Serum surfactant protein D as a predictive biomarker for the efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis: a post-hoc analysis of the phase 3 trial in Japan

Ikeda, Kimiyuki; Chiba, Hirofumi; Nishikiori, Hirotaka; Azuma, Arata; Kondoh, Yasuhiro; Ogura, Takashi; Taguchi, Yoshio; Ebina, Masahito; Sakaguchi, Hiroki; Miyazawa, Shogo; Suga, Moritaka; Sugiyama, Yukihiko; Nukiwa, Toshihiro; Kudoh, Shoji; Takahashi, Hiroki

doi:10.1186/s12931-020-01582-y

Table 2 Predictors of IPF disease progression at week 52

From: Serum surfactant protein D as a predictive biomarker for the efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis: a post-hoc analysis of the phase 3 trial in Japan

Univariate analysis				Multivariate analysis
Parameter	Odds ratio	90% CI	p-value	Parameter	Odds ratio	95% CI	p-value
(A) Pirfenidone group
Gender; male vs. female	0.529	0.260, 1.077	0.1407	Gender; male vs. female
Age	0.968	0.927, 1.011	0.2223	Age
BMI	0.822	0.734, 0.921	0.0047	BMI	0.849	0.723, 0.998	0.0469
Smoking; current and former vs. never	0.444	0.224, 0.880	0.0510	Smoking; current and former vs. never	0.831	0.305, 2.266	0.7172
Dyspnea scale (modified by Fletcher)	1.359	0.884, 2.089	0.2413	Dyspnea scale (modified by Fletcher)
PaO₂	1.016	0.984, 1.050	0.4188	PaO₂
AaDO₂	0.968	0.940, 0.998	0.0806	AaDO₂	0.969	0.932, 1.007	0.1069
Lowest SpO₂ during a 6MET	1.011	0.888, 1.151	0.8881	Lowest SpO₂ during a 6MET
%VC	0.939	0.918, 0.960	< 0.0001	%VC	0.943	0.916, 0.971	< 0.0001
%DLCO	1.011	0.995, 1.029	0.2653	%DLCO
Serum SP-D	1.004	1.002, 1.006	0.0059	Serum SP-D	1.003	1.000, 1.006	0.0278
Serum SP-A	0.997	0.989, 1.004	0.4486	Serum SP-A
Serum KL-6	1.000	0.999, 1.000	0.2321	Serum KL-6
(B) Placebo group
Gender; male vs. female	0.700	0.317, 1.546	0.4589	Gender; male vs. female
Age	0.995	0.950, 1.042	0.8616	Age
BMI	0.791	0.690, 0.908	0.0053	BMI	0.833	0.704, 0.985	0.0323
Smoking; current and former vs. never	0.509	0.222, 1.166	0.1803	Smoking; current and former vs. never
Dyspnea scale (modified by Fletcher)	1.187	0.696, 2.025	0.5979	Dyspnea scale (modified by Fletcher)
PaO₂	0.973	0.937, 1.011	0.2349	PaO₂
AaDO₂	1.005	0.971, 1.041	0.8057	AaDO₂
Lowest SpO₂ during a 6MET	0.839	0.708, 0.994	0.0889	Lowest SpO₂ during a 6MET	0.908	0.723, 1.141	0.4084
%VC	0.949	0.925, 0.973	0.0006	%VC	0.957	0.927, 0.987	0.0049
%DLCO	0.981	0.962, 1.001	0.1139	%DLCO
Serum SP-D	1.001	0.999, 1.002	0.6032	Serum SP-D
Serum SP-A	1.001	0.996, 1.007	0.7249	Serum SP-A
Serum KL-6	1.000	1.000, 1.000	0.9441	Serum KL-6

The disease progression was defined by a > 10% relative decline in vital capacity from baseline and/or death. Logistic regression analysis
IPF idiopathic pulmonary fibrosis, CI confidence interval, BMI body mass index, PaO₂ partial pressure of oxygen in arterial blood, AaDO₂ alveolar–arterial oxygen difference, SpO₂ peripheral capillary oxygen saturation, 6MET 6-min steady-state exercise test, VC vital capacity, DLCO diffusion capacity of the lung for carbon monoxide, SP surfactant protein, KL Krebs von den Lungen

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ISSN: 1465-993X

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