AMSTERDAM — Rituximab was not effective in treating fatigue in unselected patients with primary biliary cholangitis despite metabolic modulation through improvement of anaerobic threshold, according to results of the RITPBC trial presented at the International Liver Congress.
“This is the first randomized controlled trial of a treatment for fatigue in patients with PBC,” Amardeep Khanna, MD, PhD, from Newcastle University, U.K., said in a press release. “Rituximab was not found to be effective for the treatment of PBC-associated fatigue in this study, but we feel that future studies should target more specific types of fatigue, which may produce more favorable results.”
The RITPBC trial comprised 57 patients with PBC and moderate or severe fatigue. Patients received either rituximab infusion 1,000 mg or saline infusion at day 1 and day 15. Follow-up was at 12 weeks and 6, 9 and 12 months.
The adjusted mean difference between fatigue score in the rituximab group and placebo group was –0.9 (95% CI, –4.6 to 3.1). There was, however, improvement in both groups. The mean score in the rituximab group decreased from 41.2 to 36.2 and the mean score in the placebo group decreased from 43 to 38.1.
Anaerobic threshold improved significantly in the rituximab group compared with the placebo group.
“The fact that the results were non-significant from a clinical perspective should not undermine the relevance of the findings. Any new study results, positive or negative, in a rare disease such as PBC, adds to the body of evidence and will be crucial in informing the direction of future clinical studies,” Marco Marzioni, MD, from the University Hospital of Ancona, Italy, and EASL scientific committee member, said in the press release. “The current trial shows that although rituximab was not effective in reducing fatigue, there is nevertheless still a connection between the symptom and the immunopathological process. Therefore, further characterization of the type of fatigue experienced by PBC patients may be crucial in helping identify optimal treatment.” – by Talitha Bennett
Reference: Khanna A, et al. Abstract #LBP-506. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.
Disclosure: The researchers report no relevant financial disclosures.