Patients with scalp psoriasis experience first-hand improvements in itch, flaking, pain from deucravacitinib

An interim analysis of patient-reported outcomes from the phase IIIb/IV PSORIATYK SCALP trial shows that treatment with the allosteric tyrosine kinase 2 (TYK2) inhibitor deucravacitinib significantly reduces itch, flaking, and pain specific to the scalp, as well as whole-body itch, vs placebo at week 16 in patients with moderate-to-severe scalp psoriasis, including those with less extensive body surface area (BSA) involvement.

On an 11-point numeric rating scale (NRS) from 0 to 10, the adjusted mean change from baseline to week 16 in scalp-specific itch, a key secondary endpoint, was −3.2 for deucravacitinib vs −0.7 for placebo (p<0.0001). [EADV 2024, abstract 5390]

For exploratory endpoints, significantly greater improvements on the NRS for scalp-specific flaking (−3.9 vs −1; p<0.0001), scalp-specific pain (−2.1 vs −0.1; p<0.0001), and whole-body itch (−2.9 vs −0.4; p<0.0001) were reported at week 16 among patients treated with deucravacitinib vs those receiving placebo.

Unlike the prior phase III POETYK trials, patients with ≥3 percent BSA involvement could enrol (vs ≥10 percent in POETYK), provided that the mandatory scalp involvement criteria were fulfilled. [J Am Acad Dermatol 2023;88:29-39; J Am Acad Dermatol 2023;88:40-51] “This is a different population, probably one with a phenotype primarily localized to the scalp,” said Professor Diamant Thaçi from the Institute of Inflammation Medicine, University of Lübeck in Lübeck, Germany, during his presentation at EADV 2024.

"These patients in many countries do not fulfil the criteria for systemic treatment. I think that’s going to change because they suffer just as much as other patients and have a high need for treatment as well," said Thaçi, highlighting the implications of less extensive overall psoriasis as part of PSORIATYK SCALP’s eligibility criteria.

“Scalp matters”

PSORIATYK SCALP is an ongoing trial that includes adults with moderate-to-severe scalp psoriasis, defined as a scalp-specific Physician Global Assessment score ≥3, a scalp surface area involvement ≥20 percent, and a Psoriasis Scalp Severity Index score ≥12. Patients had to have evidence of plaque psoriasis in a nonscalp area and be candidates for systemic therapy or phototherapy. All patients had either failed to respond to or were intolerant of ≥1 topical therapy for scalp psoriasis.

The scalp-specific trial randomized 154 patients 2:1 to receive either deucravacitinib 6 mg or placebo, administered orally once daily.

“Scalp matters,” Thaçi repeated three times during the presentation. “If you see how the patients were reporting their scalp-specific itch at baseline in the trial, it was 6.4 on average out of 10. This is a lot.” Other patient-reported assessments at baseline on the NRS were 6.9 for scalp-specific flaking, 4.2 for scalp-specific pain, and 5.8 for whole-body itch.

Response rates, based on a minimum clinically important difference (MCID) of ≥4-point improvement, were also compared between patients treated with deucravacitinib and placebo to provide a more clinically relevant interpretation. For each NRS measure, the MCID response rates were significantly higher in the deucravacitinib arm vs the placebo arm, with the greatest between-arm difference observed for scalp-specific flaking (53.4 percent vs 19.6 percent; p<0.0001).

“We know that at week 16, that is not a plateau with the TYK2 inhibitor. In the upcoming 52-week results that we're going to present, we will likely see even higher response rates, which I expect,” concluded Thaçi.