Trial Outcomes & Findings for The Quality of Life Study in Psoriasis Patients After Ustekinumab Treatment (NCT NCT01511315)

NCT ID: NCT01511315

Last Updated: 2016-02-12

Results Overview

The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

Baseline, 36 weeks

Results posted on

2016-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Ustekinumab Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Overall Study STARTED	36
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Quality of Life Study in Psoriasis Patients After Ustekinumab Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ustekinumab n=32 Participants Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Age, Continuous	41.2 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 36 weeks

Population: Only participants who completed the study were included in this analysis (n=32).

The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.

Outcome measures

Outcome measures
Measure	Ustekinumab n=32 Participants Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.	23.97 units on a scale Standard Error 3.65

SECONDARY outcome

Timeframe: Baseline, 12 and 24 weeks

Population: Only participants who completed the study were included in this analysis (n=32).

The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.

Outcome measures

Outcome measures
Measure	Ustekinumab n=32 Participants Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline week 24	19.97 units on a scale Standard Error 3.93
Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline week 12	18.63 units on a scale Standard Error 3.22

SECONDARY outcome

Timeframe: Baseline, 36 Weeks

Population: Only participants who completed the study were included in this analysis (n=32).

The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. The WPAI:PSO was created specifically for administering to patients with psoriasis. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduced productivity at work due to psoriasis), total activity impairment (TAI, percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (TWPI, total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Each WPAI score is expressed as impairment percentages (0-100), with higher scores representing greater impairment (worse outcomes)

Outcome measures

Outcome measures
Measure	Ustekinumab n=32 Participants Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline Employment	1 units on a scale Standard Deviation 3.1
Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline total work productivity impairment	-21.6 units on a scale Standard Deviation 36.4
Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline Absenteeism	-4.8 units on a scale Standard Deviation 11.7
Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline Presenteeism	18.6 units on a scale Standard Deviation 35.2
Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline total activity impairment	-26.6 units on a scale Standard Deviation 35.9

SECONDARY outcome

Timeframe: Baseline, 12, 24, and 36 Weeks

Population: Only participants who completed the study were included in this analysis (n=32).

The PQOL-12 is a 12-item psoriasis-specific validated PRO based entirely on the patient's own assessment of their situation. The items were data-derived based on a series of population-based statistical studies and clinical trials conducted over a decade. The KMPI is one of the first tools used in dermatology to incorporate a validated PRO in critical medical decision-making. The scores range from 0-120 with higher scores indicating worse outcomes.

Outcome measures

Outcome measures
Measure	Ustekinumab n=32 Participants Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Change in Psoriasis Quality of Life - 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline week 36	-38.34 units on a scale Standard Error 7.67
Change in Psoriasis Quality of Life - 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline week 24	-43.78 units on a scale Standard Error 8.01
Change in Psoriasis Quality of Life - 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline week 12	-40.06 units on a scale Standard Error 6.82

SECONDARY outcome

Timeframe: Baseline, 12, 24, and 36 Weeks

Population: Only participants who completed the study were included in this analysis (n=32).

The DLQI is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment.

Outcome measures

Outcome measures
Measure	Ustekinumab n=32 Participants Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline week 36	12.91 units on a scale Standard Error 1.30
Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline week 24	13.65 units on a scale Standard Error 1.23
Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline week 12	13.00 units on a scale Standard Error 1.23

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Only participants who completed the study were included in this analysis (n=32).

The Physician Global Assessment (PGA) scoring system is used to assess the severity and extent of psoriasis using a score of 0-6 (clear, almost clear, minimal, moderate, severe, to very severe) averaged over all lesions.

Outcome measures

Outcome measures
Measure	Ustekinumab n=32 Participants Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36 week 36	71.8 percentage of participants
Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36 week 24	67.7 percentage of participants
Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36 week 12	56.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 12, 24, and 36

Population: Only participants who completed the study were included in this analysis (n=32).

The Psoriasis Area and Severity Index (PASI) incorporates erythema, induration, and scale on a score of 0-4 weighted by percentage of body surface area involvement. PASI scores range from 0 to 72, with higher scores indicating worse disease. The percentage of patients achieving 75% reduction or better from the baseline PASI score in a designated time period has become the gold standard to measure the efficacy of psoriasis treatment options.

Outcome measures

Outcome measures
Measure	Ustekinumab n=32 Participants Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36 week 36	78.1 percentage of participants
Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36 week 24	78.1 percentage of participants
Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36 week 12	71.9 percentage of participants

Adverse Events

Ustekinumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mio Nakamura, MD

UCSF Psoriasis Center

Phone: 4154764701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place