Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Patient Support Program, adalimumab
Brief summary
This study is a non-confirmatory post-marketing observational study to explore and describe the effectiveness of adalimumab on rheumatoid arthritis (RA) treatment course and participant satisfaction over time in context with utilization of a patient support program (PSP). The core elements of the PSP were call centers (in and outbound)/hotlines, nursing services, starter packs, provision of educational materials (print and digital) regarding RA and adalimumab, and injection guides. Other elements of the PSP, which varied between countries, included (but were not limited to) refill reminders, email contacts, support groups, and newsletters.
Detailed description
The main objectives of the study are to examine the effectiveness of adalimumab treatment with respect to PSPs by means of Health Assessment Questionnaire Disability Index (HAQ-DI), Disease Activity Score (DAS28) results, and European League Against Rheumatism (EULAR) response criteria, as well as to evaluate the contribution of PSP to disease control, treatment continuation over time, participant's satisfaction, and PSP utilization. The primary endpoint is the percentage of participants achieving a minimal clinically important difference (MCID) in HAQ-DI at Week 78. (MCID is improvement of at least 0.22 in HAQ-DI compared to Baseline). Secondary endpoints include the percentage of participants achieving MCID in HAQ-DI at Weeks 12, 24, 36, 52, 64 and other effectiveness parameters, including: changes in DAS28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), ACR 20/50/70 and EULAR moderate and good responses. Other secondary endpoints include health outcomes assessments including HAQ-DI, Work Productivity and Activity Impairment (WPAI), Compliance Questionnaire Rheumatology (CQR), and Treatment Satisfaction Questionnaire for Medication (TSQM) scores, expectation regarding PSP and health management via Patient Activation Measure (PAM-13), change in participant perceptions as measured by the Beliefs about Medicines Questionnaire (BMQ), and satisfaction with PSP as measured by PSP satisfaction assessment.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged at least 18 years that has been newly prescribed adalimumab therapy according to the local product label, with the first dose corresponding to the Enrollment/Baseline visit. * Patient with a diagnosis of moderate to severe RA, who has had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs), and has a prescription of adalimumab according to the local regulations. * Patients should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB (per local requirements and according to the local product label). * Patients must be able and willing to provide written authorization to disclose and use personal health information (and informed consent where applicable) and comply with the requirements of this study protocol as well as agree to data being collected and provided to AbbVie.
Exclusion criteria
* Patients should not be enrolled if they cannot be treated in accordance with the local adalimumab product label. * Patients treated with \> 1 prior biologic DMARD for RA. Any prior treatment with adalimumab is prohibited.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78 | Baseline, Week 78 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12 | Baseline, Week 12 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. |
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24 | Baseline, Week 24 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. |
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36 | Baseline, Week 36 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. |
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52 | Baseline, Week 52 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. |
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64 | Baseline, Week 64 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | Baseline, Week 24 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement. |
| Mean Change From Baseline in WPAI at Week 52 | Baseline, Week 52 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement. |
| Mean Change From Baseline in WPAI at Week 78 | Baseline, Week 78 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement. |
| Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | Baseline, Week 24 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). |
| Mean Change From Baseline in TSQM Scores at Week 52 | Baseline, Week 52 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). |
| Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13 | Baseline, Week 78 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. |
| Mean Change From Baseline in TSQM Scores at Week 78 | Baseline, Week 78 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). |
| Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Baseline and Weeks 24, 52, 78 | The DAS28 is a validated combined index of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher numbers indicating more disease activity. |
| Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78 | Baseline, Week 78 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. |
| Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78 | Baseline, Week 78 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. |
| Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78 | Baseline, Week 78 | The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis. Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale. Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores. Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication. Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications. |
| PSP Satisfaction Questionnaire Responses at Week 12 | Week 12 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. |
| PSP Satisfaction Questionnaire Responses at Week 24 | Week 24 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. |
| PSP Satisfaction Questionnaire Responses at Week 52 | Week 52 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. |
| PSP Satisfaction Questionnaire Responses at Week 78 | Week 78 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. |
| Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Baseline, Week 24, 52, and 78 | The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement. The agreements are based on a 4-point Likert scale with anchors don't agree at all (score = 1), don't agree (score = 2), agree (score = 3), and agree very much (score = 4). The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57. The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance). |
| Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Baseline, Weeks 24, 52, and 78 | The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. |
| Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Baseline, Weeks 24, 52, and 78 | The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. |
| Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | Week 78 | ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * HAQ-DI * Acute phase reactant value (CRP or erythrocyte sedimentation date \[ESR\]) |
| Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | Week 78 | A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity. * A Good Response is defined as an improvement (decrease) in the DAS28 of \> 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. * A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. * No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1 |
| Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | Week 78 | A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity. * A Good Response is defined as an improvement (decrease) in the DAS28 of \>1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. * A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. * No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With RA Receiving Adalimumab Participants with RA who initiated adalimumab based on current clinical practice criteria (without taking participation in the study into account), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated by ADA for their RA. | 1,025 |
| Total | 1,025 |
Baseline characteristics
| Characteristic | Participants With RA Receiving Adalimumab |
|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 13.33 |
| Sex: Female, Male Female | 790 Participants |
| Sex: Female, Male Male | 235 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 95 / 1,025 |
| serious Total, serious adverse events | 97 / 1,025 |
Outcome results
Primary
Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Time frame: Baseline, Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78 | 48.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78 | 37.8 percentage of participants |
p-value: <0.001Chi-squared
Secondary
Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Time frame: Baseline, Week 12
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12 | 60.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12 | 50.0 percentage of participants |
Secondary
Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Time frame: Baseline, Week 24
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24 | 52.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24 | 46.4 percentage of participants |
p-value: 0.058Chi-squared
Secondary
Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Time frame: Baseline, Week 36
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36 | 49.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36 | 43.0 percentage of participants |
Secondary
Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Time frame: Baseline, Week 52
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52 | 48.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52 | 39.2 percentage of participants |
p-value: 0.003Chi-squared
Secondary
Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Time frame: Baseline, Week 64
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64 | 48.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64 | 37.3 percentage of participants |
Other Pre-specified
Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78
The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis. Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale. Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores. Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication. Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications.
Time frame: Baseline, Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing Baseline and at least 1 non-missing post-Baseline value. Observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78 | Necessity | -0.03 units on a scale | Standard Deviation 0.743 |
| Participants With RA Receiving Adalimumab: PSP User | Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78 | Concern | -0.12 units on a scale | Standard Deviation 0.902 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78 | Necessity | -0.04 units on a scale | Standard Deviation 0.729 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78 | Concern | -0.17 units on a scale | Standard Deviation 0.842 |
Comparison: Necessityp-value: 0.019ANCOVA
Comparison: Concernp-value: 0.56ANCOVA
Other Pre-specified
Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78
The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
Time frame: Baseline, Weeks 24, 52, and 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 24 | -20.42 units on a scale | Standard Deviation 15.16 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 78 | -20.56 units on a scale | Standard Deviation 16.52 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 52 | -20.61 units on a scale | Standard Deviation 15.63 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 24 | -21.94 units on a scale | Standard Deviation 15.6 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 52 | -22.58 units on a scale | Standard Deviation 15.84 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 78 | -22.66 units on a scale | Standard Deviation 16.67 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 24 | -18.93 units on a scale | Standard Deviation 14.58 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 78 | -18.55 units on a scale | Standard Deviation 16.13 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | Change at Week 52 | -18.71 units on a scale | Standard Deviation 15.21 |
Comparison: Week 24p-value: 0.023ANCOVA
Comparison: Week 52p-value: 0.002ANCOVA
Comparison: Week 78p-value: 0.002ANCOVA
Other Pre-specified
Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78
The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement. The agreements are based on a 4-point Likert scale with anchors don't agree at all (score = 1), don't agree (score = 2), agree (score = 3), and agree very much (score = 4). The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57. The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance).
