The treatment of Xolair for nasal polpys is currently being investigated. Chronic sinusitis with nasal polyps is common and is estimated to affect up to 15% of the population. It is associated with adult onset asthma. Many patients have uncontrolled symptoms despite use of nasal steroids. Even after surgery up to 80% of patients can experience a recurrence of symptoms.
Besides nasal steroids, Dupixent is currently the only approved biological medication approved for nasal polyps. IgE is thought to play a central role in the growth of polyps by activating mast cells, basophils and eosinophils. Currently Xolair (omalizumab) has an indication for moderate to severe persistent asthma and chronic idiopathic urticaria.
A recent study looked at two 24-week Phase 3 trials (POLYP 1 and POLYP 2) that evaluated the safety and efficacy of the anti-IgE monoclonal antibody, xolair, in patients with chronic sinusitis and nasal polyps after intranasal steroid treatment.
From as early as 4 weeks to study end, treatment with Xolair showed:
- reductions in nasal polyp size
- improvements in symptoms including nasal congestion and loss of smell
- improvements in disease-related quality of life.
Safety results were consistent with Xolair and the most common adverse events observed were headache, injection site reactions, arthralgia, dizziness and upper abdominal pain. Rare events such as anaphylaxis were not observed in these trials.
Nasal polyps are very difficult to treat as nasal steroids are inadequate. Oral steroids help, but long term use can cause significant side effects. Surgery is initially effective, but the polyps can back in the majority of patients. Dupilumab has been shown to be helpful in many patients. In this study, another future option may be Xolair, which could be a viable alternative for patients who fail the above therapies.
It remains to be seen whether or not Xolair for nasal polyps will be a new indication. Check back for future updates on this medication.
Update December 2, 2020
Xolair for nasal polyps just received FDA approval. It is for add on therapy for patients 18 years and older who have failed nasal steroids.
“With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal polyps in two pivotal Phase III studies,” said Joseph Han, MD, Chief of the Division of Rhinology and the Division of Allergy at Eastern Virginia Medical School and study investigator of the POLYP 1 and POLYP 2 trials. “Xolair provides a new option for treating these patients, who often have other respiratory and allergic conditions that may further worsen symptoms.”
The dosing for nasal polyps for Xolair is based on the total IgE level (IU/ml) and the weight of the patient. It is dosed from 75mg to 600mg every 2 to 4 weeks.