New biologic for type 2 inflammation asthmatics subsidised

Patients using prednisone multiple times per year may have access to dupilumab on the PBS.

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A group of severe asthma patients may now get the subsidised biologic dupilumab if their disease is not controlled by high-dose steroids.

From 1 April, the injectable medication will be available on the PBS for the treatment of uncontrolled severe eosinophilic or allergic asthma, both with and without oral corticosteroid dependence, for patients aged 12 and above.

Dupilumab (Dupixent, Sanofi) inhibits interleukin proteins IL-4 and IL-13. These are key contributors to type 2 inflammation in 50%-70% of patients with severe asthma.  

National Asthma Council director Professor Peter Wark told TMR the listing did not expand the group of patients who qualified for monoclonal antibody products but did give prescribers more treatment options.

“The patients who qualify for monoclonal antibodies would have received treatment in the past with omalizumab, or mepolizumab, or benralizumab … the difference is that for the use of dupilumab, you can have either elevated eosinophils or allergy,” Professor Wark, who is also a respiratory physician at John Hunter Hospital in Newcastle.

“The way that dupilumab is different is that as a monoclonal antibody against both IL-4 and IL-13 it targets a different pathway to the anti-IL-5 agents,” he said.

“In trials, the people who had both elevated blood eosinophils and an elevation in fractional exhaled nitric oxide were the people who did best with this.”

There are no direct comparisons of the available monoclonal antibody treatments for patients with type 2 airway inflammation that persists despite optimal dosing with inhaled steroids and long-acting beta agonist (LABA) combinations.

But over the past decade, trials have shown dupilumab to effectively reduce the frequency of exacerbations and improve day-to-day asthma symptoms, Professor Wark said.

Professor Wark took part in some of the trials of dupilumab involved in its registration and has sat on a dupilumab advisory board.

Although GPs are unlikely to prescribe dupilumab they can first ensure other options have been explored, he said.

“We are still encouraging people to ensure the diagnosis is asthma, that patients know how to use their inhaler devices, are using them on a regular basis and are adhering to them,” said Professor Wark. Patients also needed to be prescribed the right type of devices and have a written asthma action plan before monoclonal antibody therapy was considered.

If GPs noticed that their patients needed prednisone more than once or twice a year, that should trigger referral to a respiratory specialist, as these individuals may benefit from a monoclonal antibody, he said.

“We want to minimise exposure for people to prednisone where possible and minimise the risk of exacerbation and more severe asthma,” said Professor Wark, adding all the monoclonal antibodies were effective at doing so.

Dupilumab was also listed on the PBS for severe atopic dermatitis on 1 March.

“So where you’ve got comorbid atopic dermatitis and severe asthma, you could see some advantages,” Professor Wark said.    

While the drug was not listed for severe asthma without type 2 inflammation, Professor Wark said that research indicated it may be beneficial in reducing steroid use in these patients.

In a press release, Sanofi said patients should be alert to any new or worsening eye problems.  

Care should also be taken in patients with parasitic worms and the treating clinician should discuss use during pregnancy and breastfeeding, it said.

Other side effects included headache and allergic reaction, and in rarer cases, keratitis, Professor Wark said.