Trial Outcomes & Findings for Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa (NCT NCT01635764)
NCT ID: NCT01635764
Last Updated: 2018-01-24
Results Overview
Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
508 participants
Primary outcome timeframe
Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Results posted on
2018-01-24
Participant Flow
Subjects were evaluated for entry into Study M12-555 at the final study visit of the prior phase 3 study in which they participated. Therefore, the Study M12-555 Week 0 visit and administration of the first dose of study drug in Study M12-555 was performed on the same day as the final or last visit of the prior Phase 3 study.
Participant milestones
| Measure |
Adalimumab Every Week
Adalimumab 40 mg every week.
|
|---|---|
|
Overall Study
STARTED
|
508
|
|
Overall Study
COMPLETED
|
235
|
|
Overall Study
NOT COMPLETED
|
273
|
Reasons for withdrawal
| Measure |
Adalimumab Every Week
Adalimumab 40 mg every week.
|
|---|---|
|
Overall Study
Adverse Event
|
46
|
|
Overall Study
Lack of Efficacy
|
76
|
|
Overall Study
Exceed Protocol-specified Interventions
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
|
Overall Study
Withdrew Consent
|
67
|
|
Overall Study
Lost to Follow-up
|
53
|
|
Overall Study
Other
|
28
|
Baseline Characteristics
Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
EW/EW/EW
n=88 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
n=90 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
n=92 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
PBO/EW/EW
n=115 Participants
All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
|
PBO/PBO/EW
n=123 Participants
All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
|
Total
n=508 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
36.1 years
STANDARD_DEVIATION 10.50 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 11.92 • n=4 Participants
|
37.0 years
STANDARD_DEVIATION 12.28 • n=21 Participants
|
36.8 years
STANDARD_DEVIATION 11.35 • n=8 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
328 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
180 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: All participants with evaluable data at given time point.
Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=88 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
n=90 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
n=92 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 192
|
51.1 percentage of participants
|
55.6 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 84
|
56.8 percentage of participants
|
56.7 percentage of participants
|
55.4 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 96
|
56.8 percentage of participants
|
54.4 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 108
|
60.2 percentage of participants
|
56.7 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 120
|
56.8 percentage of participants
|
52.2 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 132
|
52.3 percentage of participants
|
52.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 144
|
51.1 percentage of participants
|
54.4 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 156
|
48.9 percentage of participants
|
52.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 168
|
52.3 percentage of participants
|
53.3 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 180
|
51.1 percentage of participants
|
54.4 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 2
|
34.1 percentage of participants
|
39.8 percentage of participants
|
34.1 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 4
|
38.6 percentage of participants
|
41.1 percentage of participants
|
40.2 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 8
|
51.1 percentage of participants
|
48.9 percentage of participants
|
47.8 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 12
|
52.3 percentage of participants
|
55.6 percentage of participants
|
51.1 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 16
|
50.0 percentage of participants
|
56.7 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 20
|
56.8 percentage of participants
|
45.6 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 24
|
48.9 percentage of participants
|
47.8 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 36
|
62.5 percentage of participants
|
54.4 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 48
|
58.0 percentage of participants
|
55.6 percentage of participants
|
58.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 60
|
62.5 percentage of participants
|
57.8 percentage of participants
|
58.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 72
|
59.1 percentage of participants
|
61.1 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 204
|
50.0 percentage of participants
|
54.4 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Week 216
|
50.0 percentage of participants
|
54.4 percentage of participants
|
46.7 percentage of participants
|
PRIMARY outcome
Timeframe: Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204Population: All participants with evaluable data at given time point.
Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=115 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 36
|
57.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 48
|
60.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 60
|
57.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 72
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 84
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 96
|
53.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 108
|
52.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 120
|
53.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 132
|
56.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 144
|
51.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 156
|
52.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Entry of Period B
|
26.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 12
|
54.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 24
|
57.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 168
|
55.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 180
|
54.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 192
|
53.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 204
|
53.5 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192Population: All participants with evaluable data at given time point.
Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=123 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 18
|
57.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 24
|
55.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 36
|
60.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 48
|
54.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 60
|
55.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 72
|
54.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 84
|
54.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 96
|
57.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 108
|
54.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 120
|
52.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 132
|
54.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 144
|
51.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 156
|
50.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 168
|
51.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 180
|
51.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 192
|
51.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Entry of M12-555
|
19.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 4
|
46.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 8
|
51.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Week 12
|
48.4 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: All participants with evaluable data at given time point.
