Bimekizumab

UCB-Pharma SA

Humanised anti-IL17A, anti-IL17F and anti-IL17AF monoclonal antibody

Use for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy

Yes

Treatment of adult patients with severe plaque psoriasis in whom phototherapy or one of the following conventional systemic therapies (ciclosporin, methotrexate, acitretin) have shown no therapeutic success

Pre-filled syringe, pre-filled pen

Differential blood count, liver values, CRP, pregnancy test, screening for HBV, HCV, HIV and optionally TB.
Patient training before using autoinjectors; first administration under medical supervision.

Every 3 months: Differential blood count, CRP, pregnancy test

Every 3 months, can be performed via teledermatology

s.c.

320 mg (administered as 2 subcutaneous injections of 160 mg each) in weeks 0, 4, 8, 12, 16 and every 8 weeks thereafter.

Onset of action after 2 - 6 weeks
Consider discontinuation of therapy if therapy is not successful after 16 weeks

Week 16: 95%

Week 16: 91%

Week 16: 68%

Patients with chronic inflammatory bowel disease, patients with chronic and/or active severe infections, hypersensitivity to active substance content, no data on safety and efficacy in patients with liver dysfunction, avoid live vaccines

13897 (19242.9)

Not recommended, insufficient data

19-39%, not relevant for treatment

Absolute C/I: Active tuberculosis or acute, severe infections, live vaccinations, active chronic hepatitis B, pregnancy and breastfeeding
Relative C/I: Inflammatory bowel diseases such as Crohn's disease (close monitoring). Malignant diseases (except BCC and lymphoproliferative diseases)

Upper respiratory tract infections, oral candidiasis (up to 11%), tinea infections, ear infections, herpes simplex infections, gastroenteritis, folliculitis, conjunctivitis, neutropenia, headaches, dermatitis, local reactions at the injection site

Exclusion and/or treatment of active HBV infections recommended before starting treatment

Exclusion and/or treatment of active HCV infections recommended before starting treatment

Exclusion and/or treatment of active HIV infections recommended before starting treatment

No live vaccines (30 days before until the end of therapy)

Not recommended, insufficient data

Insufficient data

Insufficient data: no increased risk of malignancy was observed in clinical studies up to one year. Long-term studies are still pending.

Regular screening for cutaneous malignancies recommended.