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General Information

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist.

Dupixent is specifically indicated for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Dupixent is specifically indicated for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Dupixent is supplied as a solution for subcutaneous administration. The recommended dose of Dupixent for adults is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week. Dupixent can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. If a dose is missed, the injection should be administered within 7 days from the missed dose and then the original schedule should be resumed. If the missed dose is not administered within 7 days, the patient should wait until the next dose on the original schedule.

Clinical Results

FDA Approval

The FDA approval of Dupixent was based on three randomized, double-blind, placebo-controlled trials which enrolled subjects 18 years of age and older with moderate-to-severe atopic dermatitis (AD) not adequately controlled by topical medication(s). Disease severity was defined by an Investigator’s Global Assessment (IGA) score ≥3 in the overall assessment of AD lesions on a severity scale of 0 to 4, an Eczema Area and Severity Index (EASI) score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%. All three trials assessed the primary endpoint, the change from baseline to Week 16 in the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and at least a 2-point improvement.

LIBERTY AD SOLO 1 and SOLO 2 enrolled 1,379 adults with moderate-to-severe AD in the identically-designed trials. Subjects were randomized into one of three treatment groups: dupilumab 300 mg subcutaneously once per week, dupilumab 300 mg subcutaneously every two weeks, or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo. Both trials met the primary endpoints. For SOLO 1 and SOLO 2, respectively, 37 and 36% of patients who received dupilumab 300 mg weekly, and 38 and 36% of patients who received dupilumab 300 mg every two weeks, achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 10 and 8.5% with placebo (p less than 0.0001).

LIBERTY AD CHRONOS enrolled 700 adults with moderate-to-severe AD. The trial was designed to demonstrate the efficacy of dupilumab when administered concomitantly with topical corticosteroids through 16 weeks. Secondary objectives of the study included the long-term safety and efficacy of dupilumab up to 52 weeks. The primary endpoints at week 16 were reached: 39% of patients who received either dupilumab 300 mg weekly with TCS or dupilumab 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12% of patients receiving placebo with TCS (p less than 0.0001). 64% of patients who received dupilumab 300 mg weekly with TCS, and 69% of patients who received dupilumab 300 mg every two weeks with TCS achieved EASI-75, a 75 percent reduction on an index measuring eczema severity, compared to 23% of patients receiving placebo with TCS (p less than 0.0001). The secondary endpoint 52-week results were also reached and showed the following: 40% of patients who received dupilumab 300 mg weekly with TCS, and 36% of patients who received dupilumab 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12.5% of patients receiving placebo with TCS (p less than 0.0001). 64% of patients who received 300 mg weekly with TCS, and 65% of patients who received 300 mg every two weeks with TCS achieved EASI-75, compared to 22% with placebo with TCS (p less than 0.0001).

The FDA approval of Dupixent for children with atopic dermatitis was based on data that includes pivotal Phase 3 results on the efficacy and safety of Dupixent combined with topical corticosteroids (TCS) compared to TCS alone in children with severe atopic dermatitis. In the trial, children treated with Dupixent and TCS experienced significant improvements in overall disease severity, skin clearance and itch. Results at 16 weeks showed:

84% improvement in average EASI (Eczema Area and Severity Index) score from baseline in patients who received Dupixent every four weeks and 80% in patients who received Dupixent every two weeks, compared to 49% and 48% for TCS alone, respectively.
75% of patients who received Dupixent every four weeks and 75% of patients who received Dupixent every two weeks achieved EASI-75 (Eczema Area and Severity Index-75), compared to 28% and 26% for TCS alone, respectively.
54% of patients who received Dupixent every four weeks and 61% of patients who received Dupixent every two weeks experienced at least a 4-point reduction in itch intensity on a 0 to 10-point scale (weekly average of daily Peak Pruritus Numerical Rating Scale), compared to 12% and 13% for TCS alone, respectively.
30% of patients who received Dupixent every four weeks and 39% of patients who received Dupixent every two weeks achieved clear or almost clear skin (Investigator's Global Assessment or IGA), compared to 13% and 10% for TCS alone, respectively.

Side Effects

Adverse effects associated with the use of Dupixent may include, but are not limited to, the following:

injection site reactions
conjunctivitis
blepharitis
oral herpes
keratitis
eye pruritus
other herpes simplex virus infection
dry eye

Mechanism of Action

Dupixent (dupilumab) is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines and IgE.