A pilot study of interleukin-11 in subjects with chronic hepatitis C and advanced liver disease nonresponsive to antiviral therapy

Eric J. Lawitz, Matthew J. Hepburn, Thomas J. Casey

Research output: Contribution to journalArticle

20 Scopus citations

Abstract

OBJECTIVES: To evaluate the effects of recombinant human interleukin (rhIL)-11 on liver histology in patients with chronic hepatitis C virus (HCV) infection and advanced liver disease who had failed antiviral therapy. METHODS: This was an open-label study of rhIL-11 (Neumega®, Wyeth Laboratories, Collegeville, PA) at a dose of 5 μg/kg administered by subcutaneous injection daily for 12 wk. The primary efficacy endpoint was the change in the Knodell Histology Activity Index (HAI) between pre- and posttreatment liver biopsies. Secondary efficacy endpoints included changes in plasma alanine transaminase (ALT) concentrations and in the number of platelets. RESULTS: The Knodell HAI improved in 11 (55%) of the 20 subjects enrolled, with the mean score improving from 7.3 to 5.9 (p = 0.006). Eight subjects (40%) experienced significant improvement as defined by a decrease of at least two points in the HAI. IL-11 treatment was also associated with a decrease in ALT levels from a mean level of 113 IU/L at baseline to 65 IU/L at week 12 (p < 0.001). Platelet levels increased from a mean of 143 × 103/μl at baseline to 198 × 103/μl at week 12 of treatment (p < 0.001). Overall, rhIL-11 was well tolerated and no serious adverse events (AEs) were reported. The most common AE was edema of the lower extremities, which occurred in all subjects. CONCLUSIONS: The findings from this pilot study suggest that rhIL-11 maybe beneficial for patients with hepatic inflammation and advanced liver disease associated with chronic HCV infection. Larger clinical trials are warranted to further evaluate the long-term antiinflammatory and antifibrotic effects of rhIL-11.

Original languageEnglish (US)
Pages (from-to)2359-2364
Number of pages6
JournalAmerican Journal of Gastroenterology
Volume99
Issue number12
DOIs
StatePublished - Dec 1 2004
Externally publishedYes

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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