Biologic Medications for AERD (Samter's Triad)

This area of research has seen an explosion of activity in the past several years. Biologic drugs are administered by injection, usually once every 2 to 8 weeks. Biologic medications are designed to inhibit specific components of the immune system that play crucial roles in fueling inflammation.

Aspirin Exacerbated Respiratory Disease is difficult to control with conventional treatments. These new biologic drugs offer hope to AERD (Samter's Triad) patients who haven't found relief from other medications. Most of these medications are currently only approved by the FDA for the treatment of severe asthma, but Dupixent (dupilumab) has been approved for the treatment of nasal polyps. Biologic medications can be difficult to get approved for. Your blood work may need to demonstrate that you meet certain criteria (such as high enough eosinophil levels). In addition to this, biologic medications can be expensive depending on your insurance coverage. If you are approved for one of these medications and need help paying for it, many of the drug manufacturers do have prescription assistance plans.

The most commonly prescribed biologics for AERD are discussed in detail below, but numerous others are in development. It is expected that several new medications of this class will be available within the next few years.

Omalizumab (Xolair)

Omalizumab (Xolair) works by blocking IgE (immunoglobulin E), a substance made by the body that plays a key role in the allergic response. Xolair is approved by the FDA for the treatment of inadequately controlled moderate-to-severe asthma. One study found that Xolair may also be helpful in the treatment of nasal polyps. There is even some limited research and case reports which suggest that Xolair may reduce or eliminate reactions to aspirin and NSAIDs in some AERD (Samter's Triad) patients, but more research in this area is needed. Xolair is expected to be approved by the FDA for treatment of nasal polyps in 2020. It has already been approved for this indication in the European Union.

Research on Omalizumab (Xolair)

Omalizumab for Aspirin-Hypersensitivity and Leukotriene Overproduction in Aspirin-Exacerbated Respiratory Disease: A Randomized Trial

Omalizumab treatment in Samter's triad: case series and review of the literature

 

Effect of Omalizumab on Outcomes in Patients with Aspirin-Exacerbated Respiratory Disease

Omalizumab in the Treatment of Aspirin-Exacerbated Respiratory Disease

Omalizumab Can Inhibit Respiratory Reaction During Aspirin Desensitization

Mepolizumab (Nucala)

Mepolizumab is an anti-interleukin-5 monoclonal antibody. Nucala is approved by the FDA for the treatment of severe asthma in patients 12 years or older and with an eosinophilic phenotype. Nucala is recommended for those with asthma that is not able to be controlled with inhaled steroid medications. A recent study found that Nucala reduced the need for sinus surgery in patients with severe nasal polyps. Research done at Brigham & Women's found that Nucala reduced sinus symptoms, including anosmia and congestion, in AERD patients.  A 2017 study found that serious adverse reactions to Nucala are rare. Of 1,300 patients taking Nucala for severe eosinophilic asthma, only 2 serious adverse events were reported (asthma exacerbations). Nucala is taken every 4 weeks.

Research on Mepolizumab (Nucala)

 

Reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial

Mepolizumab, a humanized anti–IL-5 mAb, as a treatment option for severe nasal polyposis

Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma

A Pragmatic Analysis of Mepolizumab in Patients with Aspirin-Exacerbated Respiratory Disease

 

Reslizumab (Cinqair)

Reslizumab (Cinqair) is another anti-interleukin-5 antibody. Cinqair has been shown to reduce the number of asthma exacerbations and improve lung function in patients with eosinophilic asthma. The FDA has approved reslizumab (Cinqair) for patients aged 18 years and older who have a history of severe asthma attacks despite other treatments. Again, there is research suggesting that Cinqair may be helpful in the treatment of nasal polyps. Cinqair is taken every 4 weeks.

Research on Reslizumab (Cinqair)

Efficacy of Reslizumab in Asthma Patients with Aspirin Sensitivity and Elevated Blood Eosinophils

Efficacy of Reslizumab with Asthma, Chronic Sinusitis with Nasal Polyps and Elevated Blood Eosinophils

Effects of Reslizumab on Nasal Polyp Inflammation in Aspirin Exacerbated Respiratory Disease

Benralizumab (Fasenra)

Fasenra (benralizumab) is approved in the US for the treatment of severe eosinophilic asthma. Like Nucala and Cinqair, it is an anti-IL5 antibody. It hasn't been studied in AERD patients specifically, but it has been shown to be effective for the type of asthma that AERD patients suffer from. It is currently being studied for nasal polyps. Fasenra has been shown to rapidly deplete eosinophil levels, reduce oral steroid use, and reduce the occurrence of severe asthma attacks. Fasenra is the only biologic medication currently available for asthma that has an 8 week dosing schedule, which may make it more convenient for patients. 

Research on Benralizumab (Fasenra)

 

Efficacy and Safety of Benralizumab in Patients with Eosinophilic Asthma: A Meta-Analysis

The Clinical Profile of Benralizumab in the Management of Severe Eosinophilic Asthma

Oral Glucocorticoid–Sparing Effect of Benralizumab in Severe Asthma

 

 

 

Dupilumab (Dupixent)

 

Dupixent is approved for the treatment of moderate to severe asthma and also for nasal polyps. Dupixent is an IL-4 and IL-13 monoclonal antibody. This medication has been shown to improve asthma, reduce nasal polyp symptoms, and improve smell function. Dupilumab is approved for home administration after proper training. 

Research on Dupilumab (Dupixent)

 

Dupilumab Improves Nasal Polyp Burden and Asthma Control in Patients with CRSwNP and AERD

Efficacy and Safety of Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps: Results from the Randomized Phase 3 Sinus-24 Study

Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis

Dupilumab in the Management of Moderate-to-Severe Asthma: The Data So Far

Dupilumab Improves Sense of Smell and Reduces Anosmia Among Patients with Nasal Polyposis and Chronic Sinusitis

Risks of Biologic Medications

These medications are generally well tolerated, but side effects do occur in some patients. We recommend visiting the manufacturer's website to see detailed side effect information on each medication. Biologic medications are newer treatments, so the long term safety has not been established. 

Aspirin Desensitization vs Biologic Medications

With the availability of new treatments, patients must now consider which treatment option is right for them. At this point, there is no definite answer about which treatment will work best for which patient. Both of these treatments can be successful for patients and some patients may require both aspirin desensitization and a biologic medication to feel well. Other patients are not able tolerate one or the other due to side effects. At this time, there's no definite answer as far as which of these will be most successful for which patient. One consideration is that aspirin desensitization should be done after surgery, whereas this is not required with biologic medications like Dupixent. There may also be significant difference in the cost of these treatments for patients - daily aspirin is relatively inexpensive, whereas biologic medications may be expensive depending on insurance coverage. Patients and doctors should discuss the pros and cons of both treatments and come up with a plan that takes the patients preference into consideration.

In this webinar, Dr. Tanya Laidlaw of the Brigham AERD Center discusses the treatment of nasal polyps with new biologic medications. 

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