Deucravacitinib bestows benefits in Asian patients with plaque psoriasis
The benefit of deucravacitinib in moderate to severe plaque psoriasis was demonstrated in a population of Asian patients, according to results of the phase III POETYK PSO-3 trial.
Study participants were 220 adults (mean age 40.6 years, 81.8 percent male, mean BMI 26 kg/m2) from mainland China, Taiwan, and South Korea, with a diagnosis of stable moderate to severe plaque psoriasis for ≥6 months (PASI* ≥12 [mean 24.5], ≥10 percent body surface area affected [mean 33.9 percent], sPGA* score ≥3 [81 percent with sPGA 3]). They were randomized 2:1 to receive the oral selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (6 mg QD) or placebo. At week 16, patients assigned to placebo crossed over to receive deucravacitinib, while those assigned to deucravacitinib continued treatment up to 52 weeks.
Patients were a mean 28 years of age at disease onset and had experienced the condition for a mean 13.4 years. The primary locations affected were the scalp (93.2 percent) and fingernail (76.4 percent). Sixty-one percent each had prior exposure to phototherapy and systemic treatment, with 47 percent in the latter group having prior exposure to biologics.
At week 16, PASI 75 (≥75 percent reduction from baseline in PASI score) was achieved by significantly more patients assigned to deucravacitinib than placebo (68.8 percent vs 8.1 percent; p<0.0001). Significantly more deucravacitinib than placebo recipients also achieved sPGA 0/1 (clear/almost clear with a ≥2-point improvement from baseline; 55.6 percent vs 6.8 percent; p<0.0001). [EADV 2022, abstract N°: 3448]
At week 16, more patients assigned to deucravacitinib than placebo achieved PASI 90 (≥90 percent reduction from baseline in PASI score; 38.2 percent vs 1.4 percent; p<0.0001), sPGA 0 (13.9 percent vs 0 percent; p=0.0007), and scalp-specific (ss)PGA 0/1 (62.9 percent v 9.8 percent; p<0.0001). There was also a nominally significant improvement in quality of life, as per Dermatology Life Quality Index (DLQI) score 0/1, with deucravacitinib vs placebo (36.4 percent vs 11.6 percent; p<0.0001).
There were nominally significant differences between patients in the deucravacitinib and placebo groups for PASI 75 and sPGA 0/1 response rates (p=0.006 and p=0.0006, respectively) as early as week 4.
The PASI 75 and sPGA 0/1 outcomes with deucravacitinib were maintained at week 52 (71.0 and 51.0 percent, respectively). Patients originally assigned to placebo experienced improvements in PASI 75 and sPGA 0/1 following cross over to deucravacitinib (70.3 and 52.7 percent, respectively), achieving levels similar to those achieved by patients on continuous deucravacitinib.
At week 52, patients on continuous deucravacitinib experienced improvements in PASI 90 (from 38.2 to 45.5 percent) and PASI 100 (from 4.2 to 18.6 percent), as did patients who crossed over from placebo (PASI 90: from 1.4 to 50.0 percent; PASI 100: from 0 to 17.6 percent). sPGA 0 rates also improved among patients on continuous deucravacitinib (from 13.9 to 20.7 percent) and those who crossed over (from 0 to 24.3 percent), as did DLQI 0/1 rates (from 36.4 to 44.7 percent [continuous deucravacitinib] and from 11.6 to 43.5 percent [cross over]), while ssPGA 0/1 outcomes were maintained among continuous deucravacitinib recipients (from 62.9 to 53.3 percent) and improved in the cross over group (from 9.8 to 49.0 percent).
At week 52, adverse events (AEs) were documented in 84.6 and 58.1 percent of deucravacitinib and placebo recipients, respectively, with 52.3 and 18.9 percent, respectively, deemed treatment related. Twelve and one patient in the respective groups experienced serious AEs, with AEs leading to discontinuation in five deucravacitinib and no placebo recipients. There were no deaths in either group.
The most common AEs (≥5 percent) in deucravacitinib recipients were upper respiratory infection (25.7 percent) and nasopharyngitis (15.9 percent). There were no reports of tuberculosis, opportunistic infections, malignancies, thrombosis, adjudicated major adverse cardiovascular events, or suicidal ideation. Herpes zoster occurred in five patients, with all incidents mild, localized, and not resulting in treatment interruption or discontinuation. There were no changes in laboratory parameters.
“The majority of AEs were mild or moderate in severity,” remarked Renata Kisa, a representative from the study sponsor Bristol-Myers Squibb, who presented the findings at EADV 2022 on behalf of the investigators. The most common skin AE in deucravacitinib recipients was folliculitis (6.5 percent), with none of the incidents leading to discontinuation.
Consistent with global findings
Two large global phase III trials (POETYK PSO-1 and PSO-2) previously demonstrated the robust efficacy and durability and maintenance of responses with deucravacitinib compared with placebo and apremilast, said Kisa. [J Am Acad Dermatol 2022;doi:10.1016/j.jaad.2022.07.002; J Am Acad Dermatol 2022;doi:10.1016/j.jaad.2022.08.061]
“[In this study,] deucravacitinib was superior to placebo at week 16 for the coprimary endpoints of PASI 75 and sPGA 0/1 in an East Asian, predominant Chinese population, with stable, moderate to severe plaque psoriasis [with the efficacy maintained through week 52],” noted Kisa.
“The efficacy and safety profile of deucravacitinib was consistent with that shown in the … POETYK PSO-1 and PSO-2 trials,” she concluded.