Findings seen in 12-week, phase 2 trial at oral doses over 3 mg daily
TUESDAY, Oct. 9, 2018 (HealthDay News) — Selective inhibition of TYK2 with the oral agent BMS-986165 at doses of 3 mg daily and higher results in greater clearing of psoriasis versus placebo over 12 weeks, according to a phase 2 study published in the Oct. 4 issue of the New England Journal of Medicine.
Kim Papp, M.D., Ph.D., from K. Papp Clinical Research and Probity Medical Research in Peterborough, Ontario, Canada, and colleagues randomly assigned 267 patients to receive a TYK2 inhibitor, BMS-986165, orally (3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, or 12 mg daily) or placebo.
The researchers found that at week 12, the percentage of patients with ≥75 percent reduction in the Psoriasis Area and Severity Index score was 7 percent (three of 45 patients) with placebo, 9 percent (four of 44 patients) with 3 mg of BMS-986165 every other day (P = 0.49 versus placebo), 39 percent (17 of 44 patients) with 3 mg daily (P < 0.001 versus placebo), 69 percent (31 of 45 patients) with 3 mg twice daily (P < 0.001 versus placebo), 67 percent (30 of 45 patients) with 6 mg twice daily (P < 0.001 versus placebo), and 75 percent (33 of 44 patients) with 12 mg daily (P < 0.001 versus placebo). For patients in the intervention group, there were three serious adverse events.
“Larger and longer-duration trials of this drug are required to determine its safety and durability of effect in patients with psoriasis,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Bristol-Myers Squibb, which manufactures BMS-986165 and funded the study.
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