GlaxoSmithKline and partner Johnson & Johnson have posted a mixed bag of results from their next-gen IL-6 arthritis med sirukumab when pitted against the blockbuster anti-TNF Humira (adalimumab).
There was a two-part process to the late-stage test in rheumatoid arthritis (RA) and in the first, sirukumab showed a greater improvement in patients using the $13-billion-a-year Humira, according to data published this weekend at the American College of Rheumatology in Washington, reported by Reuters.
This positive news did not however spread to the second part of the test as, although the signs and symptoms of RA were lowered by at least half among a number of patients, the proportion of those who achieved that goal was not significantly different across all groups.
Back in June, the two released positive Phase III data for their experimental med showing it hit its co-primary endpoints of having less joint damage after one year compared to placebo, and it improved patients’ condition by 20% or more in half of those in the treatment arms under the ACR20 score.
And two months ago, the partners submitted their marketing app to European regulators for a subcutaneous formulation of sirukumab for patients with moderately to severely active RA.
It is battling with rivals Regeneron ($RGEN) and Sanofi’s ($SNY) offering sarilumab--although this was hit with a setback at the end of October when it handed a complete response letter from the FDA for manufacturing concerns, likely delaying any approval until next year.
Back in March, their drug however showed that it could beat out AbbVie's ($ABBV) Humira in a Phase III head-to-head.
If approved, both drugs will face competition from incumbents including Humira, an incoming wave of biosimilars and, potentially in the future, JAK1 inhibitors and other next-generation products from the likes of AbbVie and Gilead ($GILD).