Amikacin liposome inhalation suspension (ALIS) improved symptoms and infection clearance in treatment-naive Mycobacterium avium complex (MAC) lung disease, the ENCORE trial showed.
For the primary endpoint, the aminoglycoside antibacterial improved respiratory symptom score by 3.11 more points on the 100-point scale than did placebo, which was statistically significant albeit modest (mean change 17.77 vs 14.66 from baseline to month 13, P=0.0299). More than half of the ALIS group met the minimal clinical important difference of 16.67.
Three months after the end of treatment, the difference had widened to 4.80 points (P=0.0015), Charles L. Daley, MD, of National Jewish Health and the University of Colorado School of Medicine in Denver, reported at the American Thoracic Society annual meeting in Orlando.
The findings could expand use from the current indication as part of a multi-drug regimen for adults with limited or no alternative treatment options for refractory MAC lung disease.
"I think all of our views are that this is a drug that clearly works. It's been shown now in multiple trials in both refractory and now treatment naive. So I would like to give it if I can," even if it takes a dose reduction for some patients, Daley said.
