Safety and Effectiveness of MEDI-528 in Asthma Patients
Author Information
Author(s): Parker Joseph M, Oh Chad K, LaForce Craig, Miller S David, Pearlman David S, Le Chenxiong, Robbie Gabriel J, White Wendy I, White Barbara, Molfino Nestor A
Primary Institution: MedImmune, LLC
Hypothesis
Can multiple subcutaneous doses of MEDI-528, a humanized anti-IL-9 monoclonal antibody, improve asthma control and safety in patients with asthma?
Conclusion
MEDI-528 demonstrated an acceptable safety profile and potential clinical activity in patients with mild to moderate asthma.
Supporting Evidence
- In study 1, only 1 out of 27 MEDI-528-treated subjects had an asthma exacerbation compared to 2 out of 9 in the placebo group.
- Study 2 showed a trend in reduced maximum decrease in FEV1 post-exercise for MEDI-528 compared to placebo.
- No anti-MEDI-528 antibodies were detected in either study.
Takeaway
This study tested a new medicine for asthma called MEDI-528, and it seemed safe and might help people breathe better.
Methodology
Two randomized, placebo-controlled studies were conducted with adults receiving MEDI-528 or placebo subcutaneously twice weekly for 4 weeks.
Potential Biases
Potential bias due to the small sample size and the premature halt of one study.
Limitations
The studies were limited by small sample sizes and mild disease severity of participants.
Participant Demographics
Adults aged 18-65 years with mild asthma; predominantly white and female.
Statistical Information
P-Value
0.148
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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