Oral ME3183 shows higher PASI-75 response rates than placebo in moderate to severe plaque psoriasis trial

In a 16-week, randomized, double-blind, placebo-controlled trial, 132 patients with moderate to severe plaque psoriasis received oral ME3183 at doses of 5 mg twice daily, 10 mg once daily, 7.5 mg twice daily, or 15 mg once daily, or placebo. The primary outcome was the proportion of patients achieving ≥75% reduction in baseline Psoriasis Area and Severity Index (PASI) scores at Week 16.

At Week 16, the proportions achieving PASI-75 were 58.3%, 32.0%, 61.5%, and 52.0% in the ME3183 groups, compared with 14.8% in the placebo group. All ME3183 groups showed statistically significant differences versus placebo (all p < 0.01), except for the 10 mg once daily group. The study did not report absolute numbers or effect sizes for these comparisons.

The most common adverse events across ME3183 groups were diarrhoea (16.0%-38.5%), nausea (7.7%-30.8%), and headache (7.7%-42.3%). The study did not report serious adverse events, discontinuation rates, or tolerability data. Key limitations include the short 16-week follow-up, lack of reported absolute numbers and effect sizes, and absence of data on funding or conflicts of interest.

This trial provides preliminary evidence of efficacy for oral ME3183 in plaque psoriasis, but the abstract explicitly states the drug 'should be further investigated' as a treatment alternative rather than being ready for clinical use. The safety profile requires more comprehensive evaluation in larger, longer-term studies.