Trial Outcomes & Findings for Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (NCT NCT01084668)

NCT ID: NCT01084668

Last Updated: 2012-06-29

Results Overview

Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

• Recruitment status: COMPLETED
• Target enrollment: 46 participants
• Primary outcome timeframe: Inclusion visit (Week 0), Week 4, Week 36, Week 52
• Results posted on: 2012-06-29

Participant Flow

A total of 46 participants were screened for this PMOS at 9 study sites in Austria. One participant did not meet entry criteria (screening failure), and 45 participants were enrolled and received treatment with adalimumab in the study.

Three participants were excluded from the database because they had been treated with adalimumab prior to their Visit 1. Statistical analysis has been performed for the 42 participants included in the All Treated population.

Participant milestones

Measure	Adalimumab Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Overall Study STARTED	42
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Adalimumab Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Overall Study Lack of Efficacy	5
Overall Study Withdrawal by Subject	2
Overall Study Pregnancy	1
Overall Study Non-compliance	1

Baseline Characteristics

Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs

Baseline characteristics by cohort

Measure	Adalimumab n=42 Participants Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Age Continuous	47.1 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment Austria	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Inclusion visit (Week 0), Week 4, Week 36, Week 52

Population: Analysis was performed on the All Treated population using an observed case approach. PASI score was assessed at Weeks 0, 4, 36, and 52 in 41, 36, 28, and 27 participants, respectively.

Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Outcome measures

Measure	All Treated n=42 Participants Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure	Subgroup With Nail Psoriasis Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
Psoriasis Area and Severity Index (PASI) Score Week 0	15.5 units on a scale Standard Deviation 11.4	—
Psoriasis Area and Severity Index (PASI) Score Week 4	7.6 units on a scale Standard Deviation 4.5	—
Psoriasis Area and Severity Index (PASI) Score Week 36	2.5 units on a scale Standard Deviation 5.2	—
Psoriasis Area and Severity Index (PASI) Score Week 52	2.0 units on a scale Standard Deviation 4.9	—

PRIMARY outcome

Timeframe: Inclusion visit (Week 0) to Week 52

Population: Analysis was performed on the All Treated population using an observed case approach. PASI response was assessed in 26 participants at Week 52.

PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Outcome measures

Measure	All Treated n=26 Participants Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure	Subgroup With Nail Psoriasis Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)	23 participants 4.9	—

SECONDARY outcome

Timeframe: Inclusion visit (Week 0), Week 4, Week 36, Week 52

Population: Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively.

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, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).

Outcome measures

Measure	All Treated n=42 Participants Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure	Subgroup With Nail Psoriasis Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
Dermatology Life Quality Index (DLQI) Score Week 36	2.2 units on a scale Standard Deviation 3.4	—
Dermatology Life Quality Index (DLQI) Score Week 52	2.2 units on a scale Standard Deviation 4.8	—
Dermatology Life Quality Index (DLQI) Score Week 0	13.8 units on a scale Standard Deviation 8.3	—
Dermatology Life Quality Index (DLQI) Score Week 4	7.2 units on a scale Standard Deviation 5.6	—

SECONDARY outcome

Timeframe: Inclusion visit (Week 0), Week 4, Week 36, and Week 52

Population: Analysis was performed using an observed case approach. For the All Treated population, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 34, 30, 24, and 25 participants, respectively. For the Subgroup with nail psoriasis, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 18, 16, 12, and 13 participants, respectively.

The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).

Outcome measures

Measure	All Treated n=42 Participants Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure	Subgroup With Nail Psoriasis n=18 Participants Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
Nail Psoriasis Severity Index (NAPSI) Score Week 0	15.4 units on a scale Standard Deviation 24.0	29.0 units on a scale Standard Deviation 26.5
Nail Psoriasis Severity Index (NAPSI) Score Week 4	14.9 units on a scale Standard Deviation 22.9	28.0 units on a scale Standard Deviation 25.0
Nail Psoriasis Severity Index (NAPSI) Score Week 36	4.0 units on a scale Standard Deviation 9.6	7.9 units on a scale Standard Deviation 12.6
Nail Psoriasis Severity Index (NAPSI) Score Week 52	4.0 units on a scale Standard Deviation 7.8	7.7 units on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: From the time of participant consent until 70 days after last dose of study drug

Population: Analysis was performed on the All Treated population.

Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.

Outcome measures

Measure	All Treated n=42 Participants Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure	Subgroup With Nail Psoriasis Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions Non-serious adverse events	8 participants	—
Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions Serious adverse events	1 participants	—

Adverse Events

Adalimumab

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab n=42 participants at risk Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Injury, poisoning and procedural complications Ligament rupture	2.4% 1/42 • Number of events 2 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Surgical and medical procedures Arthroscopic surgery	2.4% 1/42 • Number of events 1 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.

Other adverse events

Measure	Adalimumab n=42 participants at risk Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
Infections and infestations Acute tonsillitis	4.8% 2/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Infections and infestations Nasopharyngitis	4.8% 2/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
General disorders Injection site pain	2.4% 1/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
General disorders Injection site reaction	2.4% 1/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
General disorders Injection site urticaria	2.4% 1/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Injury, poisoning and procedural complications Tooth fracture	2.4% 1/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Skin and subcutaneous tissue disorders Psoriasis	2.4% 1/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Gastrointestinal disorders Nausea	2.4% 1/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.
Vascular disorders Hypertension	2.4% 1/42 • Up to 1 year (from the time of participant consent through the final Week 52 visit) plus 70 days following administration of the last dose of physician-prescribed study treatment.

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER