DUPIXENT has demonstrated results in two 24-week randomized, double-blind, placebo-controlled, multicenter, parallel-group studies. A total of 311 adults in PRIME and PRIME2 (24 weeks each) with severe pruritus (WI-NRS ≥7 on a scale of 0 to 10) and ≥20 nodular lesions, whose disease was not adequately controlled with topical prescription therapies or when those therapies were not advisable, were randomized to DUPIXENT or placebo.^1,2

In these studies, subjects received either subcutaneous DUPIXENT 600 mg (two 300 mg injections) on Day 1, followed by 300 mg Q2W for 24 weeks, or matching placebo. Mean age was 49.5 years, the median weight was 71 kg, and 65% of subjects were female. At baseline, the mean WI-NRS was 8.5, 66% of subjects had 20 to 100 nodules (moderate), and 34% had greater than 100 nodules (severe). Approximately 60% of trial participants were on a stable regimen of background TCS/TCI therapy; the remaining ≈40% of participants received DUPIXENT monotherapy for their PN or placebo. Fifty-seven percent did not have a history of atopy (defined as having a medical history of atopic dermatitis, allergic rhinitis/rhinoconjunctivitis, asthma, or food allergy).^1,2

The WI-NRS consists of a single item, rated on a scale from 0 (“no itch”) to 10 (“worst imaginable itch”). Subjects were asked to rate the intensity of their worst pruritus (itch) over the past 24 hours using this scale. The IGA PN-S is a scale that measures the approximate number of nodules using a 5-point scale from 0 (clear) to 4 (severe).¹

The primary efficacy endpoint was the proportion of subjects with improvement (reduction) in WI-NRS by ≥4 points. Key secondary endpoints included the proportion of subjects with IGA PN-S 0 or 1 (the equivalent of 0 to 5 nodules) and the proportion of subjects who achieved a response in both WI-NRS and IGA PN-S per the criteria above.^1,2

• ≈3x as many patients in PRIME had significantly reduced itch at Week 24 (60% with DUPIXENT vs 18% with placebo; P<0.001), as measured by the WI-NRS^1,2
• 37% of DUPIXENT patients in PRIME2 achieved a meaningful response at Week 12 vs 22% with placebo; P=0.022 (primary endpoint). At Week 24, 58% of DUPIXENT patients in PRIME2 achieved significant itch relief vs 20% with placebo; P<0.001 (secondary endpoint)^1,2
• ≈2.5x as many patients in PRIME achieved clear or almost-clear skin at Week 24 (48% with DUPIXENT vs 18% with placebo; P<0.001), as measured by the IGA PN-S^1,2
• 45% of DUPIXENT patients in PRIME2 achieved significant nodule clearance (IGA PN-S 0 or 1) at Week 24 vs 16% with placebo; P<0.001 (secondary endpoint)^1,2

The most common adverse reactions in adult patients with prurigo nodularis (≥2%, pooled safety data across PRIME and PRIME2) are nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.¹

Discontinuation due to adverse events: 0% with DUPIXENT vs 3% with placebo. Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment.¹