麻豆传媒

People with psoriasis achieved full skin clearance with bimekizumab (Bimzelx) and maintained the improvement through 96 weeks of an extended randomized controlled trial. Patients taking secukinumab (Cosentyx) who switched to bimekizumab achieved similar responses.

That's according to trial results published recently in the .

The BE RADIANT phase 3b randomized controlled trial consisted of a 48-week double-blinded period, in which patients received bimekizumab (320 mg every 4 or 8 weeks) or secukinumab (300 mg weekly to week 4, then every 4 weeks thereafter), and an open-label extension.

Full skin clearance was maintained to week 96 in 70.8% of continuous bimekizumab patients. Patients who switched from secukinumab to bimekizumab had increased rates at week 96 (76.6%). In general, safety data were consistent with the known safety profile of bimekizumab.

The study was conducted by a multinational team including report first author Bruce Strober, MD, PhD, a clinical professor of dermatology at Yale University School of Medicine. The following study excerpts have been lightly edited for length and clarity.

What was the goal of this investigation?

BE RADIANT was the first phase 3 trial comparing dual IL-17A and IL-17F inhibition via bimekizumab with IL-17A inhibition alone via secukinumab.

Bimekizumab was shown to be more effective than secukinumab over 48 weeks, including in complete skin clearance (100% improvement in Psoriasis Area and Severity Index [PASI] from baseline, or PASI 100). Bimekizumab was also well-tolerated.

However, given the chronic nature of psoriasis and the potential loss of clinical response over time with biologics, it was important to ascertain more about the long-term safety and efficacy of bimekizumab.

Further, establishing the safety and efficacy of bimekizumab following prior IL-17A inhibition via secukinumab also was important.

What were the key findings?

The high levels of clinical response seen through the first 48 weeks of bimekizumab treatment were generally sustained through 96 weeks, demonstrating that the rapid responses reported previously were durable.

High Dermatology Life Quality Index (DLQI) rates accompanying skin clearance reported in the paper indicated, researchers said, notable and sustained improvements in quality of life with bimekizumab treatment. Rates for both continuous bimekizumab and secukinumab/bimekizumab patients increased to week 48 and were maintained to week 96.

What was the safety profile?

Serious adverse events were 5.0 and 5.3/100 patient years in continuous bimekizumab and secukinumab/bimekizumab patients and did not increase with a longer duration of bimekizumab exposure.

There was one death during Year 2 in a secukinumab/bimekizumab patient that was not considered to be treatment-related. This patient had not consented to sharing further clinical record details.

The most common treatment-emergent adverse events were nasopharyngitis (continuous bimekizumab: 11.8/100 patient-years; secukinumab/bimekizumab: 12.1/100 patient-years), oral candidiasis (7.8/100 patient-years; 12.2/100 patient-years), and urinary tract infection (4.5/100 patient-years; 5.7/100 patient-years).

What is the bottom-line takeaway for dermatologists?

Patients who switched from secukinumab to bimekizumab saw improved clinical responses at week 96, similar to those who received 96 weeks of continuous bimekizumab. Bimekizumab was well-tolerated with longer-term exposure and in patients who switched from secukinumab without washout or induction. Overall, safety data were consistent with the known safety profile.

These data indicate that longer-term bimekizumab treatment and switching from another anti-IL-17 biologic to bimekizumab are generally well-tolerated and efficacious options for patients with moderate-to-severe plaque psoriasis.