SINUS-24 Trial Results

MD Magazine’s Kevin Kunzmann reports on Joseph Han, MD and the SINUS-24 Trial results. Han revealed monoclonal antibody biologic dupilumab (Dupixnt) may positively impact chronic rhinosinusitis patients with nasal polyps.  The SINUS-24 trial was a multicenter, double-blind study including 276 patients,  randomized to either subcutaneous 300 mg dupilumab or placebo for 24 weeks.  After the trial, patients improved significantly nasal polyp congestion scores.  MD Magazine includes an interview with lead investigator Joseph Han, MD—follow the link below.

TrialSite News provides an overview of the study but first a description of nasal polyps.

What are Nasal Polyps?

Nasal polyps (NP)  are noncancerous growths within the nose or sinuses. Symptoms include trouble breathing through the nose, loss of smell, decreased taste, post nasal drip, and a runny nose. The growths are sac-like, movable, and non-tender, although face pain may occasionally occur. They typically occur in both nostrils. Complications may include sinusitis and broadening of the nose.

The exact cause of NP is unclear. They may be related to chronic inflammation of the lining of the sinuses. They occur more commonly among people who have allergiescystic fibrosisaspirin sensitivity, or certain infections. The polyp itself represents an overgrowth of the mucous membranes. Diagnosis may occur by looking up the nose. A CT scan may be used to determine the number of polyps and help plan surgery.

Typical treatment includes steroids, often in the form of a nasal spray. If this is not effective, surgery may be considered. The condition often recurs following surgery; thus, continued use of a steroid nasal spray is often recommended. Antihistamines may help with symptoms but do not change the underlying disease. Antibiotics are not required for treatment unless an infection occurs.

About 4% of people currently have nasal polyps while up to 40% of people develop them at some point in their life. They most often occur after the age of 20 and are more frequent in males than females. Nasal polyps are described in documentation from the era of ancient Egypt.

What is Dupilumab?

It is a monoclonal antibody designed for the treatment of allergic diseases such as eczema (atopic dermatitis). Side effects include allergic reactionscold sores, and inflammation of the cornea. It was developed by Regeneron Pharmaceuticals and Sanofi Genzyme. It received FDA approval for moderate-to-severe atopic dermatitis in 2017. As of 2017 it costs about 37,000 USD per year.

SINUS-24 Trial

Sponsored by French biopharmaceutical giant Sanofi and partner Regeneron, the team launched a controlled clinical study of Dupilumab in patients with nasal polyps. The study started in 2016 and concluded in late 2018.  It was tested at over 70 research sites. The sponsors did not share the names of the research institutions.

Trial Results

See Dr. Han’s video in the MD Magazine online article.  Two primary end points was looking at changes in polyps. Traditionally, a change of one would be clinically significant.  The study results were incredible—a change of two, also a change in congestion. By the end of the study, mild to no congestion as reported. Endpoints were met.

Lead Research/Investigator

Joseph Han, MD  Medical Director of the Division of Allergy, Eastern Virginia Medical School