2 research outputs found
Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis.
BACKGROUND
Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits
signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important
drivers of atopic or allergic diseases such as atopic dermatitis.
METHODS
In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1
and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose
disease was inadequately controlled by topical treatment. Patients were randomly
assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg)
or placebo weekly or the same dose of dupilumab every other week alternating
with placebo. The primary outcome was the proportion of patients who had both
a score of 0 or 1 (clear or almost clear) on the Investigator’s Global Assessment
and a reduction of 2 points or more in that score from baseline at week 16.
RESULTS
We enrolled 671 patients in SOLO 1 and 708 in SOLO 2. In SOLO 1, the primary
outcome occurred in 85 patients (38%) who received dupilumab every other week and
in 83 (37%) who received dupilumab weekly, as compared with 23 (10%) who received
placebo (P<0.001 for both comparisons with placebo). The results were similar in
SOLO 2, with the primary outcome occurring in 84 patients (36%) who received dupilumab
every other week and in 87 (36%) who received dupilumab weekly, as compared
with 20 (8%) who received placebo (P<0.001 for both comparisons). In addition,
in the two trials, an improvement from baseline to week 16 of at least 75% on the
Eczema Area and Severity Index was reported in significantly more patients who received
each regimen of dupilumab than in patients who received placebo (P<0.001 for
all comparisons). Dupilumab was also associated with improvement in other clinical
end points, including reduction in pruritus and symptoms of anxiety or depression
and improvement in quality of life. Injection-site reactions and conjunctivitis were
more frequent in the dupilumab groups than in the placebo groups.
CONCLUSIONS
In two phase 3 trials of identical design involving patients with atopic dermatitis,
dupilumab improved the signs and symptoms of atopic dermatitis, including
pruritus, symptoms of anxiety and depression, and quality of life, as compared
with placebo. Trials of longer duration are needed to assess the long-term effectiveness
and safety of dupilumab. (Funded by Sanofi and Regeneron Pharmaceuticals;
SOLO 1 ClinicalTrials.gov number, NCT02277743; SOLO 2 ClinicalTrials
.gov number, NCT02277769.