US-MULT-221082
Primary endpoint in PIONEER I and II trials: Many adults with moderate to severe HS achieved HiSCR at Week 12, defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess count and draining tunnel count.2
Moderate/Stage II:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Martin Miehe. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Andreas Pinter. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Severe/Stage III:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Severe/Stage III:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
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 (adalimumab) 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.1,2
EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation; LOCF=last observation carried forward
P=0.003 vs control
P<0.001 vs control
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
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.2
EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation
Adult patients receiving continuous weekly treatment, up to week 168, in PIONEER I, II, and OLE
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
LOCF Analysis (n=88)
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 tunnel count relative to baseline.
OLE LIMITATIONS: In an open-label extension, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
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.2
EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation; LOCF=last observation carried forward
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.
*Strength of Recommendation based on: A – Consistent and good-quality patient-oriented evidence; B – Inconsistent or limited-quality patient-oriented evidence; C – Consensus, opinion, case studies or disease-oriented evidence.
Evidence Grading Level: Level I – Good-quality patient-oriented evidence; Level II – Limited-quality patient-oriented evidence; Level III – Other evidence, including consensus guidelines, opinion, case studies, or disease-oriented evidence.
NOTE: These guidelines reflect the best available efficacy evidence at the time of preparation, but did not include safety considerations and should not be interpreted as setting the standard of care.
Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
It is a widely used classification tool categorizing disease severity based largely on scarring and sinuses.
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
US-HUMD-210291
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Gender, n (%) |
Female Male |
91 (59.5) 62 (40.5) |
105 (68.2) 49 (31.8) |
108 (66.3) 55 (33.7) |
113 (69.3) 50 (30.7) |
Race,h n (%) |
White Black Otheri |
116 (75.8) 33 (21.6) 4 (2.6) |
118 (76.6) 29 (18.8) 7 (4.5) |
143 (87.7) 9 (5.5) 11 (6.7) |
130 (79.8) 20 (12.3) 13 (8.0) |
Age in years: |
36.2 (10.8) |
37.8 (11.3) |
34.9 (10.0) |
36.1 (12.2) |
|
Body weight in kg: |
Female Male |
(n=91)92.3 (23.2) (n=62)104.1 (25.8) |
(n=105)97.5 (23.1) (n=49)103.1 (28.8) |
(n=108)87.3 (21.8) (n=55)95.9 (20.7) |
(n=113)90.9 (23.2) (n=50)106.5 (28.4) |
Body mass index in |
(n=152)33.0 (7.6) |
(n=154)34.5 (7.9) |
(n=163)31.3 (7.4) |
(n=161)32.9 (7.9) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Hurley Stage,j n (%) |
II III |
80 (52.3) 73 (47.7) |
81 (52.6) 73 (47.4) |
86 (52.8) 77 (47.2) |
89 (54.6) 74 (45.4) |
Previous systemic |
Any |
71 (46.4) |
63 (40.1) |
82 (50.3) |
76 (46.6) |
Disease duration in |
8.8 (1.1, 40.4) |
9.4 (1.0, 43.0) |
9.0 (1.0, 43.5) |
9.9 (1.2, 68.5) |
|
Family history of HSk |
39 (25.5) |
32 (20.8) |
39 (24.1) |
43 (26.4) |
|
hs-CRP in mg/L: |
(n=152)20.3 (25) |
(n=151)17.4 (20.2) |
13.3 (18.0) |
18.3 (30.7) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Abscess and |
≤5 6-10 ≥11 |
24 (15.7) 54 (35.3) 75 (49.0) |
36 (23.4) 33 (21.4) 85 (55.2) |
47 (28.8) 61 (37.4) 55 (33.7) |
50 (30.7) 51 (31.3) 62 (38.0) |
Abscess and |
14.3 (11.9) |
14.4 (14.8) |
10.7 (8.1) |
11.9 (11.0) |
|
Abscesses, mean (SD) |
2.8 (3.5) |
2.7 (3.7) |
2.0 (2.6) |
2.4 (3.3) |
|
Inflammatory nodules, |
11.5 (10.9) |
11.6 (13.9) |
8.6 (6.9) |
9.4 (9.6) |
|
Draining tunnels, |
4.6 (5.2) |
3.8 (4.4) |
3.0 (4.1) |
3.7 (5.2) |
|
Baseline characteristics identified as different between PIONEER I and PIONEER II are2:
These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.
eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.
