Patients with idiopathic pulmonary fibrosis (IPF) or nonspecific interstitial pneumonia (NSIP) who experienced an acute exacerbation may benefit from Recomodulin (recombinant human soluble thrombomodulin), a new drug available for the treatment of a coagulation disorder in Japan.
The study, “Efficacy of thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis and nonspecific interstitial pneumonia: a nonrandomized prospective study,” was developed by researchers at Chiba University in Japan, and published in Drug Design, Development and Therapy.
Acute exacerbation (AE) is an important complication of IPF and NSIP, characterized by a sudden acceleration of the disease that leads to a significant decline in lung function and high mortality rates. It is estimated that 14.2 percent of IPF patients and 4.2 percent of NSIP patients experience an acute exacerbation in one year, revealing the urgent need for effective treatments for these patients.
Currently, high-dose corticosteroid therapy is administered to IPF patients with acute exacerbations, but there is a lack of evidence that corticosteroid treatment is effective in these cases. Thrombomodulin has both an anticoagulation and an anti-inflammatory effect, and its administration to patients with a coagulation disorder was found to improve mortality and respiratory disfunction.
Now, researchers sought to explore whether Recomodulin could improve the outcomes of AE-IPF/NSIP patients. The study enrolled 16 patients with AE-IPF and six patients with AE-NSIP who were treated at Chiba University Hospital between October 2012 and August 2014. Patients received treatment with methylprednisone pulse therapy and maintenance therapy with corticosteroids, with some receiving Recomodulin (intravenous 0.06 mg/kg/day during the first six days of treatment).
The study’s primary endpoint was mortality at 90 days after acute exacerbation treatment, and secondary endpoint was the safety of the treatment for AE-IPF/NSIP patients.
The researchers found that, in the Recomodulin group, the mortality rate was significantly decreased at 90 days (36 percent) compared to the group that did not receive the drug (90 percent). No serious adverse events were reported.
Researchers also performed two distinct analyses to identify prognostic factors of AE-IPF/NSIP. The results of the univariate analysis showed that patients’ respiratory rate increased the risk of death at 90 days in 9 percent, whereas Recomodulin administration decreased this risk in 79 percent.
A multivariate analysis, however, which assesses all variables at the same time, only identified Recomodulin administration as an independent predictor of mortality at 90 days, reducing the risk of death in 83 percent.
These findings suggest that Recomodulin administration may improve the outcomes of AE-IPF/NSIP patients. Nonetheless, further randomized, double-blinded studies with larger samples should be performed to confirm the study’s findings.