Drug for nasal polyps gets TGA green light

Patients with severe chronic rhinosinusitis with nasal polyps can access the first directly targeted anti-IL-5 therapy approved by the regulator.

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Patients with severe chronic rhinosinusitis with nasal polyps can now access the first directly targeted anti-IL-5 therapy approved for the condition by the regulator.

Mepolizumab (Nucala, GSK) is indicated as an add-on treatment for adults who do not adequately respond to intranasal corticosteroids. It is now one of several biologics recently approved by the regulator for these patients, including dupilumab and omalizumab. 

“This adds enormously to the growing option of biologics in managing patients with terrible nasal polyp disease,” Professor Richard Harvey, president of the Australian Rhinologic Society, told TMR.

Chronic rhinosinusitis is one of the most common chronic conditions globally, and the nasal polyp subgroup typically involves chronic inflammation, with interleukin-5 playing a key role. 

Symptoms include nasal obstruction, discharge, loss of smell and facial pressure. These can significantly impair patients’ quality of life and reduce productivity, said Professor Harvey, otolaryngology surgeon and researcher at the University of NSW and Macquarie University. 

Mepolizumab addresses the underlying eosinophilic inflammation that comes with recurrent nasal polyps by seemingly inhibiting interleukin-5 from attaching to its receptor on the eosinophil surface. 

The monoclonal antibody was first PBS listed in 2017 to treat severe eosinophilic asthma and, like benralizumab and other biologics used for that indication, has been explored for its benefit in patients with severe chronic rhinosinusitis with nasal polyps. 

The TGA approval hinged on a randomised controlled phase 3 trial that found patients treated with mepolizumab were 57% less likely to need surgery compared to the control group. The 400 participants recruited for the study all had surgery previously and needed further surgery due to symptom severity and polyp growth. 

In addition to clinically significant improvements to quality of life, those treated with the drug needed fewer courses of systemic corticosteroids over the yearlong study period. 

There were no apparent increases in adverse events. 

The Australasian Society of Clinical Immunology and Allergy’s (ASCIA) position paper on the condition advises that patients can trial biologics for six months if they have uncontrolled disease and have trialled oral corticosteroids for two-to-three weeks, reaching a cumulative dose of 500mg in 12 months. 

Patients with a high polyp load, such as those with polyps coming out of their nose, may need assessment by an ENT specialist and surgery to remove the tissue first. 

While biologics can make the polyps shrink for some people, especially if these formed recently, many others would need surgery first. 

“The mechanisms of disease can be shut down through this treatment, but that doesn’t mean that all the polypoid tissue will disappear – and it often doesn’t,” Professor Harvey said.

“It’s a slightly more complicated regime because you have to manage the polyp load and the mechanical issue that comes with the polyp load.” 

“In the 12-month period after surgery, if you reach your limit of any form of corticosteroid again then you end up qualifying for a biologic,” he said. 

Professor Harvey said that research was still underway on long-term use but, like oral corticosteroids, patients would probably need to use biologics for several years while their disease was very active. 

Without a PBS listing for these biologics, patients may be out-of-pocket around $1000 or more per injection, with injections often required every four weeks. 

Specialist respiratory physician Dr Andrew Gillman, author of the phase 3 trial, welcomed the approval of mepolizumab, a drug he said respiratory physicians had experience using in patients with severe eosinophilic asthma. 

“Patients with chronic rhinosinusitis with nasal polyps often have coexisting severe asthma, so biological treatments can play an important role in managing upper and lower airway diseases,” Dr Gillman said in a statement.   

“Nucala has demonstrated improvements in patient quality of life across nasal symptoms, ear/face symptoms, fatigue, impact on sleep and emotional impact. This means that in addition to targeting the underlying eosinophilic inflammation associated with recurrent nasal polyps, treatment is also helping improve quality of life for patients.”