TRAVERSE enrolled more than 2200 asthma patients, evaluated through ~3 years2,6

TRAVERSE (N=2284), 48 to 96 weeks

Randomized

DUPIXENT + SOC
300 mg Q2W
48 weeksd (n=2282)

DUPIXENT + SOC
300 mg Q2W
96 weekse (n=1906)

Subjects were initially enrolled for a 96-week treatment period; however, an amendment was issued to shorten the treatment period to
48 weeks for all patients who enrolled following the amendment
Study population
  • Pediatric patients (12-17 years) and adults (≥18 years) with moderate-to-severe asthma who completed the treatment period in a previous DUPIXENT asthma clinical study (QUEST, VENTURE, EXPEDITION) or subjects with asthma who completed the treatment and follow-up periods in the previous DUPIXENT asthma study DRI12544
  • Subjects were on a background dose of medium- or high-dose ICS, as maintained during the parent study in which they participated, in combination with a second controller medication (and OCS for subjects from VENTURE)
  • Subjects requiring a third controller medication (eg, LABA, LTRA, methylxanthine) were allowed to enroll
Primary endpoint

Proportion of patients experiencing any TEAEs up to Week 96 of the OLE in populations from DRI12544, QUEST, EXPEDITION, and VENTURE
Select other endpoints
  • Number and annualized rate of severe exacerbation events
  • Forced expiratory volume in 1 second (FEV1) (L)
  • In the OCS-dependent population, percent reduction from baseline in OCS dose and proportions of patients achieving ≥50% reduction and completely tapering off OCS
Exclusion criteria

Subjects who developed a new medical condition, suffered a change in status of an established medical condition, developed a laboratory abnormality, or required a new treatment or medication during the screening period that would adversely affect participation in the study or require discontinuation of study medicationf

There are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.

d Total number of subjects enrolled and exposed to treatment in OLE.6

e Total number of subjects who continued to be exposed to treatment beyond 48 weeks.6

f Exclusion criteria of parent studies also applied, including pregnant/breastfeeding women, alcohol/drug abuse, clinically significant comorbidity/lung disease other than asthma, smoking, and lung disease that would impair lung function tests (eg, COPD).2
 

Select baseline characteristics2,6

Patients enrolled from DRI12544 and QUEST (n=2062): Mean duration of asthma: 21 years; never smoked: 80%; mean exacerbations in previous year: 2.2; high-dose ICS use: 55%; pre-dose FEV1 at baseline: 1.79 L; percent reversibility: 26%; atopic medical history, overall: 82%; atopic dermatitis: 10%; nasal polyposis: 13%; allergic rhinitis: 67%; mean FeNO: 36 ppb; mean total IgE: 438 IU/mL; and mean baseline blood eosinophil count: 360 cells/μL.

Patients enrolled from VENTURE (n=187): Mean duration of asthma: 21 years; never smoked: 82%; mean exacerbations in previous year: 2.0; high-dose ICS use: 91%; pre-dose FEV1 at baseline: 1.58 L; percent reversibility: 20%; atopic medical history, overall: 73%; atopic dermatitis: 8%; nasal polyposis: 20%; allergic rhinitis: 58%; mean FeNO: 37 ppb; mean total IgE: 451 IU/mL; and mean baseline blood eosinophil count: 350 cells/μL.  

COPD, chronic obstructive pulmonary disease; FeNO, fractional exhaled nitric oxide; ICS, inhaled corticosteroid; LABA, long-acting beta agonist; LTRA, leukotriene receptor antagonist; OCS, oral corticosteroid; OLE, open-label extension; Q2W, once every 2 weeks; SOC, standard of care; TEAE, treatment-emergent adverse event.