Trial Outcomes & Findings for Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation) (NCT NCT01155570)

NCT ID: NCT01155570

Last Updated: 2013-10-08

Results Overview

This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than "not related" (ie, "probable," "possible," or "unclear"). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events.

• Recruitment status: COMPLETED
• Target enrollment: 752 participants
• Primary outcome timeframe: From study registration through Week 24
• Results posted on: 2013-10-08

Participant Flow

Ninety-four participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.

Of the 752 participants registered, 4 participants did not have case report forms retrieved (2 whose registration was duplicated and 2 who did not receive Humira). Of the remaining 748 participants, 14 were excluded from analysis (7 changed hospital after registration, 7 didn't visit clinic after the first Humira administration).

Participant milestones

Measure	Humira Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Study STARTED	734
Overall Study Efficacy Analysis Population	708
Overall Study COMPLETED	592
Overall Study NOT COMPLETED	142

Reasons for withdrawal

Measure	Humira Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Study Adverse Event	39
Overall Study Lack of Efficacy	46
Overall Study Participant's Economic Reasons	17
Overall Study No Hospital Visits	7
Overall Study Adverse Event + Lack of Efficacy	2
Overall Study Adverse Event + Other Reasons	7
Overall Study Participant's Economic Reasons + Other	1
Overall Study Other Reasons	23

Baseline Characteristics

Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

Baseline characteristics by cohort

Measure	Humira n=734 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Age Continuous	50.7 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	176 Participants n=5 Participants
Sex: Female, Male Male	558 Participants n=5 Participants
Physician's Global Assessment (PGA)	2.7 units on a scale STANDARD_DEVIATION 5.7 • n=5 Participants
Psoriasis Area and Severity Index (PASI)	15.7 units on a scale STANDARD_DEVIATION 12.2 • n=5 Participants
Dermatology Life Quality Index (DLQI)	8.43 units on a scale STANDARD_DEVIATION 6.77 • n=5 Participants
Pain Visual Analog Scale (VAS)	49.5 units on a scale STANDARD_DEVIATION 30.7 • n=5 Participants
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR])	4.4 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP])	3.5 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: From study registration through Week 24

Population: Safety Analysis Population

This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than "not related" (ie, "probable," "possible," or "unclear"). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events.

Outcome measures

Measure	Humira n=734 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs AEs	237 participants	—
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs SAEs	35 participants	—
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs ADRs	191 participants	—
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs SADRs	24 participants	—
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs Deaths	4 participants	—
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs Discontinuations Due to AEs	48 participants	—

PRIMARY outcome

Timeframe: Week 4

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

• 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
• 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
• 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
• 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
• 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
• 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).

Outcome measures

Measure	Humira n=640 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Physician's Global Assessment at Week 4	2.2 units on a scale Standard Deviation 1.1	—

PRIMARY outcome

Timeframe: Week 8

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

• 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
• 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
• 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
• 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
• 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
• 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).

Outcome measures

Measure	Humira n=591 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Physician's Global Assessment At Week 8	1.8 units on a scale Standard Deviation 1.1	—

PRIMARY outcome

Timeframe: Week 16

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

• 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
• 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
• 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
• 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
• 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
• 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).

Outcome measures

Measure	Humira n=550 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Physician's Global Assessment at Week 16	1.5 units on a scale Standard Deviation 1.1	—

PRIMARY outcome

Timeframe: Week 24

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:

• 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
• 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
• 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
• 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
• 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
• 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).

Outcome measures

Measure	Humira n=502 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Physician's Global Assessment at Week 24	1.2 units on a scale Standard Deviation 1.1	—

PRIMARY outcome

Timeframe: Week 16

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).

Outcome measures

Measure	Humira n=522 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Psoriasis Area and Severity Index (PASI) at Week 16	5.0 units on a scale Standard Deviation 7.3	—

PRIMARY outcome

Timeframe: Week 24

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).

Outcome measures

Measure	Humira n=476 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Psoriasis Area and Severity Index (PASI) at Week 24	4.0 units on a scale Standard Deviation 7.4	—

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.

Outcome measures

Measure	Humira n=522 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) n=463 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16	49.2 percentage of participants	52.9 percentage of participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.

Outcome measures

Measure	Humira n=476 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) n=422 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24	58.2 percentage of participants	62.1 percentage of participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.

Outcome measures

Measure	Humira n=522 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) n=463 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16	27.0 percentage of participants	28.7 percentage of participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.

Outcome measures

Measure	Humira n=476 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) n=422 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24	39.3 percentage of participants	41.7 percentage of participants

PRIMARY outcome

Timeframe: Week 16

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.