The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=88 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 108
|
46.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 120
|
44.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 132
|
44.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 144
|
43.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 156
|
45.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 168
|
46.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 180
|
46.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 192
|
47.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 204
|
47.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 2
|
22.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 4
|
28.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 8
|
38.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 12
|
35.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 16
|
37.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 20
|
42.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 24
|
36.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 36
|
48.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 48
|
46.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 60
|
43.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 72
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 84
|
45.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 96
|
44.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Week 216
|
46.6 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192Population: All participants with evaluable data at given time point.
The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=90 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
n=92 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
n=123 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Entry of M12-555
|
31.1 percentage of participants
|
22.8 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 4
|
35.6 percentage of participants
|
34.8 percentage of participants
|
44.3 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 8
|
43.2 percentage of participants
|
42.4 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 12
|
45.5 percentage of participants
|
44.6 percentage of participants
|
45.1 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 18
|
50.0 percentage of participants
|
41.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 24
|
43.2 percentage of participants
|
46.7 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 36
|
54.5 percentage of participants
|
45.7 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 48
|
50.0 percentage of participants
|
42.4 percentage of participants
|
52.5 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 60
|
48.9 percentage of participants
|
43.5 percentage of participants
|
51.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 72
|
50.0 percentage of participants
|
43.5 percentage of participants
|
54.1 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 84
|
53.4 percentage of participants
|
44.6 percentage of participants
|
50.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 96
|
51.1 percentage of participants
|
40.2 percentage of participants
|
52.5 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 108
|
51.1 percentage of participants
|
40.2 percentage of participants
|
51.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 120
|
46.6 percentage of participants
|
37.0 percentage of participants
|
52.5 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 132
|
51.1 percentage of participants
|
37.0 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 144
|
48.9 percentage of participants
|
41.3 percentage of participants
|
52.5 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 156
|
47.7 percentage of participants
|
39.1 percentage of participants
|
51.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 168
|
51.1 percentage of participants
|
35.9 percentage of participants
|
51.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 180
|
51.1 percentage of participants
|
35.9 percentage of participants
|
51.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 192
|
51.1 percentage of participants
|
35.9 percentage of participants
|
51.6 percentage of participants
|
PRIMARY outcome
Timeframe: Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204Population: All participants with evaluable data at given time point.
The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=115 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 156
|
45.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Entry of Period B
|
20.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 12
|
38.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 24
|
43.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 36
|
42.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 48
|
43.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 60
|
45.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 72
|
43.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 84
|
43.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 96
|
46.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 108
|
42.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 120
|
45.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 132
|
46.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 144
|
49.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 168
|
46.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 180
|
45.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 192
|
45.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Week 204
|
45.6 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216Population: All participants with evaluable data at given time point.
The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=88 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 168
|
-41.5 units on a scale
Standard Deviation 130.40
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 2
|
-18.0 units on a scale
Standard Deviation 25.27
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 4
|
-21.0 units on a scale
Standard Deviation 31.81
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 8
|
-22.8 units on a scale
Standard Deviation 35.45
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 12
|
-23.9 units on a scale
Standard Deviation 48.30
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 16
|
-26.6 units on a scale
Standard Deviation 54.63
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 20
|
-32.1 units on a scale
Standard Deviation 73.69
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 24
|
-36.6 units on a scale
Standard Deviation 74.99
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 36
|
-41.6 units on a scale
Standard Deviation 93.11
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 48
|
-42.2 units on a scale
Standard Deviation 115.22
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 60
|
-41.9 units on a scale
Standard Deviation 119.98
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 72
|
-43.2 units on a scale
Standard Deviation 122.30
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 84
|
-42.8 units on a scale
Standard Deviation 123.18
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 96
|
-43.2 units on a scale
Standard Deviation 126.21
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 108
|
-43.2 units on a scale
Standard Deviation 124.92
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 120
|
-43.4 units on a scale
Standard Deviation 127.65
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 132
|
-42.5 units on a scale
Standard Deviation 128.45
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 144
|
-42.4 units on a scale
Standard Deviation 129.37
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 156
|
-40.7 units on a scale
Standard Deviation 130.30
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 180
|
-41.8 units on a scale
Standard Deviation 129.89
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 192
|
-41.9 units on a scale
Standard Deviation 130.46
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 204
|
-41.4 units on a scale
Standard Deviation 130.72
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Week 216
|
-41.4 units on a scale
Standard Deviation 130.94
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192Population: All participants with evaluable data at given time point.
