Trial Outcomes & Findings for Safety and Efficacy of Combining nbUVB to Etanercept in Patients (NCT NCT00640393)

NCT ID: NCT00640393

Last Updated: 2011-09-09

Results Overview

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale: * 0 = No symptoms * 1 = Slight * 2 = Moderate * 3 = Marked * 4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6. Total scale 0 = best and 72 = worst

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 99 participants
• Primary outcome timeframe: 112 and 140 days
• Results posted on: 2011-09-09

Participant Flow

Participant milestones

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Part 1 STARTED	99	0	0
Part 1 COMPLETED	94	0	0
Part 1 NOT COMPLETED	5	0	0
Randomization STARTED	94	0	0
Randomization COMPLETED	75	0	0
Randomization NOT COMPLETED	19	0	0
Part 2 STARTED	0	37	38
Part 2 COMPLETED	0	27	35
Part 2 NOT COMPLETED	0	10	3

Reasons for withdrawal

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Part 1 Lost to Follow-up	2	0	0
Part 1 Withdrawal by Subject	3	0	0
Randomization Withdrawn per protocol	17	0	0
Randomization Never randomized by site	2	0	0
Part 2 Lost to Follow-up	0	2	2
Part 2 Withdrawal by Subject	0	6	1
Part 2 Non-adherence	0	1	0
Part 2 Adverse Event	0	1	0

Baseline Characteristics

Safety and Efficacy of Combining nbUVB to Etanercept in Patients

Baseline characteristics by cohort

Measure	Part 1 - Etanercept n=99 Participants All participants received etanercept 50 mg twice a week for 12 weeks.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	94 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	43.9 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Region of Enrollment Canada	99 participants n=5 Participants
PASI - (Psoriasis area and severity index)	17.1 Total units on a scale STANDARD_DEVIATION 7.4 • n=5 Participants
PGA - Physician's Global Assessment.	3.6 Units on a scale STANDARD_DEVIATION 0.7 • n=5 Participants
BSA - Body surface area	21.7 Percentage of the body affected STANDARD_DEVIATION 14.2 • n=5 Participants
DLQI - Dermatology life quality index	12.9 Units on a scale STANDARD_DEVIATION 6.7 • n=5 Participants

PRIMARY outcome

Timeframe: 112 and 140 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT Day 84	—	0 Participants	0 Participants
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT Day 112	—	3 Participants	1 Participants
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT Day 140	—	5 Participants	5 Participants
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT Day 168	—	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 112, 140 and 168 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT Day 84	—	18 Participants	13 Participants
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT Day 112	—	15 Participants	12 Participants
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT Day 140	—	23 Participants	17 Participants
Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT Day 168	—	19 Participants	17 Participants

SECONDARY outcome

Timeframe: 112, 140 and 168 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT Day 84	—	0 Participants	0 Participants
Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT Day 112	—	2 Participants	0 Participants
Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT Day 140	—	1 Participants	1 Participants
Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT Day 168	—	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 28 and 84 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept n=99 Participants All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT Day 28	37 Participants	—	—
Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT Day 84	82 Participants	—	—

SECONDARY outcome

Timeframe: 28 and 84 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept n=99 Participants All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT Day 28	13 Participants	—	—
Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT Day 84	50 Participants	—	—

SECONDARY outcome

Timeframe: 28 and 84 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept n=99 Participants All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT Day 28	3 Participants	—	—
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT Day 84	17 Participants	—	—

SECONDARY outcome

Timeframe: 28 and 84 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept n=99 Participants All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT Day 28	2 Participants	—	—
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT Day 84	8 Participants	—	—

SECONDARY outcome

Timeframe: 0, 112, 140 and 168 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Non Responder (NRI).

Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).

PGA scores are evaluated at each time point.

The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:

• 0 = clear
• 1 = minimal
• 2 = mild
• 3 = moderate
• 4 = severe
• 5 = very severe

The scale evaluates plaque elevation, scaling and erythema.

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT Day 84	—	11 Participants 0.6	11 Participants 0.72
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT Day 112	—	13 Participants 0.88	8 Participants 0.88
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT Day 140	—	13 Participants 0.79	11 Participants 0.94
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT Day 168	—	12 Participants 0.86	13 Participants 1.01

SECONDARY outcome

Timeframe: 0, 84, 112, 140 and 168 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).

BSA scores are evaluated at each time point.

BSA is a measure of the percentage of body surface affected by psoriasis.

