Abstract
Background
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.
Aims
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
Methods
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.
Results
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).
A271 Table 1:
Demographics, treatment satisfaction and disease progression of patients with IBD receiving ABP-654
| Patients with IBD receiving ABP- 654 | |
|---|---|
| Age, years, mean (SD) | 46.3 (15.7) |
| Sex, male, n (%) | 19 (59) |
| Ethnicity, white, n (%) | 23 (72) |
| Disease duration, years, median [IQR] | 3.9 [1.4, 7.3] |
| GI reported treatment satisfaction | |
| Satisfied and I believe this is the best control that can be achieved | 28 (88) |
| Satisfied, but I believe better control can be achieved | 4 (13) |
| Not satisfied1 | 0 (0) |
| GI reported disease progression at initiation of ABP-654, n (%) | |
| Improving | 1 (3) |
| Stable | 4 (13) |
| Deteriorating | 27 (84) |
| GI reported disease progression at most recent consultation, n (%) | |
| Improving | 15 (47) |
| Stable | 16 (50) |
| Deteriorating | 1 (3) |
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’.
Conclusions
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.
Funding Agencies
Amgen Inc