US-MULT-221082
INDICATION1
Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
References:
- HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.
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).
- Patients were to have plaque psoriasis for at least 1 year and stable plaque psoriasis for at least 2 months
- Patients were candidates for systemic therapy or phototherapy
- All patients were naïve to anti-TNF therapy and MTX
- Concomitant psoriasis therapies were not permitted during the study, with the exception of shampoos free of corticosteroids, bland emollients, and low-potency topical corticosteroids for the palms, soles, face, inframammary areas, and groin only, provided they were not used within 24 hours of a study visit
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
- 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.10,11
- Patients must have active psoriatic skin lesions or a documented history of psoriasis.11
- 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 24.1,11
- Select secondary endpoints include ACR20 at week 24, ACR50/70 at weeks 12 and 24, and HAQ-DI at week 12 and 24.11
- 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.11
- 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.6,10
US-HUMD-190337
ADEPT STUDY DESIGN1-3,5
EOW=every other week
a315 patients were initially randomized; however, 2 patients did not receive study drug.3
- 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.2,3
- Patients must have active psoriatic skin lesions or a documented history of psoriasis.3
- 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 24.1,3
- Select secondary endpoints include ACR20 at week 24, ACR50/70 at weeks 12 and 24, and HAQ-DI score at week 12 and 24.3
- 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.3
- Select additional endpoints include: ACR components at week 2 and pain data at weeks 2 and 24.1,6
- 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.2,5
US-HUMD-200130
PIONEER I and II STUDY DESIGNS1,12,14,15
The first and only completed Phase 3 trials in HS
- Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
- Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
- Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
PIONEER I control=placebo PIONEER II control=placebo +/- antibiotic
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
HUMIRA demonstrated significant improvements from baseline in ACR components of disease activity (P<0.001)1
| 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 demonstrated significant improvements from baseline in every ACR component (P<0.001)1
| 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
PIONEER I and II STUDY DESIGNS—88 PATIENTS STUDIED IN OLE1-4
88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.
- Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
- Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
- Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
PIONEER I control=placebo PIONEER II control=placebo +/- antibiotic
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
ADEPT STUDY DESIGN1-4
EOW=every other week
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
- Select secondary endpoints include ACR20 at week 24, ACR 50/70 at weeks 12 and 24, and HAQ-DI score at week 12 and 24.2
- 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
- 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-200257
PIONEER I and II STUDY DESIGNS1,3-5
- Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
- Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
- Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
PIONEER I control=placebo PIONEER II control=placebo +/- antibiotic
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.
SELECT BASELINE PATIENT CHARACTERISTICS3,6
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) |
|
SELECT BASELINE DISEASE CHARACTERISTICS3,6,7
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) |
|
SELECT BASELINE LESION TYPE3,6,7
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:
- baseline weight
- baseline lesion count
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
PIONEER I and II STUDY DESIGNS1,3,5,6
- Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
- Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
- Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
PIONEER I control=placebo PIONEER II control=placebo +/- antibiotic
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.
SELECT BASELINE PATIENT CHARACTERISTICS3,4
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) |
|
SELECT BASELINE DISEASE CHARACTERISTICS3,4,7
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) |
|
SELECT BASELINE LESION TYPE3,4,7
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:
- Baseline weight
- Baseline lesion count
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
PIONEER I and II STUDY DESIGNS 1,3,8,13
The first and only completed Phase 3 trials in HS.
- Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
- Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
- Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
SELECT BASELINE PATIENT CHARACTERISTICS8
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) |
|
SELECT BASELINE DISEASE CHARACTERISTICS8,15
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) |
|
SELECT BASELINE LESION TYPE8.15
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:
- baseline weight
- baseline lesion count
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
PIONEER I and II STUDY DESIGNS—88 PATIENTS STUDIED IN OLE1,3,8,13
88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.
- Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
- Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
- Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
PIONEER I control=placebo PIONEER II control=placebo +/- antibiotic
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
Safety data from randomized control and OLE periods in PIONEER I and II3,6,8,14
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
ADEPT Study Design1-4
EOW=every other week
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 STUDY DESIGN1,2,5
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
Fingernail Psoriasis Study Design1,2,9,13
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:
- Moderate to severe chronic plaque psoriasis with disease duration of at least 6 months and psoriasis in at least one fingernail
- Fingernail involvement ≥ moderate as measured by 5-point PGA-F scale
- mNAPSI score of target fingernail ≥8
- BSA ≥10%, or ≥5% BSA with a total mNAPSI score for all fingernails ≥20
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