Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Adalimumab treatment, Evaluation of the patients' Health Related Quality of Life, Cost of the disease management
Brief summary
Evaluation of Health Related Quality of Life (HRQL) is of a paramount importance in assessing the impact of rheumatoid arthritis on patients' health status, however when costs associated with rheumatoid arthritis are also taken into account, the information provided may lead to a more balanced view in analyzing the treatment of the disease. In accordance with the above, the main objective this study was to evaluate the impact of adalimumab treatment not only on patients' Health Related Quality of Life but also on the cost of the disease management. In order to accomplish this the study has been focused on: 1. Estimating the direct and indirect cost incurred by adalimumab treatment. 2. Measuring the Health Related Quality of Life of rheumatoid arthritis patients under adalimumab treatment. 3. Exploring the cost-utility relationship of rheumatoid arthritis patients treated with adalimumab by combining the Health Related Quality of Life of rheumatoid arthritis patients and direct as well as indirect costs due to RA. More specifically, data related to patients' Health Related Quality of Life and cost associated with rheumatoid arthritis will be recorded for one-year period, and collected at four subsequent visits: baseline, month 3, 6 and 12. The visit before starting treatment with adalimumab will be considered as baseline. This information was used to compare Health Related Quality of Life and cost data before and after adalimumab initiation and therefore identify the effect of adalimumab treatment in patients with rheumatoid arthritis.
Detailed description
Data concerning patients' Health Related Quality of Life as well as the cost of the disease treatment were collected at four subsequent periods and specifically at baseline (Visit 1), and at months 3, 6 and 12. Moreover, at baseline patients' socioeconomic, and history of illness data as well as the use of other prescribed medication and costs due to rheumatoid arthritis have been recorded, in order to identify patients' health state before adalimumab treatment initiation. Patients discontinuing therapy (drop-outs) either due to adverse events or on their own initiative were categorized and analyzed separately, while reasons leading to discontinuation were recorded. Adverse events were not collected in this study with the exception of adverse events leading to withdrawal. In order to evaluate the cost-utility of adalimumab both the cost of the disease treatment and the Health Related Quality of Life of rheumatoid arthritis patients have been taken into account. The process is described below: Face-to-face interviews were conducted by the physicians/investigators in charge in all four subsequent periods as well as before adalimumab treatment initiation. A questionnaire, divided into the following sections, was administered: 1. Patients' Sociodemographic Characteristics 2. Measurement of Health Related Quality of Life in Rheumatoid Arthritis patients 3. Cost Assessment
Interventions
None listed
Sponsors
Institute of Political Economical & Social Researches, Greece
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving adalimumab under normal clinical practice for at least one month and according to the approved Summary of Product Characteristics (SmPC) in the European Union. * Patients must be willing to consent to data being collected and provided to Abbott Laboratories.
Exclusion criteria
* Contraindications according to the SmPC * Patients should not participate in other observational Abbott study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Enrollment visit (Baseline), month 3, month 6, month 12 | Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability. |
| Health Related Quality of Life (European Quality of Life 5 Dimensions) | Enrollment visit (Baseline), month 3, month 6, month 12 | European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health. |
| Health Related Quality of Life (Health Assessment Questionnaire) | Enrollment visit (Baseline), month 3, month 6, month 12 | Health Assessment Questionnaire (HAQ) is designed to assess patients' abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes. |
| Health Related Quality of Life (Medical Outcome Study Short Form 36) | Enrollment visit (Baseline), month 3, month 6, month 12 | Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best). |
| Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER) | 12 months | The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years \[QALYs\]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros). |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Treatment Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union | 121 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Case report form not completed | 3 |
| Overall Study | Lack of effectiveness | 15 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Adalimumab Treatment |
|---|---|
| Age Continuous | 56.2 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment Greece | 121 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 124 |
| serious Total, serious adverse events | 3 / 124 |
Outcome results
Primary
Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)
The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years \[QALYs\]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros).
Time frame: 12 months
Population: Cost-utility analysis is based on the 76 participants who completed the study through 12 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab Treatment | Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER) | 13,628 Euros |
Primary
Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability.
Time frame: Enrollment visit (Baseline), month 3, month 6, month 12
Population: Analysis is based on the number of participants completing the assessments at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Treatment | Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Direct Costs at 3 months (n=104) | 2662.73 Euros | Standard Deviation 446.86 |
| Adalimumab Treatment | Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Direct Costs at Baseline (n=121) | 272.99 Euros | Standard Deviation 383.48 |
| Adalimumab Treatment | Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Indirect Costs at Baseline (n=13) | 1162.62 Euros | Standard Deviation 1146.6 |
| Adalimumab Treatment | Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Indirect Costs at 3 months (n=8) | 659.13 Euros | Standard Deviation 648.82 |
| Adalimumab Treatment | Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Direct Costs at 6 months (n=91) | 2692.28 Euros | Standard Deviation 243.82 |
| Adalimumab Treatment | Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Indirect Costs at 6 months (n=4) | 500.00 Euros | Standard Deviation 336.65 |
| Adalimumab Treatment | Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Direct Costs at 12 months (n=76) | 2649.42 Euros | Standard Deviation 533.47 |
| Adalimumab Treatment | Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment | Indirect Costs at 12 months (n=1) | 580.00 Euros | Standard Deviation 0 |
Primary
Health Related Quality of Life (European Quality of Life 5 Dimensions)
European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health.
Time frame: Enrollment visit (Baseline), month 3, month 6, month 12
Population: Analysis is based on the number of participants completing the assessments at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Treatment | Health Related Quality of Life (European Quality of Life 5 Dimensions) | EQ-5D Score at Baseline | 0.43 Units on a scale | Standard Deviation 0.16 |
| Adalimumab Treatment | Health Related Quality of Life (European Quality of Life 5 Dimensions) | EQ-5D Score at 3 months | 0.53 Units on a scale | Standard Deviation 0.23 |
| Adalimumab Treatment | Health Related Quality of Life (European Quality of Life 5 Dimensions) | EQ-5D Score at 6 months | 0.56 Units on a scale | Standard Deviation 0.23 |
| Adalimumab Treatment | Health Related Quality of Life (European Quality of Life 5 Dimensions) | ED-5D Score at 12 months | 0.62 Units on a scale | Standard Deviation 0.25 |
Primary
Health Related Quality of Life (Health Assessment Questionnaire)
Health Assessment Questionnaire (HAQ) is designed to assess patients' abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes.
Time frame: Enrollment visit (Baseline), month 3, month 6, month 12
Population: Analysis is based on the number of participants completing the assessment at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Treatment | Health Related Quality of Life (Health Assessment Questionnaire) | HAQ Score at 6 months | 0.83 units on a scale | Standard Deviation 0.64 |
| Adalimumab Treatment | Health Related Quality of Life (Health Assessment Questionnaire) | HAQ Score at Baseline | 1.33 units on a scale | Standard Deviation 0.7 |
| Adalimumab Treatment | Health Related Quality of Life (Health Assessment Questionnaire) | HAQ Score at 3 months | 0.95 units on a scale | Standard Deviation 0.8 |
| Adalimumab Treatment | Health Related Quality of Life (Health Assessment Questionnaire) | HAQ Score at 12 months | 0.62 units on a scale | Standard Deviation 0.64 |
Primary
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best).
Time frame: Enrollment visit (Baseline), month 3, month 6, month 12
Population: Analysis is based on the number of participants completing the assessment at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Social Functioning Score at 3 months | 61.5 Units on a scale | Standard Deviation 28.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Social Functioning Score at 6 months | 63.7 Units on a scale | Standard Deviation 29.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Social Functioning Score at 12 months | 70.5 Units on a scale | Standard Deviation 26.3 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Mental Health Score at Baseline | 48.0 Units on a scale | Standard Deviation 21 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Physical Functioning Score at Baseline | 33.5 Units on a scale | Standard Deviation 26 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Physical Functioning Score at 3 months | 50.0 Units on a scale | Standard Deviation 29.4 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Physical Functioning Score at 6 months | 56.4 Units on a scale | Standard Deviation 27.8 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Physical Functioning Score at 12 months | 60.0 Units on a scale | Standard Deviation 28.9 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Role Physical Score at Baseline | 18.7 Units on a scale | Standard Deviation 34 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Role Physical Score at 3 months | 36.8 Units on a scale | Standard Deviation 43.3 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Role Physical Score at 6 months | 41.0 Units on a scale | Standard Deviation 43.7 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Role Physical Score at 12 months | 51.0 Units on a scale | Standard Deviation 45 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Bodily Pain Score at Baseline | 37.2 Units on a scale | Standard Deviation 20.6 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Bodily Pain Score at 3 months | 55.5 Units on a scale | Standard Deviation 23.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Bodily Pain Score at 6 months | 60.0 Units on a scale | Standard Deviation 24.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Bodily Pain Score at 12 months | 63.2 Units on a scale | Standard Deviation 23.1 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | General Health Score at Baseline | 33.8 Units on a scale | Standard Deviation 20.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | General Health Score at 3 months | 45.4 Units on a scale | Standard Deviation 23.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | General Health Score at 6 months | 48.5 Units on a scale | Standard Deviation 23.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | General Health Score at 12 months | 52.8 Units on a scale | Standard Deviation 23.1 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Vitality Score at Baseline | 35.8 Units on a scale | Standard Deviation 20.2 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Vitality Score at 3 months | 48.7 Units on a scale | Standard Deviation 21 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Vitality Score at 6 months | 51.0 Units on a scale | Standard Deviation 19.6 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Vitality Score at 12 months | 56.2 Units on a scale | Standard Deviation 18.4 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Social Functioning Score at Baseline | 47.4 Units on a scale | Standard Deviation 33.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Role Emotional Score at Baseline | 32.0 Units on a scale | Standard Deviation 44 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Role Emotional Score at 3 months | 50.7 Units on a scale | Standard Deviation 47.4 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Role Emotional Score at 6 months | 54.6 Units on a scale | Standard Deviation 47.5 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Role Emotional Score at 12 months | 70.2 Units on a scale | Standard Deviation 42.1 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Mental Health Score at 3 months | 57.1 Units on a scale | Standard Deviation 20 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Mental Health Score at 6 months | 58.5 Units on a scale | Standard Deviation 20 |
| Adalimumab Treatment | Health Related Quality of Life (Medical Outcome Study Short Form 36) | Mental Health Score at 12 months | 61.4 Units on a scale | Standard Deviation 16.8 |