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Body Surface Area (BSA) Affected by Psoriasis - ITT Day 0	—	19.06 Percent of body affected Standard Deviation 12.68	23.65 Percent of body affected Standard Deviation 16.91
Body Surface Area (BSA) Affected by Psoriasis - ITT Day 84	—	6.69 Percent of body affected Standard Deviation 6.95	8.28 Percent of body affected Standard Deviation 7.98
Body Surface Area (BSA) Affected by Psoriasis - ITT Day 112	—	4.92 Percent of body affected Standard Deviation 5.38	7.27 Percent of body affected Standard Deviation 7.16
Body Surface Area (BSA) Affected by Psoriasis - ITT Day 140	—	4.43 Percent of body affected Standard Deviation 5.57	6.53 Percent of body affected Standard Deviation 7.73
Body Surface Area (BSA) Affected by Psoriasis - ITT Day 168	—	3.28 Percent of body affected Standard Deviation 2.58	7.19 Percent of body affected Standard Deviation 8.17

SECONDARY outcome

Timeframe: 0, 84, 112, 140 and 168 days

Population: The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).

The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.

Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.

Scale is from 0 best to 30 worst.

0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Dermatology Life Quality Index (DLQI) - ITT Day 0	—	11.92 Units on a scale Standard Deviation 6.49	12.47 Units on a scale Standard Deviation 6.93
Dermatology Life Quality Index (DLQI) - ITT Day 84	—	3.69 Units on a scale Standard Deviation 3.36	5.97 Units on a scale Standard Deviation 6.28
Dermatology Life Quality Index (DLQI) - ITT Day 112	—	3.06 Units on a scale Standard Deviation 3.23	6.03 Units on a scale Standard Deviation 5.57
Dermatology Life Quality Index (DLQI) - ITT Day 140	—	2.69 Units on a scale Standard Deviation 2.86	6.05 Units on a scale Standard Deviation 5.87
Dermatology Life Quality Index (DLQI) - ITT Day 168	—	2.83 Units on a scale Standard Deviation 3.26	6.00 Units on a scale Standard Deviation 6.07

SECONDARY outcome

Timeframe: 196 days

Population: The analysis was intention to treat (ITT).

Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of adverse drug reactions.

Definition: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.

Only adverse drug reactions that were at least possibly related to etanercept were recorded. All symptoms observed at the injection site such as erythema, burning, edema and pruritus were recorded together as Injection Site Reaction.

Outcome measures

Measure	Part 1 - Etanercept n=99 Participants All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Adverse Drug Reactions - ITT	7 Adverse drug reactions.	3 Adverse drug reactions.	2 Adverse drug reactions.

SECONDARY outcome

Timeframe: 196 days

Population: The analysis was intention to treat (ITT).

Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of infectious adverse events.

Definition: An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.

Only infectious and malignant (including any type of skin cancer) adverse events were recorded.

Outcome measures

Measure	Part 1 - Etanercept n=99 Participants All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Infectious Adverse Events - ITT	21 Infectious adverse events	7 Infectious adverse events	17 Infectious adverse events

SECONDARY outcome

Timeframe: 196 days

Population: The analysis was intention to treat (ITT).

Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of serious adverse events.

Definition: any adverse event from this study that results in one of the following outcomes, or is significant for any other reason:

• death
• initial or prolonged inpatient hospitalization
• a life-threatening experience (that is, immediate risk of dying)
• persistent or significant disability/incapacity
• congenital anomaly/birth defect

Outcome measures

Measure	Part 1 - Etanercept n=99 Participants All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Serious Adverse Events - ITT	1 Serious adverse events	0 Serious adverse events	2 Serious adverse events

SECONDARY outcome

Timeframe: 84, 112, 140 and 168 days

Population: The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=7 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=29 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP Day 84	—	0 Participants	0 Participants
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP Day 112	—	3 Participants	1 Participants
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP Day 140 (n = 28 for etanercept)	—	3 Participants	5 Participants
Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP Day 168	—	3 Participants	6 Participants

SECONDARY outcome

Timeframe: 84, 112, 140 and 168 days

Population: The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=7 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=29 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP Day 140 (n = 28 for etanercept)	—	7 Participants	16 Participants
Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP Day 168	—	7 Participants	16 Participants
Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP Day 84	—	3 Participants	11 Participants
Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP Day 112	—	6 Participants	12 Participants

SECONDARY outcome

Timeframe: 84, 112, 140 and 168 days

Population: The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.

Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:

• 0 = No symptoms
• 1 = Slight
• 2 = Moderate
• 3 = Marked
• 4 = Very marked

The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.

Total scale 0 = best and 72 = worst

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=7 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=29 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP Day 84	—	0 Participants	0 Participants
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP Day 112	—	2 Participants	0 Participants
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP Day 140 (n = 28 for etanercept)	—	1 Participants	1 Participants
Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP Day 168	—	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 84, 112, 140 and 168 days

Population: The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol. And PGA was not performed for another patient (Day 168)

Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).

