Spondyloarthrosis
Conditions
Brief summary
This study is to evaluate local data in Iraqi patients with Spondyloarthropathies on Enbrel treatment with regards to efficacy and adherence using data from the Baghdad Teaching Hospital (Rheumatology Center)
Interventions
DRUGEtanercept
Patients with spondyloarthrosis as provided in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed SpA patients * 18 years of age and older. * Did not receive previous other biological treatments. * Patients have at least 1 year on Enbrel.
Exclusion criteria
* Had previously used another biological treatments. * Use of etanercept for less than 1 year duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 7 Years Adherence to Etanercept | 7 years [from the data retrieved and observed in 1 month of this study] | In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared absolute BASDAI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. |
| Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared change from baseline in BASDAI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. |
| Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared absolute BASFI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence, last visit was Year 7. |
| Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared change from baseline in BASFI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. |
Countries
Iraq
Participant flow
Pre-assignment details
Data of Iraq's participants aged greater than or equal to (\>=) 18 years, who received etanercept for at least 1 year, anytime from May 2012 through August 2019, for treatment of spondyloarthropathies (SpA) and met American College of Rheumatology/ European League Against Rheumatism (EULAR) 2019 criteria for SpA were included in the study. Data were collected from dermatology center of Baghdad teaching hospital. Available data were evaluated in 1 month of this retrospective, observational study.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants with SpA received etanercept for at least 1 year (anytime from May 2012 to August 2019) under standard real world clinical practice. Data of these participants were studied for 1 month in this retrospective, observational study. | 763 |
| Total | 763 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participants did not meet the entrance criteria | 201 |
Baseline characteristics
| Characteristic | Etanercept | — |
|---|---|---|
| Age, Continuous | 36.3 Years STANDARD_DEVIATION 10.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 136 Participants | — |
| Sex: Female, Male Male | 627 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants With 7 Years Adherence to Etanercept
In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported.
Time frame: 7 years [from the data retrieved and observed in 1 month of this study]
Population: Analysis population included all participants whose data were included in the study for retrospective observation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants With 7 Years Adherence to Etanercept | 60.6 Percentage of participants |
Other Pre-specified
Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared absolute BASDAI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.
Time frame: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]
Population: Analysis population included all participants whose data were included in the study for retrospective observation. Here, number analyzed signifies the number of participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Baseline | 8.0579 Units on a scale | Standard Deviation 0.83161 |
| Etanercept | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Year 1 (Month 12) | 1.3310 Units on a scale | Standard Deviation 1.7475 |
| Etanercept | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Baseline | 8.4813 Units on a scale | Standard Deviation 0.5183 |
| Etanercept | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Year 7 | 1.3256 Units on a scale | Standard Deviation 1.49022 |
| Etanercept: Participants Not Adherent to Treatment | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Year 1 (Month 12) | 3.8261 Units on a scale | Standard Deviation 1.71364 |
| Etanercept: Participants Not Adherent to Treatment | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Baseline | 8.0238 Units on a scale | Standard Deviation 0.81532 |
| Etanercept: Participants Not Adherent to Treatment | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Year 7 | 1.1040 Units on a scale | Standard Deviation 1.68353 |
| Etanercept: Participants Not Adherent to Treatment | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Baseline | 8.0000 Units on a scale | Standard Deviation 0.88561 |
Comparison: Year 1 Adherence: Baselinep-value: 0.75t-test, 2 sided
Comparison: Year 1 Adherence: Year 1 (Month 12)p-value: <0.05t-test, 2 sided
Comparison: Year 7 Adherence: Baselinep-value: <0.05t-test, 2 sided
Comparison: Year 7 Adherence: Year 7p-value: 0.43t-test, 2 sided
Other Pre-specified
Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment
BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared absolute BASFI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence, last visit was Year 7.
Time frame: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]
Population: Analysis population included all participants whose data were included in the study for retrospective observation. Here, number analyzed signifies the number of participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Baseline | 7.7324 Units on a scale | Standard Deviation 1.13568 |
| Etanercept | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Year 1 (Month 12) | 1.3028 Units on a scale | Standard Deviation 1.69316 |
| Etanercept | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Baseline | 6.6812 Units on a scale | Standard Deviation 1.60341 |
| Etanercept | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Year 7 | 1.3256 Units on a scale | Standard Deviation 1.49022 |
| Etanercept: Participants Not Adherent to Treatment | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Year 7 | 0.9720 Units on a scale | Standard Deviation 1.3984 |
| Etanercept: Participants Not Adherent to Treatment | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Baseline | 7.9143 Units on a scale | Standard Deviation 0.93668 |
| Etanercept: Participants Not Adherent to Treatment | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Baseline | 7.8058 Units on a scale | Standard Deviation 0.98626 |
| Etanercept: Participants Not Adherent to Treatment | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Year 1 (Month 12) | 3.7372 Units on a scale | Standard Deviation 1.71182 |
Comparison: Year 1 Adherence: Baselinep-value: 0.21t-test, 2 sided
Comparison: Year 1 Adherence: Year 1 (Month 12)p-value: <0.05t-test, 2 sided
Comparison: Year 7 Adherence: Baselinep-value: 0.62t-test, 2 sided
Comparison: Year 7 Adherence: Year 7p-value: 0.18t-test, 2 sided
Other Pre-specified
Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared change from baseline in BASDAI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.
Time frame: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]
Population: Analysis population included all participants whose data were included in the study for retrospective observation. Here, number analyzed signifies the number of participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Change at Year 1 (Month 12) | 6.7269 Units on a scale | Standard Deviation 1.90446 |
| Etanercept | Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Change at Year 7 | 6.8344 Units on a scale | Standard Deviation 1.86489 |
| Etanercept: Participants Not Adherent to Treatment | Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Change at Year 1 (Month 12) | 4.1977 Units on a scale | Standard Deviation 1.84639 |
| Etanercept: Participants Not Adherent to Treatment | Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Change at Year 7 | 6.4096 Units on a scale | Standard Deviation 2.30636 |
Comparison: Year 1 Adherence: Change at Year 1 (Month 12)p-value: 0.0001t-test, 2 sided
Comparison: Year 7 Adherence: Change at Year 7p-value: 0.247t-test, 2 sided
Other Pre-specified
Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment
BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared change from baseline in BASFI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.
Time frame: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]
Population: Analysis population included all participants whose data were included in the study for retrospective observation. Here, number analyzed signifies the number of participants evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Change at Year 1 (Month 12) | 6.4296 Units on a scale | Standard Deviation 2.03555 |
| Etanercept | Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Change at Year 7 | 5.1206 Units on a scale | Standard Deviation 2.38577 |
| Etanercept: Participants Not Adherent to Treatment | Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 Adherence: Change at Year 1 (Month 12) | 4.1771 Units on a scale | Standard Deviation 1.88158 |
| Etanercept: Participants Not Adherent to Treatment | Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 7 Adherence: Change at Year 7 | 6.3327 Units on a scale | Standard Deviation 1.9451 |
Comparison: Year 1 Adherence: Change at Year 1 (Month 12)p-value: 0.0001t-test, 2 sided
Comparison: Year 7 Adherence: Change at Year 7p-value: 0.003t-test, 2 sided