HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

Flare data in HS

Analyses of flares in HUMIRA-treated patients2,3

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

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

Study Design Introductions

PIONEER I (N=307) and II (N=326) were 2 similarly designed clinical trials in adult patients with 2 double-blind, placebo-controlled periods. In Period A, patients were assigned to either HUMIRA 40 mg weekly (after initial doses) or placebo for 12 weeks. In period B, patients were reassigned to HUMIRA weekly or EOW, or placebo for 24 weeks. PRIMARY ENDPOINT was HiSCR at week 12, defined as at least a 50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining-fistula counts.4

22% (of 100) patients who were withdrawn from HUMIRA after 12 weeks experienced flare.1,4

View full study design and baseline characteristics

Through 3 months

Flare incidence through 3 months

Lower occurrence of flare in the short term vs control2,3

Pre-specified other secondary endpoint

For those experiencing flares, the duration of flares was shorter for patients on HUMIRA vs control. 2,3

graph showing the duration of flares for patients on HUMIRA as 19 days vs. 32 days for control patients

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 baseline1-3

Flare was a pre-specified other secondary endpoint in Period A. Since PIONEER I did not reach statistical significance at the first key secondary endpoint, all endpoints in this integrated analysis cannot be regarded as statistically significant.4,5

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

3 through 9 months

Flare incidence from 3 through 9 months

80% of HUMIRA (adalimumab) treated patients did not experience flares from 3 through 9 months2,3,6

A post-hoc analysis with a proportion of OLE patients*

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 baseline1-3

Flare was a pre-specified other secondary endpoint in Period A. Non-ranked endpoints are not controlled for multiplicity and thus require careful interpretation. Control comparator group not available past week 12 due to study design allowing early escape to OLE. Period B flare results analyzed post-hoc. Since PIONEER I did not reach statistical significance at the first key secondary endpoint, all endpoints in this integrated analysis cannot be regarded as statistically significant.4,5

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

View study design for HUMIRA EW population