Source: Alert from UpdatesPlus-IBD
Abbvie has announced three new Phase 3 studies of Humira in IBD
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.
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- 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