Effect of Subcutaneous Dupilumab on Nasal Polyp Burden

Sandi Harris, Mercer University College of Pharmacy

 

A review of four clinical trials concluded that it is unclear what the most effective management strategy was for patients with chronic sinusitis and nasal polyps when choosing between different treatment options, such as medication therapy or surgery. [1]

 

Another review of 29 studies found that leukotriene antagonists improved nasal symptoms in patients with nasal polyps. [2]

Title: Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis; A Randomized Clinical Trial

 

Design Randomized, double-blind, placebo-controlled parallel-group study;

N= 60

Objective To assess inhibition of interleukins four and 13 with dupilumab in patients with chronic sinusitis and nasal polyposis
Study Groups Patients receiving mometasone furoate nasal spray (MFNS) and a placebo injection (n= 30); patients receiving MFNS and a loading then weekly dose of dupilumab. (n=30)
Methods After a 4-week run-in period of treatment with mometasone furoate nasal spray (100 μg in each nostril twice daily), patients were randomly allocated to add-on therapy with subcutaneous dupilumab (a 600 mg loading dose followed by 15 weekly doses of 300 mg) or matched placebo for 16 weeks.
Duration August 2013- August 2014
Primary Outcome Measure Change in endoscopic nasal polyp score
Baseline Characteristics Placebo plus MFNS

(n=30)

Dupilumab plus MFNS (n=30)
Average age, y 49.3 47.4
Male gender % 53.3% 60%
White race 100% 96.7%
Average bilateral endoscopic nasal polyp score 5.7 5.9
Results The least squares mean change in bilateral endoscopic nasal polyp score between baseline and week 16 was −0.3 (95% CI, −1.0 to 0.4) in the placebo plus mometasone furoate nasal spray group and −1.9 (95% CI, −2.5 to −1.2) in the dupilumab plus mometasone furoate nasal spray group (least squares mean difference, −1.6 [95% CI, −2.4 to −0.7], (p < .001)
Adverse Events Common Adverse nasopharyngitis (47%); injection site reaction (40%); headache (20%)
Serious Adverse Events:  herpes zoster (3.5%) and arrhythmia with upper extremity pain or numbness (3.5%)
Percentage that Discontinued due to Adverse Events: 7%
Study Author Conclusions Among adults with symptomatic chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids, the addition of subcutaneous dupilumab to mometasone furoate nasal spray compared with mometasone alone reduced endoscopic nasal polyp burden after 16 weeks.

 

 

The use of dupilumab injections may help some patients willing to use an injectable medication in order to delay or avoid the need for surgery to remove nasal polyps.  The symptom improvement previously described in studies may be due to the physical effect of dupilumab on the size of the polyps.

 

References

 

  1. Rimmer J, Fokkens W, Chong LY, Hopkins C. Surgical versus medical interventions for chronic rhinosinusitis with nasal polyps. Cochrane Database Syst Rev. 2014;12
  2. Rudmik L, Soler ZM. Medical Therapies for Adult Chronic Sinusitis: A Systematic Review. JAMA. 2015;314(9):926-39.
  3. Bachert C, Mannent L, Naclerio RM, et al. Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016;315(5):469-79.

 

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