Rheumatoid Arthritis
Conditions
Brief summary
RA satisfaction OR: This study aim to compare treatment satisfaction and quality of life between patients who have been using tofacitinib citrate and patients who have been using adalimumab for 6 months or more and less than 2 year in RA treatment of rheumatoid arthritis.
Detailed description
RA satisfaction OR: This study aim to compare treatment satisfaction and quality of life between patients who have been using tofacitinib citrate and patients who have been using adalimumab for 6 months or more and less than 2 year in RA treatment of rheumatoid arthritis. Study design: Non-interventional, multi-centers, cross-sectional study
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patients aged 19 years or older 2. Patients diagnosed with RA 3. Treatment groups: 1\) Tofacitinib citrate users: Patients currently on treatment with tofacitinib citrate in RA therapy for 6 months or more 2) Adalimumab users: Patients currently on treatment with adalimumab in the RA therapy for 6 months or more 4. Reading and writing with enough proficiency to complete assessment instruments in Korean
Exclusion criteria
1. Patients currently on tofacitinib citrate or adalimumab for 2 year or more 2. Patients taking Azathioprine and cyclosporine 3. Patients participating in other drug interventional study 4. Patients who have been treated with bDMARDs except Rheumatoid arthritis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Day 1 (during approximately 20 months of data collection and observation) | TSQM version 1.4: participant rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as (\[{sum of item 1 to 3} - 3\]/18)\*100; if 1 question (Q) was missing: (\[{sum of item 1 to 3} -2\]/12)\*100. Side-effect measured as if item 4=No, score=100; if not then (\[{sum of item 5 to 8} -4\]/16)\*100; if 1 Q was missing: (\[{sum of item 5 to 8} -3\]/12)\*100. Convenience measured as (\[{sum of item 9 to 11} -3\]/18)\*100; if 1 Q was missing: (\[{sum of item 9 to 11} - 2\]/12)\*100. Global satisfaction as (\[{sum of item 12 to 14} -3\]/14)\*100; if item 12 or 13 was missing: (\[{sum of item 12 to 14} -2\]/10)\*100; if item 14 was missing: (\[{sum of item 12 and 13} -2\]/8)\*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score=greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score | Day 1 (during approximately 20 months of data collection and observation) | EQ-5D-3L assess health-related quality of life. It has 5 dimensions: mobility (M), self-care (SC), usual activities (UA), pain/discomfort (PD) and anxiety/depression (AD). Each dimension has 3 levels. For mobility, self-care and usual activities: 1= no effects, 2= sometimes affected, 3= very affected. For pain/discomfort and anxiety/depression: 1= none, 2= sometimes, 3= often. EQ-5D-3L index was calculated using formula = 1 - (0.0081 + \[0.1140 \* M2 + 0.6274 \* M3 + 0.0572 \* SC2 + 0.2073 \* SC3 + 0.0615 \* UA2 + 0.2812 \* UA3 + 0.0581 \* PD2+ 0.2353 \* PD3 + 0.0675 \* AD2 + 0.2351 \* AD3\]). In this formula, abbreviated form for dimension is followed by level, for example M2 = mobility level 2. Values were set to 1 if level was 2 or 3 for M2, SC2, UA2, PD2, AD2 or M3, SC3, UA3, PD3, AD3 respectively, else set to 0. Total score ranged from -0.27 to 1. Higher scores indicate better health. |
| European Quality of Life-Visual Analogue Scale (EQ-VAS) Score | Day 1 (during approximately 20 months of data collection and observation) | EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical, VAS on a scale ranging from and 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicated better health state. |
Countries
South Korea
Participant flow
Pre-assignment details
In this study data was collected from participants who had been using tofacitinib citrate or adalimumab for 6 months or more and less than 2 years for rheumatoid arthritis (RA) treatment. Data was collected and analyzed from 2-July-2018 to 12-March-2020 (approximately 20 months), for comparing treatment satisfaction and quality of life between the 2 treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib Citrate Participants who had been using tofacitinib citrate for more than 6 months or more and less than 2 years for RA treatment were included in the group. | 281 |
| Adalimumab Participants who had been using adalimumab for more than 6 months or more and less than 2 years for RA treatment were included in the group. | 129 |
| Total | 410 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not meeting eligibility criteria | 7 | 4 |
Baseline characteristics
| Characteristic | Tofacitinib Citrate | Adalimumab | Total |
|---|---|---|---|
| Age, Continuous | 54.473 years STANDARD_DEVIATION 12.098 | 51.450 years STANDARD_DEVIATION 12.176 | 53.522 years STANDARD_DEVIATION 12.189 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 241 Participants | 115 Participants | 356 Participants |
| Sex: Female, Male Male | 40 Participants | 14 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 281 | 0 / 129 |
| other Total, other adverse events | 2 / 281 | 0 / 129 |
| serious Total, serious adverse events | 0 / 281 | 0 / 129 |
Outcome results
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
TSQM version 1.4: participant rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as (\[{sum of item 1 to 3} - 3\]/18)\*100; if 1 question (Q) was missing: (\[{sum of item 1 to 3} -2\]/12)\*100. Side-effect measured as if item 4=No, score=100; if not then (\[{sum of item 5 to 8} -4\]/16)\*100; if 1 Q was missing: (\[{sum of item 5 to 8} -3\]/12)\*100. Convenience measured as (\[{sum of item 9 to 11} -3\]/18)\*100; if 1 Q was missing: (\[{sum of item 9 to 11} - 2\]/12)\*100. Global satisfaction as (\[{sum of item 12 to 14} -3\]/14)\*100; if item 12 or 13 was missing: (\[{sum of item 12 to 14} -2\]/10)\*100; if item 14 was missing: (\[{sum of item 12 and 13} -2\]/8)\*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score=greater satisfaction.
Time frame: Day 1 (during approximately 20 months of data collection and observation)
Population: The propensity score method (greedy matching method) was used in analysis of the outcome measure. The purpose of the propensity score was to create conditions similar to those of randomized trials by balancing the covariates in participants between the groups. It reduces multidimensional covariates into a one-dimensional score. Here, 'Overall Number of Participants Analyzed' signifies number of participant evaluable for this outcome measure derived from propensity score method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Citrate | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Effectiveness | 62.271 units on a scale | Standard Deviation 13.301 |
| Tofacitinib Citrate | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Side effects | 93.390 units on a scale | Standard Deviation 16.668 |
| Tofacitinib Citrate | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Convenience | 68.785 units on a scale | Standard Deviation 13.349 |
| Tofacitinib Citrate | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Global satisfaction | 56.680 units on a scale | Standard Deviation 15.412 |
| Adalimumab | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Global satisfaction | 59.860 units on a scale | Standard Deviation 15.558 |
| Adalimumab | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Effectiveness | 64.191 units on a scale | Standard Deviation 13.315 |
| Adalimumab | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Convenience | 64.946 units on a scale | Standard Deviation 12.845 |
| Adalimumab | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Side effects | 96.603 units on a scale | Standard Deviation 11.625 |
European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score
EQ-5D-3L assess health-related quality of life. It has 5 dimensions: mobility (M), self-care (SC), usual activities (UA), pain/discomfort (PD) and anxiety/depression (AD). Each dimension has 3 levels. For mobility, self-care and usual activities: 1= no effects, 2= sometimes affected, 3= very affected. For pain/discomfort and anxiety/depression: 1= none, 2= sometimes, 3= often. EQ-5D-3L index was calculated using formula = 1 - (0.0081 + \[0.1140 \* M2 + 0.6274 \* M3 + 0.0572 \* SC2 + 0.2073 \* SC3 + 0.0615 \* UA2 + 0.2812 \* UA3 + 0.0581 \* PD2+ 0.2353 \* PD3 + 0.0675 \* AD2 + 0.2351 \* AD3\]). In this formula, abbreviated form for dimension is followed by level, for example M2 = mobility level 2. Values were set to 1 if level was 2 or 3 for M2, SC2, UA2, PD2, AD2 or M3, SC3, UA3, PD3, AD3 respectively, else set to 0. Total score ranged from -0.27 to 1. Higher scores indicate better health.
Time frame: Day 1 (during approximately 20 months of data collection and observation)
Population: The propensity score method (greedy matching method) was used in analysis of the outcome measure. The purpose of the propensity score was to create conditions similar to those of randomized trials by balancing the covariates in participants between the groups. It reduces multidimensional covariates into a one-dimensional score. Here, 'Overall Number of Participants Analyzed' signifies number of participant evaluable for this outcome measure derived from propensity score method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Citrate | European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score | 0.812 units on a scale | Standard Deviation 0.146 |
| Adalimumab | European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score | 0.808 units on a scale | Standard Deviation 0.134 |
European Quality of Life-Visual Analogue Scale (EQ-VAS) Score
EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical, VAS on a scale ranging from and 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicated better health state.
Time frame: Day 1 (during approximately 20 months of data collection and observation)
Population: The propensity score method (greedy matching method) was used in analysis of the outcome measure. The purpose of the propensity score was to create conditions similar to those of randomized trials by balancing the covariates in participants between the groups. It reduces multidimensional covariates into a one-dimensional score. Here, 'Overall Number of Participants Analyzed' signifies number of participant evaluable for this outcome measure derived from propensity score method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Citrate | European Quality of Life-Visual Analogue Scale (EQ-VAS) Score | 65.403 units on a scale | Standard Deviation 19.974 |
| Adalimumab | European Quality of Life-Visual Analogue Scale (EQ-VAS) Score | 65.668 units on a scale | Standard Deviation 19.554 |