Time frame: Baseline, Week 24, 52, and 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 52 | 2.20 units on a scale | Standard Deviation 10.75 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 24 | 2.23 units on a scale | Standard Deviation 10.11 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 78 | 2.06 units on a scale | Standard Deviation 10.53 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 52 | 2.39 units on a scale | Standard Deviation 10.2 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 24 | 2.44 units on a scale | Standard Deviation 9.78 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 78 | 2.30 units on a scale | Standard Deviation 9.63 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 24 | 2.01 units on a scale | Standard Deviation 10.45 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 78 | 1.80 units on a scale | Standard Deviation 11.41 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | Change at Week 52 | 1.99 units on a scale | Standard Deviation 11.3 |
Comparison: Week 52p-value: 0.198ANCOVA
Comparison: Week 78p-value: 0.131ANCOVA
Comparison: Week 24p-value: 0.154ANCOVA
Other Pre-specified
Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78
The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
Time frame: Baseline, Weeks 24, 52, and 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 78 | -22.12 units on a scale | Standard Deviation 17.7 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 52 | -21.97 units on a scale | Standard Deviation 17.01 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 24 | -21.78 units on a scale | Standard Deviation 16.42 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 78 | -24.50 units on a scale | Standard Deviation 18.49 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 52 | -24.46 units on a scale | Standard Deviation 17.88 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 24 | -23.59 units on a scale | Standard Deviation 17.62 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 52 | -19.54 units on a scale | Standard Deviation 15.77 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 24 | -20.00 units on a scale | Standard Deviation 14.95 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | Change at Week 78 | -19.80 units on a scale | Standard Deviation 16.58 |
Comparison: Week 24p-value: 0.059ANCOVA
Comparison: Week 52p-value: 0.003ANCOVA
Comparison: Week 78p-value: 0.01ANCOVA
Other Pre-specified
Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
Time frame: Baseline, Week 24
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM convenience | 5.51 units on a scale | Standard Deviation 20.02 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM effectiveness | 14.45 units on a scale | Standard Deviation 31.12 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM global satisfaction | 11.20 units on a scale | Standard Deviation 26.9 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM side effects | 8.17 units on a scale | Standard Deviation 32.05 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM side effects | 8.21 units on a scale | Standard Deviation 30.91 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM convenience | 6.67 units on a scale | Standard Deviation 20.27 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM global satisfaction | 11.44 units on a scale | Standard Deviation 26.43 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM effectiveness | 14.56 units on a scale | Standard Deviation 32.25 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM side effects | 8.10 units on a scale | Standard Deviation 33.74 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM effectiveness | 14.29 units on a scale | Standard Deviation 29.53 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM global satisfaction | 10.85 units on a scale | Standard Deviation 27.6 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM convenience | 3.85 units on a scale | Standard Deviation 19.58 |
Comparison: TSQM conveniencep-value: 0.017ANCOVA
Comparison: TSQM effectivenessp-value: 0.164ANCOVA
Comparison: TSQM global satisfactionp-value: 0.003ANCOVA
Comparison: TSQM side effectsp-value: 0.335ANCOVA
Other Pre-specified
Mean Change From Baseline in TSQM Scores at Week 52
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
Time frame: Baseline, Week 52
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM convenience | 6.30 units on a scale | Standard Deviation 20.15 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM effectiveness | 15.79 units on a scale | Standard Deviation 30.8 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM side effects | 8.28 units on a scale | Standard Deviation 32.29 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM global satisfaction | 11.94 units on a scale | Standard Deviation 26.68 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM effectiveness | 16.06 units on a scale | Standard Deviation 31.84 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM global satisfaction | 12.53 units on a scale | Standard Deviation 26.35 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM convenience | 7.38 units on a scale | Standard Deviation 19.94 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM side effects | 8.09 units on a scale | Standard Deviation 31.23 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM side effects | 8.55 units on a scale | Standard Deviation 33.81 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM effectiveness | 15.41 units on a scale | Standard Deviation 29.38 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM convenience | 4.77 units on a scale | Standard Deviation 20.38 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM global satisfaction | 11.12 units on a scale | Standard Deviation 27.15 |
Comparison: TSQM conveniencep-value: 0.021ANCOVA
Comparison: TSQM effectivenessp-value: 0.106ANCOVA
Comparison: TSQM global satisfactionp-value: 0.002ANCOVA
Comparison: TSQM side effectsp-value: 0.269ANCOVA
Other Pre-specified
Mean Change From Baseline in TSQM Scores at Week 78
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
Time frame: Baseline, Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM global satisfaction | 10.93 units on a scale | Standard Deviation 27.07 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM effectiveness | 15.14 units on a scale | Standard Deviation 30.58 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM convenience | 6.20 units on a scale | Standard Deviation 20.14 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM side effects | 8.32 units on a scale | Standard Deviation 31.72 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM effectiveness | 16.24 units on a scale | Standard Deviation 31.22 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM convenience | 7.23 units on a scale | Standard Deviation 19.87 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM global satisfaction | 11.68 units on a scale | Standard Deviation 26.67 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM side effects | 8.37 units on a scale | Standard Deviation 30.98 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM global satisfaction | 9.87 units on a scale | Standard Deviation 27.63 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM effectiveness | 13.62 units on a scale | Standard Deviation 29.68 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM convenience | 4.76 units on a scale | Standard Deviation 20.47 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM side effects | 8.25 units on a scale | Standard Deviation 32.8 |
Comparison: TSQM conveniencep-value: 0.049ANCOVA
Comparison: TSQM effectivenessp-value: 0.011ANCOVA
Comparison: TSQM global satisfactionp-value: <0.001ANCOVA
Comparison: TSQM side effectsp-value: 0.272ANCOVA
Other Pre-specified
Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78
The DAS28 is a validated combined index of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher numbers indicating more disease activity.
