Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• Population and interventions: 1721 patients (1680 adults; 41 adolescents) randomized to brensocatib 10 mg, brensocatib 25 mg, or placebo.
• Primary outcome — annualized rate of pulmonary exacerbations: 10 mg: 1.02; 25 mg: 1.04; placebo: 1.29. Rate ratios vs placebo: 10 mg: 0.79 (95 % confidence interval [CI], 0.68 to 0.92; adjusted P = 0.004); 25 mg: 0.81 (95 % CI, 0.69 to 0.94; adjusted P = 0.005).
• Secondary outcomes: Time to first exacerbation - hazard ratios vs placebo: 10 mg: 0.81 (95 % CI, 0.70 to 0.95; adjusted P = 0.02); 25 mg: 0.83 (95 % CI, 0.70 to 0.97; adjusted P = 0.04). Percentage exacerbation-free at week 52: 10 mg: 48.5 %; 25 mg: 48.5 %; placebo: 40.3 %; rate ratios vs placebo: 10 mg: 1.20 (95 % CI, 1.06 to 1.37; adjusted P = 0.02); 25 mg: 1.18 (95 % CI, 1.04 to 1.34; adjusted P = 0.04). Change in forced expiratory volume in 1 second (FEV1): decline - 10 mg: 50 ml; 25 mg: 24 ml; placebo: 62 ml; least-squares mean difference vs placebo - 10 mg: 11 ml (95 % CI, -14 to 37; adjusted P = 0.38); 25 mg: 38 ml (95 % CI, 11 to 65; adjusted P = 0.04).
• In adults and adolescents receiving brensocatib 10 mg, brensocatib 25 mg, or placebo, the overall incidence of adverse events was similar across groups.
• Hyperkeratosis occurred more frequently with brensocatib than with placebo.