Topical ruxolitinib: a new hope for patients with prurigo nodularis?

Ruxolitinib cream demonstrated significantly superior efficacy compared with vehicle in reducing itch, as measured by the Worst-Itch Numerical Rating scale (WI-NRS), in a pooled analysis of prurigo nodularis (PN) patients. In the intention-to-treat (ITT) population, 42.3% of patients achieved a treatment response compared with 28.1% on vehicle.

The severity and chronicity of PN-associated itch drastically impact quality-of-life, and there is an urgent medical need for an approved, effective treatment. Ruxolitinib has previously shown antipruritic activity. Now, pooled data from phase 3 TRuE-PN1 and 2 trials (NCT05755438 and NCT05764161) and their open-label extension (OLE) up to week 24 were presented by Prof. Sonja Ständer (University Hospital Münster, Germany) [1]. In total, 394 adults with mild-to-severe PN were enrolled. The primary endpoint at week 12 was WI-NRS response.

In the ITT cohort, the median age was 61-62 years, 58.9%-60.4% were women, all patients reported severe itch (baseline WI-NRS 8.3-8.4), and around 80% had moderate-to-severe disease, defined by an Investigator's Global Assessment of Chronic Prurigo Scale (IGA-CPG S) score ≥3.

With 1.5% ruxolitinib cream applied twice daily, 42.3% achieved a ≥ 4-point improvement in WI-NRS, versus 28.1% on vehicle (P<0.01). In the OLE, all patients received active treatment, and response rates at week 24 were similar across groups (63.6% and 62.8%, respectively). Notably, the separation of response curves between ruxolitinib and vehicle was already evident by day 3. Superiority of ruxolitinib at week 12 was also observed for overall treatment success combining WI-NRS and IGA-CPG S responses (lesion reduction): 12.2% with ruxolitinib vs 4.6% with vehicle (P<0.01).

Dermatology Life Quality Index (DLQI) trajectories did not separate as early, but at week 12, the results still favoured ruxolitinib (74.5 vs 63.3, P=0.03), with improvements rising to 81.3% and 80.4%, respectively, at week 24.

Safety findings showed a low incidence of application-site reactions (1.1%), and no ≥ grade 3 or serious treatment-emergent adverse events were attributed to therapy.

“All signs are positive for the development of ruxolitinib cream as a topical treatment in patients with PN,” Prof. Ständer concluded, expressing that it may become the first approved therapy for this disease.

1. Ständer S, et al. Efficacy and safety of ruxolitinib cream in patients with prurigo nodularis: pooled results from the phase 3 TRuE-PN1 and TRuE-PN2 randomised, vehicle-Controlled Studies. D1T01.2A, EADV Congress 2025, 17–20 September, Paris, France.

Medical writing support was provided by Dr Susanne Kammerer and Karin Drooff

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Posted on 23 September 202523 September 2025