REALITI-A Flashcards
REALITI-A study design
2 year, Global, prospective, observational, single-arm study in adults aged 18 years and over
How many patients included?
823 in the safety population
822 in the treated population
Primary endpoint
Rate of clinically significant exacerbations at 12 months
Entry criteria
Aged 18 years or older;
had a current clinical diagnosis of asthma with a physician decision to initiate mepolizumab treatment; and
had relevant medical records for 12 months or greater before enrollment
Exclusions from study
Patients were excluded if they had received mepolizumab treatment
or had participated in an interventional clinical trial in the 12
months before enrollment
Number of patients on mOCS at baseline
319/822 (39%)
Mean BEC at baseline
353
CSEs in 12 months prior to mepo
4.3
Patients with Nasal Polyps as baseline
321 (39%)
Most common steroid-induced co-morbidities
GERD (38 %)
Osteoporosis (14%)
Fracture (11%)
Anxiety (19%)
Depression (19%)
Significance of the study
REALITI-A study is the largest prospective and first international real-world study assessing the effectiveness of mepolizumab in patients with severe asthma.
CSEs at 24 months
74% reduction (4.25 –> 1.1)
CSEs requiring hospitalisations/ED visits at 24 months
79% reduction (0.92 –> 0.19)
Reduction in daily median mOCS dose at 24 months
100%
Percentage of patients discontinuing mOCS at 24 months
57%
