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.
Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval
July 24th 2024Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Phase 3 Trials Find Subcutaneous Infliximab CT-P13 Superior to Placebo in IBD
June 29th 2024Two phase 3 trials in patients with inflammatory bowel disease (IBD) found higher clinical remission rates in those treated with the subcutaneous formulation of infliximab biosimilar CT-P13 compared with placebo as maintenance therapy following an induction phase of intravenous CT-P13.
Biosimilar Adoption in the UK: Patient and Consultant Views on Safety and Switching
June 26th 2024Lack of knowledge and confidence in biosimilars continues despite growing education efforts, impacting provider willingness to prescribe biosimilar medicines and patient perceptions about their treatment and switching to a biosimilar.