The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=90 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
n=92 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
n=123 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 4
|
-30.2 units on a scale
Standard Deviation 48.99
|
-18.8 units on a scale
Standard Deviation 56.52
|
-16.2 units on a scale
Standard Deviation 56.16
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 84
|
-36.6 units on a scale
Standard Deviation 51.33
|
-20.0 units on a scale
Standard Deviation 66.02
|
-29.5 units on a scale
Standard Deviation 65.79
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 192
|
-35.6 units on a scale
Standard Deviation 53.64
|
-15.4 units on a scale
Standard Deviation 67.39
|
-28.7 units on a scale
Standard Deviation 69.81
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 96
|
-34.0 units on a scale
Standard Deviation 49.42
|
-18.3 units on a scale
Standard Deviation 65.14
|
-29.0 units on a scale
Standard Deviation 68.85
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 108
|
-34.0 units on a scale
Standard Deviation 54.41
|
-18.3 units on a scale
Standard Deviation 66.88
|
-28.4 units on a scale
Standard Deviation 71.52
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 120
|
-31.8 units on a scale
Standard Deviation 60.85
|
-16.2 units on a scale
Standard Deviation 66.82
|
-28.3 units on a scale
Standard Deviation 70.37
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 132
|
-35.1 units on a scale
Standard Deviation 53.01
|
-16.7 units on a scale
Standard Deviation 66.87
|
-28.8 units on a scale
Standard Deviation 69.79
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 144
|
-35.1 units on a scale
Standard Deviation 53.94
|
-16.6 units on a scale
Standard Deviation 67.30
|
-28.6 units on a scale
Standard Deviation 70.03
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 156
|
-34.7 units on a scale
Standard Deviation 53.95
|
-15.7 units on a scale
Standard Deviation 67.09
|
-28.0 units on a scale
Standard Deviation 69.11
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 168
|
-35.6 units on a scale
Standard Deviation 53.72
|
-15.5 units on a scale
Standard Deviation 67.40
|
-28.7 units on a scale
Standard Deviation 69.81
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 180
|
-35.6 units on a scale
Standard Deviation 53.64
|
-15.4 units on a scale
Standard Deviation 67.39
|
-28.7 units on a scale
Standard Deviation 69.81
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Entry of M12-555
|
-23.1 units on a scale
Standard Deviation 56.94
|
-10.5 units on a scale
Standard Deviation 56.74
|
0.2 units on a scale
Standard Deviation 51.35
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 8
|
-34.9 units on a scale
Standard Deviation 47.42
|
-21.2 units on a scale
Standard Deviation 63.26
|
-24.8 units on a scale
Standard Deviation 51.55
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 12
|
-34.8 units on a scale
Standard Deviation 55.71
|
-25.5 units on a scale
Standard Deviation 57.92
|
-26.2 units on a scale
Standard Deviation 54.58
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 18
|
-35.9 units on a scale
Standard Deviation 47.92
|
-26.2 units on a scale
Standard Deviation 60.59
|
-32.3 units on a scale
Standard Deviation 48.60
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 24
|
-37.1 units on a scale
Standard Deviation 47.39
|
-24.1 units on a scale
Standard Deviation 61.52
|
-33.5 units on a scale
Standard Deviation 50.20
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 36
|
-37.1 units on a scale
Standard Deviation 46.07
|
-24.7 units on a scale
Standard Deviation 63.81
|
-33.6 units on a scale
Standard Deviation 57.58
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 48
|
-37.5 units on a scale
Standard Deviation 47.94
|
-24.8 units on a scale
Standard Deviation 63.21
|
-30.2 units on a scale
Standard Deviation 64.84
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 60
|
-34.8 units on a scale
Standard Deviation 50.17
|
-22.6 units on a scale
Standard Deviation 65.06
|
-31.7 units on a scale
Standard Deviation 66.33
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Week 72
|
-35.4 units on a scale
Standard Deviation 55.22
|
-20.1 units on a scale
Standard Deviation 64.52
|
-31.8 units on a scale
Standard Deviation 65.26
|
PRIMARY outcome
Timeframe: Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204Population: All participants with evaluable data at given time point.
