Musings On TEV-‘408 Ahead Of Data; And Our Vitiligo Pipeline Cheat Sheet

Research evidence excerpt

Musings On TEV-‘408 Ahead Of Data; And Our Vitiligo Pipeline Cheat Sheet

igo deal with RPRX

was driven in part by the well-worn regulatory pathway for the indication, we surmise that the door

remains open for broader collaboration with RPRX on TEV-‘408 to the extent that the asset produces

compelling data in different disease settings (and we certainly will find out about the road ahead in

celiac disease soon enough).

Details On The Body Of Data For Other Systemic Therapies In

Development For Vitiligo

A quick primer on VASI scores. The Vitiligo Area Scoring Index (VASI) measurements are

quantitative physician-reported measurements of vitiligo disease severity that are a function of BSA

coverage and degree of depigmentation. In the case of facial VASI (F-VASI), a patient is scored

from 0%-3% based on the extent of affected facial surface area (i.e., a score of 3% would imply

complete coverage of the face by vitiligo lesions), multiplied by the severity of depigmentation

(scored on a scale of 0-1), yielding a F-VASI score range of 0-3 (with 3 denoting the greatest

depigmentation severity). Total VASI (T-VASI) is computed via the same logic, though it is a sum of

scores from five different body regions with different maximum BSA scores (i.e., hands, upper limbs,

trunk, lower limbs, feet), yielding a total score range of 0-100 (BSA percentage is multiplied by

degree of depigmentation (ranging from 0-1)). For example, a patient with ~40% BSA coverage and

an average depigmentation score of ~0.5 would yield a 20 on T-VASI.

A closer look at the available Phase III data in vitiligo. Rinvoq’s Phase III program in vitiligo

consisted of two replicate-designed 48-week studies (Viti-Up-1 and -2), each randomizing ~300