• SEQUENCE, a Phase 3 head-to-head study, compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNFs¹
• Risankizumab met both primary endpoints of non-inferiority for clinical remission^a (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remission^b at week 48 versus ustekinumab¹
• Risankizumab showed superiority versus ustekinumab for all ranked secondary endpoints, including achievement of clinical remission^a at week 48, achievement of endoscopic response^c at week 48 and 24, achievement of steroid-free endoscopic remission^d at week 48 and achievement of steroid-free clinical remission^e at week 48¹
• Safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified

"At AbbVie, we are committed to developing medicines and generating evidence that advance care for people living with immune-mediated conditions, including inflammatory bowel diseases," said Roopal Thakkar, M.D., senior vice president, development and regulatory affairs and chief medical officer, AbbVie. "Results such as these not only help differentiate SKYRIZI as an option for managing Crohn's disease, but also may help to evolve the field by further informing on therapeutic strategies for patients."

The SEQUENCE study included two sequentially tested primary endpoints:

• The results of the first primary endpoint, clinical remission (CDAI <150) at week 24, met non-inferiority of risankizumab versus ustekinumab (pre-defined non-inferiority margin of 10%); remission rates were 59% in risankizumab group and 40% in ustekinumab group.¹ This endpoint was also analyzed post hoc to test for superiority and achieved nominal p<0.01.¹
• The results of the second primary endpoint, endoscopic remission (Simple Endoscopic Score for Crohn's disease [SES-CD] ≤4 and at least a 2-point reduction versus baseline and no sub-score greater than 1 in any individual component) at week 48 demonstrated superiority with risankizumab compared to ustekinumab with remission rates of 32% in risankizumab group and 16% in ustekinumab group (p<0.0001).¹

Additionally, 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 48.¹

^*The first primary endpoint was clinical remission (per CDAI) at week 24, and the second primary endpoint was endoscopic remission (per SES-CD) at week 48. Non-inferiority was met for the first primary endpoint. The second primary and all secondary endpoints achieved statistical significance with a p-value of <0.0001 vs ustekinumab.
^†The first primary endpoint was tested when 50% of participants completed the week 24 visit or ended the study participation.
^aClinical remission (per CDAI) was defined as CDAI <150.
^bEndoscopic remission (per SES-CD) was defined as SES-CD ≤4 with at least a 2-point reduction from baseline and no sub-score greater than 1 in any individual component, as scored by central reviewer.
^cEndoscopic response (per SES-CD) was defined as a decrease in SES-CD >50% from baseline (or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline), as scored by central reviewer.
^dSteroid-free endoscopic remission (per SES-CD) was defined as the achievement of endoscopic remission without receiving steroids at the corresponding visit.
^eSteroid-free clinical remission (per CDAI) was defined as the achievement of clinical remission without receiving steroids at the corresponding visit.

"The results from the SEQUENCE study provide physicians with important data to help inform therapy options that can help patients reach treatment goals," said Laurent Peyrin-Biroulet, M.D., Ph.D., director of the Infinity Institute, professor of gastroenterology and head of the inflammatory bowel disease group, gastroenterology department at the University Hospital of Nancy, France. "These findings reaffirm SKYRIZI as an efficacious interleukin-23 inhibitor that can support the achievement of stringent targets that contribute to improved care for patients."

The safety profile of risankizumab in the SEQUENCE study was consistent with the known safety profile of risankizumab, with no new safety risks observed.¹ 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.¹ Serious adverse events occurred in 10% of risankizumab-treated patients and 17% of ustekinumab-treated patients, respectively.¹

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.¹

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