Thursday, February 20, 2014

Abbvie announces new Phase 3 Humira studies for IBD - pediatric UC study and an investigation of high dose Humira for UC and CD

Source: Alert from UpdatesPlus-IBD

Abbvie has announced three new Phase 3 studies of Humira in IBD
  • The first study is a Phase 3 study evaluating Humira in pediatric UC [NCT02065557].  Data are expected in 2018.  Placing this in context, Remicade has a pediatric UC indication; a Simponi study in this cohort has opened although this is a Phase 1
  • Humira is normally given for IBD as an induction dose of 160mg followed by 80mg two weeks later and then a maintenance dose of 40mg q2w thereafter. Two further studies are are evaluating new treatment regimens in UC [NCT02065622] and CD [NCT02065570].  In both cases a new, higher induction dose is being employed.  In the UC study, the higher dose is also being employed through the maintenance period
  • The studies are expected to complete 2018
Comments:  The pediatric study is important as it will maintain competitiveness with other biologics, offering a similar breadth of indications.  The two studies evaluating the new treatment regimens are potentially more important.  These studies may carry two implications.  Firstly, it may be that Abbvie can strengthen its patent portfolio by claiming specific new regimens.  We note that for the past year Abbvie has been hinting at new Humira presentations as a biosimilar defense and the new studies may reflect this strategy.  These data will likely emerge at around the same time as biosimilar adalimumab data.  This will allow Abbvie at the very least to deflect attention away from biosimilar.  At best, Abbvie may be able to claim proprietary on a higher dose than that to be employed by biosimilars (note that current Phase 3 adalimumab biosimilar trials are for RA and/or PsO and use in IBD will require extrapolation.  This is not a given as recently observed in Canada where extrapolation to IBD was denied for Inflectra).   Secondly, despite the commercial success of Humira, its efficacy as an induction agent is suboptimal.  With  a new dosing regimen Abbvie may be able to improve induction efficacy.

Regular analysis of breaking events in IBD is provided through our UpdatesPlus-IBD service. For an executive summary of our January issue click here