Trial Outcomes & Findings for Study Evaluating the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy (NCT NCT00303186)

NCT ID: NCT00303186

Last Updated: 2012-07-30

Results Overview

Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.

• Recruitment status: COMPLETED
• Target enrollment: 107 participants
• Primary outcome timeframe: Month 12
• Results posted on: 2012-07-30

Participant Flow

Participant milestones

Measure	All Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Overall Study STARTED	107
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Measure	All Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Overall Study Other	52

Baseline Characteristics

Study Evaluating the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy

Baseline characteristics by cohort

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Age Continuous	49.68 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Mean Cost per Participant per Month Overall	253.20 Euro/participant-month STANDARD_DEVIATION 324.19 • n=5 Participants
Mean Cost per Participant per Month Pharmacological treatment	105.14 Euro/participant-month STANDARD_DEVIATION 160.53 • n=5 Participants
Mean Cost per Participant per Month Hospitalizations	27.92 Euro/participant-month STANDARD_DEVIATION 104.56 • n=5 Participants
Mean Cost per Participant per Month Diagnostic, laboratory, specialist visits	14.12 Euro/participant-month STANDARD_DEVIATION 22.70 • n=5 Participants
Mean Cost per Participant per Month Transports	9.96 Euro/participant-month STANDARD_DEVIATION 16.03 • n=5 Participants
Mean Cost per Participant per Month Indirect costs	96.05 Euro/participant-month STANDARD_DEVIATION 260.85 • n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.

Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Mean Cost Per Participant Per Month at Month 12 Overall	1026.32 Euro/participant-month Standard Deviation 443.86
Mean Cost Per Participant Per Month at Month 12 Pharmacological treatment	970.14 Euro/participant-month Standard Deviation 445.87
Mean Cost Per Participant Per Month at Month 12 Hospitalizations	4.14 Euro/participant-month Standard Deviation 35.46
Mean Cost Per Participant Per Month at Month 12 Diagnostic, laboratory, specialist visits	13.60 Euro/participant-month Standard Deviation 8.96
Mean Cost Per Participant Per Month at Month 12 Transports	11.32 Euro/participant-month Standard Deviation 24.19
Mean Cost Per Participant Per Month at Month 12 Indirect costs	27.11 Euro/participant-month Standard Deviation 52.35

PRIMARY outcome

Timeframe: Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.

Outcome measures

Measure	All Participants n=55 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Mean Cost Per Participant Per Month at Month 60 Overall	986.34 Euro/participant-month Standard Deviation 469.17
Mean Cost Per Participant Per Month at Month 60 Pharmacological treatments	946.70 Euro/participant-month Standard Deviation 462.71
Mean Cost Per Participant Per Month at Month 60 Hospitalizations	16.97 Euro/participant-month Standard Deviation 36.36
Mean Cost Per Participant Per Month at Month 60 Diagnostic, laboratory, specialist visits	8.55 Euro/participant-month Standard Deviation 8.63
Mean Cost Per Participant Per Month at Month 60 Transports	2.58 Euro/participant-month Standard Deviation 4.87
Mean Cost Per Participant Per Month at Month 60 Indirect costs	11.55 Euro/participant-month Standard Deviation 37.06

PRIMARY outcome

Timeframe: Baseline up to Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

ICER: ratio of the incremental cost of treatment over the incremental effectiveness. Incremental cost = difference in cost between baseline and month 60. Effectiveness was defined as quality adjusted life year (QALY) gained, i.e. difference in Euro Quality of Life 5 Dimension (EQ-5D)- health state profile utility score between baseline and month 60. (EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Total score range -0.594 to 1.000; higher score indicates a better health state.)

Outcome measures

Measure	All Participants n=53 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Incremental Cost-effectiveness Ratio (ICER)	39678.6 ratio Interval 24271.2 to 84692.1

SECONDARY outcome

Timeframe: Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change >= 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for >= 3 domains, and no worsening in remaining domain.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Number of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 Response Month 12 (n=103)	75 participants
Number of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 Response Month 60 (n=51)	37 participants

SECONDARY outcome

Timeframe: Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 12 (n=106)	86 participants
Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Month 60 (n=50)	38 participants

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, 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); total possible score range: 0= no disease to 72= maximal disease.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Psoriasis Area and Severity Index (PASI) Baseline (n=107)	5.04 units on a scale Standard Deviation 7.29
Psoriasis Area and Severity Index (PASI) Month 12 (n=93)	1.29 units on a scale Standard Deviation 1.69
Psoriasis Area and Severity Index (PASI) Month 60 (n=53)	2.08 units on a scale Standard Deviation 3.74