The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=115 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Entry of Period B
|
-18.0 units on a scale
Standard Deviation 38.32
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 12
|
-43.2 units on a scale
Standard Deviation 48.07
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 24
|
-43.0 units on a scale
Standard Deviation 53.08
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 36
|
-49.5 units on a scale
Standard Deviation 57.05
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 48
|
-47.1 units on a scale
Standard Deviation 61.95
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 60
|
-46.2 units on a scale
Standard Deviation 60.94
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 72
|
-44.5 units on a scale
Standard Deviation 67.13
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 84
|
-46.8 units on a scale
Standard Deviation 64.57
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 96
|
-45.5 units on a scale
Standard Deviation 70.63
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 108
|
-45.0 units on a scale
Standard Deviation 74.15
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 120
|
-45.9 units on a scale
Standard Deviation 75.30
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 132
|
-44.4 units on a scale
Standard Deviation 78.09
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 144
|
-45.4 units on a scale
Standard Deviation 76.53
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 156
|
-46.0 units on a scale
Standard Deviation 76.17
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 168
|
-46.1 units on a scale
Standard Deviation 75.84
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 180
|
-45.8 units on a scale
Standard Deviation 75.96
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 192
|
-45.8 units on a scale
Standard Deviation 75.89
|
—
|
—
|
|
Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Week 204
|
-45.9 units on a scale
Standard Deviation 75.96
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192Population: All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point
The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=63 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 2
|
47.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 4
|
46.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 8
|
44.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 12
|
42.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 16
|
46.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 20
|
50.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 24
|
54.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 36
|
58.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 48
|
54.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 60
|
52.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 72
|
54.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 84
|
52.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 96
|
49.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 108
|
54.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 120
|
50.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 132
|
46.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 144
|
54.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 156
|
52.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 168
|
52.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 180
|
52.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 192
|
52.4 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192Population: All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point
The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=65 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
n=64 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
n=84 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 108
|
50.8 percentage of participants
|
42.9 percentage of participants
|
50.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 120
|
42.9 percentage of participants
|
47.6 percentage of participants
|
45.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 132
|
41.3 percentage of participants
|
47.6 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 144
|
41.3 percentage of participants
|
50.8 percentage of participants
|
47.0 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 156
|
39.7 percentage of participants
|
46.0 percentage of participants
|
49.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 168
|
41.3 percentage of participants
|
49.2 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 180
|
41.3 percentage of participants
|
49.2 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 192
|
41.3 percentage of participants
|
49.2 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Entry of M12-555
|
40.0 percentage of participants
|
21.9 percentage of participants
|
22.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 4
|
47.5 percentage of participants
|
43.1 percentage of participants
|
44.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 8
|
45.2 percentage of participants
|
47.6 percentage of participants
|
51.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 12
|
41.3 percentage of participants
|
54.0 percentage of participants
|
51.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 18
|
47.6 percentage of participants
|
50.8 percentage of participants
|
55.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 24
|
42.9 percentage of participants
|
47.6 percentage of participants
|
54.2 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 36
|
49.2 percentage of participants
|
47.6 percentage of participants
|
55.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 48
|
47.6 percentage of participants
|
50.8 percentage of participants
|
56.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 60
|
47.6 percentage of participants
|
50.8 percentage of participants
|
50.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 72
|
47.6 percentage of participants
|
42.9 percentage of participants
|
50.6 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 84
|
50.8 percentage of participants
|
46.0 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 96
|
50.8 percentage of participants
|
55.6 percentage of participants
|
48.2 percentage of participants
|
PRIMARY outcome
Timeframe: Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204Population: All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point
The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=79 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Entry of Period B
|
31.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 12
|
51.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 24
|
55.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 36
|
55.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 48
|
53.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 60
|
58.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 72
|
64.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 84
|
63.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 96
|
62.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 108
|
55.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 120
|
56.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 132
|
53.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 144
|
55.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 156
|
51.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 168
|
57.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 180
|
57.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 192
|
56.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Week 204
|
57.7 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192Population: All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.
The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=50 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 2
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 4
|
52.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 8
|
48.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 12
|
46.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 16
|
40.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 20
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 24
|
46.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 36
|
58.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 48
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 60
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 72
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 84
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 96
|
54.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 108
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 120
|
48.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 132
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 144
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 156
|
58.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 168
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 180
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 192
|
56.0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192Population: All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.
The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=55 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
n=53 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
n=69 Participants
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 108
|
49.1 percentage of participants
|
44.2 percentage of participants
|
54.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Entry of M12-555
|
43.6 percentage of participants
|
37.7 percentage of participants
|
31.9 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 4
|
49.0 percentage of participants
|
46.8 percentage of participants
|
61.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 8
|
46.2 percentage of participants
|
55.8 percentage of participants
|
61.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 12
|
39.6 percentage of participants
|
59.6 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 18
|
45.3 percentage of participants
|
59.6 percentage of participants
|
63.2 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 24
|
39.6 percentage of participants
|
53.8 percentage of participants
|
54.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 36
|
45.3 percentage of participants
|
48.1 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 48
|
47.2 percentage of participants
|
51.9 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 60
|
43.4 percentage of participants
|
53.8 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 72
|
47.2 percentage of participants
|
59.6 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 84
|
49.1 percentage of participants
|
48.1 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 96
|
47.2 percentage of participants
|
57.7 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 120
|
39.6 percentage of participants
|
48.1 percentage of participants
|
54.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 132
|
43.4 percentage of participants
|
50.0 percentage of participants
|
54.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 144
|
43.4 percentage of participants
|
50.0 percentage of participants
|
54.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 156
|
43.4 percentage of participants
|
46.2 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 168
|
43.4 percentage of participants
|
48.1 percentage of participants
|
54.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 180
|
43.4 percentage of participants
|
48.1 percentage of participants
|
54.4 percentage of participants
|
|
Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 192
|
43.4 percentage of participants
|
48.1 percentage of participants
|
54.4 percentage of participants
|
PRIMARY outcome
Timeframe: Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204Population: All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.
