New open-label extension data support the long-term use of the systemic therapy in patients with moderate-to-severe disease.
Patients with plaque psoriasis treated with bimekizumab reported sustained treatment response and continued safety through the third year of dosing in an open-label extension trial.
In new data from the BE BRIGHT assessment, an open-label extension of the phase 3 BE SURE trial, a team of investigators observed sustained efficacy in psoriasis clearance at 3 years with bimekizumab. The team additionally observed improved long-term efficacy among BE SURE participants who were switched from adalimumab to bimekizumab in the extension trial.
Led by Diamant Thaci, MD, of the Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lubeck in Germany, investigators sought to assess the long-term efficacy and safety of bimekizumab in patients with moderate-to-severe psoriasis previously enrolled in BE SURE and entered into the open-label extension.
Thaci and colleagues noted that bimekizumab demonstrated superior efficacy per Psoriasis Area Severity Index (PASI) score to adalimumab over 24 weeks in BE SURE.
“After patients switched from adalimumab to bimekizumab at week 24, responses improved and were maintained over 2 years, with no unexpected safety findings,” they wrote. “Here, we consider long-term efficacy and safety over 3 years.”
Investigators adjusted doses at weeks 56 and 80 as needed in participants from the combined trials. All participants were treated with bimekizumab every 8 weeks from week 104. Efficacy outcomes were reported for the intention-to-treat population through week 152. Safety data included weeks 104-152.
The final analysis included 478 patients initially randomized 1:1:1 to bimekizumab every 4 weeks through both trials, bimekizumab every 4 weeks then transitioned to every 8 weeks, and or adalimumab every 4 weeks then transitioned to bimekizumab every 4 weeks.
In the primary endpoint of percentage of patients achieving PASI 90, the first arm reported 92.6%, 90.2% and 85.5% achievement rates at weeks 56, 104 and 152, respectively. Such rates were lower (89.6%, 89.0%, 87.3%) among the second bimekizumab treatment arm, and higher (94.3%, 97.1%, 96.1%) among the adalimumab/bimekizumab treatment arm.
“Bimekizumab-randomized patients maintained high levels of PASI 90 and PASI 100 responses to 3 years of treatment,” investigators wrote. “Among adalimumab-randomized patients, the rapid increases seen in PASI 90 and PASI 100 responses for after the Week 24 adalimumab to bimekizumab switch were durable to Week 152, reaching similar levels to bimekizumab-randomized patients.”
Regarding safety outcomes, investigators observed 101.7 treatment-emergent adverse events (TEAEs) per 100 patient-years among all patients administered bimekziumab (95% CI, 88.7 - 116.0). The serious TEAE rate was 6.2 per 100 patient-years (95% CI, 3.9 - 9.5). The most common TEAEs including COVID-19 infection, nasopharyngitis, and oral candidiasis.
Investigators concluded the findings indicate a sustained and tolerable efficacy of bimekizumab in patients receiving long-term care for psoriasis.
“Clinical and health-related quality of life responses observed during the first two years of treatment were sustained to 3 years of treatment, regardless of bimekizumab maintenance dose frequency prior to the third year,” they wrote.
The study, “Bimekizumab efficacy and safety through three years in patients with moderate to severe plaque psoriasis: Long-term results from the BE SURE randomized controlled trial and the BE BRIGHT open-label extension,” was presented at Dermatology Fall Clinical 2022.