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a Visual Analog Scale (VAS) of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions. Total possible score range: 0-100, where higher score referred to higher impairment in the functional ability.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Bath Ankylosing Spondylitis Functional Index (BASFI) Baseline (n=107)	43.37 units on a scale Standard Deviation 24.49
Bath Ankylosing Spondylitis Functional Index (BASFI) Month 12 (n=107)	25.65 units on a scale Standard Deviation 22.53
Bath Ankylosing Spondylitis Functional Index (BASFI) Month 60 (n=53)	22.46 units on a scale Standard Deviation 22.78

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Baseline (n=107)	5.95 units on a scale Standard Deviation 1.82
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Month 12 (n=107)	3.23 units on a scale Standard Deviation 2.32
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Month 60 (n=55)	3.34 units on a scale Standard Deviation 2.46

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: Data was not statistically analyzed because of insufficient data collected and small sample size achieved.

BASRI- Radiographs of participants with AS were scored using the New York criteria for the sacroiliac joints on a scale of 2 to 4, the lumbar and cervical spine on a scale of 0 to 4 (0 = normal, 1 = suspicious, 2 = mild, 3 = moderate, 4 = severe). These 3 scores were added together to produce the BASRI-spine (BASRI-s) score (range 2 to 12). Similarly, hip joints were scored on a scale of 0 to 4 to give BASRI-hip (BASRI-h). Sum of BASRI-s and BASRI-h produced BASRI-total (BASRI-t) score; total range 2 to 16, higher score represented worse health state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bend forward, knees fully extended, with spine in full flexion.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Modified Schober's Test Baseline (n=52)	10.65 cm Standard Deviation 12.45
Modified Schober's Test Month 12 (n=0)	NA cm Standard Deviation NA Data was not analyzed because none of the participants was evaluable for this measure at Month 12.
Modified Schober's Test Month 60 (n=53)	5.91 cm Standard Deviation 5.91

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line).

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Chest Expansion Measurement Baseline (n=52)	4.38 cm Standard Deviation 5.52
Chest Expansion Measurement Month 12 (n=0)	NA cm Standard Deviation NA Data was not analyzed because none of the participants was evaluable for this measure at Month 12.
Chest Expansion Measurement Month 60 (n=52)	10.85 cm Standard Deviation 16.72

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Occiput-to-wall Distance Baseline (n=51)	7.02 cm Standard Deviation 6.24
Occiput-to-wall Distance Month 12 (n=0)	NA cm Standard Deviation NA Data was not analyzed because none of the participants was evaluable for this measure at Month 12.
Occiput-to-wall Distance Month 60 (n=54)	6.24 cm Standard Deviation 5.50

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Maastricht Ankylosing Spondylitis Enthesis Score (MASES) Baseline (n=107)	3.65 units on a scale Standard Deviation 3.76
Maastricht Ankylosing Spondylitis Enthesis Score (MASES) Month 12 (n=107)	2.17 units on a scale Standard Deviation 3.52
Maastricht Ankylosing Spondylitis Enthesis Score (MASES) Month 60 (n=54)	1.43 units on a scale Standard Deviation 2.53

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Number of Swollen and Tender Joints Baseline: swollen joints (n=107)	7.60 joints Standard Deviation 6.39
Number of Swollen and Tender Joints Baseline: tender joints (n=107)	16.97 joints Standard Deviation 11.8
Number of Swollen and Tender Joints Month 12: swollen joints (n=107)	1.26 joints Standard Deviation 2.54
Number of Swollen and Tender Joints Month 12: tender joints (n=107)	7.97 joints Standard Deviation 10.18
Number of Swollen and Tender Joints Month 60: swollen joints (n=55)	0.96 joints Standard Deviation 1.94
Number of Swollen and Tender Joints Month 60: tender joints (n=55)	5.49 joints Standard Deviation 9.34

SECONDARY outcome

Timeframe: Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Month 12 (n=107)	62.6 percentage of participants
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Month 60 (n=51)	70.6 percentage of participants

SECONDARY outcome

Timeframe: Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

ACR50 response: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Month 12 (n=106)	41.5 percentage of participants
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Month 60 (n=51)	43.1 percentage of participants

SECONDARY outcome

Timeframe: Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

ACR70 response: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Month 12 (n=106)	19.8 percentage of participants
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Month 60 (n=52)	26.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 12, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Radiographic score based on wassenberg consisted of 2 sub-scores, proliferation score (PS) assessing bone proliferation and destruction score (DS) assessing joint surface destruction. Score range for PS and DS was 0 to 160 (where higher score represented higher bone proliferation) and 0 to 200 (where higher score represented higher destruction), respectively. Total score = sum of PS and DS (range 0 to 360); higher score represented worse state.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Radiographic Score Based on Wassenberg Baseline (n=77)	13.58 units on a scale Standard Deviation 24.21
Radiographic Score Based on Wassenberg Month 12 (n=96)	11.66 units on a scale Standard Deviation 21.37
Radiographic Score Based on Wassenberg Month 60 (n=14)	28.29 units on a scale Standard Deviation 32.93

