4CPS-141 Indirect comparison of risankizumab versus upadacitinib for the maintenance of moderate to severe crohn’s disease

<h3>Background and Importance</h3> Risankizumab has recently been approved for use in patients with moderate to severe Crohn’s disease (msCD). There is a direct comparison between risankizumab and ustekinumab, but the clinical benefit versus upadacitinib is unknown. <h3>Aim and Objectives</h3> The aim of this study was to perform an indirect treatment comparison (ITC) of the efficacy during the maintenance phase of risanlizumab and upadacitinib in patients with msCD using a common comparator, and to establish whether both treatments can be declared equivalent therapeutic alternatives (ETA). <h3>Material and Methods</h3> A bibliographic search was conducted in MEDLINE-Pubmed to identify phase III clinical trial (CTs), with similar population and with the same variable, which could allow comparison between risanlizumab and upadacitinib. The clinical remission (CR) beteween week 44–52 was used as the main variable. An ITC was performed using the Bucher method, using the Indirect Treatment Comparisons calculator from the Canadian Agency for Health Technology. Delta value (D, maximum difference as a clinical criterion of equivalence) was calculated using the reference value used for the sample calculation in the clinical trial of risankizumab vs ustekinumab (absolute risk reduction (ARR)=10%). To establish the positioning, ETA guidelines were applied. <h3>Results</h3> A total of 3 CTs were included in the ITC: SEQUENCE (risanlizumab 360mg every 8 week vs ustekinumab 90mg every 8 week), IM-UNITI (ustekinumab 90 mg every 8 week vs placebo) and U-ENDURE (upadacitinib 30mg every 24 hours vs placebo). The results of each trial and the conducted ITC are summarised in table 1. Applying the ETA guidelines, both treatments can be declared ATE, as the probability of clinically relevant difference is minus 50%, and the failure does not involve serious/irreversible damage. <h3>Conclusion and Relevance</h3> ITC showed no statistically significant differences in CR between risankizumab and upadacitinib. According to the ETA guidelines, as the percentage outside the delta margin was small, both drugs could be considered as ETA in most patients with msCD during the maintenance phase. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest