Case Studies
Gastroenterology Programs
Anti-Integrin Biologic
Challenge
Differentiating gut-selective safety profile from systemic immunosuppressive therapies while demonstrating comparable efficacy
ArcaScience Approach
Comparative BRA integrating infection rates, PML surveillance, and endoscopic response across 15,000 patient-years of exposure
Results
- ✓Gut-selectivity safety advantage quantified
- ✓PML risk monitoring framework established
- ✓69% reduction in comparative BRA preparation time
JAK1-Selective Inhibitor
Challenge
Addressing class-wide JAK inhibitor safety concerns while demonstrating benefit in TNF-refractory Crohn's disease patients
ArcaScience Approach
JAK selectivity-based safety differentiation with cardiovascular and malignancy signal monitoring in a high-risk IBD population
Results
- ✓MACE/VTE risk contextualized for IBD population
- ✓TNF-refractory benefit quantified
- ✓Regulatory submission BRA accepted without queries
IL-23 Inhibitor
Challenge
Expanding from psoriasis indication to IBD with different dose requirements and patient population safety profile
ArcaScience Approach
Cross-indication safety analysis with IBD-specific endpoint integration and infection risk assessment in immunocompromised GI patients
Results
- ✓Cross-indication safety database unified
- ✓Endoscopic response BRA integration automated
- ✓Multi-indication PSUR streamlined
Aggregate Outcomes
Results Across Gastroenterology Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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