Primary sclerosing cholangitis (PSC) is a chronic, immune-mediated, progressive biliary disease that is closely associated with inflammatory bowel disease (IBD). PSC has no cure, and up to 40% of cases eventually require patients to receive liver transplants. Given the efficacy of biologics in treating IBD, the potential to treat PSC with these same drugs is a matter of interest for healthcare providers.
Primary sclerosing cholangitis (PSC) is a chronic, immune-mediated, progressive biliary disease that is closely associated with inflammatory bowel disease (IBD). PSC involves recurrent bile duct infections, cirrhosis, and cholangiocarcinoma. PSC has no cure, and up to 40% of cases eventually require patients to receive liver transplants. Given the efficacy of biologics in treating IBD, the potential to treat PSC with these same drugs is a matter of interest for healthcare providers.
A recent study sought to evaluate the effect of biologic therapies on PSC progression in patients with IBD diagnoses using a retrospective cohort of 75 patients with concomitant PSC and IBD who received biologic treatment between 2002 and 2017. Biologics considered in this study were infliximab, adalimumab, and vedolizumab. Twelve patients were treated with more than 1 biologic.
The researchers compared patients’ hepatic biochemistries before, 6 to 8 months after, and 12 to 14 months after initiating treatment with a biologic. They found that adalimumab was associated with a significant decrease in alkaline phosphatase (ALP) after 6 to 8 months, but this decrease did not reach statistical significance by 12 to 14 months. No statistically significant change in ALP was observed with vedolizumab or infliximab.
No significant changes in elastography score or radiographic imaging of biliary tree dilation or strictures were observed from 6 to 12 months after initiating treatment.
While decreases in ALP associated with adalimumab did not reach statistical significance, further exploration of the phenomenon would be worthwhile, they write, as lower ALP levels in patients with PSC are known to be associated with a decreased incidence cholangiocarcinoma, liver transplantation, and death. Further study will be needed to clarify whether there is any potential benefit to be derived from using adalimumab in patients with PSC.
Reference
Tse CS, Loftus EV, Raffals LE, Gossard AA, Lightner AL. Effects of vedolizumab, adalimumab and infliximab on biliary inflammation in individuals with primary sclerosing cholangitis and inflammatory bowel disease. [Published online May 28, 2018.] Aliment Pharmacol Ther. doi.org/10.1111/apt.14829.
Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake
March 18th 2024Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.
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 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.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
FDA Green Lights Second Tocilizumab Biosimilar
March 7th 2024The FDA has approved Fresenius Kabi's tocilizumab biosimilar (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.