The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Outcome measures
| Measure |
EW/EW/EW
n=62 Participants
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
|
EW/EOW/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
|
EW/PBO/EW
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
|
|---|---|---|---|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Entry of Period B
|
30.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 12
|
59.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 24
|
61.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 36
|
61.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 48
|
53.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 60
|
60.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 72
|
58.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 84
|
60.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 96
|
61.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 108
|
62.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 120
|
62.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 132
|
59.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 144
|
60.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 156
|
55.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 168
|
62.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 180
|
62.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 192
|
60.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Week 204
|
62.3 percentage of participants
|
—
|
—
|
Adverse Events
All Adalimumab
Serious events: 99 serious events
Other events: 349 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Adalimumab
n=508 participants at risk
Participants who received at least 1 dose of adalimumab (40 mg every week) in M12-555.
|
|---|---|
|
Cardiac disorders
CARDIAC FAILURE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Cardiac disorders
PALPITATIONS
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Congenital, familial and genetic disorders
ODONTOGENIC CYST
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Gastrointestinal disorders
AUTOIMMUNE PANCREATITIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Gastrointestinal disorders
INCARCERATED UMBILICAL HERNIA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Gastrointestinal disorders
PERITONEAL CYST
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
General disorders
PYREXIA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
APPENDICITIS
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
CELLULITIS
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
ERYSIPELAS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
GROIN ABSCESS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
INFECTION
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
PERITONITIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
PERIUMBILICAL ABSCESS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
PILONIDAL CYST
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
PNEUMONIA
|
0.59%
3/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
PNEUMONIA CHLAMYDIAL
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
SEPSIS
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
VULVAL ABSCESS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
BURNS SECOND DEGREE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
PROCEDURAL DIZZINESS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
RADIAL HEAD DISLOCATION
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
SCAR
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Investigations
AUTOANTIBODY POSITIVE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Metabolism and nutrition disorders
OBESITY
|
0.59%
3/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Musculoskeletal and connective tissue disorders
JOINT INSTABILITY
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER STAGE III
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CARDIAC MYXOMA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE BREAST CARCINOMA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY CYSTADENOMA LYMPHOMATOSUM
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEMINOMA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Nervous system disorders
COMA HEPATIC
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Nervous system disorders
HEMIPLEGIA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Renal and urinary disorders
URETERIC OBSTRUCTION
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Reproductive system and breast disorders
DYSFUNCTIONAL UTERINE BLEEDING
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Reproductive system and breast disorders
PELVIC PROLAPSE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Reproductive system and breast disorders
UTERINE CYST
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Skin and subcutaneous tissue disorders
CUTIS LAXA
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
5.7%
29/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Skin and subcutaneous tissue disorders
PUSTULAR PSORIASIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Skin and subcutaneous tissue disorders
PYODERMA GANGRENOSUM
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Social circumstances
SEXUAL ABUSE
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Vascular disorders
HYPERTENSION
|
0.39%
2/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.20%
1/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
Other adverse events
| Measure |
All Adalimumab
n=508 participants at risk
Participants who received at least 1 dose of adalimumab (40 mg every week) in M12-555.
|
|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
6.5%
33/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Gastrointestinal disorders
NAUSEA
|
6.3%
32/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
General disorders
PYREXIA
|
5.7%
29/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
BRONCHITIS
|
7.3%
37/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
GASTROENTERITIS
|
5.1%
26/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
INFLUENZA
|
7.9%
40/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
NASOPHARYNGITIS
|
18.1%
92/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
SINUSITIS
|
5.7%
29/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
16.5%
84/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.9%
40/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.5%
38/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.5%
33/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Nervous system disorders
HEADACHE
|
15.7%
80/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.3%
27/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
24.6%
125/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
|
Vascular disorders
HYPERTENSION
|
5.5%
28/508 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
|
Additional Information
Global Medical Services
AbbVie
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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Restriction type: OTHER