In a recent study, published in the journal Clinical Gastroenterology and Hepatology, Hedin, et al., reported the effects of tumor necrosis factor (TNF) antagonists on liver function and efficacy in therapy of inflammatory bowel disease (IBD) among patients with Primary Sclerosing Cholangitis (PSC). This was retrospective study of 141 patients with PSC and IBD receiving treatment with anti-TNF agents (either infliximab or adalimumab) at 20 medical centers across Europe and North America. Anti-TNF treatment produced a response or remission of IBD in 48%, and 23% of patients, respectively. There was no difference in PSC symptom frequency before or following exposure to the drugs. The most common reason for discontinuation of anti-TNF were side effects (18%) and primary non-response of IBD (17%). At 3 months, infliximab-treated patients or adalimumab-treated patients had a median reduction in serum alkaline phosphatase of 4% or 15%, respectively. Factors associated with lower serum alkaline phosphatase were normal values of this enzyme at baseline (P<0.01), treatment with adalimumab (P=0.090), and treatment in Europe (P=0.083). The study suggests that anti-TNF agents were moderately effective and were not associated with exacerbation of PSC symptoms or specific side-effects. The retrospective nature of the study and the small size of patients included are notable limitations. Sizable prospective studies are needed to further investigate the association between use of adalimumab and reduced serum levels of alkaline phosphatase as well as the clinical importance of this observation.
Read the paper from Dr. Hedin