Case Studies
Dermatology Programs
IL-23 Inhibitor
Challenge
Demonstrating superior risk-benefit profile versus IL-17 and TNF classes in head-to-head and network meta-analysis comparisons
ArcaScience Approach
Cross-class comparative BRA integrating 18 clinical trials, real-world registry data, and post-marketing safety signals across 35,000 patients
Results
- ✓Class-level safety differentiation quantified
- ✓PASI 90/100 benefit-risk ratio calculated
- ✓73% reduction in comparative BRA preparation time
JAK Inhibitor (Topical)
Challenge
Establishing local safety and efficacy of topical JAK inhibition while addressing systemic JAK inhibitor class safety concerns
ArcaScience Approach
Systemic exposure modeling integrated with local skin safety assessment and EASI/DLQI benefit quantification
Results
- ✓Systemic absorption risk quantified below safety thresholds
- ✓Local tolerability profile characterized
- ✓Differentiated BRA from oral JAK inhibitors established
Dupilumab (IL-4/13 Inhibitor)
Challenge
Multi-indication BRA across dermatology, respiratory, and ENT indications with different patient populations
ArcaScience Approach
Cross-indication safety pooling with indication-specific benefit assessment for 3 approved uses
Results
- ✓Unified safety database across indications
- ✓Conjunctivitis signal characterized and contextualized
- ✓Multi-indication PSUR automation
Aggregate Outcomes
Results Across Dermatology Programs
70%+
Reduction in BRA Preparation Time
90%+
Accuracy in AE Classification
3x
Faster Regulatory Submissions
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