Reslizumab

Reslizumab is a humanized monoclonal antibody produced by recombinant DNA technology in mouse myeloma cells (NS0) and is used to treat refractory bronchial asthma. Date of authorisation: 16 August 2016.

Reslizumab is a humanized monoclonal antibody (IgG4, κ) directed against human interleukin-5 (IL-5). Reslizumab binds specifically to IL-5 and interferes with the binding of IL-5 to its cell surface receptor. IL-5 is an important cytokine for the differentiation, maturation, recruitment and activation of human eosinophils. Reslizumab binds with picomolar affinity to human IL-5 and thereby inhibits its biological function. The survival rate and activity of eosinophils are reduced.

Studies have shown that reslizumab significantly reduced asthma exacerbations in both the refractory (59%) and non-refractory populations (49%) compared to placebo.

Reslizumab is used as an adjunct long-term therapy in adult patients with severe eosinophilic asthma that is difficult to control despite high-dose inhaled corticosteroids plus another maintenance therapy drug.

Pregnancy: To date, there is no or very limited experience (less than 300 pregnancy outcomes) with the use of reslizumab in pregnant women. Animal studies have not shown any evidence of direct or indirect adverse health effects in terms of reproductive toxicity.

Lactation: It is not known whether reslizumab passes into breast milk.

Fertility: To date there are no data available on fertility in humans.

The recommended intravenous dose depends on body weight and is 3 mg/kg bw once every four weeks.

The most commonly reported side effect during treatment was an increase in blood creatine phosphokinase, which occurred in about 2% of patients. Anaphylactic reactions occurred in less than 1% of patients. Myalgia was also reported (about 1% of patients)

Parasitic infections (worm infections): An existing worm infection should be treated with Reslizumab in patients before starting treatment. If patients become infected with worms during reslizumab treatment and do not respond to anthelmintic treatment, temporary discontinuation of treatment should be considered.

No dose adjustment is required for patients with impaired kidney function. No dose adjustment is required for patients with impaired liver function