a ti e n ts ( % ) 9.3 37.0 36.8 * * *P < 0.0001 vs placebo IGA = 0 or 1 and ≥ 2-point reduction from baseline at Week 16 A B EASI-75 at Week 16 *P < 0.0001 vs placebo 0 10 20 30 40 50 60 70 80 90 100 13.3 47.7 50.2 * * Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw Figure 2. IGA 0/1 and ≥ 2-point improvement from baseline (A) and EASI-75 (B) at Week 16. –60 –100 –70 –40 –50 –30 –20 –10 0 0 1 2 4 6 8 12 16 L S m e a n % c h a n g e in E A S I sc o re fr o m b a se lin e ( ± S E ) –10 L S m e a n % c h a n g e in S C O R A D to ta l s c o re f ro m b a se lin e ( ± S E ) EASI Study week –34.3 –70.0* –70.7* –80 –90 *P < 0.0001 vs placebo –60 –100 –70 –40 –50 –30 –20 0 0 1 2 4 6 8 12 16 SCORAD Study week –24.0 –54.3* –55.2* –80 –90 *P < 0.0001 vs placebo A B Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw Figure 3. Percent change from baseline in EASI score (A) and SCORAD score (B). Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw –2 L S m e a n c h a n g e in P O E M sc o re f ro m b a se lin e ( ± S E ) –12 –8 –10 –6 –4 0 0 1 2 4 6 8 12 16 POEM Study week Pruritus NRS improvement ≥ 4-points from baseline –4.2 –10.9* –11.2* *P < 0.0001 vs placebo A B P a ti e n ts ( % ) Study week 10.9 38.4* * * 39.6* *P < 0.0001 vs placebo 0 0 10 20 30 40 50 60 70 80 90 100 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Figure 4. Proportions of patients achieving peak pruritus NRS score improvement of ≥ 4 points at Week 16 (A), and change from baseline in POEM score (B). –1 0 0 1 2 4 6 8 12 16 L S m e a n c h a n g e in H A D S t o ta l sc o re f ro m b a se lin e ( ± S E ) –1 L S m e a n c h a n g e in D L Q I sc o re f ro m b a se lin e ( ± S E ) HADS total score Study week –1.6 –5.1* –5.5* –2 –3 –4 –5 –6 *P < 0.0001 vs placebo –6 –10 –7 –4 –5 –3 –2 0 0 1 2 4 6 8 12 16 DLQI Study week –4.3 –9.2* –9.3* –8 –9 *P < 0.0001 vs placebo A B Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw Figure 5. Change from baseline in HADS total score (A) and DLQI score (B). Table 2. Adverse events. c c Patient eligibility Clinical efficacy P P P P Pruritus P P FC17PosterRegeneronSanofiFerrandizDupilumabAtopicDermatitis.pdf