Time frame: Baseline and Weeks 24, 52, 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 78 | -2.15 units on a scale | Standard Deviation 1.63 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 52 | -2.11 units on a scale | Standard Deviation 1.56 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 24 | -2.09 units on a scale | Standard Deviation 1.48 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 78 | -2.33 units on a scale | Standard Deviation 1.68 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 24 | -2.24 units on a scale | Standard Deviation 1.55 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 52 | -2.31 units on a scale | Standard Deviation 1.62 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 52 | -1.92 units on a scale | Standard Deviation 1.49 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 24 | -1.94 units on a scale | Standard Deviation 1.39 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | Change at Week 78 | -1.97 units on a scale | Standard Deviation 1.56 |
Comparison: Week 24p-value: 0.027ANCOVA
Comparison: Week 52p-value: 0.006ANCOVA
Comparison: Week 78p-value: 0.018ANCOVA
Other Pre-specified
Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24
The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement.
Time frame: Baseline, Week 24
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI absenteeism | -3.81 units on a scale | Standard Deviation 29.07 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI presenteeism | -17.88 units on a scale | Standard Deviation 27.75 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI overall work impairment | -17.85 units on a scale | Standard Deviation 31.74 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI activity impairment | -22.04 units on a scale | Standard Deviation 27.49 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI activity impairment | -23.90 units on a scale | Standard Deviation 29.03 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI absenteeism | -2.32 units on a scale | Standard Deviation 25.4 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI overall work impairment | -17.55 units on a scale | Standard Deviation 31.79 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI presenteeism | -18.68 units on a scale | Standard Deviation 27.41 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI activity impairment | -20.11 units on a scale | Standard Deviation 25.69 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI presenteeism | -17.06 units on a scale | Standard Deviation 28.15 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI overall work impairment | -18.17 units on a scale | Standard Deviation 31.8 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | WPAI absenteeism | -5.43 units on a scale | Standard Deviation 32.58 |
Comparison: WPAI absenteeismp-value: 0.625ANCOVA
Comparison: WPAI presenteeismp-value: 0.736ANCOVA
Comparison: WPAI overall work impairmentp-value: 0.7ANCOVA
Comparison: WPAI activity impairmentp-value: 0.023ANCOVA
Other Pre-specified
Mean Change From Baseline in WPAI at Week 52
The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement.
Time frame: Baseline, Week 52
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in WPAI at Week 52 | WPAI absenteeism | -3.97 units on a scale | Standard Deviation 30.75 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in WPAI at Week 52 | WPAI overall work impairment | -17.24 units on a scale | Standard Deviation 33.21 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in WPAI at Week 52 | WPAI activity impairment | -23.04 units on a scale | Standard Deviation 28.63 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in WPAI at Week 52 | WPAI presenteeism | -17.69 units on a scale | Standard Deviation 28.23 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 52 | WPAI overall work impairment | -17.77 units on a scale | Standard Deviation 32.09 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 52 | WPAI absenteeism | -2.80 units on a scale | Standard Deviation 29.25 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 52 | WPAI presenteeism | -18.34 units on a scale | Standard Deviation 26.56 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 52 | WPAI activity impairment | -25.06 units on a scale | Standard Deviation 29.23 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 52 | WPAI absenteeism | -5.18 units on a scale | Standard Deviation 32.28 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 52 | WPAI activity impairment | -20.97 units on a scale | Standard Deviation 27.89 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 52 | WPAI presenteeism | -17.02 units on a scale | Standard Deviation 29.88 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 52 | WPAI overall work impairment | -16.69 units on a scale | Standard Deviation 34.44 |
Comparison: WPAI absenteeismp-value: 0.89ANCOVA
Comparison: WPAI presenteeismp-value: 0.835ANCOVA
Comparison: WPAI overall work impairmentp-value: 0.883ANCOVA
Comparison: WPAI activity impairmentp-value: 0.019ANCOVA
Other Pre-specified
Mean Change From Baseline in WPAI at Week 78
The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement.
