Psoriatic Arthritis
Conditions
Brief summary
This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist in Baghdad Teaching Hospital registry.
Interventions
DRUGEnbrel
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 PsA patients. * ≥18 years of age * Have not received previous biological treatment
Exclusion criteria
* Previous use of other biological treatments. * Etanercept use for less than 1 year duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1 | Baseline, Month 1 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. |
| Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12 | Baseline, Month 12 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | Month 1, 6 and 12 | DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (\<=) 3.2 = low disease activity, DAS28 ESR greater than (\>) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants. |
Countries
Iraq
Participant flow
Pre-assignment details
Data of Iraq's participants, 1) who aged greater than or equal to (\>=) 18 years, 2) who met American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for psoriatic arthritis (PsA), and 3) who received etanercept for at least for 1 year from May 2012 until August 2019 in the Baghdad teaching hospital (rheumatology center) were collected. Data collected were assessed in approximately 1.8 months of this retrospective observational study.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months. | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet entrance criteria | 14 |
Baseline characteristics
| Characteristic | Etanercept | — |
|---|---|---|
| Age, Continuous | 43.0 Years STANDARD_DEVIATION 12.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 71 Participants | — |
| Sex: Female, Male Male | 56 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 Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
Time frame: Baseline, Month 1
Population: Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.
Primary
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \[mg/dL\]), participant assessment of pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
Time frame: Baseline, Month 12
Population: Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.
Other Pre-specified
Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12
DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (\<=) 3.2 = low disease activity, DAS28 ESR greater than (\>) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
Time frame: Month 1, 6 and 12
Population: Analysis was performed on all participants who were included in this study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: ACCP Positive | Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | Month 1 | 4.2 units on a scale | Standard Deviation 0.77 |
| Etanercept: ACCP Positive | Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | Month 6 | 4.06 units on a scale | Standard Deviation 0.93 |
| Etanercept: ACCP Positive | Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | Month 12 | 3.34 units on a scale | Standard Deviation 1.1 |
| Etanercept: ACCP Negative | Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | Month 1 | 4.1 units on a scale | Standard Deviation 0.8 |
| Etanercept: ACCP Negative | Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | Month 6 | 3.35 units on a scale | Standard Deviation 1.08 |
| Etanercept: ACCP Negative | Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12 | Month 12 | 2.66 units on a scale | Standard Deviation 0.91 |
Comparison: At Month 1: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.p-value: 0.6Student's t-test
Comparison: At Month 6: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.p-value: 0.007Student's t-test
Comparison: At Month 12: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.p-value: 0.004Student's t-test