Dupixent Study for Alternate Administration

Madigan Army Medical Center

Status and phase

Active, not recruiting

Phase 4

Conditions

Chronic Disease

Nasal Polyps

Sinusitis

Treatments

Biological: Dupilumab

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT06750471

222008

Details and patient eligibility

About

Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.

Full description

Dupixent was recently approved by the FDA for chronic rhinosinusitis patients with nasal polyposis in April 2019. Literature support for this approval comes from results obtained from a landmark Phase III trial (LIBERTY SINUS-24 and SINUS-52) that were published in November 2019. The data suggests that Dupilumab improves subjective quality of life significantly in patients with chronic sinusitis with nasal polyposis and there is objective evidence of decreased disease burden and severity of other comorbidities (asthma, aspirin exacerbated respiratory disease). Therefore, there is robust scientific evidence supporting the use of this medication in chronic rhinosinusitis with nasal polyposis patients along with the FDA indication for usage of this medication in this subset of patients.

Otolaryngologists see and manage most (if not all) of chronic sinusitis patients with persistent symptoms and give recommendations for surgical and medical therapies. Given our unique ability to perform a detailed examination and provide medical and surgical care, investigators believe that this patient population will be best served with us making the determination of when to initiate the treatment if other treatment strategies fail. Given the cost associated with this medication (~ $45,630/patient/year based on price of $1,755/injection), investigators can make the judicious determination for when to prescribe this medication based on published evidence and guidelines in literature.

After careful assessment of LIBERTY study, most subjective and objective outcomes appear to show statistically and clinically significant benefit after 8 weeks of therapy. Moreover, one of the study arms had patients on this medication every 2 weeks until 26 weeks and then switched to every 4 weeks for the rest of the year. Given the apparent benefit of medication compared to placebo at 8 weeks, investigators propose that an alternate medication schedule with less frequent dosing after 8 weeks will be just as effective in improving subjective and objective outcomes in this patient population. If a non-inferior improvement is noted in the alternate medication schedule, then this will translate into significant cost saving to DoD and DHA (~$21,000/patient/year) when patients are placed on this medication due to the refractory nature of their disease.

Moreover, if the alternate schedule is just as effective, then this will validate use of this schedule in active duty service members (ADSM) during temporary duty or deployments to keep them medically fit and ready. Although topical steroid rinses are beneficial after surgery, the lack of distilled water in some austere environments prohibit usage and some patients have disease recurrence despite steroids and therefore require alternate medications or additional surgery. If the alternate regimen is proven to be non-inferior, then ADSMs or their medical team can carry the pre-made medication with them while following appropriate storage instructions according to drug information. Based on the FDA information website, Dupilumab can be stored below the room temperature (<77F or <25C) in pre-filled syringes up to 14 days or within refrigerator (between 2-8 C) until expiration. As long as these storage conditions can be met, ADSMs can continue this regimen while they are away. Additionally, if they are stable on long term Dupilumab therapy, there is potential for even longer time intervals between injections to help manage their chronic disease process.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility: patients =>18 years old with recurrent chronic rhinosinusitis with nasal polyposis (CRSwNP) despite standard of care (i.e topical medical therapies and full endoscopic sinus surgery)

Inclusion criteria:

Age=>18 y/o with recurrent CRSwNP based on reported symptoms and endoscopic assessment
history of atleast 1 endoscopic sinus surgery
Current use of intranasal corticosteroid spray or irrigation
Active duty servicemembers must be in the area for at least 7 months after starting the medication to complete the necessary follow ups

Exclusion Criteria:

Previous use of other biologic therapy in last 6 months
if history of asthma, FEV1< 50%
history of cystic fibrosis, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, kartagener syndrome, primary ciliary dyskinesia
Patient is a pregnant woman, may become pregnant or breastfeeding.