A new oral phosphodiesterase-4 inhibitor achieved impressive rates of complete or near-complete skin clearance in a phase 2 study that also found the drug was well tolerated. AAD2023 Psoriasis
NEW ORLEANS — For the treatment of plaque psoriasis, a novel oral phosphodiesterase-4 inhibitor achieved high rates of response compared with placebo, according to results of a phase 2 clinical trial presented as a late-breaker at the annual meeting of the American Academy of Dermatology.The phase 2b data, which are prompting a phase 3 trial, suggest that the drug, called orismilast,"is a potential new addition to the psoriasis armamentarium," reported Lars E.
, but the newest study tested a modified-release formulation of orismilast to test its potential to improve tolerability., 202 adult patients with moderate-to-severe psoriasis were randomly assigned to one of three doses of orismilast or to placebo. Each of the three doses — 20 mg, 30 mg, or 40 mg — were administered twice daily. The primary endpoint was change in PASI score at 16 weeks. Secondary endpoints included PASI-75 responses and safety.
In the intention-to-treat analysis with missing data counted as nonresponders, the proportion of patients reaching PASI-75 scores at 16 weeks were 39%, 49%, 45%, and 17%, in the 20-mg, 30-mg, 40-mg, and placebo groups, respectively. The proportion of patients experiencing complete or near-complete skin clearance defined by a PASI-90 were 24%, 22%, 28%, and 8%, respectively.
Based on the limited therapeutic gain but greater risk for adverse events on the 40-mg twice-daily dose,"the question is now whether to move forward with the 20-mg or the 30-mg dose," according to French, who said planning of a phase 3 trial is underway.However, this was not the only set of data on an oral PDE4 inhibitor presented as a latebreaker at the AAD meeting.
In a population with a relatively high rate of smoking, Egeberg further reported, lung function was improved, a remark initially interpreted as a joke by some attending the presentation. However, Egeberg confirmed that lung function was monitored, and objective improvements were recorded.
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