For the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older
Clinically meaningful improvement at week 12
Offer your moderate to severe HS patients a chance at achieving HiSCR1,2
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 40mg 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.2
Week 12 data
Significantly more adult patients achieved clinically meaningful improvement at week 12 with HUMIRA vs control1,2
PIONEER I1,2 P=0.003
42%
vs
26%
ACHIEVED HiSCR
PIONEER II1,2 P<0.001
59%
vs
28%
ACHIEVED HiSCR
HUMIRA 40 mg EW (PIONEER I, n=64/153, control=placebo; PIONEER II, n=96/163, control=placebo +/- antibiotic)
Control (PIONEER I, n=40/154, control=placebo; PIONEER II, n=45/163, control=placebo+/- antibiotic)
Efficacy in adolescents extrapolated from adult data
HUMIRA efficacy in adolescent HS patients is extrapolated from the adult HS patient data based on the likelihood that the disease course and drug effects are similar to that of adults at the same exposure levels determined through pharmacokinetic modeling.1
EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation
Open-label extension
HiSCR response up to OLE Week 1683
Adult patients receiving continuous weekly treatment, up to week 168, in PIONEER I, II, and OLE
HUMIRA EW Population: Graph represents HUMIRA EW population of 88 patients who received continuous 40 mg weekly HUMIRA in Periods A and B of PIONEER I or II and in the OLE.
HiSCR: (Hidradenitis Suppurativa Clinical Response) was defined as ≥ 50% reduction in AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.
Limitations associated with an open-label extension analysis apply, such as uncontrolled nature of the data and enrichment of responder population.
EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation; LOCF=last observation carried forward
