Unmet needs and new models for future trials in autoimmune hepatitis

Lancet Gastroenterol Hepatol. 2018 May;3(5):363-370. doi: 10.1016/S2468-1253(18)30043-8. Epub 2018 Apr 6.

Abstract

Despite advances in understanding and treatment of autoimmune hepatitis, important unmet clinical needs remain in both adult and paediatric patient populations. The evolving research landscape and assembly of large patient cohorts are creating unique opportunities to translate science into new therapies and care pathways, with the potential to substantially improve the lives of patients with autoimmune hepatitis. However, these areas of unmet need represent real challenges that need to be addressed if this vision is to be realised. In this Viewpoint, we outline the challenges in adult autoimmune hepatitis, particularly in relation to disease-modifying therapy, and trial design and delivery. Paediatric autoimmune hepatitis presents its own set of challenging problems.

MeSH terms

  • Adrenal Cortex Hormones / adverse effects
  • Adrenal Cortex Hormones / therapeutic use
  • Adult
  • Azathioprine / adverse effects
  • Azathioprine / therapeutic use
  • Biomarkers / blood
  • Child
  • Disease Progression
  • Hepatitis, Autoimmune / diagnosis
  • Hepatitis, Autoimmune / drug therapy*
  • Hepatitis, Autoimmune / pathology
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use
  • Medication Adherence
  • Patient Outcome Assessment
  • Prednisolone / adverse effects
  • Prednisolone / therapeutic use
  • Recurrence
  • Remission Induction

Substances

  • Adrenal Cortex Hormones
  • Biomarkers
  • Immunosuppressive Agents
  • Prednisolone
  • Azathioprine