Ankylosing Spondylitis
Conditions
Brief summary
This study is to evaluate available data in Iraqi patients with ankylosing spondylitis on Enbrel treatment with regards to the impact of early treatment using data from the Baghdad Teaching Hospital registry
Interventions
DRUGEtanercept
Patients with ankylosing spondylitis 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 AS patients. * 18 years old * Did not receive previous biological treatment for any reason
Exclusion criteria
* Patients previously or currently treated with other biological therapies. * Use of etanercept for less than 1 year duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] | BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (\<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (\>) 10 years after diagnosis with AS. |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] | BASDAI is a set of 6 questions to determine disease activity in participant with AS. 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. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in \<= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and \>10 years after diagnosis with AS. |
Countries
Iraq
Participant flow
Recruitment details
Data of Iraq's participants aged greater than or equal to (\>=) 18 years, who received etanercept for at least 1 year anytime from August 2012 through March 2020 for treatment of ankylosing spondylitis (AS) and met American College of Rheumatology/ European League Against Rheumatism (EULAR) 2019 criteria for AS were included in the study. Data were collected from dermatology center of Baghdad teaching hospital. Available data were evaluated in 2 months of this retrospective, observational study.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants received etanercept to treat AS for at least 1 year (anytime from August 2012 to March 2020) under standard real world clinical practice (In Iraq, the recommended dose of etanercept \[Enbrel\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly).Data of these participants were studied for 2 months in this retrospective, observational study. | 763 |
| Total | 763 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participants did not meet entrance criteria | 201 |
Baseline characteristics
| Characteristic | Etanercept | — |
|---|---|---|
| Age, Continuous | 36.3 Years STANDARD_DEVIATION 10.5 | — |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 8.1 Units on a scale STANDARD_DEVIATION 0.8 | — |
| Bath Ankylosing Spondylitis Functional Index (BASFI) | 7.7 Units on a scale STANDARD_DEVIATION 1.1 | — |
| Current Steroid Therapy | 614 Participants | — |
| Disease Duration | 5.9 Years STANDARD_DEVIATION 6.1 | — |
| Education Level Higher education | 213 Participants | — |
| Education Level Primary education | 319 Participants | — |
| Education Level Secondary education | 231 Participants | — |
| Human Leukocyte Antigen B27 (HLA-B27) Negative | 167 Participants | — |
| Human Leukocyte Antigen B27 (HLA-B27) Not done | 354 Participants | — |
| Human Leukocyte Antigen B27 (HLA-B27) Positive | 242 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 136 Participants | — |
| Sex: Female, Male Male | 627 Participants | — |
| Smoking Status No | 374 Participants | — |
| Smoking Status Yes | 389 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
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12
BASDAI is a set of 6 questions to determine disease activity in participant with AS. 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. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in \<= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and \>10 years after diagnosis with AS.
Time frame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
Population: Analysis population included all participants whose data were included in the study for retrospective observation. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Early Referral (<=1 Year) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Baseline | 8.32 Units on a scale | Standard Deviation 0.88 |
| Etanercept: Participants With Early Referral (<=1 Year) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Change from baseline at month 12 | -6.86 Units on a scale | Standard Deviation 1.55 |
| Etanercept: Participants With Delayed Referral (1.1 to 5 Years) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Baseline | 8.36 Units on a scale | Standard Deviation 0.47 |
| Etanercept: Participants With Delayed Referral (1.1 to 5 Years) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Change from baseline at month 12 | -6.05 Units on a scale | Standard Deviation 1.549 |
| Etanercept: Participants With Delayed Referral (5.1 to 10 Years) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Change from baseline at month 12 | -4.82 Units on a scale | Standard Deviation 1.782 |
| Etanercept: Participants With Delayed Referral (5.1 to 10 Years) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Baseline | 8.46 Units on a scale | Standard Deviation 0.72 |
| Etanercept: Participants With Delayed Referral (>10 Years) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Change from baseline at month 12 | -4.4 Units on a scale | Standard Deviation 1.728 |
| Etanercept: Participants With Delayed Referral (>10 Years) | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Baseline | 8.22 Units on a scale | Standard Deviation 0.86 |
Comparison: Change from Baseline at Month 12: For Early Referralp-value: 0.001Regression, Logistic
Primary
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12
BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (\<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (\>) 10 years after diagnosis with AS.
Time frame: Baseline, Month 12 [from the data retrieved and observed in 2 months of this study]
Population: Analysis population included all participants whose data were included in the study for retrospective observation. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Participants With Early Referral (<=1 Year) | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Change from baseline at month 12 | -6.21 Units on a scale | Standard Deviation 1.557 |
| Etanercept: Participants With Early Referral (<=1 Year) | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Baseline | 7.75 Units on a scale | Standard Deviation 1.11 |
| Etanercept: Participants With Delayed Referral (1.1 to 5 Years) | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Change from baseline at month 12 | -5.44 Units on a scale | Standard Deviation 1.51 |
| Etanercept: Participants With Delayed Referral (1.1 to 5 Years) | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Baseline | 7.74 Units on a scale | Standard Deviation 1.11 |
| Etanercept: Participants With Delayed Referral (5.1 to 10 Years) | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Change from baseline at month 12 | -4.14 Units on a scale | Standard Deviation 1.697 |
| Etanercept: Participants With Delayed Referral (5.1 to 10 Years) | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Baseline | 7.72 Units on a scale | Standard Deviation 1.15 |
| Etanercept: Participants With Delayed Referral (>10 Years) | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Change from baseline at month 12 | -4.04 Units on a scale | Standard Deviation 1.631 |
| Etanercept: Participants With Delayed Referral (>10 Years) | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Baseline | 7.78 Units on a scale | Standard Deviation 1.13 |
Comparison: Change from Baseline at Month 12: For Early Referralp-value: 0.001Regression, Logistic