‘Surprisingly high’ remission rates for both ustekinumab, adalimumab in Crohn’s patients
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Ustekinumab and adalimumab demonstrated equally high rates of clinical remission in biologic-naïve patients with moderate to severe Crohn’s disease through 1 year of treatment, according to results of the SEAVUE study in The Lancet.
“Although SEAVUE did not demonstrate superior efficacy of ustekinumab over adalimumab, both agents showed surprisingly high rates of clinical remission at 1 year of treatment in this population of patients who were naïve to biologic agents,” Bruce E. Sands, MD, MS, chief of gastroenterology at Mount Sinai Health System and lead study author, told Healio. “This is important information for clinicians and underscores that early treatment with either class of agent — anti-TNF antibody or anti-p40 IL-12/23 antibody — can be quite effective. These results should be contextualized with the known safety profiles of each agent, which may guide the choice of therapy for a specific patient.”
Sands and colleagues conducted a randomized, double-blind, parallel-group, active-comparator, phase 3b trial (SEAVUE) and enrolled 386 adults with moderate to severe Crohn’s disease from 121 hospitals or private practices in 18 countries. Patients were included if they were biologic-naïve, had a score of 220 to 450 on the Crohn’s Disease Activity Index (CDAI), were unresponsive or intolerant to conventional therapy, and had at least one ulcer at baseline endoscopic examination. The primary study endpoint was clinical remission (CDAI score < 150) at week 52.
Researchers randomized patients to receive ustekinumab (n = 191; 6 mg/kg IV on day 0, then 90 mg subcutaneously every 8 weeks) or adalimumab (n = 195; 160 mg on day 0, 80 mg at 2 weeks, then 40 mg every 2 weeks subcutaneously) for 56 weeks. Twenty-nine ustekinumab patients and 46 adalimumab patients terminated their participation before week 52.
At week 52, 124 patients (65%) in the ustekinumab group and 119 patients (61%) in the adalimumab group reached clinical remission, demonstrating no significant difference between treatment groups. Thus, secondary study endpoints of corticosteroid-free remission and clinical response were nominal and deemed nonsignificant.
Safety results were similar to established safety profiles of the biologic agents, with serious infections reported in 2% of ustekinumab patients and 3% of adalimumab patients. No deaths were reported during the 52-week study.
“Our findings suggest that almost two-thirds of biologic-naive patients who receive ustekinumab or adalimumab will, in time, reach and maintain clinical remission without dose adjustment at least up to 1 year,” Sands and colleagues concluded. “The results of this study support the use of safe and effective biologic agents for patients with moderately to severely active Crohn’s disease early in the disease course and reinforce the need for direct active-comparator studies for inflammatory bowel disease treatment, rather than indirect comparisons.”
Perspective
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The SEAVUE study by Sands et al is the first of its kind, head-to-head, randomized controlled, comparative trial of two biologics – adalimumab and ustekinumab – for the treatment of Crohn's disease. The results found that both were equally effective and there was no difference in safety; in fact, both had good safety profiles.
This is an important study that furthers our understanding of head-to-head comparisons of biologic therapies for Crohn's disease. The very high rates of remission, approximately two-thirds, suggests that earlier treatment of biologic-naïve Crohn's disease patients is important. It's possible that the differences between biologic therapies will be less pronounced when used early in the disease course as first-line therapy.
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