YUPELRI delivers a full 24 hours of efficacy in a single nebulized daily dose
YUPELRI was studied in two 12-week, randomized, double-blind, placebo-controlled, parallel-group confirmatory studies (Studies 1 and 2) to evaluate the efficacy of once-daily YUPELRI vs placebo in patients with moderate to very severe COPD1
Consistent improvement in FEV1 vs placebo over 24 hours on days 84/851,11
In Studies 1 and 2, serial spirometry was performed on a substudy population. Pooled results are shown.
Primary efficacy endpoint was change from baseline in trough (predose) FEV1 at day 85 vs placebo.
- In Studies 1 and 2, a prespecified exploratory analysis was performed. In Study 1, LS mean changes from baseline in FEV1 ranged from 55.8 mL to 240.4 mL in the YUPELRI group, and from -113.6 mL to 59.6 mL in the placebo group. In Study 2, LS mean changes from baseline in FEV1 ranged from 19.8 mL to 148.5 mL in the YUPELRI group, and from -176.4 mL to -13.0 mL in the placebo group11
YUPELRI delivers consistent control* over 12 weeks
Consistent improvements† in trough FEV1 over the 12-week study period1,11
Pooled data from Studies 1 and 2. Primary efficacy endpoint: change from baseline in trough (predose) FEV1 at day 85 vs placebo.
†The first measurement was taken at 2 weeks.
‡LS mean difference from placebo (SE) is 148.13 (16.782), pooled estimate adjusts the LS mean for placebo as well.11
Studies 1 and 2 patient characteristics1
- Mean age 64 years (range, 41-88 years)
- Mean smoking history of 53 pack-years; 48% current smokers
- Moderate to very severe COPD (mean post-bronchodilator % predicted FEV1 of 55%)
- 37% were on concomitant LABA or ICS/LABA therapy
COPD symptom improvement
Activities of daily living
Social interaction
- In Study 1, the SGRQ responder rate for the YUPELRI treatment arm on day 85 was 49% compared to 34% for placebo (odds ratio=2.11; 95% CI, 1.14-3.92)1§
- In Study 2, the SGRQ responder rate for the YUPELRI treatment arm was 45% compared to 39% for placebo (odds ratio=1.31; 95% CI, 0.72-2.38)1
- The clinical relevance of the above data is unknown
Indication
YUPELRI® inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Important Safety Information
YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.
YUPELRI should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD, or for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
