Negative Impact of Anorexia and Weight Loss During Prior Pirfenidone Administration on Subsequent Nintedanib Treatment in Patients With Idiopathic Pulmonary Fibrosis

Satoshi Ikeda; Akimasa Sekine; Tomohisa Baba; Takuma Katano; Erina Tabata; Ryota Shintani; Shinko Sadoyama; Hideaki Yamakawa; Tsuneyuki Oda; Ryo Okuda; Hideya Kitamura; Tae Iwasawa; Tamiko Takemura; Takashi Ogura

Disclosures

BMC Pulm Med. 2019;19(78) 

In This Article

Methods

Patients and Settings

This retrospective study was performed at Kanagawa Cardiovascular and Respiratory Center in Yokohama, Japan. All consecutively enrolled patients had (1) IPF diagnosed based on the official American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association statement of 2011,[12] (2) discontinued pirfenidone due to a decline in FVC or intolerable AEs despite dose modification or symptomatic therapy, and (3) newly started nintedanib (150 mg twice daily) during September 2015–August 2017. Patients with a history of receiving anti-fibrotic treatments other than pirfenidone or advanced lung cancer complications were excluded. Subsequently, we compared the characteristics, treatment status, and AEs between the aforementioned study participants (switch-group) and other IPF patients who had newly started nintedanib at a dose of 150 mg twice daily during September 2015–August 2017 at our hospital and were without any prior anti-fibrotic treatment or advanced lung cancer complications (pirfenidone-naïve group). This study was performed in accordance with the Declaration of Helsinki. The Ethics Committee of the Kanagawa Cardiovascular and Respiratory Center approved the study protocol (approval date: January 16, 2018; approved number: KCRC-17-0040), and the need for patient consent was waived because this was a retrospective study and anonymity was secured.

Data Availability

The datasets generated and/or analyzed during this study are available from the corresponding authors on reasonable request.

Clinical and Laboratory Findings

The clinical and laboratory data were retrieved from patient medical records. Age, gender, height, body weight, laboratory data [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, γ-glutamyl transpeptidase, serum creatinine, Krebs von den Lungen-6 (KL-6), and Surfactant protein-D (SP-D)], pulmonary function tests, and concomitant therapy were evaluated. Serum levels of KL-6 and SP-D were measured using chemiluminescent enzyme immunoassay system (BML, Inc. Shibuya-ku, Tokyo, Japan).

Assessment of and Response to AEs

The grading of worst examination values of AEs was based on the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0.[13] When a patient developed AEs, treatment interruption or dose reduction was performed in accordance with the guideline for the appropriate use of nintedanib (Ofev®).[14]

Statistical Analysis

Categorical data are presented as numbers (percentages), and compared using Fisher's exact test. Continuous data are presented as medians (interquartile ranges), and compared using Mann–Whitney U test. A multivariate logistic regression analysis was performed to verify the risk. A p value of < 0.05 was considered statistically significant. All statistical analyses were performed using EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan),[15] which is a graphical user interface for R version 3.2.2 (The R Foundation for Statistical Computing, Vienna, Austria).

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