Bimekizumab

Commercial name

Bimzelx®

Manufacturer

UCB-Pharma SA

Mechanism of action

Humanised monoclonal anti-IL-17A, anti-IL-17F and anti-IL-17AF antibodies.

Authorization in dermatology

Indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy.

SVK coverage

Yes

Limitation for reimbursement

Treatment of adult patients with severe plaque psoriasis in whom phototherapy or one of the following conventional systemic therapies (ciclosporin, methotrexate, acitretin) has not been successful.

Dosage form

Pre-filled syringe, pre-filled pen.

Before starting therapy

Differential blood count, liver function tests, CRP, pregnancy test, screening for HBV, HCV, HIV and TB (optional: including chest X-ray); patient training prior to using auto-injectors; first dose administered under medical supervision.

Monitoring laboratory parameters

Every 3 months: differential blood count, CRP, pregnancy test.

Monitoring intervals

Every 3 months

Administration

s.c.

Dosage

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

Onset of effect

Onset of action after 2–6 weeks.
Consider discontinuing treatment if no response is seen after 16 weeks.

Caution

Patients with chronic inflammatory bowel disease, patients with chronic and/or active severe infections, hypersensitivity to the active substance, no data on safety and efficacy in patients with hepatic impairment, no live vaccines.

Cost per year in CHF (first year including induction phase)

14,472 (22,914)

Interruption

Insufficient data

Clinical evaluation

Insufficient data

Development of anti-drug antibodies

Insufficient data

Contraindications

Hypersensitivity to the active substance or to any of the other ingredients. Active, recent severe or chronic infections. Pregnancy and breastfeeding (a careful risk-benefit assessment is recommended).

Adverse drug reactions

Upper respiratory tract infections (15 %), oral candidiasis, tinea infections, ear infections, herpes simplex infections, gastroenteritis, folliculitis, conjunctivitis, neutropenia, headaches, dermatitis, local reactions at the injection site.

Use in HBV infection

It is recommended that active HBV infections be ruled out and/or treated before starting treatment.

Use in HCV infection

It is recommended that active HCV infections be ruled out and/or treated before starting treatment.

Use in HIV infection

It is recommended that active HIV infections be ruled out and/or treated before starting treatment.

Interactions

No live vaccines (from 30 days prior to the end of treatment).

Use in latent TB infection

Insufficient data

Use in the event of a planned operation

Insufficient data

Cancer risk

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

Regular screening for cutaneous malignancies is recommended.