‘Landmark’ study shows potential of ruxolitinib cream 1.5% for prurigo nodularis

Key takeaways:

• Currently, there are no approved topicals for the treatment of prurigo nodularis.
• According to the presenter, ruxolitinib cream 1.5% could become the first.

ORLANDO — Ruxolitinib cream 1.5% shows “breakthrough” results as a treatment for prurigo nodularis, according to a presenter at the American Academy of Dermatology Annual Meeting.

Ruxolitinib cream is a selective Janus kinase 1 and 2 inhibitor. According to Shawn G. Kwatra, MD, professor and chair of dermatology at the University of Maryland School of Medicine, ruxolitinib has high potential as a treatment for prurigo nodularis, a disease that Kwatra says has been “overlooked” for much too long.

“There are no FDA-approved topicals for the treatment of prurigo nodularis,” Kwatra told Healio. “Janus kinase 1 is important in itch biology, so we think that this could be really an incredible study to have the first approved topical agent for prurigo nodularis.”

In a late-breaking presentation, Kwatra discussed the 12-week results from TRuE-PN1, a phase 3 study that includes a 12-week, double-blind, vehicle-controlled treatment period, followed by a 40-week open-label extension period.

Patients with prurigo nodularis were randomly assigned to receive 1.5% ruxolitinib cream (n = 101) or vehicle (n = 103) twice daily for 12 weeks. According to the presentation, all patients had a median disease duration of over 4 years and a mean Worst Itch Numerical Rating Scale (WI-NRS) score of 8.4.

At the end of the 12 weeks, 44.6% of patients treated with ruxolitinib cream achieved the primary endpoint of a 4-point or greater improvement from baseline in WI-NRS vs. 20.6% of the vehicle group (P = .0003). Ruxolitinib also showcased rapid-onset of efficacy with 22.4% of ruxolitinib-treated patients reaching the primary endpoint vs. 8% of the vehicle group (P = .0064)

A higher proportion of ruxolitinib- vs. vehicle-treated patients also achieved one of the key secondary endpoints, defined as an IGA for Stage of Chronic Prurigo Treatment Success score of 0 or 1 with a 2-grade or higher improvement from baseline at week 12 (15.8% vs. 3.9%; P = .0048).

Treatment success, defined as an achievement of both the primary and aforementioned secondary endpoint, was reached by 11.9% of the ruxolitinib group vs. 2.9% of the vehicle group (P = 0.0034).

About one-third (31%) of patients in the ruxolitinib group experienced a treatment-emergent adverse event vs. 35.9% in the vehicle group. According to Kwatra, the safety profile of 1.5% ruxolitinib cream was very similar with previous studies.

“This is just a really landmark, breakthrough-type trial that has never been done before,” Kwatra told Healio.

In his talk, Kwatra also stated he received preliminary, topline data from the TRuE-PN2 trial just days before his presentation. These data showed that 40% of 93 patients treated with 1.5% ruxolitinib cream achieved the primary endpoint at week 12 vs. 36.2% of the 96 patients in the vehicle group.

“There was a slightly increased placebo response in itch which is something that has been common throughout many itch studies and something that is very important to keep in mind with trial design, so we will be looking into that more,” Kwatra concluded in his presentation. “But, overall, ruxolitinib cream may be a novel approach to the treatment of prurigo nodularis.”