AbbVie's SKYRIZI® (risankizumab) Versus STELARA® (ustekinumab) Head-to-Head Study in Crohn's Disease Meets All Primary and Secondary Endpoints

AbbVie, a leading pharmaceutical company, has announced positive results from its Phase 3 SEQUENCE study evaluating the efficacy and safety of risankizumab (SKYRIZI®) compared to ustekinumab (STELARA®) in patients with moderately to severely active Crohn’s disease. The data, presented at the United European Gastroenterology (UEG) Week 2023, demonstrated that risankizumab was superior to ustekinumab in achieving clinical remission and endoscopic response.

Crohn’s disease is a chronic inflammatory condition that affects the gastrointestinal tract, causing symptoms such as persistent diarrhea and abdominal pain. It is a progressive disease that can worsen over time and may require urgent medical intervention, including surgery. The unpredictable nature of the disease places a significant burden on patients, both physically and emotionally.

The SEQUENCE study included patients who had failed one or more anti-tumor necrosis factor (TNF) therapies. Risankizumab, an interleukin-23 (IL-23) inhibitor, demonstrated superiority over ustekinumab in achieving clinical remission and endoscopic response at both week 24 and week 48. These findings provide physicians with valuable data to inform treatment options and help patients reach their treatment goals.

Dr. Roopal Thakkar, Senior Vice President, Development and Regulatory Affairs, and Chief Medical Officer at AbbVie, expressed the company’s commitment to advancing care for patients with immune-mediated conditions. The positive results from the SEQUENCE study not only differentiate SKYRIZI as a treatment option for managing Crohn’s disease but also contribute to the evolving field of therapeutic strategies.

Dr. Laurent Peyrin-Biroulet, Director of the Infinity Institute and Professor of Gastroenterology, emphasized the significance of these findings in supporting the achievement of stringent treatment targets for patients. The efficacy of SKYRIZI as an interleukin-23 inhibitor highlights its potential to improve care and outcomes for individuals living with Crohn’s disease.

The safety profile of risankizumab in the SEQUENCE study was consistent with its known safety profile, with no new safety risks observed. The most common adverse events reported were COVID-19, headache, and Crohn’s disease. Serious adverse events occurred in a small percentage of patients.

Risankizumab is currently approved for the treatment of Crohn’s disease, psoriatic arthritis, and psoriasis. Ongoing clinical trials are evaluating its efficacy in treating moderate to severe ulcerative colitis.

AbbVie’s collaboration with Boehringer Ingelheim in the development and commercialization of risankizumab underscores the company’s commitment to delivering innovative medicines and solutions. AbbVie aims to make a positive impact on the lives of patients across various therapeutic areas, including immunology, oncology, neuroscience, and eye care.

In conclusion, AbbVie’s presentation of positive results from the SEQUENCE study highlights the potential of risankizumab as an effective treatment option for patients with moderately to severely active Crohn’s disease. These findings contribute to the advancement of therapeutic strategies and offer hope for improved care and outcomes for individuals living with this chronic condition.