AbbVie : Phase 3 Study Of Skyrizi In Crohn's Disease Meets All Primary And Secondary Endpoints

(RTTNews) - AbbVie (ABBV) presented positive results from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of risankizumab (Skyrizi, 600 mg intravenous [IV] at week 0, 4 and 8 and 360 mg subcutaneous [SC] starting at week 12 and every 8 weeks thereafter) compared to ustekinumab (STELARA, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) in patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs.

The data were presented at the United European Gastroenterology Week 2023, October 14-17.

The company noted that Risankizumab met both primary endpoints of non-inferiority for clinical remissiona (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remissionb at week 48 versus ustekinumab.

In addition, risankizumab demonstrated superiority compared to ustekinumab for all ranked secondary endpoints, including achievement of clinical remission at week 48, achievement of endoscopic response at week 48 and 24, achievement of steroid-free endoscopic remission at week 48, and achievement of steroid-free clinical remission at week 48.

The company noted that the safety profile of risankizumab in the SEQUENCE study was consistent with the known safety profile of risankizumab, with no new safety risks observed. The most common adverse events in risankizumab-treated patients were COVID-19, headache and Crohn's disease. COVID-19, Crohn's disease and arthralgia were most common among ustekinumab-treated patients. Serious adverse events occurred in 10% of risankizumab-treated patients and 17% of ustekinumab-treated patients, respectively.

Risankizumab is an IL-23 inhibitor approved for Crohn's disease, psoriatic arthritis and psoriasis and is being evaluated as a treatment for adults with moderate to severe ulcerative colitis.

Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain. It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.

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