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Cinqair (reslizumab): A new add-on maintenance treatment for patients with eosinophilic phenotype wi

Tuesday, September 19, 2017  
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Cinqair (reslizumab): A new add-on maintenance treatment for patients with eosinophilic phenotype with severe asthma

Raphael Ezuduemoih, PharmD candidate 2019

Hyun Bin Kim, PharmD candidate 2019

Jennifer Andres, PharmD, BCPS

Temple University School of Pharmacy

 

            Asthma is a chronic inflammatory disorder that affects the airways. The asthma prevalence in the United States in 2014 was 24 million people, with 44% of them having had one or more asthma attacks that year.1 There were 439,435 inpatient hospital discharges in 2010 due to asthma, and 3,651 deaths in 2014 with asthma as the underlying cause.1 There is no cure for asthma, but the symptoms can be controlled through treatment.Severe asthma is classified as having asthma symptoms throughout the day, frequent night time awakenings (seven times weekly), use of short-acting beta 2-agonist several times per day, having normal activity be extremely challenging, and FEV1 or PEF 60% predicted.3 Reslizumab is a new drug approved by the FDA in March 2016 as an interleukin-5(IL-5) antagonist monoclonal antibody for add-on maintenance treatment of patients with severe asthma caused by elevated eosinophils aged 18 years and older.

 

IL-5 is the major cytokine, released from T-cells and mast cells, that is responsible for the growth, differentiation, recruitment, activation, and survival of eosinophils.4 Reslizumab binds to IL-5 and inhibits its ability to bind to the alpha chain of the IL-5 receptor complex, located on the surface of eosinophils, thereby preventing release of pro-inflammatory cytokines. Inflammation is an important component in the pathogenesis of asthma. By binding and inhibiting IL-5 signaling, reslizumab reduces the production and proliferation of eosinophils which ultimately reduces inflammation.4

 

The safety and efficacy of reslizumab was established in double blind, randomized, placebo-controlled trials in patients with moderate to severe asthma. Patients excluded from these studies included those with hypereosinophilic syndrome, current smokers, those using systemic immunosuppressive agents six months prior to screening or currently using systemic corticosteroids, and patients who had an active parasitic infection within six months of the screening. Patients received reslizumab or placebo every four weeks as add-on treatment to their maintenance medications. Patients’ background asthma therapy included a short acting beta-2 agonist such as albuterol, and an inhaled corticosteroid, such as fluticasone propionate. The proportion of patients who did not experience an asthma exacerbation was higher in the reslizumab group (75%) compared to the placebo group (55%). In addition, significant improvement in lung function was observed. Treatment with reslizumab resulted in 30% increase in FEV1 from the baseline, compared to 15% increase in FEV1 by placebo.4-6 Anaphylaxis to reslizumab was reported in 0.3% of asthma patients in placebo-controlled clinical studies.4 These events occurred within 20 minutes during or after the infusion and were reported as early as the second dose. Reslizumab should be discontinued if this occurs.6 Additionally, in clinical studies, 6/1028 (0.6%) patients receiving reslizumab had at least one malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group.4-6

 

Reslizumab is provided as a preservative-free, sterile, clear to slightly hazy/opalescent, colorless to slightly yellow solution in a single-use 100mg/10ml vial. Before use, each vial should be inspected visually for any particulate matter and discoloration. Administration can only occur in a health-care setting, done by intravenous infusion of 3mg/kg once every 4 weeks, administration over 20-50 minutes. Reslizumab should be withdrawn from vial following recommended weight-based dosing with care not to shake vial to minimize foaming, and dispensed slowly into an infusion bag containing 50mL of 0.9% sodium chloride injection.4

 

When ready to administer, use an infusion set with an in-line, low protein-binding filter (pore size of 0.2 micron). Monitoring has to be done for anaphylaxis and/or hypersensitivity during and after infusion through a peak flow meter, or other pulmonary function tests. Furthermore, signs and symptoms of infections need to be checked since eosinophils are involved in the immunological response. Patients should be instructed to contact their healthcare professional immediately if they experience any allergy symptoms after administration of reslizumab.4  

Reslizumab is compatible with polyvinylchloride (PVC) or polyolefin infusion bags, and cellulose acetate in-line infusion filters. If not used immediately, store diluted solutions of reslizumab in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature up to 25°C (77°F), protected from light, for up to 16 hours. The time between preparation of reslizumab and administration should not exceed 16 hours. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of reslizumab with other agents so do not mix or dilute with other drugs.4

 

To aid healthcare providers and patients receiving reslizumab, teva support solutions is a program available to provide personalized support, training, and education to the patient and their healthcare provider throughout treatment. Through the program, a trained clinical nurse educator can guide prospective customers through the insurance process and provide financial assistance options.7

 

Although reslizumab has benefits in improving lung function and preventing asthma attacks in patients with elevated eosinophils, it is limited by route of administration, safety concerns, and cost ($1,002.00 per 10ml vial). It should be noted that reslizumab does not treat acute asthma symptoms or acute exacerbations. Patients should continue to avoid their asthma triggers along with the continuation of their quick relief and long term asthma control medications. Patients categorized as having uncontrolled asthma should discuss with their doctor about whether reslizumab is a good option for them.     

 

References:

1. "Most Recent Asthma Data." Centers for Disease Control and Prevention, 30 Mar. 2016. Web. 21 Dec. 2016. https://www.cdc.gov/asthma/most_recent_data.htm."

2. “Learn How to Control Asthma." Centers for Disease Control and Prevention, 2009. Web. 21 Dec. 2016. https://www.cdc.gov/asthma/faqs.htm.

3. Asthma Care Quick Reference. June 2002. National Heart, Lung, and Blood Institute. Bethesda, MD 20824–0105. https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf

4. Cinqair (reslizumab) [prescribing information]. Frazer, PA: Teva; March 2016.

5. Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3(5):355-66.

6. Bjermer L, Lemiere C, Maspero J, et al. Reslizumab for Inadequately Controlled Asthma With Elevated Blood Eosinophil Levels: A Randomized Phase 3 Study. Chest. 2016; 150(4):789-798.

7.  Cinqair (reslizumab) [Teva Support Solutions Financial Assistance] Frazer, PA: Teva; Web. Dec. 2016. 

 


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