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There remains a need for longer-term observational studies comparing the 2 treatments.
New data shows a similar efficacy between anti-tumor necrosis factor agents (anti-TNF) and ustekimumab in treating patients with Crohn’s disease.
A team, led by Hisashi Shiga, Tohoku University Graduate School of Medicine, compared the efficacy of anti-TNF agents and ustekinumab in biologic-naïve patients with Crohn’s disease in data presented at the Digestive Disease Week (DDW) 2022 Meeting in San Diego.
Despite positive trial results, there remains a need for larger, longer-term studies comparing the efficacy of anti-TNF agents with ustekinumab in patients with Crohn’s disease.
In the study, the investigators examined data from a large nationwide, anonymized Japanese database with administrative medical claims data and various other related patient data.
The system has been introduced in more than 1700 acute care hospitals in Japan as of April 2020.
The investigators excluded patients with confirmed diagnosis of concomitant diseases that could lead to the use of biologics and patients with a history of biologic use within 6 months prior to the first administration of biologics to be evaluated.
The investigators compared efficacy between patients treated with anti-TNF agents and ustekinumab in a propensity score matched cohort with similar clinical characteristics.
The investigators sought primary outcomes of the rates of hospitalization, surgery, and persistence, defined as the changes in biologics due to the exacerbation of Crohn’s disease.
Overall, there were 53,540 patients with confirmed Crohn’s disease identified, 7047 of which were extracted for eligibility. Of this group, 5665 were treated with anti-TNF agents and 1382 were treated with ustikenumab.
After the propensity score matching using the 1:1 nearest neighbor method, 1379 patients in each group were included in the analysis.
The cumulative hospitalization rates were similar between the anti-TNF cohort and the ustekinumab group (P = 0.85; 25.3% vs. 26.5% at 1 year, 33.8% vs. 39.8% at 2 years). The cumulative surgery rates were also comparable (P = 0.46; 5.5% vs. 5.1% at 1 year, 8.3% vs. 8.4% at 2 years).
The persistence rate at 1 year was, however, higher in the ustinumab group (90.8% vs. 92.5%), while at 2 years it was higher in the anti-TNF group (81.2% and 74.6%).
However, there was no significant difference in the cumulative persistence rate between the 2 groups (P = 0.55).
There were some limitations identified in the study. For example, the database used does not provide accurate information for disease activity and the investigators were unable to adjust for factors that they did not measure.
The next step though would be to evaluate long-term outcomes, including surgery using a longer observation period.
“Anti-TNF agents and UST appear to have comparable efficacy in biologic-naïve patients with CD,” the authors wrote “This study might provide useful information on the selection of biologic agents for biologic-naïve patients with CD.”
The study, “EP1276: USTEKINUMAB HAS COMPARABLE LONG-TERM EFFECTIVENESS AS ANTI-TNF AGENTS IN BIOLOGIC-NAÏVE PATIENTS WITH CROHN'S DISEASE,” was published online by DDW 2022.