Omalizumab versus intranasal steroids in the post-operative management of patients with allergic fungal rhinosinusitis.

Abstract

PURPOSE:

Allergic fungal rhinosinusitis (AFRS) is a common disorder with a high prevalence and a very high incidence of recurrence. Management includes surgery and medical treatment in the form of local and/or systemic steroids. However, some cases are resistant to the action of steroids and further treatment is warranted. Being an immune-mediated disorder, targeting IgE seems a logical step. Immunotherapy drugs acting on the IgE (e.g. omalizumab) can modify the clinical course of the disease. This study aimed at evaluating the effect of omalizumab on the clinical course of patients undergoing surgery for AFRS.

MATERIALS AND METHODS:

This is a two-arm prospective, randomized, single blind clinical trial among patients with AFRS. Twenty patients were included and randomly divided into two groups: Group A; 10 patients received a single subcutaneous injection of omalizumab (Xolair ' Novartis) (150 mg) 2 weeks postoperatively. Group B: 10 patients received local steroids nasal sprays (budesonide or mometasone furoate, 100 μg twice daily for 6 months, starting 2 weeks postoperatively. All patients underwent history, examination, CT scan and IgE level estimation and were submitted to endoscopic sinus surgery. They were evaluated at 4 weeks interval for 6 months.

RESULTS:

In both groups there were highly significant differences between pre/post-operative SNOT-20 scores, TNSS scores, total IgE level and Philpott-Javer staging scores. Comparison between the two study groups at 24 weeks showed a highly significant difference (p = 0.001) between post-operative SNOT 20 and TNSS scores in favour of group A. There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores. There were two recurrences in both arms, but no significant side effects.

DISCUSSION:

We compared a single post operative injection of omalizumab with twice daily intranasal steroid spray for 6 months. Both treatments were effective, but the omalizumab group showed a more significant clinical and endoscopic response. There were no significant side effects in both arms. This novel approach used a single low dose injection of omalizumab increased the compliance of the patients with minimal complications. Longer follow-up of the patients is ongoing to determine the optimal time for re-injection. The only downside was the higher cost of omalizumab compared to that of local steroids.

• Authors: Badr Eldin Mostafa, Michael Fadel, Mohammed Amir Mohammed, Tarek Abdel Hamid Hamdi, Anas Mohammed Askoura
• Journal: European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery (Eur Arch Otorhinolaryngol) Vol. 277 Issue 1 Pg. 121-128 (Jan 2020) ISSN: 1434-4726 [Electronic] Germany
• PMID: 31552526 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Allergic Agents
• Glucocorticoids
• Nasal Sprays
• Mometasone Furoate
• Omalizumab
• Immunoglobulin E
• Budesonide

Topics

• Administration, Intranasal
• Adolescent
• Adult
• Anti-Allergic Agents (administration & dosage, therapeutic use)
• Budesonide (administration & dosage, immunology, therapeutic use)
• Chronic Disease
• Endoscopy
• Female
• Glucocorticoids (administration & dosage, therapeutic use)
• Health Status Indicators
• Humans
• Immunoglobulin E (immunology)
• Injections, Subcutaneous
• Male
• Mometasone Furoate (administration & dosage, therapeutic use)
• Mycoses (drug therapy, immunology, microbiology, surgery)
• Nasal Polyps (drug therapy, immunology, surgery)
• Nasal Sprays
• Omalizumab (administration & dosage, therapeutic use)
• Prospective Studies
• Rhinitis, Allergic (drug therapy, immunology, microbiology, surgery)
• Single-Blind Method
• Sinusitis (drug therapy, immunology, microbiology, surgery)
• Tomography, X-Ray Computed
• Young Adult