AAD 2023: Efficacy of Bimekizumab in the Treatment of Hidradenitis Suppurativa

Hidradenitis suppurativa and a New Treatment Option

HS is a chronic, very painful, and debilitating inflammatory skin disease characterized by flare-ups, which significantly impact a patient's quality of life. It develops in early adulthood and affects approximately 1% of the population in countries where it has been most studied. It manifests as nodules, abscesses, and draining fistulas with scar formation typically occurring in the armpits, groin, and buttocks. Approximately one-third of patients with HS have a positive family history of the disease, and lifestyle factors (smoking, obesity) significantly contribute to its clinical course.

Bimekizumab, a humanized IgG1 monoclonal antibody that selectively inhibits the pro-inflammatory cytokines IL-17A and IL-17F, has shown promising results in the therapy of this disease. In August 2021, it was approved by the European Medicines Agency (EMA) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Methodology and Progress of the BE HEARD I and II Studies

These were multicenter, randomized, double-blind, placebo-controlled phase III studies with parallel groups. BE HEARD I included 505 and BE HEARD II included 509 patients diagnosed with moderate to severe HS. Both studies had a 16-week initial treatment phase and a 32-week maintenance phase. Patients were randomized into 4 groups in a 2 : 2 : 2 : 1 ratio and the results for 3 groups receiving bimekizumab in 3 dosing regimens (320 mg every 2 weeks [Q2W] throughout or 320 mg every 4 weeks [Q4W] throughout or Q2W for 16 weeks followed by Q4W for the remaining 32 weeks) were compared with 1 group where patients received placebo Q2W during the initial 16 weeks and then bimekizumab Q2W in the maintenance phase. 

The primary evaluated parameter was at least a 50% reduction in the total number of abscesses and inflammatory nodules (HiSCR50) at week 16 compared to baseline, and the key secondary parameter was their 75% reduction (HiSCR75), also assessed at week 16. Other evaluations included quality of life, pain, and adverse events. 

Results

Regarding efficacy, the key findings were as follows:

• A significantly higher proportion of patients treated with bimekizumab achieved HiSCR50 at week 16 compared to the placebo group, both in the Q2W dosing (BE HEARD I: 47.8 vs. 28.7%; p = 0.006; BE HEARD II: 52.0 vs. 32.2%; p = 0.003) and Q4W dosing (BE HEARD I: 45.3 vs. 28.7%; p = 0.030; BE HEARD II: 53.8 vs. 32.2%; p = 0.004). 
• At week 16, a deeper clinical response and greater proportion of HiSCR75 were achieved in patients treated with bimekizumab compared to the placebo group. The difference was statistically significant in both dosing regimens in the BE HEARD II study and in the Q2W bimekizumab regimen in the BE HEARD I study.
• At week 16, health-related quality of life (HRQoL) improved in both studies and with both dosing regimens of bimekizumab compared to the placebo group.
• HiSCR50 and HiSCR75 continued in the majority of patients with ongoing bimekizumab treatment in both studies and at both dosing regimens. At week 48, >75% of patients maintained HiSCR50 and >55% of patients maintained HiSCR75. 

The safety profile of bimekizumab in both studies was consistent with previous evaluations, and no new safety signals were observed. The most common adverse events (in >5% of patients) in the initial 16 weeks included hidradenitis (7.2% in BE HEARD I and 8.8% in BE HEARD II), oral candidiasis (4.4% and 6.7%), headache (7.0% and 5.8%), and diarrhea (7.0% and 5.3%).

Introduction to Practice

The registration of bimekizumab for the indication of moderate to severe HS is expected in the 3rd quarter of 2023.

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Sources:
1. Bimekizumab phase 3 data in hidradenitis suppurativa show clinically meaningful, deep and maintained response over 48 weeks. UCB, 2023 Mar 18. Available at: www.ucb.com/stories-media/Press-Releases/article/Bimekizumab-Phase-3-Data-in-Hidradenitis-Suppurativa-Show-Clinically-Meaningful-Deep-and-Maintained-Response-over-48-Weeks
2. SPC Bimzelx. Available at: www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf
3. A study to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (BE HEARD I). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT04242446 
4. A study to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (BE HEARD II). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT04242498
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