Belimumab

GlaxoSmithKline AG

Humanized IgG1λ antibody against B-Lymphocyte Stimulator (BLyS)

Serologically active systemic lupus erythematosus in adults who, despite baseline therapy (e.g., prednisone, antimalarial drugs, immunosuppressants), exhibit high disease activity (e.g., positive test for anti-dsDNA antibodies ≥ 30 IU/ml and low complement (C3: <90 mg/dL and low C4: <16 mg/dL)).

Lupus nephritis.

No

Systemic lupus erythematosus: Initial prescription by specialists in clinical immunology and rheumatology; treatment of adult patients who, despite baseline therapy (prednisone, immunosuppressants, antimalarial drugs), exhibit high disease activity (ANA titer >1:80, anti-dsDNA > 30 IU/ml and/or low complement levels C3 < 90 mg/dl, C4 < 16 mg/dl).

Solution for injection (pre-filled syringe, pre-filled pen, solution for infusion).

Differential blood count, CRP, urinalysis, pregnancy test, screening for HBV, HCV, HIV, and TB (optionally including chest X-ray), ANA, anti-dsDNA, complement C3, C4. Women of childbearing age must use at least one reliable method of contraception during treatment and for up to 4 months after treatment.

Every 3 months: complete blood count, CRP, pregnancy test, urinalysis; additionally after 3 and 6 months: anti-dsDNA and complement C3, C4.

every 3 months

s.c., i.v.

SLE: 200 mg once weekly; when switching from IV to SC, allow 2 weeks between the last IV and the first SC administration.

Onset of action after 16–24 weeks.

Adjust the treatment if no improvement is seen after 6 months.

No data on safety and efficacy in patients with severe CNS, liver, or kidney involvement. Insufficient experience with subcutaneous administration in patients <18 years of age

Use caution when administering concomitantly with other B-cell-targeted therapies; autoinjectors must never be administered intravenously

13,632 (Benlysta s.c. (200 mg each))

Treatment may need to be interrupted in the event of acute severe infections, severe psychiatric symptoms, or malignancies

0.7–4.8%, no antibodies detected after 52 weeks following subcutaneous administration.

Data insufficient to assess changes in pharmacokinetics in affected individuals.

Hypersensitivity to the active ingredient or any of the other ingredients. Active, previous severe, or chronic infections.
Pregnancy and breastfeeding (a careful risk-benefit assessment and consultation with a pediatrician are recommended in each case).

Infections (70%), leukopenia, bradycardia, depression, suicidal thoughts, suicidal behaviour, upper respiratory tract infections, bronchitis, viral gastroenteritis (diarrhoea, nausea), hypersensitivity reactions, progressive multifocal leukoencephalopathy, insomnia, pain in the extremities, and infusion reactions.

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

Screening not recommended by the manufacturer.

Insufficient data

Possible increased incidence of malignant tumours; data currently insufficient.