Bimekizumab

UCB-Pharma SA

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

Indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are suitable 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) has not been successful.

Pre-filled syringe, pre-filled pen.

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.

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

Every 3 months

s.c.

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

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.

14,472 (22,914)

Insufficient data

Insufficient data

Insufficient data

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).

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.

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

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

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

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

Insufficient data

Insufficient data

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.