Efficacy of rituximab in difficult-to-manage Autoimmune Hepatitis: Results from the International Autoimmune Hepatitis Group

Abstract Background & Aim Treatment options remain limited for patients with autoimmune hepatitis (AIH), alongside concern over consequences of long-term corticosteroid use. Few studies suggested a role for B cell driven autoimmune liver injury in AIH. This multicentre, international retrospective cohort study from the International Autoimmune Hepatitis Group (IAIHG) aims to evaluate the clinical efficacy and safety of rituximab in difficult-to-manage AIH. Methods Clinical data from 22 patients who received rituximab between 2007 and 2017 were collected from centres in the United Kingdom, Germany and Canada. Clinical response was assessed using changes in biochemical and immunological parameters up to 24 months post rituximab infusion. In addition, prednisolone doses were compared between pre and 12 months post-treatment, and the freedom from AIH flares over the post-treatment period were assessed. Results Twenty-two patients with type-1 AIH were included, with a median age of 40 years at diagnosis (range 19–79); 15/22 (68%) were female and 18/22 (82%) were Caucasian. The median period from diagnosis to the end of follow up in these patients was 11 years (Range: 3, 28). Values of alanine aminotransferase, aspartate aminotransferase and albumin improved significantly following rituximab therapy, and were sustained for up to two years (all p  Conclusion In patients with difficult-to-manage AIH, rituximab appears clinically effective and well tolerated. Treatment was associated with sustained improvements in serum liver tests, an absence of clinical disease flares, and a reduction in prednisolone dose. B-cell targeting therapies warrant further controlled trial evaluation in patients with AIH. Lay summary Autoimmune hepatitis is an autoimmune condition of liver, usually treated with medications which suppress the immune system such as steroids. In some patients, liver continues to inflame despite treatment with conventional medications and for that reason, we had to escalate the treatment. Rituximab is an infusion given to those whom are not responding to first- and second-line therapies. The treatment is only given in specialised liver centres. This is the international study and we collected data from 22 patients whom had rituximab therapy. The aim was to examine the safety of the medication and the response of therapy in patients with autoimmune liver disease. The study showed that it is safe as well as improve liver blood tests in 70% of patients during the period of 2 years follow up. In patients who had rituximab, we managed to taper down the dose of steroids in 2/3rd of the patients which is a good clinical outcome since steroid is associated with significant side effects such as weight gain, increased risk of diabetes and osteoporosis.