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.

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

 

Key learnings

In PSOARING 1 and 2, treatment with tapinarof 1% cream daily for 12 weeks led to rapid and significant improvements in PP-NRS, itch-free state, and DLQI scores in patients with mild to severe plaque psoriasis. The prescribing information for tapinarof 1% cream daily lists no restrictions in its duration of use, extent of body surface area treated, or body sites to which treatment can be applied, indicating that it is an adaptable treatment option that can be utilized for pruritus.