Improvement in pruritus with tapinarof 1% cream: Post-hoc analysis of PSOARING 1 and 2

Pruritus, also known as itching, affects up to 90% of patients with psoriasis. Pruritus can affect quality of life by impacting physical activity, functioning, and psychological well-being. The intensity of pruritus can be associated with the severity of plaques, and the clearance of itch occurs alongside the clearance of plaques.

Here, we summarize results from the PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) clinical trials, published by Kircik et al.¹ in Dermatology and Therapy, which evaluated patient-reported outcomes following treatment with daily tapinarof cream 1% vs vehicle control in patients with mild to severe plaque psoriasis.

Study design¹

• Patients were aged 18–75 years, with chronic plaque psoriasis, a Physician’s Global Assessment of 2–4 at baseline, and a body surface area involvement of 3–20%
  • PSOARING 1: 510 patients enrolled (tapinarof, n = 340; vehicle, n = 170)
  • PSOARING 2: 515 patients enrolled (tapinarof, n = 343; vehicle, n = 172)
• Pruritus was assessed using the Peak Pruritus Numerical Rating Scale (PP-NRS), an 11-point scale where 0 is no itch, and 10 is the “worst imaginable itch” within the last 24 hours
• The Dermatology Life Quality Index (DLQI) item 1 score (assessing itch, soreness, painfulness, or stinging) was used to evaluate the impact of itch on quality of life
• The proportion of patients achieving a PP-NRS score of 0 or 1 was compared between the treatment groups at Weeks 2, 4, 8, and 12

Key findings¹

• Baseline patient characteristics were similar across the tapinarof and vehicle groups in both trials.
• There were significantly greater improvements in mean PP-NRS total scores for patients treated with tapinarof compared with vehicle as early as Week 2, which continued to Week 12. Mean improvements at Week 12 were −3.9 vs −2.9 (p = 0.0002) for tapinarof vs vehicle in PSOARING 1 and −3.0 vs −1.4 (p < 0.0001) for tapinarof vs vehicle in PSOARING 2.
• In both trials, significantly more tapinarof- vs vehicle-treated patients achieved a PP-NRS response (at least a 4-point reduction in PP-NRS score) at Week 12 (Figure 1).
• Significantly more tapinarof vs vehicle-treated patients achieved an itch-free state and improvement in DLQI item 1 score in both trials over 12 weeks.
• Most treatment-emergent adverse events in both trials were mild or moderate in severity.

Figure 1. Proportion of patients achieving PP-NRS response at Week 12* 

PP-NRS, peak pruritus numerical rating scale.
*Data from Kircik, et al.¹