Prurigo Nodularis

WEDNESDAY, May 10, 2023 (HealthDay News) -- For adults with prurigo nodularis (PN), dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin (IL)-4 and IL-13, demonstrates clinically meaningful and significant improvements in itch and skin lesions in two phase 3 trials (LIBERTY-PN PRIME and PRIME2), according to a study published online May 4 in Nature Medicine.Gil Yosipovitch, M.D., from the University of Miami, and colleagues randomly assigned adults with PN with ≥20 nodules and severe itch uncontrolled with topical therapies to dupilumab or placebo subcutaneously every two weeks for 24 weeks. Pruritus improvement, measured by the proportion of patients with a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2), was the primary end point.A total of 151 and 160 patients were enrolled in PRIME and PRIME2, respectively. The researchers found that both trials met all primary and key secondary end points. A ≥4-point reduction in WI-NRS was achieved at week 24 by 60.0 and 18.4 percent of patients in the dupilumab and placebo arms, respectively, in PRIME and at week 12 by 37.2 and 22.0 percent of patients, respectively, in PRIME2."These positive studies support the involvement of type 2 cytokines in driving PN disease pathogenesis and the targeting of the IL-4/IL-13 axis as a novel therapeutic paradigm for patients with PN," the authors write.Several authors disclosed financial ties to pharmaceutical companies, including Sanofi and Regeneron, which manufacture dupilumab and funded the study.

All primary and key secondary end points met in two phase 3 trials of adults with PN with ≥20 nodules

Dupilumab Beneficial for Adults With Prurigo Nodularis

The U.S. Food and Drug Administration approved Dupixent (dupilumab) as the first treatment for adults with prurigo nodularis, according to Regeneron Pharmaceuticals.




 Prurigo nodularis, a chronic, debilitating skin disease with underlying type 2 inflammation, is estimated to impact 75,000 U.S. adults and, until now, had no systemic treatment options.




 The approval was based on priority review using data from two direct-to-phase 3 trials evaluating the efficacy and safety of Dupixent. In the two trials, more patients randomly assigned to Dupixent experienced a clinically meaningful reduction in itch from baseline to both 12 weeks (44 and 37 percent, respectively, versus 16 and 22 percent with placebo) and 24 weeks (60 and 58 percent, respectively, versus 18 and 20 percent for placebo). Compared with placebo (18 and 16 percent), more than twice as many Dupixent patients (48 and 45 percent) achieved clear or almost clear skin at 24 weeks. The safety profile was consistent with use of Dupixent for other dermatological conditions and included nasopharyngitis, conjunctivitis, herpes infection, dizziness, muscle pain, and diarrhea.




 "Patients living with prurigo nodularis must often contend with dozens, if not hundreds, of itchy and painful nodules covering their body," George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer at Regeneron, said in a statement. "With this approval, those suffering with prurigo nodularis finally have a medicine to address the debilitating signs and symptoms of the disease."




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This priority review-based approval makes Dupixent the first treatment for the inflammatory skin condition

FDA Approves Dupixent for Prurigo Nodularis

For patients with prurigo nodularis, dupilumab yields significant improvements in itch response and skin lesions, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 25 to 29 in Boston.




 Gil Yosipovitch, M.D., from the Miller School of Medicine at the University of Miami, and colleagues conducted a randomized placebo-controlled phase 3 trial in adults with prurigo nodularis with ≥20 nodules and severe itch, inadequately controlled with topical prescription therapies or for whom these therapies are inadvisable. Patients received dupilumab 300 mg subcutaneously or matching placebo every two weeks for 24 weeks (78 and 82 patients, respectively).




 The researchers found that among dupilumab- and placebo-treated patients, 37.2 and 22.0 percent, respectively, achieved a ≥4-point reduction in the 24h Worst-Itch Numeric Rating Scale (WI-NRS) at week 12, and 57.7 and 19.5 percent, respectively, achieved a ≥4-point reduction in the WI-NRS at week 24. At week 24, 44.9 and 15.9 percent, respectively, achieved an Investigator's Global Assessment Prurigo Nodularis-Stage of 0 or 1. For dupilumab versus placebo, the rate of treatment-emergent adverse events was 57.1 versus 51.2 percent.




 "Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch response and skin lesions versus placebo in adult patients with prurigo nodularis," the authors write.




 The study was funded by Sanofi and Regeneron, the manufacturers of dupilumab.




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Significantly more dupilumab-treated patients achieved ≥4-point reduction in 24h Worst-Itch Numeric Rating Scale at weeks 12 and 24

Prurigo Nodularis Condition Center

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