Navigating the Unknown

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Navigating the Unknown

Listen to actual HUMIRA-treated patients describe the impact of HS, and watch HS-treating dermatologists discuss why they choose HUMIRA for moderate to severe HS

HUMIRA is approved for the treatment of moderate to severe
hidradenitis suppurativa (HS) in patients 12 years of age and older.

FLARE DATA IN HS

ANALYSES OF FLARES IN HUMIRA-TREATED PATIENTS

HUMIRA’s flare data is an integrated analysis of PIONEER I and II. In the analyses, flare occurrence data was examined through 3 months, and 3 through 9 months. In the PIONEER clinical trials, flare was defined as a ≥25% increase in AN count and an absolute increase of ≥2 relative to baseline.1,2

Primary endpoint in PIONEER I and II trials: 42% (PIONEER I) and 59% (PIONEER II) of HUMIRA-treated adult patients achieved HiSCR* at Week 12, vs 26% and 28% on placebo, respectively.1,3

*HiSCR=Hidradenitis Suppurativa Clinical Response.

88% OF HUMIRA-TREATED PATIENTS DID NOT EXPERIENCE FLARES THROUGH 3 MONTHS2

Pre-specified other secondary endpoint

Through 3 months

Pre-specified Other Secondary Endpoint

Graph explaining flare data in HUMIRA-treated patients vs. control patients.

For those experiencing flares, they were shorter for patients on HUMIRA vs control

Graph showing those experiencing flares, were shorter for patients on HUMIRA vs control

Mean Days on Flare

13 FEWER DAYS

OF FLARE ACTIVITY

For those experiencing flares, the mean Days on Flare was 13 days shorter for HUMIRA-treated patients vs control (19 days vs 32 days, respectively).

Integrated analysis of PIONEER I and PIONEER II through 12 weeks (Period A)

Flare: ≥25% increase in AN count and an absolute increase of ≥2 relative to baseline1,2

DATA LIMITATIONS

Flare and Days on Flare were pre-specified other secondary endpoints in Period A and not controlled for multiplicity. This data cannot be regarded as statistically or clinically significant, and therefore, no conclusions can be drawn.3,4

PIONEER I control=placebo

PIONEER II control=placebo +/- antibiotic

AN=abscess and inflammatory nodules; DMARDs=disease-modifying antirheumatic drugs; EOW=every other week; EW=every week

22% (of 100) patients who were withdrawn from HUMIRA after 12 weeks experienced flare.1

STUDY DESIGN INTRO

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at Week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess count and draining tunnel count.1,3

80% of HUMIRA-treated patients did not experience flares from 3 through 9 months2

A post hoc analysis with a proportion of OLE patients

Graph explaining flare data for HUMIRA-treated patients from 3 through 9 months. Graph explaining flare data for HUMIRA-treated patients from 3 through 9 months. Graph explaining flare data for HUMIRA-treated patients from 3 through 9 months.

Integrated analysis of PIONEER l and PIONEER ll through 36 weeks

Flare: ≥25% increase in AN count and an absolute increase of ≥2 relative to baseline1,2

DATA LIMITATIONS

Flare and Days on Flare were pre-specified other secondary endpoints in Periods A and B and were not controlled for multiplicity. This data cannot be regarded as statistically or clinically significant, and therefore, no conclusions can be drawn. Control comparator group not available past Week 12 due to study design allowing early escape to OLE.3,4

OLE=open-label extension

PIONEER I control=placebo

PIONEER II control=placebo +/- antibiotic

Including 11 ADAew/ew patients who escaped Period B early due to loss of response or worsening or absence of improvement and continued ADAew treatment in the OLE.

Patients who underwent early escape experienced either a loss of response following achievement of HiSCR at Week 12 or worsening or absence of improvement for patients not achieving HiSCR at Week 12. Loss of response was defined as loss of at least 50% of AN improvement from baseline to Week 12. Worsening or absence of improvement was defined as AN count ≥ baseline AN count at 2 consecutive visits (excluding Week 12) occurring ≥14 days apart on or after Week 16.

 

AN=abscess and inflammatory nodules; DMARDs=disease-modifying antirheumatic drugs; EOW=every other week; EW=every week

22% (of 100) patients who were withdrawn from HUMIRA after 12 weeks experienced flare.1

STUDY DESIGN INTRO

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at Week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess count and draining tunnel count.1,3