Negative impact of anorexia and weight loss during prior pirfenidone administration on subsequent nintedanib treatment in patients with idiopathic pulmonary fibrosis

Table 5 Logistic regression analysis for verifying the risk factors for the early termination of nintedanib

	Univariate			Multivariate
	Odds ratio	95% CI	p value	Odds ratio	95% CI	p value
Age	1.02	0.885–1.18	0.751
Gender (male/female)	1.18	0.197–7.08	0.855
Never smoker (%)	0.857	0.104–7.04	0.886
Body weight (kg)	0.931	0.861–1.01	0.0702
Body mass index	0.704	0.519–0.955	0.0239	0.487	0.280–0.849	0.0111
Body surface area (DuBois, m²)	0.0418	0.000541–3.22	0.152
Creatinine (mg/dL)	1.07	0.0280–40.7	0.972
Krebs von den Lungen-6 (U/mL)	1	0.999–1.00	0.348
Surfactant protein D (ng/dL)	0.995	0.989–1.00	0.08	0.997	0.990–1.00	0.315
Forced vital capacity (L)	0.561	0.150–2.1	0.391
% Forced vital capacity (%)	0.967	0.918–1.02	0.213
% DLco (%)	1.01	0.9580–1.06	0.739
Administration period of Pirfenidone	1	0.999–1.00	0.329
Time from pirfenidone discontinuation to nintedanib initiation	1.01	0.994–1.02	0.355
Discontinued pirfenidone due to FVC decline	0.333	0.0751–1.48	0.148
Anorexia during the period of pirfenidone	1.65	0.370–7.37	0.512
Weight loss during the period of pirfenidone	2.93	0.657–13.1	0.159
Weight loss with grade ≥ 2 during the period of pirfenidone	7.8	0.804–75.6	0.0764	3.29	0.184–58.8	0.418

Univariate analysis showed that the association between low body mass index and the early termination of nintedanib was statistically significant (p = 0.0239). In addition, the association between weight loss with a CTCAE grade of ≥2 during the pirfenidone administration period and the early termination of nintedanib was also marginally significant (p = 0.0764). A multivariate logistic regression analysis using backward stepwise selection showed that the association between BMI and the early termination of nintedanib was statistically significant (p = 0.0111)
Abbreviation: DLCO diffusing capacity for lung carbon monoxide