Skyrizi Surpasses Stelara: AbbVie’s Breakthrough in Late-Stage Crohn’s Disease Trial

Skyrizi Triumphs Over Stelara: AbbVie’s Breakthrough in Crohn’s Disease Trial

In a head-to-head showdown, AbbVie’s Skyrizi (risankizumab) has not only matched but potentially outpaced Johnson & Johnson’s Stelara (ustekinumab) in patients battling Crohn’s disease, according to the latest data from the Phase III SEQUENCE trial.

This pivotal trial was designed to determine if Skyrizi could establish non-inferiority to Stelara in terms of clinical remission. However, Skyrizi not only met this threshold but also showed promising signs of superiority. An impressive 59% of Skyrizi-treated patients achieved remission compared to just 40% among those treated with Stelara.

The primary endpoint of the study, remission, was defined as achieving scores below 150 on the Crohn’s Disease Activity Index by week 24.

Roopal Thakkar, AbbVie’s Chief Medical Officer and Senior Vice President of Development and Regulatory Affairs, hailed the results as a significant win for Skyrizi and a boon for Crohn’s disease patients. Thakkar emphasized that Skyrizi’s potential extends beyond clinical remission, offering hope for both clinical and endoscopic remission.

Both Skyrizi and Stelara have received FDA approval for Crohn’s disease, although Stelara secured its regulatory green light roughly six years earlier in September 2016, with Skyrizi following suit in June 2022. These therapeutic antibodies share common indications, including plaque psoriasis and psoriatic arthritis.

While their mechanisms of action are similar, with both disrupting the inflammatory cascade, Skyrizi specifically blocks the interaction between IL-23 and its receptor. In contrast, Stelara targets both IL-12 and IL-23 in the inflammatory pathway, addressing critical symptoms in related conditions.

The SEQUENCE trial, initiated in August 2020, engaged in a rigorous comparison of Skyrizi and Stelara among 527 patients with moderate-to-severe Crohn’s disease who had previously failed anti-tumor necrosis factor therapy. Alongside evaluating efficacy, the study also assessed Skyrizi’s safety profile, finding no new safety concerns.

Common side effects associated with AbbVie’s antibody included headaches, COVID-19, and Crohn’s disease itself.

This recent success in the SEQUENCE trial adds to Skyrizi’s growing list of achievements. In ulcerative colitis, another form of inflammatory bowel disease, Skyrizi has demonstrated significant and clinically meaningful improvements in remission, both as an induction and maintenance therapy. These findings formed the basis for AbbVie’s recent regulatory submissions.

Back in July 2023, Skyrizi also emerged victorious in another head-to-head study, this time outperforming Amgen’s Otezla (apremilast) in the treatment of plaque psoriasis.

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