SEQUENCE: Risankizumab versus ustekinumab across endpoints

Risankizumab outperformed ustekinumab regarding symptom improvement, clinical response and remission rates, and patient-reported outcomes, across all timepoints, in patients with moderate-to-severe Crohn’s disease (CD) for whom at least 1 prior TNF inhibitor had failed. This was shown in an updated analysis of the phase 3b SEQUENCE trial.

“STRIDE-II recommendations suggest that symptom relief should be an early treatment goal for patients with moderate-to-severe CD,” stated Prof. Marla Dubinsky (Mount Sinai Hospital, NY, USA) [1,2]. The SEQUENCE trial (NCT04524611) compared risankizumab and ustekinumab in patients with moderate-to-severe CD who had been treated with 1 or more anti-TNF agents (n=520). The participants were randomised in a 1:1 fashion and a previous presentation had demonstrated that the primary endpoints –week 24 clinical remission and week 48 endoscopic remission– were met [3]. Prof. Dubinsky presented updated and additional results for various clinical endpoints [2].

“Crohn's Disease Activity Index (CDAI) clinical response (defined as a reduction of CDAI ≥100 points from baseline) significantly improved in participants receiving risankizumab compared with those receiving ustekinumab at week 8 (60.7% vs 51.3%), week 24 (69.8% vs 54.3%), and week 48 (67.4% vs 46.8%),” expressed Prof. Dubinsky. Moreover, in the updated data set, CDAI clinical remission (defined as CDAI ≤150) rates continued to significantly favour risankizumab over ustekinumab at week 24 (59.6% vs 42.6%) and week 48 (60.8% vs 40.8%). Similar results were observed for stool frequency/abdominal pain score clinical remission at week 24 and week 48 (see Figure).

Figure: SF/APS clinical remission in the SEQUENCE trial [2]



SF/APS clinical remission defined as average stool frequency ≤2.8 and abdominal pain score ≤1, and neither worse than baseline.

“Greater symptom improvements and higher clinical response and clinical remission rates were seen in patients on risankizumab than in patients on ustekinumab in this analysis that used the full dataset of the SEQUENCE trial,” Prof. Dubinsky concluded.

1. Turner D, et al. Gastroenterology. 2021;160:1570-1583.
2. Dubinsky MC, et al. Risankizumab versus Ustekinumab for the achievement of clinical outcomes and symptom improvements in patients with moderate to severe Crohn’s disease: results from the phase 3b SEQUENCE trial. OP36, 19^th Congress of ECCO, 21–24 February 2024, Stockholm, Sweden.
3. Peyrin-Biroulet L, et al. Abstract LB01, UEG Journal. 2023;11(S8).

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Posted on 18 April 202418 April 2024