PMID- 15571583
OWN - NLM
STAT- MEDLINE
DCOM- 20050201
LR  - 20171116
IS  - 0002-9270 (Print)
IS  - 0002-9270 (Linking)
VI  - 99
IP  - 12
DP  - 2004 Dec
TI  - A pilot study of interleukin-11 in subjects with chronic hepatitis C and advanced 
      liver disease nonresponsive to antiviral therapy.
PG  - 2359-64
AB  - 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 microg/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 x 10(3)/microl 
      at baseline to 198 x 10(3)/mul 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 
      may be 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.
FAU - Lawitz, Eric J
AU  - Lawitz EJ
AD  - Gastroenterology Service, Brooke Army Medical Center, San Antonio, Texas, USA.
FAU - Hepburn, Matthew J
AU  - Hepburn MJ
FAU - Casey, Thomas J
AU  - Casey TJ
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Interleukin-11)
RN  - 0 (Recombinant Proteins)
RN  - HM5641GA6F (oprelvekin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Female
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Interleukin-11/administration & dosage/*therapeutic use
MH  - Liver Function Tests
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Platelet Count
MH  - Polymerase Chain Reaction
MH  - Recombinant Proteins/administration & dosage/*therapeutic use
MH  - Statistics, Nonparametric
MH  - Treatment Outcome
EDAT- 2004/12/02 09:00
MHDA- 2005/02/03 09:00
CRDT- 2004/12/02 09:00
PHST- 2004/12/02 09:00 [pubmed]
PHST- 2005/02/03 09:00 [medline]
PHST- 2004/12/02 09:00 [entrez]
AID - AJG40047 [pii]
AID - 10.1111/j.1572-0241.2004.40047.x [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2004 Dec;99(12):2359-64. doi: 
      10.1111/j.1572-0241.2004.40047.x.