AbbVie's Skyrizi Outperforms J&J's Stelara in Head-to-Head Crohn’s Disease Trial with 59% CDAI Remission Rate

According to FIERCEPharma, in the latest head-to-head study with Johnson & Johnson's Stelara for Crohn’s disease, Skyrizi (risankizumab) has once again put pressure on Johnson & Johnson.

Image Source: FIERCEPharma

AbbVie said Tuesday that Skyrizi was on par with Stelara in inducing clinical remission in patients with active moderate to severe Crohn's disease who failed conventional anti-tumor necrosis factor drug therapy.

Stelara is the world's first biologic that can simultaneously selectively target IL-12 and IL-23, and is also one of Johnson & Johnson's key products.

The market performance in 2022 was also exceptionally strong, with sales reaching a new high of $9.723 billion, approaching the $10 billion mark.

In the IIIb phase STARDUST study, presented at the 15th European Crohn's and Colitis Organisation (ECCO) Congress in 2020, 79% of patients achieved clinical response and 67% were in clinical remission at week 16 after receiving one intravenous infusion of Stelara at 6mg/kg and one subcutaneous injection of 90mg. Among the 220 CDAI70 responders randomized to the treat-to-target group, 37% achieved endoscopic response at week 16. During the 16-week period, the safety profile of Stelara was consistent with that observed in phase III inflammatory bowel disease (IBD) clinical trials and in other indications.

SkyriziSEQUENCE Phase 3 Trial Designed to Measure Non-Inferiority for Primary Endpoint, but Skyrizi Also Showed Significantly Superior Treatment Effectiveness Compared to Stelara. According to AbbVie,Measured by the Crohn's Disease Activity Index (CDAI), at week 24, Skyrizi achieved a CDAI of 59%, compared to Stelara at 40%.

In another study with the primary endpoint of endoscopic remission,Skyrizi Again Outperforms Stelara. In the Crohn's Disease Simplified Endoscopic Score, 32% of patients taking Skyrizi experienced remission by week 48, significantly higher than the 16% in the Stelara group.

AbbVie also stated that Skyrizi demonstrated statistically significant advantages over Stelara across all secondary endpoints, including superiority on the CDAI clinical remission scale at week 48.

In June 2022, Skyrizi received FDA approval for the treatment of Crohn's disease, based on two induction studies and one maintenance trial, which compared the IL-23 inhibitor with placebo or treatment withdrawal. Roopal Thakkar, AbbVie’s chief medical officer, stated in a Tuesday announcement. Current new head-to-head data once again demonstrates that Skyrizi is an effective treatment option for patients with Crohn's disease.

AbbVie Chief Commercial Officer Jeff Stewart mentioned in the Q2 earnings call in July that, one year after its launch, Skyrizi has captured approximately 25% of the market share among newly diagnosed and switching patients in the U.S., nearly on par with Stelara. In Q2, Skyrizi’s sales grew by 50% year-over-year, reaching nearly $1.9 billion.

Skyrizi has been achieving consecutive victories in clinical research lately. Recently, in two Phase III trials for another subtype of inflammatory bowel disease, ulcerative colitis, Skyrizi demonstrated positive results both as an induction therapy and a maintenance therapy, meeting primary and secondary endpoints.

Two weeks ago, AbbVie announced the submission of an application to the U.S. Food and Drug Administration and the European Medicines Agency for Skyrizi in the treatment of ulcerative colitis.

Just weeks before its victory in the Crohn's disease indication trial, Skyrizi also decisively outperformed Amgen’s Otezla in a plaque psoriasis trial. Study results showed that by week 16, 55.9% of patients with moderate psoriasis achieved clear or almost clear skin after taking Skyrizi, compared to only 5.1% of those taking Otezla.

Source:
AbbVie'sSkyrizidealsheavyblowtoJ&J'sStelarainhead-to-headCrohn'sdiseasestudy|FiercePharma

Editor: Baiji

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