DUPIXENT has demonstrated results in 7 clinical trials in atopic dermatitis including1,2:
917 adults in SOLO 1 and SOLO 2 (16 weeks each) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. All patients who received DUPIXENT were given 300 mg Q2W after a 600 mg loading dose. Patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 51% had an IGA score of 3 (moderate), 49% had an IGA of 4 (severe), mean EASI score was 30, and weekly averaged Peak Pruritus NRS was 7.7 on a scale of 0 to 10.1-3
The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (38% of patients treated with DUPIXENT vs 10% with placebo in SOLO 1, P<0.001; and 36% of patients treated with DUPIXENT vs 9% with placebo in SOLO 2, P<0.001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (51% of patients treated with DUPIXENT vs 15% with placebo in SOLO 1, P<0.001; and 44% of patients treated with DUPIXENT vs 12% with placebo in SOLO 2, P<0.001) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (41% of patients treated with DUPIXENT vs 12% with placebo in SOLO 1, P<0.001; and 36% of patients treated with DUPIXENT vs 10% with placebo in SOLO 2, P<0.001).1,3
251 adolescents (12-17 years) in AD-1526 (16 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. Adolescents ≥60 kg received DUPIXENT 300 mg Q2W after a 600 mg loading dose, and adolescents <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 46% had an IGA score of 3 (moderate), 54% had an IGA of 4 (severe), mean EASI score was 36, and weekly averaged Peak Pruritus NRS was 8 on a scale of 0 to 10.1
The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (24% of patients treated with DUPIXENT vs 2% with placebo, P<0.001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (42% of patients treated with DUPIXENT vs 8% with placebo, P<0.001) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (37% of patients treated with DUPIXENT vs 5% with placebo, P<0.001).1,6
421 adults in CHRONOS (52 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. All patients who received DUPIXENT were given 300 mg Q2W after a 600 mg loading dose with concomitant TCS. Patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 50% had an IGA score of 3 (moderate), 50% had an IGA of 4 (severe), mean EASI score was 31, and weekly averaged Peak Pruritus NRS was 7.7 on a scale of 0 to 10.1,4
The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (39% of patients treated with DUPIXENT + TCS vs 12% with placebo + TCS in CHRONOS, P<0.0001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (69% of patients treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (59% of patients treated with DUPIXENT + TCS vs 20% with placebo + TCS in CHRONOS, P<0.0001).1,4
367 children (6-11 years of age) in AD-1652 (16 weeks) with severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. Patients ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose. Patients had an IGA score of 4, an EASI score ≥21, and BSA involvement ≥15%. Mean EASI score was 37.9 and weekly averaged Peak Pruritus NRS was 7.8 on a scale of 0 to 10.1
The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (39% of patients ≥30 kg treated with DUPIXENT + TCS vs 10% with placebo + TCS, and 30% of patients <30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (75% of patients ≥30 kg treated with DUPIXENT + TCS vs 26% with placebo + TCS, and 75% of patients <30 kg treated with DUPIXENT + TCS vs 28% with placebo + TCS) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (61% of patients ≥30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS, and 54% of patients <30 kg treated with DUPIXENT + TCS vs 12% with placebo + TCS).1,7
162 infants to preschoolers (6 months to 5 years) in AD-1539 (16 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. Patients 15 kg but >30 kg received 300 mg Q4W. Patients 5 kg but <15 kg received 200 mg Q4W. Patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 23% of infants to preschoolers had an IGA score of 3 (moderate), 77% had an IGA of 4 (severe), mean EASI score was 34.1, and weekly average of daily Worst Scratch/Itch NRS was 7.6 on a scale of 0 to 10.1,8
The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (28% of patients treated with DUPIXENT + TCS vs 4% with placebo + TCS, P<0.0001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (53% of patients treated with DUPIXENT + TCS vs 11% with placebo + TCS, P<0.0001) and ≥4-point improvement in the Worst Scratch/Itch NRS at Week 16 (48% of patients treated with DUPIXENT + TCS vs 9% with placebo + TCS, P<0.0001).1,8
133 subjects aged 12 years and older in AD-HAFT (16 weeks) with atopic dermatitis with moderate-to-severe hand and/or foot involvement inadequately controlled with or intolerant to topical Rx therapies were randomized to DUPIXENT or placebo. Participants included subjects with both hand and foot involvement (n=71), foot-only involvement (n=4), and hand-only involvement (n=58). All DUPIXENT-treated adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose and adolescents <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients had an IGA hand and foot score ≥3 on a scale of 0 to 4. At baseline, 72% had an IGA hand and foot score of 3 (moderate), 28% had an IGA hand and foot score of 4 (severe), mean hand and foot Peak Pruritus NRS was 7.1 on a scale of 0 to 10, and mean HECSI score was 46.8 on a scale of 0 to 360.1,2
The primary endpoint was the proportion of subjects with an IGA hand and foot 0 (clear) or 1 (almost clear) at Week 16 (40% of patients treated with DUPIXENT vs 17% with placebo, P=0.0030). Other endpoints included the proportion of subjects with a ≥4-point improvement in hand and foot Peak Pruritus NRS at Week 16 (52% of patients treated with DUPIXENT vs 14% with placebo, P<0.0001) and the proportion of subjects with ≥75% improvement in HECSI (HECSI-75) at Week 16 (47% of patients treated with DUPIXENT vs 22% with placebo, P=0.0028).1,2