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Measured using a 100 millimeter (mm) VAS ranging from 0 mm = very good to 100 mm = very bad.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Patient Global Assessment (PtGA) of Disease Activity Score Baseline (n=107)	63.51 mm Standard Deviation 17.25
Patient Global Assessment (PtGA) of Disease Activity Score Month 12 (n=107)	32.07 mm Standard Deviation 22.33
Patient Global Assessment (PtGA) of Disease Activity Score Month 60 (n=55)	33.16 mm Standard Deviation 24.50

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Physician Global Assessment (PGA) of Disease Activity Baseline (n=107)	60.15 mm Standard Deviation 13.33
Physician Global Assessment (PGA) of Disease Activity Month 12 (n=107)	26.43 mm Standard Deviation 18.53
Physician Global Assessment (PGA) of Disease Activity Month 60 (n=50)	23.00 mm Standard Deviation 16.42

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Visual Analogue Scale for Pain (VAS-pain) Baseline (n=107)	62.83 mm Standard Deviation 21.10
Visual Analogue Scale for Pain (VAS-pain) Month 12 (n=107)	31.39 mm Standard Deviation 23.59
Visual Analogue Scale for Pain (VAS-pain) Month 60 (n=51)	31.92 mm Standard Deviation 26.51

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Erythrocyte Sedimentation Rate (ESR) Baseline (n=105)	42.07 mm/hr Standard Deviation 121.18
Erythrocyte Sedimentation Rate (ESR) Month 12 (n=104)	16.36 mm/hr Standard Deviation 16.79
Erythrocyte Sedimentation Rate (ESR) Month 60 (n=49)	16.61 mm/hr Standard Deviation 14.77

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
C-reactive Protein (CRP) Baseline (n=104)	59.41 milligram/deciliter (mg/dL) Standard Deviation 148.83
C-reactive Protein (CRP) Month 12 (n=103)	42.07 milligram/deciliter (mg/dL) Standard Deviation 129.70
C-reactive Protein (CRP) Month 60 (n=46)	2.30 milligram/deciliter (mg/dL) Standard Deviation 3.60

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: Data was not statistically analyzed because of insufficient data collected and small sample size achieved.

Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

HAQ: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Health Assessment Questionnaire (HAQ) Baseline (n=107)	1.14 units on a scale Standard Deviation 0.57
Health Assessment Questionnaire (HAQ) Month 12 (n=93)	0.71 units on a scale Standard Deviation 0.56
Health Assessment Questionnaire (HAQ) Month 60 (n=55)	0.65 units on a scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score Baseline (n=105)	0.38 units on a scale Standard Deviation 0.32
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score Month 12 (n=107)	0.63 units on a scale Standard Deviation 0.27
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score Month 60 (n=55)	0.63 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) Baseline (n=105)	46.91 mm Standard Deviation 20.98
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) Month 12 (n=107)	66.76 mm Standard Deviation 20.37
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) Month 60 (n=54)	64.17 mm Standard Deviation 21.08

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60

Population: ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.

Outcome measures

Measure	All Participants n=107 Participants Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
36-Item Short-Form Health Survey (SF-36) Baseline: Physical Component Score (n=94)	31.88 units on a scale Standard Deviation 8.22
36-Item Short-Form Health Survey (SF-36) Baseline: Mental Component Score (n=94)	40.80 units on a scale Standard Deviation 6.50
36-Item Short-Form Health Survey (SF-36) Month 12: Physical Component Score (n=103)	40.44 units on a scale Standard Deviation 12.06
36-Item Short-Form Health Survey (SF-36) Month 12: Mental Component Score (n=103)	39.15 units on a scale Standard Deviation 8.08
36-Item Short-Form Health Survey (SF-36) Month 60: Physical Component Score (n=55)	40.77 units on a scale Standard Deviation 9.54
36-Item Short-Form Health Survey (SF-36) Month 60: Mental Component Score (n=55)	45.03 units on a scale Standard Deviation 12.42

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=107 participants at risk Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
General disorders Abdominal colic	1.9% 2/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	1.9% 2/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Benign prostatic hyperplasia	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Bronchopneumonia	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Epidermal cyst	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Gastrointestinal tract adenoma	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Hiatus hernia	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Osteoarthritis	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Psoriasis flare-up	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Renal colic	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Soft tissues neoplasms benign	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Thrombocytopenia	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Transaminases increased	0.93% 1/107 • Year 3 up to Year 5 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER