Ankylosing Spondylitis
Conditions
Brief summary
Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.
Detailed description
retrospective and prospective 150
Interventions
OTHERno intervention
in real life of drug,dosage,frequency and duration
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
retrospective:12 months at least first anti-TNF therapy prospective: at maximum 6 months observation AS patients with axial involvement
Exclusion criteria
patients in other AS studies involved
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18 | Baseline up to Month 18 | First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported. |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18 | Baseline, Month 18 | BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\[Q5+Q6/2\]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. |
| Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity | Month 12, 18 | Low disease activity was defined as a BASDAI score of less than or equal to (\<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18 | Month 18 | ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant's quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period). |
| C Reactive Protein Level at Baseline | Baseline | C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation. |
| Erythrocyte Sedimentation Rate at Baseline | Baseline | Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anti-Tumor Necrosis Factor (Anti-TNF) Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician's discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months. | 144 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Changed Site/Structure | 1 |
| Overall Study | Did not met inclusion criteria | 8 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Other | 1 |
Baseline characteristics
| Characteristic | Anti-Tumor Necrosis Factor (Anti-TNF) |
|---|---|
| Age, Continuous | 41.85 years STANDARD_DEVIATION 12.46 |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 144 |
| serious Total, serious adverse events | 0 / 144 |
Outcome results
Primary
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18
BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\[Q5+Q6/2\]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.
Time frame: Baseline, Month 18
Population: FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-Tumor Necrosis Factor (Anti-TNF) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18 | 3.84 units on a scale | Standard Deviation 2.41 |
Primary
Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity
Low disease activity was defined as a BASDAI score of less than or equal to (\<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.
Time frame: Month 12, 18
Population: FAS included all participants who met the inclusion criteria. Here, n signifies number of participants evaluable for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-Tumor Necrosis Factor (Anti-TNF) | Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity | Month 12 (n=65) | 60.19 percentage of participants |
| Anti-Tumor Necrosis Factor (Anti-TNF) | Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity | Month 18 (n=73) | 61.86 percentage of participants |
Primary
Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18
First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.
Time frame: Baseline up to Month 18
Population: FAS included all participants who met the inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anti-Tumor Necrosis Factor (Anti-TNF) | Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18 | 85.42 percentage of participants |
Secondary
Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18
ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant's quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).
Time frame: Month 18
Population: FAS included all participants who met the inclusion criteria. Here, n signifies number of participants evaluable each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-Tumor Necrosis Factor (Anti-TNF) | Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18 | Switchers (n= 21) | 5.4 units on a scale | Standard Deviation 4.7 |
| Anti-Tumor Necrosis Factor (Anti-TNF) | Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18 | Non-switchers (n= 123) | 3.0 units on a scale | Standard Deviation 4.2 |
Secondary
C Reactive Protein Level at Baseline
C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.
Time frame: Baseline
Population: FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-Tumor Necrosis Factor (Anti-TNF) | C Reactive Protein Level at Baseline | 5.91 milligram per liter | Standard Deviation 10.53 |
Secondary
Erythrocyte Sedimentation Rate at Baseline
Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).
Time frame: Baseline
Population: FAS included all participants who met the inclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-Tumor Necrosis Factor (Anti-TNF) | Erythrocyte Sedimentation Rate at Baseline | 25.91 millimeter per hour | Standard Deviation 19.64 |