What is the use of Nucala (Mepolizumab)?

From the Guidelines

Nucala (mepolizumab) is recommended as a first-line treatment for patients with relapsing-refractory eosinophilic granulomatosis with polyangiitis (EGPA) without organ- or life-threatening manifestations, at a dose of 300 mg every 4 weeks, due to its effectiveness in inducing and maintaining remission, as well as reducing glucocorticoid exposure 1.

Key Points

• Mepolizumab is an IL-5 inhibitor that targets eosinophils, a type of white blood cell involved in inflammation.
• The medication is effective in treating severe eosinophilic asthma, EGPA, hypereosinophilic syndrome (HES), and chronic rhinosinusitis with nasal polyps (CRSwNP).
• For EGPA treatment, the recommended dose is 300 mg every 4 weeks, which can be adjusted to 100 mg every 4 weeks in patients with limited respiratory manifestations.
• Common side effects include headache, injection site reactions, back pain, and fatigue.
• Patients should continue their regular asthma medications and report any allergic reactions immediately.

Treatment Considerations

• Mepolizumab should be considered for induction therapy in patients with relapsing-refractory disease without organ- or life-threatening manifestations.
• The medication can also be used for remission maintenance, mainly for the control of asthma and to reduce glucocorticoid exposure.
• Other IL-5 or IL-5 receptor inhibitors, such as benralizumab and reslizumab, may be considered in patients with disease refractory to mepolizumab therapy, although data from randomized controlled trials are limited 1.

Patient Selection

• Patients with high eosinophil counts who have not responded adequately to standard treatments may benefit from mepolizumab therapy.
• The medication is particularly effective in patients with EGPA who require a daily prednisone dose ≥7.5 mg for the control of their respiratory manifestations 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Overview of Nucala

• Nucala, also known as mepolizumab, is a humanized monoclonal antibody against interleukin-5, a cytokine involved in the development, recruitment, and activation of eosinophils 2.
• It is indicated as an add-on treatment for severe eosinophilic asthma, and has been shown to reduce the rate of clinically relevant asthma exacerbations and improve asthma control, health-related quality of life, and lung function 2, 3, 4.

Efficacy of Nucala

• Studies have demonstrated that Nucala is effective in reducing the rate of clinically significant exacerbations in patients with severe eosinophilic asthma, with a significant reduction in exacerbations observed in patients treated with Nucala compared to placebo 2, 3, 4.
• Nucala has also been shown to improve lung function, as measured by forced expiratory volume in 1 second (FEV1), and to reduce oral corticosteroid use in patients with severe eosinophilic asthma 3, 4.
• The drug has been found to be effective in patients with blood eosinophil counts ≥150 cells/μL, regardless of allergic characteristics or omalizumab eligibility 3.

Real-World Effectiveness of Nucala

• A multi-country, self-controlled, observational cohort study found that Nucala was effective in reducing the burden of severe asthma in real-world settings, with significant reductions in clinically significant exacerbations, oral corticosteroid use, and healthcare resource utilization observed 4.
• The study also found that Nucala improved lung function and symptom control, as measured by the Asthma Control Test (ACT) scores, and reduced the proportion of patients with high blood eosinophil counts 4.

Switching from Omalizumab to Nucala

• A study found that patients with uncontrolled severe eosinophilic asthma who were switched directly from omalizumab to Nucala experienced clinically significant improvements in asthma control, health status, and exacerbation rate, with no tolerability issues reported 5.
• The study suggested that Nucala may be a viable treatment option for patients who are not optimally controlled with omalizumab, and that switching from omalizumab to Nucala may be a effective strategy for improving asthma outcomes in these patients 5.