EFFICACY AND SAFETY OF THERAPIES FOR INDUCTION AND MAINTENANCE OF REMISSION IN CROHN’S DISEASE: PROTOCOL FOR A NETWORK META-ANALYSIS

Abstract

Crohn’s disease (CD) is a complex immune mediated inflammatory disease of the intestine, affecting approximately 1 in 300 patients in countries with high prevalence such as the United States of USA and the United Kingdom and is expected to increase in future. (1)
Conventional therapies such as corticosteroids, immunomodulators and surgery played a central role in the management of IBD before the development of advanced targeted therapies. The management principles since then have been transforming, since approval of the first biologic therapy targeting tumour necrosis factor (TNF), infliximab, in early 2000s. Since then various classes of biologics namely anti-integrins, anti-IL-12/23p49, anti-IL23p19 and oral small molecules (JAKi) have been developed in the last two decades and many of them have been approved. With the availability of multiple treatment options, the choice of therapy can be challenging in clinical practice. While head-to-head blinded controlled trials are the ideal method for comparing the efficacy of different drugs, practical limitations make it challenging to conduct multiple trials encompassing all available treatment options.
There is a need for NMAs that examines and compares the efficacy and safety of advanced therapies for CD and immunomodulators.
This protocol describes the steps that will be followed to produce an NMA for induction of remission and another for maintenance of remission.