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The Extent of Serum Periostin Reduction in Asthma Patients Treated with Lebrikizumab Is Related to Baseline Periostin Levels: A Pooled Analysis of Phase II Studies
Saturday, March 5, 2016
South Exhibit Hall H (Convention Center)
David F Choy, Cecile T.J. Holweg, PhD, Fang Cai, Joseph R. Arron, John G. Matthews, MB, BS, MRSCP, PhD, Heleen Scheerens, PhD
Rationale: Serum periostin has been used as a biomarker of Type 2 airway inflammation in asthma and may identify patients most likely to benefit from treatment with the anti-IL-13 mAb lebrikizumab. In this study we investigated the effect of lebrikizumab on serum periostin levels over time in relation to baseline levels.

Methods: Serum periostin was measured (clinical trial version of the Elecsys® Periostin assay) in samples from 228 placebo- and 453 lebrikizumab-treated moderate-to-severe uncontrolled asthma subjects from 3 independent Phase II trials MILLY (NCT00930163) LUTE and VERSE (NCT01545440 and NCT01545453). The studies were pooled for this analysis. The percent change in serum periostin measurements at weeks 4, 12, 20, and 24 was estimated by a generalized linear model, in relation to treatment, week 0 periostin levels, and week of serum periostin measurement.

Results: Serum periostin levels were reduced as early as one week after treatment with lebrikizumab, reduced further over time and reduction was sustained through week 24. The mean placebo corrected percent reduction of serum periostin in lebrikizumab-treated patients ranged from -2.6 to -4.7% during weeks 4 through 24. The reduction of serum periostin was proportionately greater in lebrikizumab-treated subjects with increased baseline periostin levels during all assessed timepoints (P < 0.05 interaction test).

Conclusions: In three independent lebrikizumab trials, serum periostin levels decreased as early as week 1 after initiation of treatment with lebrikizumab. The greatest reduction of periostin was observed in patients with the highest baseline levels of periostin. This observation supports the link between IL-13 and periostin in asthma.