Chest
Clinical Investigations: Interstitial Lung DiseaseAnalyses of Efficacy End Points in a Controlled Trial of Interferon-γ1b for Idiopathic Pulmonary Fibrosis
Section snippets
Patients and Study Design
We used data from a recently reported randomized study comparing subcutaneous IFN-γ1b (200 μg; n = 162) with placebo (n = 168), administered three times weekly, in 330 patients who met the diagnostic criteria for IPF according to the American Thoracic Society.13 Eligible patients were aged 20 to 79 years, had mild-to-moderate IPF (eg, FVC of 50 to 90% of predicted and Dlco ≥ 25% of predicted), had definite or probable IPF on high-resolution CT scan based on protocol-specified criteria, and had
Components of the Primary Efficacy End Point
A primary end point event (ie, either disease progression according to change in P(A-a)O2 or percentage of predicted FVC criteria, or death; see “Methods and Methods”) occurred in 75 IFN-γ1b patients (46.3%) and 87 placebo patients (51.8%) [p = 0.53, likelihood score test from the Cox proportional hazards model; Table 1]. The majority of study patients reaching the primary end point did so on the basis of disease progression rather than death (IFN-γ1b, 90.7%; placebo, 86.2%), and the majority
Discussion
Using data from a parallel-group, randomized, double-blind study comparing treatment with IFN-γ1b vs placebo in patients with IPF,3 we sought to explore the components of the protocol-specified primary efficacy end point to guide selection of end points for future clinical trials of IFN-γ 1b.
References (10)
- et al.
Changes in pulmonary function test results after 1 year of therapy as predictors of survival in patients with idiopathic pulmonary fibrosis
Chest
(1995) Idiopathic pulmonary fibrosis: diagnosis and treatment; international consensus statement
Am J Respir Crit Care Med
(2000)- et al.
A preliminary study of long-term treatment with interferon γ-1b and low-dose prednisolone in patients with idiopathic pulmonary fibrosis
N Engl J Med
(1999) - et al.
A placebo-controlled trial of interferon γ-1b in patients with idiopathic pulmonary fibrosis
N Engl J Med
(2004) Interferon-γ1b for pulmonary fibrosis
N Engl J Med
(2004)
Cited by (209)
Predictors of Mortality in Sarcoidosis
2024, Clinics in Chest MedicinePrediction of forced vital capacity with dynamic chest radiography in interstitial lung disease
2021, European Journal of Radiology
Drs. King, Safrin, Brown, Noble, Raghu, and Schwartz are consultants to InterMune, Inc.; Dr. King is a consultant to Actelion, AstraZeneca, Centocor, Biogen, FibroGen, Genzyme, Human Genome Sciences, Merck, Nektar, Shionogi & Co, Wyeth-Ayerst, and GlaxoSmithKline; Dr. Starko is an employee of InterMune, Inc.; Dr. Brown is a consultant to Wyeth, Actelion, Fibrogen, and Genzyme; Dr. Noble is a consultant to Bristol Myers Squibb and Genzyme; and Dr. Raghu is a consultant to Actelion, Shionogi, Fibrogen, and Genzyme.
Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (e-mail: [email protected]).