US-HUMD-210291
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Gender, n (%) |
Female Male |
91 (59.5) 62 (40.5) |
105 (68.2) 49 (31.8) |
108 (66.3) 55 (33.7) |
113 (69.3) 50 (30.7) |
Race,h n (%) |
White Black Otheri |
116 (75.8) 33 (21.6) 4 (2.6) |
118 (76.6) 29 (18.8) 7 (4.5) |
143 (87.7) 9 (5.5) 11 (6.7) |
130 (79.8) 20 (12.3) 13 (8.0) |
Age in years: |
36.2 (10.8) |
37.8 (11.3) |
34.9 (10.0) |
36.1 (12.2) |
|
Body weight in kg: |
Female Male |
(n=91)92.3 (23.2) (n=62)104.1 (25.8) |
(n=105)97.5 (23.1) (n=49)103.1 (28.8) |
(n=108)87.3 (21.8) (n=55)95.9 (20.7) |
(n=113)90.9 (23.2) (n=50)106.5 (28.4) |
Body mass index in |
(n=152)33.0 (7.6) |
(n=154)34.5 (7.9) |
(n=163)31.3 (7.4) |
(n=161)32.9 (7.9) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Hurley Stage,j n (%) |
II III |
80 (52.3) 73 (47.7) |
81 (52.6) 73 (47.4) |
86 (52.8) 77 (47.2) |
89 (54.6) 74 (45.4) |
Previous systemic |
Any |
71 (46.4) |
63 (40.1) |
82 (50.3) |
76 (46.6) |
Disease duration in |
8.8 (1.1, 40.4) |
9.4 (1.0, 43.0) |
9.0 (1.0, 43.5) |
9.9 (1.2, 68.5) |
|
Family history of HSk |
39 (25.5) |
32 (20.8) |
39 (24.1) |
43 (26.4) |
|
hs-CRP in mg/L: |
(n=152)20.3 (25) |
(n=151)17.4 (20.2) |
13.3 (18.0) |
18.3 (30.7) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Abscess and |
≤5 6-10 ≥11 |
24 (15.7) 54 (35.3) 75 (49.0) |
36 (23.4) 33 (21.4) 85 (55.2) |
47 (28.8) 61 (37.4) 55 (33.7) |
50 (30.7) 51 (31.3) 62 (38.0) |
Abscess and |
14.3 (11.9) |
14.4 (14.8) |
10.7 (8.1) |
11.9 (11.0) |
|
Abscesses, mean (SD) |
2.8 (3.5) |
2.7 (3.7) |
2.0 (2.6) |
2.4 (3.3) |
|
Inflammatory nodules, |
11.5 (10.9) |
11.6 (13.9) |
8.6 (6.9) |
9.4 (9.6) |
|
Draining tunnels, |
4.6 (5.2) |
3.8 (4.4) |
3.0 (4.1) |
3.7 (5.2) |
|
Baseline characteristics identified as different between PIONEER I and PIONEER II are2:
These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.
eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.
US-HUMD-210291
88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
US-HUMD-210291
REVEAL was a randomized, double-blind, placebo-controlled study of 1212 patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12, and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).
In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, patients who maintained at least a PASI 75 response at week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive HUMIRA 40 mg EOW or placebo for an additional 19 weeks. Co-primary efficacy endpoints at week 16 were proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.
Eligible adult patients had moderate to severe plaque psoriasis (defined as ≥10% BSA and PASI ≥10).
aPatients were randomized to receive HUMIRA (80 mg followed by 40 mg EOW beginning 1 week later) or placebo in a 2:1 ratio.
Co-primary efficacy endpoints were proportion of patients achieving PASI 75 relative to baseline and proportion of patients achieving a PGA of clear or minimal by week 16.
US-HUMD-200130
REVEAL was a randomized, double-blind, placebo-controlled study of 1212 patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12, and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).8,9
In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, patients who maintained at least a PASI 75 response at week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive HUMIRA 40 mg EOW or placebo for an additional 19 weeks. Primary efficacy endpoints at week 16 were proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.
US-HUMD-190337
EOW=every other week
a315 patients were initially randomized; however, 2 patients did not receive study drug.11
US-HUMD-190337
EOW=every other week
a315 patients were initially randomized; however, 2 patients did not receive study drug.3
US-HUMD-200130
The first and only completed Phase 3 trials in HS
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
US-HUMD-190337
| HUMIRAa 40 mg EOW (n=151) | Placebo EOW (n=162) | |||
|---|---|---|---|---|
| Parameter: median | Baseline | 24 Weeks | Baseline | 24 Weeks |
| Tender joint countb | 20.0 | 5.0 | 23.0 | 17.0 |
| Swollen joint countc | 11.0 | 3.0 | 11.0 | 9.0 |
| Physician global assessmentd | 55.0 | 16.0 | 53.0 | 49.0 |
| Patient global assessmentd | 48.0 | 20.0 | 49.5 | 49.0 |
| Paind | 54.0 | 20.0 | 49.0 | 49.0 |
| Disability index (HAQ)e | 1.0 | 0.4 | 1.0 | 0.9 |
| CRP (mg/dL)f | 0.8 | 0.2 | 0.8 | 0.7 |
aP<0.001 for HUMIRA vs placebo; comparisons based on mean changes.
bScale 0-78.
cScale 0-76.
dVisual analog scale; 0=best, 100=worst.
eDisability Index of the Health Assessment Questionnaire (HAQ-DI); 0=best, 3=worst; measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity.
fNormal range: 0-0.287 mg/dL.
US-HUMD-200130
| HUMIRA 40 mg EOW (n=151) | Placebo EOW (n=162) | |||
|---|---|---|---|---|
| Parameter: median | Baseline | 24 Weeks | Baseline | 24 Weeks |
| Number of tender joints | 20.0 | 5.0 | 23.0 | 17.0 |
| Number of swollen joints | 11.0 | 3.0 | 11.0 | 9.0 |
| Physician global assessment | 55.0 | 16.0 | 53.0 | 49.0 |
| Patient global assessment | 48.0 | 20.0 | 49.5 | 49.0 |
| Pain | 54.0 | 20.0 | 49.0 | 49.0 |
| Disability index (HAQ) | 1.0 | 0.4 | 1.0 | 0.9 |
| CRP (mg/dL) | 0.8 | 0.2 | 0.8 | 0.7 |
aP<0.001 for HUMIRA vs placebo; comparisons based on mean changes.
bScale 0-78.
cScale 0-76.
dVisual analog scale; 0=best, 100=worst.
eDisability Index of the Health Assessment Questionnaire (HAQ-DI); 0=best, 3=worst; measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity.
fNormal range: 0-0.287 mg/dL.
