AbbVie has shared the top-line findings from the Phase 3 SEQUENCE clinical trial, in which Skyrizi (risankizumab) was evaluated versus Stelara (ustekinumab) in patients with moderate to severe Crohn's disease who had resistance to one or more anti-TNF therapies.
Risankizumab met both primary endpoints:
Clinical remission (CDAI <150) at week 24 demonstrates non-inferiority compared to ustekinumab. Remission rates were 59% with risankizumab and 40% with ustekinumab.
Endoscopic remission at week 48, showing superiority over ustekinumab. Remission rates were 32% with risankizumab and 16% with ustekinumab.
All secondary endpoints also showed statistically significant superiority for risankizumab over ustekinumab. The safety profile of risankizumab remained consistent, with no new safety concerns identified during the study.
The SEQUENCE study was a Phase 3, multicenter, randomized, head-to-head trial evaluating risankizumab and ustekinumab in adult patients with moderate to severe Crohn's disease and who have failed on one or more anti-TNF therapies. Participants had a confirmed Crohn's disease diagnosis, moderate to severe disease activity, and demonstrated intolerance or inadequate response to anti-TNF treatments.
AbbVie has released detailed findings from the Phase 3 COMMAND maintenance study, highlighting the efficacy and safety of Skyrizi (risankizumab) in adults with moderate to severe ulcerative colitis.
The study enrolled patients who had previously shown a clinical response to risankizumab induction treatment. The study's primary endpoint was clinical remission, assessed using the Adapted Mayo Score at week 52.
In addition to the primary endpoint, the study also evaluated critical secondary endpoints. These included endoscopic improvement, histologic endoscopic mucosal improvement, and steroid-free remission at one year.
A quick overview of the response was
Clinical remission at Week 52:
Skyrizi 180 mg SC: 40%
Skyrizi 360 mg SC: 38%
Control group (only Skyrizi induction): 25%
Endoscopic improvement at Week 52:
Skyrizi 180 mg SC: 51%
Skyrizi 360 mg SC: 48%
Control group (only Skyrizi induction): 32%
Steroid-free clinical remission at Week 52:
Skyrizi 180 mg SC: 40%
Skyrizi 360 mg SC: 37%
Control group (only Skyrizi induction): 25%
The results demonstrated a significantly higher proportion of patients treated with risankizumab (180 mg or 360 mg) achieving clinical remission than those who discontinued risankizumab treatment.
In the Phase 3 INSPIRE induction study, a higher percentage of patients with moderate to severe active ulcerative colitis who received risankizumab achieved clinical remission (measured by the Adapted Mayo Score) compared to those who received placebo at week 12. Moreover, all key secondary endpoints were met. The safety results of the study were consistent with the known safety profile of Skyrizi.
The INSPIRE study included patients who were either intolerant or had an inadequate response to conventional therapies such as JAK inhibitors, biologics, and S1P receptor modulators.
Compared to the placebo, a significantly higher percentage of patients treated with risankizumab achieved endoscopic improvement at week 12 (36.5% versus 12.1%). Additionally, a higher percentage of patients treated with risankizumab (24.5%) achieved histologic-endoscopic mucosal improvement at week 12 compared to those receiving a placebo (7.7%).
The safety profile of Skyrizi was consistent with the existing profile, and no new adverse events were reported.
AbbVie is conducting a trial to determine the efficacy of Skyrizi as a maintenance therapy.