Expert Consensus on the Use of Bimekizumab in the Treatment of Plaque Psoriasis and Psoriatic Arthritis

Introduction

Despite therapeutic advancements and the use of biologic treatments for plaque psoriasis, many patients struggle to achieve adequate disease control. Due to its proven efficacy and safety, bimekizumab may be a suitable therapeutic option for patients with moderate to severe psoriasis. The aim of this work was to assemble a panel of psoriasis treatment experts to summarize the available evidence and formulate positions and recommendations for the use of bimekizumab in clinical practice.

Methodology

A systematic literature review was conducted in the PubMed, Scopus, and Google Scholar databases up to July 2023. Original studies, systematic reviews, and meta-analyses in the English language were identified using the keywords “psoriasis,” “IL-17,” and “bimekizumab.” The expert panel included 9 dermatologists specializing in psoriasis treatment. In August 2023, they reviewed and discussed the relevant studies found and formulated and voted on consensus positions and recommendations for the use of bimekizumab in the treatment of psoriasis and psoriatic arthritis (PsA). A modified Delphi method was used.

Accepted Positions and Recommendations

1. There are unmet needs for additional psoriasis treatments (strength A)

Psoriasis patients continue to seek additional therapeutic options due to loss of response, medication failure, worsening disease severity, insufficient tolerance, or the need to achieve therapeutic effect more quickly. Effective treatment for PsA is also needed. More effective therapeutic options are especially necessary for patients with plaque psoriasis + PsA.

2. Current data show the benefit of psoriasis treatments targeting both IL-17A and IL-17F (strength B)

The interleukin 17 (IL-17) cytokine family plays a crucial role in the pathogenesis of psoriasis. IL-17A is the most potent cytokine of this family, but IL-17F is found at higher concentrations in psoriatic lesions. Both isoforms are often co-expressed and contribute to skin inflammation. Bimekizumab is the first monoclonal antibody targeting both IL-17A and IL-17F simultaneously, demonstrating efficacy and safety in the treatment of moderate to severe psoriasis. Bimekizumab has also shown superiority compared to secukinumab, which targets only IL-17A.

3. Bimekizumab is highly effective in the treatment of moderate to severe psoriasis (strength A)

In a phase III study comparing bimekizumab 320 mg every 4 weeks with placebo, 91% of patients on bimekizumab achieved PASI 90 at week 16 compared to 1% with placebo (p < 0.0001). An IGA score (Investigator’s Global Assessment) of 0/1 with at least a 2-point improvement was achieved by 93% of patients on bimekizumab compared to 1% on placebo (p < 0.0001). PASI 100 was the treatment outcome for 68% and an IGA score of 0 for 70% of patients on bimekizumab. Clinically significant alleviation of psoriasis symptoms was noted at week 16 per the Psoriasis Symptoms and Impacts Measure and a Dermatology Life Quality Index score (DLQI) of 0/1 for a significantly higher number of bimekizumab patients.

4. Direct comparisons showed greater efficacy of bimekizumab in treating moderate to severe psoriasis compared to secukinumab, adalimumab, and ustekinumab (strength A)

Bimekizumab showed superiority over the IL-17A selective inhibitor secukinumab in achieving PASI 100 at week 16 (61.7% vs. 48.9%; p < 0.001) and at week 48 (67% vs. 46.2%; p < 0.001). Compared to the tumor necrosis factor-alpha (TNF-α) inhibitor adalimumab approved for moderate to severe psoriasis treatment, bimekizumab was associated with a greater likelihood of achieving PASI 90 (86.2% vs. 47.2%; p < 0.001) and PASI 100 (60.8% vs. 23.9%; p < 0.001) at week 16. Ustekinumab, an IL-12/IL-23 inhibitor approved for psoriasis treatment, ensured a significantly higher percentage of patients with PASI 90 at week 16 when compared directly to bimekizumab (85% vs. 50%; p < 0.001). These results persisted through week 52.

5. Optimal dosing of bimekizumab for psoriasis is 320 mg every 4 weeks for 16 weeks, followed by every 8 weeks; selected patients may continue dosing every 4 weeks post week 16 (strength A)

For PsA, clinical studies demonstrated efficacy of a bimekizumab dose of 160 mg every 4 weeks. The appropriate dose needs to be assessed for patients with psoriasis + PsA.

6. Based on direct comparisons, bimekizumab works faster for psoriasis than secukinumab, adalimumab, and ustekinumab (strength A)

Patients treated with bimekizumab experience significant alleviation of plaque psoriasis signs and symptoms within a few weeks of starting treatment, without a loading dose, unlike the compared treatments. According to a phase III clinical study, the effect of bimekizumab is evident and greater than that of secukinumab, adalimumab, and ustekinumab within just 4 weeks.

