Similar efficacy of ustekinumab and adalimumab for moderate-to-severe CD

Ustekinumab and adalimumab both showed high efficacy in biologic-naïve patients with moderate-to-severe Crohn’s disease (CD). No significant difference in clinical remission rate was observed between the two therapies at 52 weeks of follow-up. The multicentre, randomised, blinded SEAVUE study was the first trial comparing these two biologics head-to-head in a population of CD patients.

Head-to-head studies are needed to make informed treatment decisions. In the SEAVUE study (NCT03464136), biologic-naïve moderate-to-severe CD patients (n=386) were randomised to ustekinumab, an IL-12/23(p40) antagonist, or adalimumab, a TNF antagonist. Safety and efficacy of both therapies was assessed. Patients in the ustekinumab arm received 6 mg/kg ustekinumab, intravenously injected, followed by a subcutaneous dose of 90 mg every 8 weeks. Patients in the adalimumab arm received 4 doses of 40 mg adalimumab, subcutaneously injected, in the first 2 weeks, followed by 2 doses of 40 mg in week 2-4 of the study. Hereafter, these patients were administered 40 mg of adalimumab every 2 weeks. Clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) score <150, was the primary endpoint of this trial. Dr Peter Irving (Guy’s and St. Thomas’ Hospital, UK) presented the results [1].

There was no significant difference in clinical remission rates between adalimumab and ustekinumab at 52 weeks of follow-up (61.0% vs 64.9%; P=0.417). Major secondary endpoints confirmed this result. The number of patients in corticoid-free remission at 52 weeks was similar for the 2 arms (adalimumab 57.4% vs ustekinumab 60.7%). Endoscopic remission, defined as simple endoscopic score for Crohn’s disease (SES-CD) ≤3, did not show a significant difference in efficacy between adalimumab (30.7%) and ustekinumab (28.5%) in this population. Moreover, the 2 therapies demonstrated a similar pattern of increasing clinical remission rates over the course of the study.

The results of the safety analysis were consistent with prior experience for both medications. Among users of adalimumab, 77.9 % experienced at least one adverse event. Among ustekinumab recipients, adverse events were reported in 80.1%.

1. Irving P M, et al. Ustekinumab versus adalimumab for induction and maintenance therapy in Moderate-to-Severe Crohn’s Disease: The SEAVUE study. OP02, ECCO 2021 Virtual Congress, 2-3 & 8-10 July.

 

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Posted on 2 July 20218 April 2024