Trial Outcomes & Findings for Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy (NCT NCT01156532)

Results Overview

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). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.

Recruitment status

TERMINATED

Target enrollment

30 participants

Primary outcome timeframe

Baseline to Week 16

Results posted on

2014-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Adalimumab Treatment in Participants With Psoriasis Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab Treatment in Participants With Psoriasis Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Overall Study Family Reasons	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab Treatment in Participants With Psoriasis n=30 Participants Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Age, Continuous	51 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Participants with available data. One participant was excluded from the analysis because only baseline and not follow-up information was available. Furthermore, 3 participants did not have their PASI measurement available either at baseline or at their last follow-up visit.

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). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment in Participants With Psoriasis n=26 Participants Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response	78 percentage of participants Interval 61.0 to 95.0

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Participants with available data.

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, a little, 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. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment in Participants With Psoriasis n=26 Participants Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score	92 percentage of participants Interval 83.0 to 100.0

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Participants with available data.

EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment in Participants With Psoriasis n=26 Participants Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 Baseline	0.48 units on a scale Standard Deviation 0.40
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 Week 16	0.80 units on a scale Standard Deviation 0.32

SECONDARY outcome

Timeframe: From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).

Population: Participants who received at least one dose of study treatment.

An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment in Participants With Psoriasis n=29 Participants Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Number of Participants With Serious Adverse Events (SAEs)	1 participants

SECONDARY outcome

Timeframe: up to 16 weeks

Population: Participants who received at least one dose of study treatment.

Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment in Participants With Psoriasis n=29 Participants Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Adherence to Adalimumab Treatment No Missed Doses	24 participants
Adherence to Adalimumab Treatment One Missed Dose	3 participants
Adherence to Adalimumab Treatment Two Missed Doses	2 participants

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 16

Population: Participants with available data.

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). The mean PASI improvement was calculated using a linear regression model.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment in Participants With Psoriasis n=26 Participants Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Mean Psoriasis Area and Severity Index (PASI) Score Over Time Baseline	22.8 units on a scale Standard Deviation 9.0
Mean Psoriasis Area and Severity Index (PASI) Score Over Time Week 4	10.6 units on a scale Standard Deviation 9.8
Mean Psoriasis Area and Severity Index (PASI) Score Over Time Week 8	6.7 units on a scale Standard Deviation 8.4
Mean Psoriasis Area and Severity Index (PASI) Score Over Time Week 16	4.2 units on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 16

Population: Participants with available data.

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, a little, 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. The mean DLQI improvement was calculated using a linear regression model.

Outcome measures

Outcome measures
Measure	Adalimumab Treatment in Participants With Psoriasis n=26 Participants Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Mean Dermatology Life Quality Index (DLQI) Score Over Time Baseline	20.3 units on a scale Standard Deviation 5.5
Mean Dermatology Life Quality Index (DLQI) Score Over Time Week 4	10.8 units on a scale Standard Deviation 6.0
Mean Dermatology Life Quality Index (DLQI) Score Over Time Week 8	5.9 units on a scale Standard Deviation 5.5
Mean Dermatology Life Quality Index (DLQI) Score Over Time Week 16	4.6 units on a scale Standard Deviation 7.9

Adverse Events

Adalimumab Treatment in Participants With Psoriasis

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab Treatment in Participants With Psoriasis n=29 participants at risk Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
Infections and infestations Cellulitis	3.4% 1/29 • From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks). Adverse events are reported for all participants who received at least one dose of study treatment.

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