Dupilumab with Topical Corticosteroids (TCS) Superior to TCS Alone in Long-term Atopic Dermatitis Study

Monday, June 06, 2016 | Phase 3/4 Trials , Atopic Dermatitis , Regeneron , Sanofi


Treatment with investigational dupilumab in combination with topical corticosteroids (TCS) significantly improved measures of overall disease severity, according to one-year results of the LIBERTY AD CHRONOS study. Reported by Regeneron Pharmaceuticals, Inc. and Sanofi, the phase 3 study involved a total of 740 adult patients with moderate-to-severe AD that was inadequately controlled with topical medications. Dupilumab with topical corticosteroids (TCS) was compared to TCS alone.

At week 16, 39 percent of patients who received either dupilumab 300mg weekly with TCS or dupilumab 300mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12 percent of patients receiving placebo with TCS (p less than 0.0001). Sixty-four percent of patients who received dupilumab 300mg weekly with TCS, and 69 percent of patients who received dupilumab 300mg every two weeks with TCS achieved a 75 percent reduction on the Eczema Area and Severity Index (EASI-75), compared to 23 percent of patients receiving placebo with TCS (p less than 0.0001).

At 52-weeks, 40 percent of patients who received dupilumab 300mg weekly with TCS, and 36 percent of patients who received dupilumab 300mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12.5 percent of patients receiving placebo with TCS (p less than 0.0001). This was a secondary endpoint.

Patients were less likely to discontinue therapy in the dupilumab with TCS groups compared to placebo with TCS group (15 percent in both dupilumab groups; 33 percent placebo).

The overall rate of adverse events was comparable between the dupilumab with TCS groups (83 percent for the weekly dose (qw) and 88 percent for the every two weeks (q2w) dosing group) and the placebo with TCS group (84 percent). The rate of serious adverse events was comparable between the dupilumab with TCS groups (3 (qw) and 4 percent (q2w)) and placebo with TCS group (5 percent). Serious and/or severe infections were numerically higher in the placebo with TCS group (1 percent in both dupilumab groups and 2 percent placebo). Adverse events that were noted to have a higher rate with dupilumab included injection site reactions (20 (qw) and 16 percent (q2w) dupilumab; 9 percent placebo) and conjunctivitis (19 (qw) and 13 (q2w) percent dupilumab; 8 percent placebo); 22 percent of patients on placebo, and 23 (qw) and 28 percent (q2w) of patients on dupilumab reported a history of allergic conjunctivitis at study entry.

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