Time frame: Baseline, Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in WPAI at Week 78 | WPAI absenteeism | -6.92 units on a scale | Standard Deviation 29.92 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in WPAI at Week 78 | WPAI presenteeism | -18.41 units on a scale | Standard Deviation 29.43 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in WPAI at Week 78 | WPAI overall work impairment | -21.13 units on a scale | Standard Deviation 33.33 |
| Participants With RA Receiving Adalimumab: PSP User | Mean Change From Baseline in WPAI at Week 78 | WPAI activity impairment | -23.52 units on a scale | Standard Deviation 29.41 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 78 | WPAI activity impairment | -26.42 units on a scale | Standard Deviation 29.28 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 78 | WPAI absenteeism | -5.71 units on a scale | Standard Deviation 27.55 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 78 | WPAI overall work impairment | -22.28 units on a scale | Standard Deviation 30.7 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 78 | WPAI presenteeism | -19.07 units on a scale | Standard Deviation 28.19 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 78 | WPAI activity impairment | -20.56 units on a scale | Standard Deviation 29.28 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 78 | WPAI presenteeism | -17.75 units on a scale | Standard Deviation 30.69 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 78 | WPAI overall work impairment | -19.94 units on a scale | Standard Deviation 35.9 |
| Participants With RA Receiving Adalimumab: PSP Non-User | Mean Change From Baseline in WPAI at Week 78 | WPAI absenteeism | -8.17 units on a scale | Standard Deviation 32.23 |
Comparison: WPAI absenteeismp-value: 0.873ANCOVA
Comparison: WPAI presenteeismp-value: 0.753ANCOVA
Comparison: WPAI overall work impairmentp-value: 0.461ANCOVA
Comparison: WPAI activity impairmentp-value: <0.001ANCOVA
Other Pre-specified
Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78
ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * HAQ-DI * Acute phase reactant value (CRP or erythrocyte sedimentation date \[ESR\])
Time frame: Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | ACR20 | 75.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | ACR50 | 58.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | ACR70 | 38.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | ACR50 | 50.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | ACR70 | 32.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | ACR20 | 72.6 percentage of participants |
Other Pre-specified
Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
Time frame: Baseline, Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78 | 35.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78 | 28.1 percentage of participants |
Other Pre-specified
Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
Time frame: Baseline, Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 4 at Baseline. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13 | 52.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13 | 28.9 percentage of participants |
Other Pre-specified
Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
Time frame: Baseline, Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 3 or 4 at Baseline. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78 | 64.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78 | 53.8 percentage of participants |
Other Pre-specified
Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity. * A Good Response is defined as an improvement (decrease) in the DAS28 of \>1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. * A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. * No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1
Time frame: Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | Moderate | 22.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | Good | 65.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | None | 12.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | Good | 70.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | Moderate | 19.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | None | 9.3 percentage of participants |
Other Pre-specified
Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity. * A Good Response is defined as an improvement (decrease) in the DAS28 of \> 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. * A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. * No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1
Time frame: Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | Good | 58.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | Moderate | 28.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | No Response | 13.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | Good | 59.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | Moderate | 31.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP Non-User | Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | No Response | 9.6 percentage of participants |
Other Pre-specified
PSP Satisfaction Questionnaire Responses at Week 12
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.
