Inclusion of patients receiving Biosimilar Infliximab - Remsima™ & Inflectra™
Dr Tariq Ahmad
The latest version of the PANTS protocol allows the inclusion of Crohn's disease patients receiving Biosimilar Infliximab. Specifically this allows
- Inclusion of anti-TNF naive Crohn's disease patients starting Remsima™ or Inflectra™
- Existing PANTS study participants receiving RemicadeTM to switch to Remsima™ or Inflectra™
The PANTS study is a prospective uncontrolled cohort study investigating primary non-response, loss of response and adverse drug reactions to Infliximab and Adalimumab in patients with severe active luminal Crohn's disease. The study started in March 2013 and to date 1200 patients aged over 6 years have been recruited from 118 UK hospitals. The collection of clinical data is aligned and shared with the Royal College of Physicians UK IBD Biologics Audit (and in due course with the UK IBD registry), and individual patient laboratory data is released on the web portal.
Biosimilar Infliximab became available in the UK in February 2015 offering significant savings to the National Health Service. Extensive non-clinical and clinical data have shown comparability with the reference product, Remicade™. However the clinical data to date has emerged from the use of Biosimilar Infliximab in studies of patients with Ankylosing Spondylitis and Rheumatoid Arthritis. The PANTS study will report the initial UK experience of Biosimilar Infliximab in Crohn's disease, providing important post-authorisation data on efficacy (at week 14, 30 and 54), safety (to 3 years) and pharmacokinetics. We aim to include 225 patients treated with Biosimilar Infliximab as first-line anti-TNF treatment and 100 PANTS "switchers" over the next 12 months. Please do consider recruiting your patients to the PANTS study.
For further information please contact email@example.com or 01392 406850