Improved response
In addition to its superior results on the primary endpoint of 90-day survival, combination therapy was associated with significantly better response to therapy. The mean Lille score at day 7 was 0.14 for the combination, compared with 0.21 for prednisolone alone and 0.28 for G-CSF alone (P = .002).
There were also significantly fewer nonresponders in the combination arm than either of the monotherapy groups (P = .03).
At 90 days, the rate of new infections was significantly higher among patients treated with prednisolone alone, at 35.7%, compared with 19% in the combination arm and 7.1% in the G-CSF alone group (P = .02). There were also significantly fewer skin and mucosal bleeding episodes with the combination (19% vs, 25% and 35.7% with prednisolone and G-CSF monotherapies, respectively, P = .03), as well as lower rates of hepatic encephalopathy (9.5% vs. 47.5% and 25%, respectively, P < .01).
No differences in alcohol relapse rates were found among the three groups.
Patient selection important
“I know a lot of the G-CSF studies that have been conducted in the U.S. and Europe have all been negative,” said David Goldberg, MD, from the University of Miami, during the session. “Do you think there’s something unique in your patients, the microbiome or maybe genetics, that leads to such different results?” he asked Dr. Sarin.
European studies included patients with infections, acute kidney injury (AKI), or other comorbidities that were exclusion criteria in his study, Dr. Sarin noted.
“If you already have an infection, you already have an AKI, then it’s not a good patient for treatment, so I think the choice of patient is important,” he said.
The study was internally supported. Dr. Sarin and Dr. Goldberg report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
