Drug Development

J&J, GSK stumble coming out of the gate with mixed PhIII rheumatoid arthritis data for sirukumab

This is a big weekend for the wave of late-stage drugs lining up for a slice of the multibillion-dollar rheumatoid arthritis market. And J&J and GlaxoSmithKline got things started by spelling out the data in a less-than-stellar matchup against AbbVie’s Humira.

Investigators turned up at the annual American College of Rheumatology meeting in Washington DC to report a hit and a miss in a Phase III head-to-head between sirukumab — a top rheumatoid arthritis drug in both J&J’s as well as GSK’s late-stage pipeline — and Humira.

Patients taking 50 mg of sirukumab dosed every 4 weeks and 100 mg dosed every two weeks achieved somewhat better responses — a 2.58 and 2.96 drop from baseline on the disease activity score —  than the 2.19 drop for patients taking a lower 40 mg dose of Humira every two weeks. That was a statistically significant response.

That Humira regimen, though, beat the 50 mg sirukumab dose on hitting ACR50, a minimum 50% improvement in signs and symptoms of the disease, and barely missed matching the 100 mg dose, missing the second primary endpoint in the study. The 50 mg and 100 mg sirukumab numbers hit 27% and 35% on ACR50 compared to 32% of the Humira group.

The high dose of sirukumab also registered a higher rate of serious adverse events in the 50 mg group, with 7% reporting a serious AE compared to 3% in the 100 mg group and 4% taking Humira.

In the second Phase III study among patients resistant to anti-TNF drugs, like Humira, the ACR20 scores were 40% and 45% for the 50 mg and 100 mg sirukumab doses and 24% in the placebo arm.

None of that spells disaster for this drug. But it’s just one of several new contenders for the market crown and payers will be devoting particularly close attention to the head-to-head numbers for Humira, as biosimilars are lining up to decimate the $14 billion franchise — sooner or later.

J&J has repeatedly tapped sirukumab as a key part of its Phase III effort to line up major new products for the marketing group. GSK, meanwhile, has been trying to overcome persistent criticism that its pipeline lacks pizzazz. In their deal on sirukumab, GSK gained commercial rights in the US and the Western Hemisphere, while J&J lined up Europe and the rest of the world.

Still to come this weekend: New data on Eli Lilly’s baricitinib, an oral rival in-licensed from Incyte. Sanofi and Regeneron are grappling with a recent rejection for their IL-6 contender sarilumab, stiff-armed by the FDA due to manufacturing concerns, which also posted a superior profile to Humira for rheumatoid arthritis.

And further back in the pipeline are even more big drugs that will look to grab best-in-class status.

A few weeks ago AbbVie turned its back on Ablynx’s Phase III-ready IL-6 drug vobarilizumab, shrugging off its $175 million upfront buy-in, after that drug also turned in an unimpressive performance compared to Roche’s Actemra. AbbVie is looking to its own in-house program for ABT-494 to produce the best new drug in the field. Gilead stepped in after AbbVie also spurned its partnership with Galapagos on filgotinib, paying $725 million to acquire rights to the JAK1 drug.


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