For the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older

HiSCR requirements

HiSCR: a measure of clinical response in HS2

At week 12, many moderate to severe adult HS patients treated with HUMIRA achieved clinically meaningful improvement, defined as Hidradenitis Suppurativa Clinical Response, or HiSCR, vs placebo.1,3


HUMIRA is the first & only FDA approved treatment for hidradenitis suppurativa

STUDY DESIGN INTRODUCTION

PIONEER I (N=307) and II (N=326) were two similarly designed clinical trials in adult patients with two double-blind, placebo-controlled periods. In Period A, patients were assigned to either HUMIRA 40 mg weekly or placebo for 12 weeks. In Period B, patients were reassigned to HUMIRA 40 mg weekly (after initial doses) or EOW, following a starting dose of 160 mg or placebo for 24 weeks. Primary endpoint was a Hidradenitis Suppurativa Clinical Response, or HiSCR, at week 12. HiSCR is defined as at least a 50% reduction from baseline in abscess and inflammatory-nodule (AN) count, with no increase in draining-fistula counts.3

View full study design and baseline characteristics

HiSCR REQUIRES1:

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HiSCR requires ≥ 50% reduction in the total abscess and inflammatory nodule count relative to baseline.

with

HiSCR requires no increase in abscess count relative to baseline.

and

HiSCR requires no increase in draining fistula count relative to baseline.

HiSCR requires counting abscesses, inflammatory nodules, and draining fistulas before and after an intervention.2

Numerical assessment of HiSCR in a theoretical patient from the PIONEER study2

chart of numerical assessment of HiSCR in a theoretical patient from the PIONEER study of HUMIRA

Abscess and inflammatory nodule count was reduced from 20 to 10 in both cases. In the HiSCR nonresponder, however, abscesses increased to 8.

EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation