The study enrolled 743 patients randomized to either bimekizumab or secukinumab. After 1 year, all patients transitioned to open-label bimekizumab treatment and were followed through week 144.
By year 3, PASI 100 was achieved by 68.8% of both patients initially assigned to bimekizumab and those who switched from secukinumab, according to modified nonresponder imputation analysis. PASI 90 was observed in 89.7% of continuous bimekizumab patients and 86.8% of switchers. Improvements in body surface area involvement 1% or less, Investigator Global Assessment scores of 0/1, and Dermatology Life Quality Index scores of 0/1 were also sustained through year 3.
In a subset of 177 patients who received the U.S. Food and Drug Administration-approved regimen—bimekizumab every 4 weeks for 16 weeks followed by every 8 weeks—PASI 100 was achieved in 74.7% at week 48 and 71.1% at week 144.
The most common treatment-emergent adverse events over 3 years were nasopharyngitis (12.2 per 100 patient-years), oral candidiasis (10.0 per 100 PY), and upper respiratory tract infection (5.5 per 100 PY). Serious adverse event rates remained stable, including serious infections (1.6 per 100 PY) and opportunistic infections (0.8 per 100 PY). No cases of active tuberculosis were reported.
Among 227 reported oral candidiasis events, 223 were classified as mild or moderate. Three cases led to treatment discontinuation. Other Candida infections, such as vulvovaginal, gastrointestinal, genital, and oropharyngeal candidiasis, were infrequent.
Rates of major adverse cardiac events and inflammatory bowel disease were 0.4 and 0.3 per 100 PY, respectively. Suicidal ideation and behavior occurred at 0.2 per 100 PY.
There were 6 deaths during the 3-year period. One death occurred during year 1 due to a road traffic accident. Five occurred during the extension phase, including one considered treatment-related in a patient with metastatic neoplasm.
The safety profile of bimekizumab remained consistent over time. The rate of any treatment-emergent adverse event declined from 282.5 per 100 PY in year 1 to 201.4 per 100 PY by year 3. The subset receiving the U.S. Food and Drug Admnistration-approved dosing showed comparable outcomes in both efficacy and safety measures. The researchers noted that generalizability may be limited by the trial’s low racial diversity and the open-label extension design.
“This report demonstrates the continued benefit of selective inhibition of interleukin (IL)-17A and IL-17F in patients with psoriasis,” wrote Richard B. Warren of the Dermatology Centre, Northern Care Alliance NHS Foundation Trust and University of Manchester, United Kingdom, and colleagues.
This trial presents the longest follow-up data comparing IL-17A inhibition to dual IL-17A and IL-17F inhibition. Results showed durable skin clearance and stable safety outcomes with bimekizumab, supporting its role in long-term management of moderate-to-severe plaque psoriasis.
Fulll disclosures can be found in the published study.
Source: BJD