Methods: We conducted a pooled analysis of three trials (NCT00930163/NCT01545440/NCT01545453) including 565 patients with moderate-to-severe uncontrolled asthma receiving ICS (200–2000 µg/day fluticasone propionate or equivalent), ≥1 additional controller (>90% LABA), pre-bronchodilator FEV1 40–80% predicted and ≥12% FEV1 reversibility. Lebrikizumab (125 or 250 mg) was administered subcutaneously every 4 weeks to 337 patients, and 228 patients received placebo. Change in FEV1 at Weeks 1 and 12 was assessed according to baseline serum periostin level (≥50 ng/mL vs. <50 ng/mL).
Results: In patients with baseline serum periostin levels ≥50 ng/mL, the mean (SD) absolute increase in FEV1 from baseline was 208 (361) mL in lebrikizumab-treated patients versus 67 (262) mL with placebo at Week 1. Week 12 FEV1 improvement from baseline was 292 (390) mL in lebrikizumab versus 94 (280) mL in placebo-treated patients. Lebrikizumab-treated patients with serum periostin <50 ng/mL at baseline showed a smaller FEV1 improvement at Weeks 1 and 12 of 143 (326) mL and 180 (298) mL, respectively versus placebo 86 (266) mL and 106 (293) mL.
Conclusions: In patients with moderate-to-severe uncontrolled asthma with high serum periostin, a single dose of lebrikizumab led to a rapid, clinically meaningful increase in FEV1 within 1 week that was sustained to Week 12. These data illustrate the efficacy of lebrikizumab on improving airway function in patients with moderate-to-severe Type 2-mediated asthma.