Ustekinumab persistence high, safe at 12 months in ‘difficult-to-treat’ Crohn’s patients

ByKate Burba

Long-term ustekinumab effectively and safely treated most patients in a “difficult-to-treat” Crohn’s disease cohort, according to research presented at the European Crohn’s and Colitis Organization meeting.

“Ustekinumab (UST), an anti-interleukin-12/23 antibody, has successfully been introduced in the treatment of inflammatory bowel disease, mainly in patients failing anti-TNF-agents,” Francesca Bello, MD, of the Karolinska University Hospital IBD Unit in Stockholm, and colleagues wrote. “The STOCUSTE study includes IBD patients treated with UST at four teaching hospitals in Stockholm to provide long-term follow-up data.”

Ustekinumab treatment outcomes at 12 months among patients with Crohn’s: “Side A” – High ustekinumab persistence; 56%; “Side B” – Crohn’s disease remission; 53%

In a retrospective study, Bello and colleagues assessed disease activity [Harvey-Bradshaw Index (HBI)], Physician Global Assessment (PGA), laboratory parameters and drug persistence in 120 CD patients (51% women, median age 27 years) during 12 months of treatment with UST. Primary outcomes included remission (HBI score 4; PGA = 0) as well as response (decreased HBI 3; PGA 1) at months 3 and 12. Researchers noted 91% of patients had failed at least one anti-TNF drug regimen and 49% failed more than two.

At 3 and 12 months, respectively, researchers reported high persistence of UST in 93% and 56% of patients, with achieved remission in 38% and 53%; an additional 26% achieved response at 12 months. They further observed a decline in median fecal calprotectin levels from 272 µg/g at baseline to 75 µg/g at 3 months (P < .01), a slight decrease in C-reactive protein over 12 months (3 mg/L-1 mg/L), as well as increases in hemoglobin and serum albumin. Persisting disease activity induced treatment withdrawal among 44% of patients within the first 12 months.

“Ustekinumab was, in fact, used in a difficult-to-treat Crohn's disease patient cohort, so in patients that had priorly tried many other biological treatments. ... It was effective in the majority with a high response rate,” Bello concluded, “and it had overall favorable safety profile.”

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Source:

Bello F, et al. Abstract DOP88. Presented at: Congress of European Crohn’s and Colitis Organization; Feb.16-19, 2022 (virtual meeting).

Disclosures: Bello reports no relevant financial disclosures.

Congress of European Crohn's and Colitis Organization

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Ustekinumab persistence high, safe at 12 months in ‘difficult-to-treat’ Crohn’s patients

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