ZEPHYRUS-1
Trial question
What is the role of pamrevlumab in patients with idiopathic pulmonary fibrosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 356
356 patients (98 female, 258 male).
Inclusion criteria: patients aged 40-85 years with idiopathic pulmonary fibrosis.
Key exclusion criteria: significant obstructive lung disease or ILD other than idiopathic pulmonary fibrosis; pregnancy; smoking within 3 months of screening; sustained improvement in idiopathic pulmonary fibrosis severity within the 12 months before screening.
Interventions
N=181 pamrevlumab (at a dose of 30 mg/kg IV every 3 weeks).
N=175 placebo (matching placebo IV every 3 weeks).
Primary outcome
Decline in mean forced vital capacity at week 48
260 mL
330 mL
330.0 mL
247.5 mL
165.0 mL
82.5 mL
0.0 mL
Pamrevlumab
Placebo
No significant
difference ↔
No significant difference in decline in mean FVC at week 48 (260 mL vs. 330 mL; MD -70, 95% CI -190 to 60).
Secondary outcomes
No significant difference in disease progression (27.1% vs. 32%; HR 0.78, 95% CI 0.52 to 1.15).
No significant difference in first acute idiopathic pulmonary fibrosis exacerbation (9.9% vs. 8.6%; HR 1.13, 95% CI 0.56 to 2.3).
No significant difference in all-cause mortality (12.7% vs. 13.1%; HR 1, 95% CI 0.56 to 1.79).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients aged 40-85 years with idiopathic pulmonary fibrosis, pamrevlumab was not superior to placebo with respect to decline in mean FVC at week 48.
Reference
Ganesh Raghu, Luca Richeldi, Evans R Fernández Pérez et al. Pamrevlumab for Idiopathic Pulmonary Fibrosis: The ZEPHYRUS-1 Randomized Clinical Trial. JAMA. 2024 Aug 6;332(5):380-389.
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