Rituximab has demonstrated utility in treating other autoimmune diseases, and this phase 2, double-blind, randomized, controlled trial compared rituximab with placebo in 57 patients with primary biliary cholangitis (PBC).
A study was recently published in Efficacy and Mechanism Evaluation that investigated the potential clinical benefit of rituximab for the treatment of fatigue in primary biliary cholangitis (PBC), an autoimmune liver disease that is characterized by the loss of the intrahepatic bile ducts accompanied by progressive cholestasis. About half of patients with PBC experience fatigue.
Rituximab has demonstrated utility in treating other autoimmune diseases, and this phase 2, double-blind, randomized, controlled trial compared rituximab with placebo in 57 patients with PBC aged 18 years or older with moderate to severe fatigue as measured by a score of greater than 33 on the PBC-40 fatigue domain scale. The trial took place at a single center in the United Kingdom in Newcastle upon Tyne Hospitals National Health Service Foundation Trust.
Patients were randomized in to receive either rituximab or a placebo. Participants received 2 transfusions of rituximab (1000 mg) or placebo on days 1 and 15 of the trial and were followed up at 3-month intervals for a year following treatment.
The primary outcome measure was the PBC-40 fatigue domain evaluation at 3 months, which was assessed on an intention-to-treat basis. Although there were no serious adverse events linked to the drug, there was also no statistically significant difference in fatigue score measured at 3 months between the rituximab and placebo arms (adjusted mean difference —0.9; 95% CI, –4.6-3.1). However, the anaerobic threshold improved significantly in the rituximab arm with an adjusted mean difference at 3 months of 1.41 (95% CI, 0.03-2.80).
Overall, researchers found that rituximab is ineffective for the treatment of fatigue in patients with PBC, despite an increase in anaerobic threshold.
Reference
Khanna A, Jopson L, Howel D, et al. Rituximab for the treatment of fatigue in primary biliary cholangitis (formerly primary biliary cirrhosis): a randomized controlled trial. [Published online April 2018]. EME. PMID: 29733563.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.