| PRIME | PRIME2 | ||
| Trial Overview1,2 | Number of patients | 151 | 160 |
| Design | Randomized, phase 3, double-blind | ||
| Duration | 24 weeks | ||
| Treatment arms | DUPIXENT vs placebo | ||
| Dosing | Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) ≈60% of participants were on a stable regimen of background TCS/TCI The remaining ≈40% received DUPIXENT monotherapy or placebo |
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| Primary endpoint | ≥4-point improvement in WI-NRS at Week 24 (% of patients) | ≥4-point improvement in WI-NRS at Week 12 (% of patients) | |
| Select secondary endpoints | IGA PN-S 0 (clear) or 1 (almost clear) at Week 24 (% of patients) Composite endpoint of ≥4-point improvement in WI-NRS and IGA PN-S 0 or 1 at Week 24 (% of patients) |
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| Baseline Disease Severity / Patient Characteristics1,2 |
IGA PN-Sa | IGA PN-S 3 or 4 (equivalent to ≥20 nodular lesions) |
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| WI-NRSb | WI‑NRS ≥7 (on a scale of 0 to 10) |
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| Atopic history | 57% of participants did not have history of atopy History of atopy defined as having a medical history of ≥1 of the following:
|
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| PRIME | |
| Trial Overview1,2 | |
| Number of patients | 151 |
| Design | Randomized, phase 3, double-blind |
| Duration | 24 weeks |
| Treatment arms | DUPIXENT vs placebo |
| Dosing | Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) ≈60% of participants were on a stable regimen of background TCS/TCI The remaining ≈40% received DUPIXENT monotherapy or placebo |
| Primary endpoint | ≥4-point improvement in WI-NRS at Week 24 (% of patients) |
| Select secondary endpoints | IGA PN-S 0 (clear) or 1 (almost clear) at Week 24 (% of patients) Composite endpoint of ≥4-point improvement in WI-NRS and IGA PN-S 0 or 1 at Week 24 (% of patients) |
| Baseline Disease Severity / Patient Characteristics1,2 | |
| IGA PN-Sa | IGA PN-S 3 or 4 (equivalent to ≥20 nodular lesions) |
| WI-NRSb | WI‑NRS ≥7 (on a scale of 0 to 10) |
| Atopic history | 57% of participants did not have history of atopy History of atopy defined as having a medical history of ≥1 of the following:
|
| PRIME2 | |
| Trial Overview1,2 | |
| Number of patients | 160 |
| Design | Randomized, phase 3, double-blind |
| Duration | 24 weeks |
| Treatment arms | DUPIXENT vs placebo |
| Dosing | Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) ≈60% of participants were on a stable regimen of background TCS/TCI The remaining ≈40% received DUPIXENT monotherapy or placebo |
| Primary endpoint | ≥4-point improvement in WI-NRS at Week 12 (% of patients) |
| Select secondary endpoints | IGA PN-S 0 (clear) or 1 (almost clear) Composite endpoint of ≥4-point improvement in WI-NRS and IGA PN-S 0 or 1 |
| Baseline Disease Severity / Patient Characteristics1,2 | |
| IGA PN-Sa | IGA PN-S 3 or 4 (equivalent to ≥20 nodular lesions) |
| WI-NRSb | WI‑NRS ≥7 (on a scale of 0 to 10) |
| Atopic history | 57% of participants did not have history of atopy History of atopy defined as having a medical history of ≥1 of the following:
|
aIGA PN-S ranges from 0 (clear, no nodules) to 1 (almost clear, ≤5 nodules), 2 (mild, 6-19 nodules), 3 (moderate, 20-99 nodules), or 4 (severe, ≥100 nodules).
bThe WI-NRS is comprised of a single item, rated on a scale of 0 (“no itch”) to 10 (“worst imaginable itch”).
Watch healthcare providers discuss PN and treatment with DUPIXENT
AD, atopic dermatitis; IGA PN-S, Investigator’s Global Assessment PN Stage; PN, prurigo nodularis; Q2W, once every 2 weeks; TCI, topical calcineurin inhibitors; TCS, topical corticosteroids; WI-NRS, Worst Itch numerical rating scale.