Intestinal research · 2026
First-line biologic therapy selection highly impacts ulcerative colitis outcomes: results from the APPETISER study.
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M'Baye Diari, Hupé Marianne, Dodel Marie, Bazoge Maëva, Pereira Bruno, Buisson Anthony
Аннотация
BACKGROUND/AIMS: We compared the effectiveness of 2 strategies based on the choice of the first biologic owing to either drug efficacy or better acceptability in patients with ulcerative colitis (UC).
METHODS: We collected real-world data of all consecutive UC patients ≥ 18 years starting a first line of biologic for active UC with follow-up > 6 months. Patients were considered as receiving either an effectiveness-based strategy (EBS) if they started with infliximab or vedolizumab, or acceptability-based strategy (ABS) if they started with adalimumab or golimumab. Corticosteroid-free clinical remission (PRO2-CFREM) was defined as the absence of bleeding, normalization of stool frequency and no steroid assessed as a binary criterion each month. All comparisons were adjusted using propensity scores.
RESULTS: Overall, 130 patients and 3,355 months were analyzed. The percentage of months spent in PRO2-CFREM within the first 24 months (primary endpoint) was greater in EBS arm than in ABS arm (74.2% vs. 46.6%; P< 0.001), was higher within the first 6 months (60.4% vs. 18.9%), and was not rescued later between months 7 and 12 (73.1% vs. 38.6%), months 13 and 18 (79.9% vs. 57.0%) or M19 and M24 (83.3% vs. 64.6%) (P< 0.001 for all comparisons). EBS group had a lower risk to first-line biologic discontinuation (adjusted hazard ratio [aHR], 6.5; 95% confidence interval [CI], 2.8-15.3: P< 0.001) and a trend for lower risk of colectomy (aHR, 4.5; 95% CI, 0.9-22.3; P= 0.068).
CONCLUSIONS: The choice of first-line biologic is highly impacting UC outcome and cannot be fully compensated by later treatments, advocating for the use of the most effective therapeutic option as first-line biologic.
METHODS: We collected real-world data of all consecutive UC patients ≥ 18 years starting a first line of biologic for active UC with follow-up > 6 months. Patients were considered as receiving either an effectiveness-based strategy (EBS) if they started with infliximab or vedolizumab, or acceptability-based strategy (ABS) if they started with adalimumab or golimumab. Corticosteroid-free clinical remission (PRO2-CFREM) was defined as the absence of bleeding, normalization of stool frequency and no steroid assessed as a binary criterion each month. All comparisons were adjusted using propensity scores.
RESULTS: Overall, 130 patients and 3,355 months were analyzed. The percentage of months spent in PRO2-CFREM within the first 24 months (primary endpoint) was greater in EBS arm than in ABS arm (74.2% vs. 46.6%; P< 0.001), was higher within the first 6 months (60.4% vs. 18.9%), and was not rescued later between months 7 and 12 (73.1% vs. 38.6%), months 13 and 18 (79.9% vs. 57.0%) or M19 and M24 (83.3% vs. 64.6%) (P< 0.001 for all comparisons). EBS group had a lower risk to first-line biologic discontinuation (adjusted hazard ratio [aHR], 6.5; 95% confidence interval [CI], 2.8-15.3: P< 0.001) and a trend for lower risk of colectomy (aHR, 4.5; 95% CI, 0.9-22.3; P= 0.068).
CONCLUSIONS: The choice of first-line biologic is highly impacting UC outcome and cannot be fully compensated by later treatments, advocating for the use of the most effective therapeutic option as first-line biologic.