The results of a preliminary study published in the Journal of the American Medical Association demonstrated that infusions of recombinant human pentraxin 2 result in a slower decline in lung function in patients with idiopathic pulmonary fibrosis (IPF).
Pentraxin 2 inhibits production of transforming growth factor beta 1 and monocyte differentiation into proinflammatory macrophages, both of which are involved in the development of PF.
Ganesh Raghu, MD, from the Center for Interstitial Lung Diseases at the University of Washington Medical Center in Seattle, and colleagues conducted a phase 2, double-blind, placebo-controlled trial at 18 sites in 7 countries in patients with IPF to determine the effects of recombinant human pentraxin 2 (ClinicalTrials.gov Identifier: NCT02550873). With a total patient population of 117, the investigators randomly assigned 77 patients to pentraxin 2 (10 mg/kg intravenous every 4 weeks) and 39 to placebo for 24 weeks. The primary outcome was the least-squares mean change in forced vital capacity percentage of predicted value.
Of the original 117 patients, 111 completed the study. The investigators found that the least-squares mean change in forced vital capacity percentage of predicted values from baseline to the week 28 follow-up was −2.5 for the pentraxin 2 group compared with −4.8 for the placebo group (P =.001). However, the investigators observed no significant differences for the secondary outcomes of total lung volume, quantitative parenchymal features, interstitial lung abnormalities, or measurement of the diffusing capacity of the lungs for carbon monoxide. The change in 6-minute walk distance was significant, however: −0.5 m for the pentraxin 2 group vs −31.8 m for the placebo group (P <.001).
Cough was the most common adverse event that occurred when taking pentraxin 2 (18% vs 5% in the active medication and placebo groups, respectively). Fatigue occurred in 17% and 10% of those groups, respectively, and nasopharyngitis occurred in 16% and 23%.
The authors noted several limitations, including a small sample size that prohibited exploration of additional hypotheses beyond the primary outcome, that patients with “possible usual interstitial pneumonia” may have been included in the study, and that the high-resolution computed tomography scans were not centrally read, which may have allowed the introduction of heterogeneity in the patient population.
The authors contended that further research is needed to fully assess the efficacy and tolerability of recombinant human pentraxin 2.
Raghu G, van den Blink B, Hamblin MJ, et al. Effect of recombinant human pentraxin 2 vs placebo on change in forced vital capacity in patients with idiopathic pulmonary fibrosis. A randomized clinical trial. JAMA. 2018;319(22):2299-2307.