US-HUMD-200130
88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
US-HUMD-210291
EOW=every other week
a315 patients were initially randomized; however, 2 patients did not receive study drug.2
US-HUMD-200257
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Gender, n (%) |
Female Male |
91 (59.5) 62 (40.5) |
105 (68.2) 49 (31.8) |
108 (66.3) 55 (33.7) |
113 (69.3) 50 (30.7) |
Race,h n (%) |
White Black Otheri |
116 (75.8) 33 (21.6) 4 (2.6) |
118 (76.6) 29 (18.8) 7 (4.5) |
143 (87.7) 9 (5.5) 11 (6.7) |
130 (79.8) 20 (12.3) 13 (8.0) |
Age in years: |
36.2 (10.8) |
37.8 (11.3) |
34.9 (10.0) |
36.1 (12.2) |
|
Body weight in kg: |
Female Male |
(n=91)92.3 (23.2) (n=62)104.1 (25.8) |
(n=105)97.5 (23.1) (n=49)103.1 (28.8) |
(n=108)87.3 (21.8) (n=55)95.9 (20.7) |
(n=113)90.9 (23.2) (n=50)106.5 (28.4) |
Body mass index in |
(n=152)33.0 (7.6) |
(n=154)34.5 (7.9) |
(n=163)31.3 (7.4) |
(n=161)32.9 (7.9) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Hurley Stage,j n (%) |
II III |
80 (52.3) 73 (47.7) |
81 (52.6) 73 (47.4) |
86 (52.8) 77 (47.2) |
89 (54.6) 74 (45.4) |
Previous systemic |
Any |
71 (46.4) |
63 (40.1) |
82 (50.3) |
76 (46.6) |
Disease duration in |
8.8 (1.1, 40.4) |
9.4 (1.0, 43.0) |
9.0 (1.0, 43.5) |
9.9 (1.2, 68.5) |
|
Family history of HSk |
39 (25.5) |
32 (20.8) |
39 (24.1) |
43 (26.4) |
|
hs-CRP in mg/L: |
(n=152)20.3 (25) |
(n=151)17.4 (20.2) |
13.3 (18.0) |
18.3 (30.7) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Abscess and |
≤5 6-10 ≥11 |
24 (15.7) 54 (35.3) 75 (49.0) |
36 (23.4) 33 (21.4) 85 (55.2) |
47 (28.8) 61 (37.4) 55 (33.7) |
50 (30.7) 51 (31.3) 62 (38.0) |
Abscess and |
14.3 (11.9) |
14.4 (14.8) |
10.7 (8.1) |
11.9 (11.0) |
|
Abscesses, mean (SD) |
2.8 (3.5) |
2.7 (3.7) |
2.0 (2.6) |
2.4 (3.3) |
|
Inflammatory nodules, |
11.5 (10.9) |
11.6 (13.9) |
8.6 (6.9) |
9.4 (9.6) |
|
Draining tunnels, |
4.6 (5.2) |
3.8 (4.4) |
3.0 (4.1) |
3.7 (5.2) |
|
Baseline characteristics identified as different between PIONEER I and PIONEER II are3:
These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.
eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.
US-HUMD-210291
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
b160 mg week 0; 80 mg week 2; 40 mg from week 4.
cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
*Weeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Gender, n (%) |
Female Male |
91 (59.5) 62 (40.5) |
105 (68.2) 49 (31.8) |
108 (66.3) 55 (33.7) |
113 (69.3) 50 (30.7) |
Race,h n (%) |
White Black Otheri |
116 (75.8) 33 (21.6) 4 (2.6) |
118 (76.6) 29 (18.8) 7 (4.5) |
143 (87.7) 9 (5.5) 11 (6.7) |
130 (79.8) 20 (12.3) 13 (8.0) |
Age in years: |
36.2 (10.8) |
37.8 (11.3) |
34.9 (10.0) |
36.1 (12.2) |
|
Body weight in kg: |
Female Male |
(n=91)92.3 (23.2) (n=62)104.1 (25.8) |
(n=105)97.5 (23.1) (n=49)103.1 (28.8) |
(n=108)87.3 (21.8) (n=55)95.9 (20.7) |
(n=113)90.9 (23.2) (n=50)106.5 (28.4) |
Body mass index in |
(n=152)33.0 (7.6) |
(n=154)34.5 (7.9) |
(n=163)31.3 (7.4) |
(n=161)32.9 (7.9) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Hurley Stage,j n (%) |
II III |
80 (52.3) 73 (47.7) |
81 (52.6) 73 (47.4) |
86 (52.8) 77 (47.2) |
89 (54.6) 74 (45.4) |
Previous systemic |
Any |
71 (46.4) |
63 (40.1) |
82 (50.3) |
76 (46.6) |
Disease duration in |
8.8 (1.1, 40.4) |
9.4 (1.0, 43.0) |
9.0 (1.0, 43.5) |
9.9 (1.2, 68.5) |
|
Family history of HSk |
39 (25.5) |
32 (20.8) |
39 (24.1) |
43 (26.4) |
|
hs-CRP in mg/L: |
(n=152)20.3 (25) |
(n=151)17.4 (20.2) |
13.3 (18.0) |
18.3 (30.7) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Abscess and |
≤5 6-10 ≥11 |
24 (15.7) 54 (35.3) 75 (49.0) |
36 (23.4) 33 (21.4) 85 (55.2) |
47 (28.8) 61 (37.4) 55 (33.7) |
50 (30.7) 51 (31.3) 62 (38.0) |
Abscess and |
14.3 (11.9) |
14.4 (14.8) |
10.7 (8.1) |
11.9 (11.0) |
|
Abscesses, mean (SD) |
2.8 (3.5) |
2.7 (3.7) |
2.0 (2.6) |
2.4 (3.3) |
|
Inflammatory nodules, |
11.5 (10.9) |
11.6 (13.9) |
8.6 (6.9) |
9.4 (9.6) |
|
Draining tunnels, |
4.6 (5.2) |
3.8 (4.4) |
3.0 (4.1) |
3.7 (5.2) |
|
Baseline characteristics identified as different between PIONEER I and PIONEER II are3:
These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.
eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.
US-HUMD-210291
The first and only completed Phase 3 trials in HS.
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Gender, n (%) |
Female Male |
91 (59.5) 62 (40.5) |
105 (68.2) 49 (31.8) |
108 (66.3) 55 (33.7) |
113 (69.3) 50 (30.7) |
Race,h n (%) |
White Black Otheri |
116 (75.8) 33 (21.6) 4 (2.6) |
118 (76.6) 29 (18.8) 7 (4.5) |
143 (87.7) 9 (5.5) 11 (6.7) |
130 (79.8) 20 (12.3) 13 (8.0) |
Age in years: |
36.2 (10.8) |
37.8 (11.3) |
34.9 (10.0) |
36.1 (12.2) |
|
Body weight in kg: |
Female Male |
(n=91)92.3 (23.2) (n=62)104.1 (25.8) |
(n=105)97.5 (23.1) (n=49)103.1 (28.8) |
(n=108)87.3 (21.8) (n=55)95.9 (20.7) |
(n=113)90.9 (23.2) (n=50)106.5 (28.4) |
Body mass index in |
(n=152)33.0 (7.6) |
(n=154)34.5 (7.9) |
(n=163)31.3 (7.4) |
(n=161)32.9 (7.9) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Hurley Stage,j n (%) |
II III |
80 (52.3) 73 (47.7) |
81 (52.6) 73 (47.4) |
86 (52.8) 77 (47.2) |
89 (54.6) 74 (45.4) |
Previous systemic |
Any |
71 (46.4) |
63 (40.1) |
82 (50.3) |
76 (46.6) |
Disease duration in |
8.8 (1.1, 40.4) |
9.4 (1.0, 43.0) |
9.0 (1.0, 43.5) |
9.9 (1.2, 68.5) |
|
Family history of HSk |
39 (25.5) |
32 (20.8) |
39 (24.1) |
43 (26.4) |
|
hs-CRP in mg/L: |
(n=152)20.3 (25) |
(n=151)17.4 (20.2) |
13.3 (18.0) |
18.3 (30.7) |
|
PIONEER I |
PIONEER II |
||||
|---|---|---|---|---|---|
HUMIRA EW(n=153) g |
Controle (n=154)g |
HUMIRA EW (n=163)g |
Controlf (n=163)g |
||
Abscess and |
≤5 6-10 ≥11 |
24 (15.7) 54 (35.3) 75 (49.0) |
36 (23.4) 33 (21.4) 85 (55.2) |
47 (28.8) 61 (37.4) 55 (33.7) |
50 (30.7) 51 (31.3) 62 (38.0) |
Abscess and |
14.3 (11.9) |
14.4 (14.8) |
10.7 (8.1) |
11.9 (11.0) |
|
Abscesses, mean (SD) |
2.8 (3.5) |
2.7 (3.7) |
2.0 (2.6) |
2.4 (3.3) |
|
Inflammatory nodules, |
11.5 (10.9) |
11.6 (13.9) |
8.6 (6.9) |
9.4 (9.6) |
|
Draining tunnels, |
4.6 (5.2) |
3.8 (4.4) |
3.0 (4.1) |
3.7 (5.2) |
|
Baseline characteristics identified as different between PIONEER I and PIONEER II are13:
These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.
eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.
US-HUMD-210291
88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.
aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).
160 mg week 0; 80 mg week 2; 40 mg from week 4.
bRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.
c160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.
dWeeks of efficacy and patient-reported outcomes analysis.
†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.
‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.
US-HUMD-210291
Adverse reaction rate observed in clinical trials and open-label extension (OLE) studies may not predict the rates observed in a broader HS patient population in clinical practice.
*Safety data for PIONEER I, Period B not shown as there is no comparable control group.
†Study design dosing: HUMIRA EW/HUMIRA EW.
‡Study design dosing: HUMIRA EW/HUMIRA EW/HUMIRA EW.
§Other than lymphoma, HSTCL, leukemia, NMSC or melanoma.
US-HUMD-210291
a315 patients were initially randomized; however, 2 patients did not receive study drug.2
A 24-week, randomized, double-blind, placebo-controlled trial of HUMIRA in adult patients with moderately to severely active psoriatic arthritis (PsA) (≥3 swollen joints and ≥3 tender joints) who had an inadequate response to NSAIDs.2,4
Patients must have active psoriatic skin lesions or a documented history of psoriasis.2
Co-primary endpoints were American College of Rheumatology (ACR) 20 response at Week 12 and mean change from baseline in modified total Sharp score (mTSS) for HUMIRA-treated patients at Week 48 vs placebo patients at Week 24.1,2
After Week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.2
Select additional endpoints include ACR20 response rates at week 2, VAS pain scores at Week 2 and 24, and change from baseline in individual ACR components by visit.2
Select secondary endpoints include ACR20 at Week 24, ACR 50/70 at Weeks 12 and 24, HAQ-DI score at Weeks 12 and 24, and PASI 75 at Week 24.2
Patients who completed the original 24-week double-blind ADEPT study (n=289) were eligible for open-label treatment through Week 144, for which over 98% (n=285) elected to enroll.3,4
US-HUMD-200130
REVEAL was a randomized, double-blind, placebo-controlled study of 1212 patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12, and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).
In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, patients who maintained at least a PASI 75 response at week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive HUMIRA 40 mg EOW or placebo for an additional 19 weeks. Primary efficacy endpoints at week 16 were proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.
US-HUMD-190337
A Phase 3, randomized, double-blind study evaluated adult subjects with moderate to severe fingernail psoriasis who also had moderate to severe chronic plaque psoriasis.1,2
BSA=body surface area; EOW=every other week; mNAPSI=modified Nail Psoriasis Severity Index;
PGA-F=Physician’s Global Assessment of Fingernail Psoriasis; PGA-S=Physician’s Global Assessment of Skin Psoriasis.
Key inclusion criteria were adult subjects with2:
Primary endpoint was proportion of subjects achieving PGA-F of 0 (clear) or 1 (minimal) and at least 2-grade improvement from baseline at Week 26.
Key secondary endpoint was proportion of subjects achieving ≥75% improvement from baseline in mNAPSI (mNAPSI 75) at Week 26.
US-HUMD-200257