PGA scores are evaluated at each time point.

The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:

• 0 = clear
• 1 = minimal
• 2 = mild
• 3 = moderate
• 4 = severe
• 5 = very severe

The scale evaluates plaque elevation, scaling and erythema.

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=7 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=29 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP Day 84	—	4 Participants 0.49	9 Participants 0.69
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP Day 112	—	5 Participants 0.82	6 Participants 0.97
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP Day 140 (n = 28 for etanercept)	—	6 Participants 0.58	9 Participants 1.05
Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP Day 168 (n = 28 for etanercept)	—	7 Participants 0.38	11 Participants 1.05

SECONDARY outcome

Timeframe: 0, 84, 112, 140 and 168 days

Population: The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140.

BSA scores are evaluated at each time point.

BSA is a measure of the percentage of body surface affected by psoriasis.

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=7 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=28 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Body Surface Area (BSA) Affected by Psoriasis - PP Day 0	—	17.82 Percent of body affected Standard Deviation 8.72	24.24 Percent of body affected Standard Deviation 16.89
Body Surface Area (BSA) Affected by Psoriasis - PP Day 84	—	6.04 Percent of body affected Standard Deviation 4.78	8.63 Percent of body affected Standard Deviation 8.67
Body Surface Area (BSA) Affected by Psoriasis - PP Day 112	—	2.93 Percent of body affected Standard Deviation 4.97	7.57 Percent of body affected Standard Deviation 7.93
Body Surface Area (BSA) Affected by Psoriasis - PP Day 140	—	2.07 Percent of body affected Standard Deviation 2.28	6.68 Percent of body affected Standard Deviation 8.69
Body Surface Area (BSA) Affected by Psoriasis - PP Day 168	—	1.57 Percent of body affected Standard Deviation 1.54	7.21 Percent of body affected Standard Deviation 8.42

SECONDARY outcome

Timeframe: 0, 84, 112, 140 and 168 days

Population: The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140. Results for one were excluded because of missing DLQI questionnaire results.

The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.

Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.

Scale is from 0 best to 30 worst.

0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life

Outcome measures

Measure	Part 1 - Etanercept All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=7 Participants Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=27 Participants Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Dermatology Life Quality Index (DLQI) - PP Day 112	—	1.71 Units on a scale Standard Deviation 1.89	5.89 Units on a scale Standard Deviation 5.53
Dermatology Life Quality Index (DLQI) - PP Day 0	—	9.43 Units on a scale Standard Deviation 6.24	12.3 Units on a scale Standard Deviation 7.7
Dermatology Life Quality Index (DLQI) - PP Day 84	—	3.00 Units on a scale Standard Deviation 1.53	6.07 Units on a scale Standard Deviation 5.98
Dermatology Life Quality Index (DLQI) - PP Day 140	—	0.71 Units on a scale Standard Deviation 0.95	6.00 Units on a scale Standard Deviation 6.08
Dermatology Life Quality Index (DLQI) - PP Day 168	—	0.57 Units on a scale Standard Deviation 0.79	5.89 Units on a scale Standard Deviation 6.27

Adverse Events

Part 1 - Etanercept

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Part 2 - Etanercept and nbUVB

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2 - Etanercept

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1 - Etanercept n=99 participants at risk All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 participants at risk Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 participants at risk Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Nervous system disorders Presyncope	0.00% 0/99 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	0.00% 0/37 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	2.6% 1/38 • Number of events 1 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.
Vascular disorders Low blood pressure	1.0% 1/99 • Number of events 1 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	0.00% 0/37 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	0.00% 0/38 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.
Infections and infestations Appendicitis	0.00% 0/99 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	0.00% 0/37 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	2.6% 1/38 • Number of events 1 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.

Other adverse events

Measure	Part 1 - Etanercept n=99 participants at risk All participants received etanercept 50 mg twice a week for 12 weeks.	Part 2 - Etanercept and nbUVB n=37 participants at risk Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.	Part 2 - Etanercept n=38 participants at risk Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
Infections and infestations Common cold	9.1% 9/99 • Number of events 9 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	5.4% 2/37 • Number of events 2 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	13.2% 5/38 • Number of events 5 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.
Infections and infestations Upper respiratory tract infection	4.0% 4/99 • Number of events 4 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	2.7% 1/37 • Number of events 1 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	15.8% 6/38 • Number of events 6 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.
General disorders Injection site reaction	4.0% 4/99 • Number of events 4 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	0.00% 0/37 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.	0.00% 0/38 • Adverse events were collected over a 12 week period for part 1 and over a 16 week period for part 2.

Additional Information

Annie Levesque

Innovaderm Research Inc

Phone: 514-521-4285

Email: alevesque@innovaderm.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60