7. Bimekizumab shows long-term efficacy in the treatment of moderate to severe psoriasis (strength A)

The response to treatment of moderate/severe psoriasis was evaluated over 3 years. Of the patients who achieved PASI 90 and PASI 100 by week 16, 93% and 80.8% maintained these results at 3 years, respectively. The results did not differ based on dosing.

8. The effect of bimekizumab in psoriasis treatment persists even after discontinuation (strength A)

For patients who discontinued bimekizumab, the efficacy persisted post-discontinuation. The median time to relapse (PASI < 75) in a phase III study was 32 weeks. No rebound phenomenon was detected. However, the effect of continued bimekizumab treatment was stronger.

9. In direct comparisons, the safety profile of bimekizumab was similar to other biologics except for a higher incidence of oropharyngeal candidiasis (strength A)

The incidence of oral candidiasis with bimekizumab was 19.3% versus 3% with secukinumab, 9.5% versus 0% with adalimumab, and 15% versus 1% with ustekinumab.

10. In clinical studies with bimekizumab, more than 99% of candidiasis cases were mild to moderate (strength A)

Only 0.2% of patients discontinued bimekizumab due to candidiasis.

11. Candidiasis cases can be easily managed in patients on bimekizumab following standard protocols (strength C)

Oral candidiasis was most commonly treated with nystatin or fluconazole, and most reported infections resolved within a median of 12 days. Predisposing factors include immunodeficiency, antibiotic use, advanced age, endocrine disorders, nutritional deficiencies, smoking, inhaled corticosteroid use, poor oral hygiene, and insufficient saliva production.

12. Bimekizumab is effective in treating psoriatic arthritis across all domains (strength A)

In a phase III study, ACR50 was achieved significantly more often with bimekizumab than with placebo at week 16 in patients without prior biologic treatment (44% vs. 10%; p < 0.0001). The clinical benefit of bimekizumab was evident within 2 weeks. In patients with inadequate response or intolerance to up to 2 TNF-α inhibitors, ACR50 was achieved in 43% with bimekizumab versus 7% with placebo (p < 0.0001). This demonstrates the efficacy of bimekizumab in PsA regardless of prior treatment. Bimekizumab significantly slowed radiographic progression of joint damage and led to complete resolution of enthesitis and dactylitis at week 16 for a larger proportion of patients. Patients reported significant improvements in physical function, pain, and fatigue. In patients with ankylosing spondylitis, bimekizumab led to effective and rapid alleviation of axial spondyloarthritis.

13. Bimekizumab can be used as a therapy for moderate to severe psoriasis including in patients with psoriatic arthritis (strength A)

The choice of psoriasis therapy should be individualized. The safety and efficacy of bimekizumab as first-line treatment for moderate to severe psoriasis are supported by sufficient evidence from numerous randomized clinical trials. Due to the risk of candidiasis, the benefit-risk balance should be discussed with the patient beforehand.

14. In patients with inflammatory bowel disease (IBD) and moderate to severe psoriasis, other therapeutic options should be considered before bimekizumab (strength C)

Despite the very low occurrence of IBD exacerbations with IL-17 inhibitors, caution is advised when administering bimekizumab to patients with IBD. Patients with IBD were not included in clinical studies with bimekizumab. The incidence of newly diagnosed IBD with bimekizumab in clinical studies was 0.1 per 100 patient-years and did not increase over the length of exposure.

Conclusion

For moderate to severe psoriasis, additional treatment is still necessary. According to current evidence, treatment with bimekizumab targeting both IL-17A and IL-17F is highly effective in alleviating the manifestations and symptoms of psoriasis and PsA. These 14 statements and recommendations from a nine-expert panel based on a comprehensive literature review regarding the use of bimekizumab in the treatment of moderate/severe psoriasis and PsA may assist in clinical decision-making. Direct comparisons of bimekizumab with other biologics have shown its higher efficacy and faster onset of action. The effect of bimekizumab is long-lasting and persists for several weeks after discontinuation. According to this expert consensus, the safety of bimekizumab is comparable to other biologics, except for a higher incidence of oral candidiasis, which in most cases is mild to moderate and can be successfully managed therapeutically.

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Source: Burshtein J., Shah M., Zakria D. et al. The efficacy and safety of bimekizumab for plaque psoriasis: an expert consensus panel. Dermatol Ther (Heidelb) 2024 Feb; 14 (2): 323−339, doi: 10.1007/s13555-024-01099-y.