Trial Outcomes & Findings for Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis (NCT NCT00581100)

NCT ID: NCT00581100

Last Updated: 2013-02-25

Results Overview

Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 136 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2013-02-25

Participant Flow

Eighty-five participants were screened for the study; 13 participants were screening failures, and 72 participants were randomized to treatment.

Participant milestones

Measure	Etanercept: Twice, Then Once Weekly Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Study STARTED	38	34
Overall Study Modified Intent-To-Treat Population	36	33
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Measure	Etanercept: Twice, Then Once Weekly Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Overall Study Death	1	0
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	1	4
Overall Study Other	3	0

Baseline Characteristics

Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

Baseline characteristics by cohort

Measure	Etanercept: Twice, Then Once Weekly n=36 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=33 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period	Total n=69 Participants Total of all reporting groups
Age, Customized	46.28 years STANDARD_DEVIATION 13.51 • n=5 Participants	45.36 years STANDARD_DEVIATION 9.19 • n=7 Participants	45.84 years STANDARD_DEVIATION 11.57 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Modified Intent-to-Treat (mITT) population: all randomized participants who received at least one dose of study medication, and provided baseline and post-baseline data. N = number of participants with evaluable data.

Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail	-4.32 units on a scale Interval -4.91 to -3.73	-4.36 units on a scale Interval -4.98 to -3.74

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT, N = number of participants with evaluable data.

NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score	-22.64 units on a scale Interval -26.44 to -18.85	-22.63 units on a scale Interval -26.61 to -18.66

SECONDARY outcome

Timeframe: Week 12, Week 24

Population: mITT, N = number of participants with evaluable data.

Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=36 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=33 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 Week 12	60.61 percent of participants	51.61 percent of participants
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 Week 24	82.86 percent of participants	81.25 percent of participants

SECONDARY outcome

Timeframe: Week 12, Week 24

Population: mITT, N = number of participants with evaluable data.

Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=36 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=33 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 Week 12	18.18 percent of participants	19.35 percent of participants
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24 Week 24	57.14 percent of participants	68.75 percent of participants

SECONDARY outcome

Timeframe: Week 12, Week 24

Population: mITT, N = number of participants with evaluable data.

NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=36 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=33 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 Week 24	68.57 percent of participants	81.25 percent of participants
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 Week 12	54.55 percent of participants	48.39 percent of participants

SECONDARY outcome

Timeframe: Week 12, Week 24

Population: mITT, N = number of participants with evaluable data.

NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=36 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=33 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 Week 12	9.09 units on a scale	19.35 units on a scale
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24 Week 24	62.86 units on a scale	62.50 units on a scale

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT, N = number of participants with evaluable data.

Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score	-14.81 units on a scale Interval -16.56 to -13.05	-14.11 units on a scale Interval -15.95 to -12.28

SECONDARY outcome

Timeframe: Week 12 , Week 24

Population: mITT, N = number of participants with evaluable data.

Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=36 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=33 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 Week 12	90.91 percent of participants	87.10 percent of participants
Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 Week 24	85.71 percent of participants	84.38 percent of participants

SECONDARY outcome

Timeframe: Week 12 , Week 24

Population: mITT, N = number of participants with evaluable data.

Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=36 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=33 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 Week 12	51.52 percent of participants	58.06 percent of participants
Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24 Week 24	77.14 percent of participants	62.50 percent of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT, N = number of participants with evaluable data.

Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis	-1.65 unts on a scale Interval -2.05 to -1.26	-1.84 unts on a scale Interval -2.25 to -1.43

SECONDARY outcome

Timeframe: Baseline, Week 24 or Early Termination

Population: mITT, N = number of participants with evaluable data.

Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear	68.57 percent of participants	75.00 percent of participants

SECONDARY outcome

Timeframe: Baseline, Week 24 or Early Termination

Population: mITT, N = number of participants with evaluable data.

Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better	82.86 percent of participants	87.50 percent of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT, N = number of participants with evaluable data.

Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=31 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Change From Baseline in the Dermatology Life Quality Index (DLQI)	-8.60 units on a scale Interval -9.98 to -7.21	-8.74 units on a scale Interval -10.21 to -7.26

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT, N = number of participants with evaluable data.

Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=34 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)	-44.66 units on a scale Interval -52.11 to -37.21	-41.03 units on a scale Interval -48.7 to -33.35

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT, N = number of participants with evaluable data.

Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)	-48.89 units on a scale Interval -56.86 to -40.91	-41.69 units on a scale Interval -50.02 to -33.35

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT, N = number of participants with evaluable data.

Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.

Outcome measures

Measure	Etanercept: Twice, Then Once Weekly n=35 Participants Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=32 Participants Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Change From Baseline in Physician Fingernail Grading Assessment Total Score	-11.47 units on a scale Interval -13.54 to -9.41	-12.21 units on a scale Interval -14.37 to -10.05

Adverse Events

Etanercept: Twice, Then Once Weekly

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Etanercept: Once Weekly

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etanercept: Twice, Then Once Weekly n=38 participants at risk Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=34 participants at risk Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer stage unspecified	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Cardiac disorders Myocardial infarction	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.

Other adverse events

Measure	Etanercept: Twice, Then Once Weekly n=38 participants at risk Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24	Etanercept: Once Weekly n=34 participants at risk Etanercept 50 mg SC once weekly for the complete 24 week treatment period
Blood and lymphatic system disorders Leukocytosis not otherwise specified (NOS)	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Blood and lymphatic system disorders Neutrophilia	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Eye disorders Conjunctivitis NEC	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Gastrointestinal disorders Hyperacidity	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Gastrointestinal disorders Abdominal pain NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Gastrointestinal disorders Vomiting NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Gastrointestinal disorders Constipation	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Gastrointestinal disorders Diarrhea NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Gastrointestinal disorders Loose stools	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Gastrointestinal disorders Sore throat NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
General disorders Injection site dermatitis	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
General disorders Injection site pain	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
General disorders Pyrexia	5.3% 2/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
General disorders Application site rash	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
General disorders Influenza like illness	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
General disorders Injection site burning	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
General disorders Injection site urticaria	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Hepatobiliary disorders Liver fatty	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Infections and infestations Nasopharyngitis	10.5% 4/38 Safety population: all subjects who took at least one dose of study medication.	11.8% 4/34 Safety population: all subjects who took at least one dose of study medication.
Infections and infestations Tooth abscess	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Infections and infestations Folliculitis	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Infections and infestations Respiratory tract infection NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Infections and infestations Pharyngitis NOS	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Infections and infestations Influenza	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Investigations Transaminase NOS increased	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Musculoskeletal and connective tissue disorders Localized osteoarthritis	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in limb	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Infections and infestations Localized infection	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Nervous system disorders Headache NOS	10.5% 4/38 Safety population: all subjects who took at least one dose of study medication.	8.8% 3/34 Safety population: all subjects who took at least one dose of study medication.
Nervous system disorders Burning sensation NOS	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Nervous system disorders Paraesthesia NEC	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis allergic	5.3% 2/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Panniculitis	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Alopecia areata	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Psoriasis aggravated	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Skin disorder NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive airways disease exacerbated	0.00% 0/38 Safety population: all subjects who took at least one dose of study medication.	2.9% 1/34 Safety population: all subjects who took at least one dose of study medication.
Vascular disorders Hematoma NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.
Vascular disorders Hypertension NOS	2.6% 1/38 Safety population: all subjects who took at least one dose of study medication.	0.00% 0/34 Safety population: all subjects who took at least one dose of study medication.

Additional Information

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Email: clintrialresults@wyeth.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER