Bimzelx(bimekizumab)

Bimzelx (bimekizumab) is indicated for the treatment of moderate to severe plaque psoriasis. In clinical trials, bimekizumab demonstrated significant efficacy. The PASI 90 response rate was 90.8% and 88.8% in two separate findings, compared to a 4.8% PASI 90 response rate for placebo. At Week 12, the PASI 90 response rate for bimekizumab 320mg Q4W was 79.1%. The mean percentage change from Baseline in PASI at Week 28 for the bimekizumab 320mg group was -86.68%, versus -62.07% for the bimekizumab 320mg+PBO group.

Common safety findings included Infections and Infestations, reported in 36% of patients. The incidence of oral candidiasis was 8.5% in patients weighing <70kg and 7.0% in patients weighing >=70kg, with a positive relationship observed between Candida infection rates and bimekizumab exposure. The incidence of ADAb positive at one visit or more was 52.1% for bimekizumab 320mg Q4W/Q4W and 49.5% for bimekizumab 320mg Q4W/Q8W.

The proposed and agreed posology for moderate to severe plaque psoriasis is an induction dose of 320 mg Q4W for the first 16 weeks, followed by a maintenance dose of 320 mg Q8W thereafter. Dosage adjustments for gender, race (Asian/Japanese), or elderly patients are not warranted. The CHMP agreed on a Q4W regimen for overweight patients (BW >= 120kg) with incomplete skin clearance at week 16.