Bimekizumab

Live vaccines should not be given in patients treated with bimekizumab.

Bimekizumab has not been studied in these patient populations. Dose adjustments are not considered necessary based on pharmacokinetics.

Prior to initiating therapy with bimekizumab, completion of all age appropriate immunizations according to current immunization guidelines should be considered.

Patients treated with bimekizumab may receive inactivated or non-live vaccinations. Healthy individuals who received a single 320 mg dose of bimekizumab two weeks prior to vaccination with an inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive bimekizumab prior to vaccination.

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated.

Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating bimekizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

There is a limited amount of data on the use of bimekizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of bimekizumab during pregnancy.

It is unknown whether bimekizumab is excreted in human milk. A risk to the newborn/infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from bimekizumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

The effect of bimekizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Women of childbearing potential

Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.

Bimekizumab has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most frequently reported adverse reactions were upper respiratory tract infections (14.5%) (most frequently nasopharyngitis) and oral candidiasis (7.3%).

Tabulated list of adverse reactions

Adverse reactions from clinical studies are classified by MedDRA System Organ Class and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

^a Includes: injection site erythema, reaction, oedema, pain, swelling.

Description of selected adverse reactions

Infections

In the placebo-controlled period of Phase III clinical studies in plaque psoriasis, infections were reported in 36.0% of patients treated with bimekizumab for up to 16 weeks compared with 22.5% of patients treated with placebo. Serious infections occurred in 0.3% of patients treated with bimekizumab and 0% treated with placebo.

The majority of infections consisted of non-serious mild to moderate upper respiratory tract infections such as nasopharyngitis. There were higher rates of oral and oropharyngeal candidiasis in patients treated with bimekizumab consistent with the mechanism of action (7.3% and 1.2% respectively compared to 0% for placebo-treated patients). More than 98% of cases were non-serious, mild or moderate in severity, and did not require treatment discontinuation. A slightly higher incidence of oral candidiasis was reported in patients <70 kg (8.5% versus 7.0% in patients ≥70 kg).

Over the entire treatment period of Phase III studies in plaque psoriasis, infections were reported in 63.2% of patients treated with bimekizumab (120.4 per 100 patient-years). Serious infections were reported in 1.5% of patients treated with bimekizumab (1.6 per 100 patient-years).

Neutropenia

Neutropenia was observed with bimekizumab in phase III clinical studies in plaque psoriasis. Over the entire treatment period of Phase III studies, neutropenia grade ¾ were observed in 1% of patients treated with bimekizumab. Most cases were transient and did not require treatment discontinuation. No serious infections were associated with neutropenia.

Hypersensitivity

Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors.

Immunogenicity

Approximately 45% of plaque psoriasis patients treated with bimekizumab up to 56 weeks at the recommended dosing regimen (320 mg every 4 weeks up to week 16 and 320 mg every 8 weeks thereafter) developed anti-drug antibodies. Of the patients who developed anti-drug antibodies, approximately 34% (16% of all patients treated with bimekizumab) had antibodies that were classified as neutralising. No evidence of altered clinical response, or significantly altered safety profile was associated with anti-bimekizumab antibodies development.

Elderly patients (≥65 years)

Elderly patients may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab. In the placebo-controlled period of Phase III clinical studies in plaque psoriasis, oral candidiasis was observed in 18.2% of patients ≥65 years versus 6.3 % in <65 years, dermatitis and eczema in 7.3% of patients ≥65 years versus 2.8% in <65 years.