Imatinib-IPF
Trial question
What is the role of imatinib in patients with idiopathic pulmonary fibrosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 119
119 patients (35 female, 84 male)
Inclusion criteria: patients with idiopathic pulmonary fibrosis
Key exclusion criteria: an alternate explanation for the presence of fibrotic lung disease or known connective tissue disease; women of childbearing age or lactation; obstructive lung disease; active infection; unstable or deteriorating cardiac or neurologic disease
Interventions
N=59 imatinib (Gleevec 600 mg, six tablets PO once daily for a period of 96 weeks)
N=60 placebo (matching placebo for 96 weeks)
Primary outcome
Change in forced vital capacity at 96 weeks
-0.25
-0.18
0.0
-0.1
-0.1
-0.2
-0.3
Imatinib
Placebo
No significant
difference ↔
No significant difference in change in FVC at 96 weeks (-0.25 vs. -0.18 ; ARD 0.07, 95% CI -0.09 to 0.23)
Secondary outcomes
No significant difference in change in diffusing capacity of CO at 96 weeks (-1.1 vs. -1.6 ; ARD 0.5, 95% CI -0.7 to 1.7)
Significant increase in change in resting Pa(O2) at 96 weeks (0.3 vs. -5.6 ; ARD 5.9, 95% CI 5.9 to 5.9)
Safety outcomes
No significant differences in deaths (p=0.64), discontinuation of study drug (32% vs. 27%, p=0.51), and serious adverse events (18 vs. 19).
Conclusion
In patients with idiopathic pulmonary fibrosis, imatinib was not superior to placebo with respect to change in FVC at 96 weeks.
Reference
Daniels CE, Lasky JA, Limper AH et al. Imatinib treatment for idiopathic pulmonary fibrosis: Randomized placebo-controlled trial results. Am J Respir Crit Care Med. 2010 Mar 15;181(6):604-10.
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