First-in-Class TYK Inhibitor Shows Durable Effect for Psoriasis

 | Post date: 2021/10/2 | 

Deucravacitinib, a novel inhibitor of the JAK kinase tyrosine kinase 2 (TYK2), continues to demonstrate strong efficacy and acceptable safety after 52 weeks of follow-up, according to late-breaking data from two pivotal trials presented at the European Academy of Dermatology and Venereology (EADV) Annual Meeting.

From benefit reported on the two co-primary endpoints previously reported at 16 weeks, longer follow-up showed further gains out to 24 weeks and then persistent efficacy out to 52 weeks across these and multiple secondary endpoints, reported Richard Warren, MBChB, PhD, professor of dermatology and therapeutics, University of Manchester, Manchester, UK.

"This could be a unique oral therapy and an important treatment option for moderate to severe psoriasis," Warren contended.

The multinational double-blind trials, called POETYK PSO-1 and PSO-2, enrolled 666 and 1020 patients, respectively. The designs were similar. Patients with moderate to severe plaque psoriasis were randomly assigned in a 2:1:1 ratio to deucravacitinib (6 mg once daily), placebo, or apremilast (Otezla; 30 mg twice daily). At 16 weeks, those on placebo were switched to deucravacitinib.

For the co-primary endpoint of PASI 75 (75% clearance on the Psoriasis and Severity Index), the similar rate of response for deucravacitinib in the two studies (58.7% / 53.6%) at week 16 was superior to the rates observed on both apremilast (35.1% / 40.2%) and placebo (12.7% / 9.4%).

By week 24, the proportion of deucravacitinib patients with a PASI-75 response had reached 69.3% and 58.7% in the POETYK PSO-1 and PSO-2 trials, respectively. The proportion of patients on apremilast with PASI 75 at this timepoint did not increase appreciably in one study and fell modestly in the other.

By week 52, the response rates achieved with deucravacitinib at week 24 were generally unchanged and nearly double those observed on apremilast.

The pattern of relative benefit on the other co-primary endpoint, which was a score of 0 or 1, signifying clear or almost clear skin on the Physicians Global Assessment (sPGA), followed the same pattern. At week 16, 53.6% of patients had achieved sPGA 0/1. This was significantly higher than that observed on either apremilast or placebo, and this level of response was sustained through week 52.

When patients on placebo were switched to deucravacitinib at week 16, the PASI 75 response climbed quickly. There was complete catch-up by 32 weeks. In both groups, a PASI-75 response rate of about 65% or higher was maintained for the remainder of the study.

On a prespecified analysis, prior treatment exposure was not associated with any impact on the degree of response with deucravacitinib. This included a comparison between patients exposed to no prior biologic, one prior biologic, or two or more biologics, Warren reported.    

Unlike patients in POETYK PSO-1, those with a PASI 75 response at 16 weeks in the POETYK PSO-2 trial were re-randomized to remain on deucravacitinib or switch to placebo. Designed to evaluate response durability, this analysis showed a relatively gradual decline in disease control.

Cite this: First-in-Class TYK Inhibitor Shows Durable Effect for Psoriasis - Medscape - Oct 01, 2021.




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