Outcome measures

Measure	Humira n=205 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Dermatology Life Quality Index at Week 16	3.01 units on a scale Standard Deviation 4.51	—

PRIMARY outcome

Timeframe: Week 24

Population: Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.

Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.

Outcome measures

Measure	Humira n=193 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Dermatology Life Quality Index at Week 24	2.30 units on a scale Standard Deviation 3.89	—

PRIMARY outcome

Timeframe: Week 4

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).

Outcome measures

Measure	Humira n=133 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Pain Visual Analog Scale (VAS) at Week 4	26.7 units on a scale Standard Deviation 26.3	—

PRIMARY outcome

Timeframe: Week 16

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).

Outcome measures

Measure	Humira n=111 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Pain Visual Analog Scale (VAS) at Week 16	21.3 units on a scale Standard Deviation 23.7	—

PRIMARY outcome

Timeframe: Week 24

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).

Outcome measures

Measure	Humira n=116 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Pain Visual Analog Scale (VAS) at Week 24	16.3 units on a scale Standard Deviation 21.3	—

PRIMARY outcome

Timeframe: Week 4

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

Outcome measures

Measure	Humira n=69 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4	3.0 units on a scale Standard Deviation 1.6	—

PRIMARY outcome

Timeframe: Week 16

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

Outcome measures

Measure	Humira n=61 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16	2.4 units on a scale Standard Deviation 1.3	—

PRIMARY outcome

Timeframe: Week 24

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

Outcome measures

Measure	Humira n=62 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24	2.3 units on a scale Standard Deviation 1.3	—

PRIMARY outcome

Timeframe: Week 4

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

Outcome measures

Measure	Humira n=97 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4	2.3 units on a scale Standard Deviation 1.2	—

PRIMARY outcome

Timeframe: Week 16

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

Outcome measures

Measure	Humira n=82 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16	2.0 units on a scale Standard Deviation 0.9	—

PRIMARY outcome

Timeframe: Week 24

Population: Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.

DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.

Outcome measures

Measure	Humira n=85 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24	1.8 units on a scale Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants in the Efficacy Analysis Population with assessment at Week 24.

Overall response rating, according to investigator's subjective clinical opinion. The level of overall improvement rating was categorized as "markedly improved," "improved," "not changed," or "not assessable," comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions.

Outcome measures

Measure	Humira n=700 Participants Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.	Humira (Adalimumab-naive Participants) Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Physician's Overall Response Rating At Week 24 Markedly improved	354 participants	—
Physician's Overall Response Rating At Week 24 Improved	255 participants	—
Physician's Overall Response Rating At Week 24 Not changed	65 participants	—
Physician's Overall Response Rating At Week 24 Aggravated	16 participants	—
Physician's Overall Response Rating At Week 24 Not assessable	10 participants	—

Adverse Events

Humira

Serious events: 35 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Humira n=734 participants at risk Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Infections and infestations Diverticulitis	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Infections and infestations Encephalitis herpes	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Infections and infestations External ear cellulitis	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Infections and infestations Herpes zoster	0.27% 2/734 • From study registration through Week 24 Safety Analysis Population
Infections and infestations Meningitis bacterial	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Infections and infestations Pneumonia pneumococcal	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Infections and infestations Pulmonary tuberculosis	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal carcinoma	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Metabolism and nutrition disorders Decreased appetite	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Nervous system disorders Cerebral hemorrhage	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Nervous system disorders Cerebral infarction	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Cardiac disorders Angina pectoris	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Cardiac disorders Myocardial infarction	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Vascular disorders Temporal arteritis	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Gastrointestinal disorders Bleeding gastric ulcer	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Gastrointestinal disorders Pancreatic cyst	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Gastrointestinal disorders Alcoholic pancreatitis	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Hepatobiliary disorders Alcoholic liver disease	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Hepatobiliary disorders Cholecystitis	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Hepatobiliary disorders Cholelithiasis	0.27% 2/734 • From study registration through Week 24 Safety Analysis Population
Skin and subcutaneous tissue disorders Psoriasis	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Skin and subcutaneous tissue disorders Pustular psoriasis	0.41% 3/734 • From study registration through Week 24 Safety Analysis Population
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Renal and urinary disorders Tubulointerstitial nephritis	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Renal and urinary disorders Renal impairment	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
General disorders Chest pain	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
General disorders Malaise	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
General disorders Edema	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
General disorders Pyrexia	0.27% 2/734 • From study registration through Week 24 Safety Analysis Population
Investigations C-reactive protein increased	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Investigations Liver function test abnormal	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Injury, poisoning and procedural complications Splenic rupture	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population
Injury, poisoning and procedural complications Brain contusion	0.14% 1/734 • From study registration through Week 24 Safety Analysis Population

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

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.
• Publication restrictions are in place

Restriction type: OTHER