Aller au contenu principal

Hidradenitis Suppurativa Severity Endpoints for Clinical Trials

The AI scoring provided by Legit.Health delivers automated, clinically validated severity assessment for hidradenitis suppurativa (HS) clinical trials, computing the AIHS4 (Automated IHS4) score aligned with the International Hidradenitis Suppurativa Severity Score System.

AIHS4Scoring systemAutomated IHS4
ICC 0.727Reliability95% CI: 0.66–0.79
M-27134-01Trial validatedPhase 2/3 HS trial

Why automated IHS4 for clinical trials?

The IHS4 (International Hidradenitis Suppurativa Severity Score) is a validated, count-based severity measure that quantifies lesion burden across anatomical regions:

IHS4=(1×papules/nodules)+(2×abscesses)+(4×draining fistulae)\text{IHS4} = (1 \times \text{papules/nodules}) + (2 \times \text{abscesses}) + (4 \times \text{draining fistulae})

Manual IHS4 scoring is subject to inter-rater variability in lesion identification and counting, particularly for distinguishing abscesses from nodules and identifying draining tunnels. AIHS4 automates this through deep learning lesion detection, providing objective, reproducible counts.

How the AI works

Lesion detection and classification

A deep learning object detection model identifies three lesion types:

Lesion typeIHS4 weightAI approach
Papules/nodules×1Object detection and classification
Abscesses×2Differentiated from nodules by visual features (fluctuance, erythema pattern)
Draining fistulae (tunnels)×4Tract and opening detection
Original photograph

Input: affected anatomical region

Lesion detection overlay

Output: bounding boxes by lesion type (colour-coded)

Classification legend

Papules (×1), abscesses (×2), fistulae (×4)

Severity classification

IHS4 scoreSeverity
0–3Mild
4–10Moderate
≥ 11Severe

Validated reliability

AIHS4 achieves ICC = 0.727 (95% CI: 0.66–0.79) in the M-27134-01 clinical trial, substantially exceeding the manual inter-rater ICC of 0.47. See Clinical Evidence for full details.

Further reading