Poster Session II - A271 REAL-WORLD EFFECTIVENESS OF ABP-654 IN PATIENTS WITH INFLAMATORY BOWEL DIESEASE IN CANADA

TL;DR

This study examines the real-world effectiveness of ABP-654, a biosimilar drug, in treating inflammatory bowel disease in Canadian patients.

Contribution

The study provides initial real-world evidence on the effectiveness of ABP-654, the first approved biosimilar to ustekinumab in Canada.

Findings

Most patients improved to mild disease severity after about 8 months of ABP-654 treatment.

High rates of clinical, endoscopic, and biochemical remission were observed in patients.

Gastroenterologists reported high satisfaction with ABP-654's effectiveness.

Abstract

ABP-654 (WEZLANA®), a biosimilar to ustekinumab (UST), was approved by Health Canada in December 2023 for several immune diseases, including Crohn’s disease (CD) and ulcerative colitis (UC). Real-world data on its use remains limited.

To provide initial findings on the real-world use and effectiveness of ABP-654 as the first UST biosimilar approved for use in patients with inflammatory bowel disease (IBD) across Canada

Data were drawn from the Adelphi IBD Disease Specific Programmen TM, a cross-sectional survey with retrospective data collection from physicians conducted in Canada from May-October 2025. Gastroenterologists (GIs) provided data on their patients with IBD receiving ABP-654, who had received >2 subcutaneous doses, including demographics, clinical characteristics, treatment utilization, and satisfaction. Analyses were descriptive.

Seven GIs reported data on 32 patients (15 CD, 17 UC). Mean [standard deviation; SD] age was 46.3 [15.7] years and 59% of patients were male. Mean [SD] time since initiating ABP-654 therapy at the time of consultation was 8.4 [2.5] months; 29 initiated ABP-654 as first UST therapy and 3 previously received UST. At initiation of ABP-654, 94% (30/32) of patients had moderate to severe disease severity and 84% (27/32) of patients’ disease progression was deteriorating, as reported by their GI. Following ABP-654 therapy at the time of consultation, 22% (7/32) of patients had moderate to severe disease severity, and 3% (1/32) of patients’ disease progression was deteriorating (Figure 1A; Table 1). Additionally, 84% (27/32), 69% (22/32), and 84% (27/32) of patients had achieved clinical, endoscopic, and biochemical remission, respectively (Figure 1B). GIs reported they were satisfied and believed this was the best control that could be achieved for 88% (28/32) of patients (Table 1).

Demographics, treatment satisfaction and disease progression of patients with IBD receiving ABP-654

IBD, inflammatory bowel disease; SD, standard deviation; IQR, interquartile range; 5-ASA, 5-aminosalicyclate; GI, gastroenterologist *Patients with available data. 1GI reported treatment satisfaction is reported as a four-response categorical outcome. Not satisfied is defined as ‘not satisfied, but I believe this is the best control that can be achieved’, or ‘not satisfied and I believe better control can be achieved’.

After ∼ 8 months of follow-up, findings from this analysis indicate that most patients receiving ABP-654, improved to mild disease, achieved remission outcomes, and GIs reported high satisfaction.

Amgen Inc

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