Time frame: Week 12
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Is always there for me: score 3 | 7.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Is always there for me: score 4 | 20.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Offers real added value service: score 1 | 29.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | PSP in total: score 2 | 35.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Call center/hotline: score 2 | 23.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Call center/hotline: score 3 | 2.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Call center/hotline: score 4 | 41.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Educational materials about life with RA: score 1 | 41.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Educational materials about life with RA: score 2 | 40.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Educational materials about life with RA: score 3 | 2.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Educational materials about life with RA: score 4 | 16.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Educational materials about adalimumab: score 1 | 40.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Educational materials about adalimumab: score 4 | 16.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Injection guide: score 1 | 52.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Injection guide: score 2 | 38.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Injection guide: score 3 | 0.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Injection guide: score 4 | 8.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Nursing services: score 1 | 37.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Nursing services: score 2 | 18.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Email contact: score 1 | 9.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Email contact: score 2 | 11.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Email contact: score 3 | 0.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Email contact: score 4 | 77.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Refill reminders: score 1 | 27.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Refill reminders: score 2 | 21.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Refill reminders: score 3 | 1.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Refill reminders: score 4 | 50.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Newsletters: score 1 | 15.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Newsletters: score 2 | 19.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Financial assistance: score 4 | 89.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Other educational materials: score 2 | 26.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Offers real added value service: score 2 | 38.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Offers real added value service: score 3 | 8.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Offers real added value service: score 4 | 23.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Is exceptional: score 1 | 28.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Is exceptional: score 2 | 40.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Is exceptional: score 3 | 10.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Is exceptional: score 4 | 21.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | PSP in total: score 1 | 39.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | PSP in total: score 3 | 2.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | PSP in total: score 4 | 23.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Call center/hotline: score 1 | 33.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Educational materials about adalimumab: score 2 | 41.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Educational materials about adalimumab: score 3 | 1.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Nursing services: score 3 | 0.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Nursing services: score 4 | 43.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Newsletters: score 3 | 1.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Newsletters: score 4 | 63.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Reimbursement support: score 1 | 6.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Reimbursement support: score 2 | 7.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Reimbursement support: score 3 | 1.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Reimbursement support: score 4 | 84.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Financial assistance: score 1 | 4.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Financial assistance: score 2 | 4.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Financial assistance: score 3 | 1.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Other educational materials: score 1 | 15.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Relieves my daily burden: score 1 | 24.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Relieves my daily burden: score 2 | 32.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Relieves my daily burden: score 3 | 14.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Relieves my daily burden: score 4 | 28.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Is always there for me: score 1 | 32.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Is always there for me: score 2 | 39.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Other educational materials: score 3 | 0.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Other educational materials: score 4 | 57.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Collection/disposal of sharps container: score 1 | 30.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Collection/disposal of sharps container: score 2 | 23.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Collection/disposal of sharps container: score 3 | 2.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Collection/disposal of sharps container: score 4 | 44.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Starter pack: score 1 | 44.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Starter pack: score 2 | 32.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Starter pack: score 3 | 1.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 12 | Starter pack: score 4 | 21.6 percentage of participants |
Other Pre-specified
PSP Satisfaction Questionnaire Responses at Week 24
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.
Time frame: Week 24
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Relieves my daily burden: score 2 | 34.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Is exceptional: score 3 | 10.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Educational materials about life with RA: score 3 | 1.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Educational materials about life with RA: score 4 | 21.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Email contact: score 1 | 7.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Email contact: score 2 | 10.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Email contact: score 3 | 1.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Email contact: score 4 | 80.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Refill reminders: score 1 | 26.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Refill reminders: score 2 | 18.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Newsletters: score 2 | 22.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Relieves my daily burden: score 1 | 22.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Relieves my daily burden: score 3 | 15.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Relieves my daily burden: score 4 | 27.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Is always there for me: score 1 | 28.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Is always there for me: score 2 | 38.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Is always there for me: score 3 | 11.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Is always there for me: score 4 | 21.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Offers real added value service: score 1 | 27.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Offers real added value service: score 2 | 39.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Offers real added value service: score 3 | 8.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Offers real added value service: score 4 | 25.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Is exceptional: score 1 | 22.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Is exceptional: score 2 | 43.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Is exceptional: score 4 | 22.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | PSP in total: score 1 | 33.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | PSP in total: score 2 | 36.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | PSP in total: score 3 | 1.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | PSP in total: score 4 | 28.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Call center/hotline: score 1 | 28.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Call center/hotline: score 2 | 27.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Call center/hotline: score 3 | 1.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Call center/hotline: score 4 | 42.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Educational materials about life with RA: score 1 | 31.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Educational materials about life with RA: score 2 | 45.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Educational materials about adalimumab: score 1 | 34.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Educational materials about adalimumab: score 2 | 42.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Educational materials about adalimumab: score 3 | 0.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Educational materials about adalimumab: score 4 | 22.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Injection guide: score 1 | 44.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Injection guide: score 2 | 39.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Injection guide: score 3 | 0.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Injection guide: score 4 | 15.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Nursing services: score 1 | 27.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Nursing services: score 2 | 16.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Nursing services: score 3 | 1.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Nursing services: score 4 | 54.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Refill reminders: score 3 | 0.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Refill reminders: score 4 | 54.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Newsletters: score 1 | 11.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Newsletters: score 3 | 2.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Newsletters: score 4 | 64.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Reimbursement support: score 1 | 7.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Reimbursement support: score 2 | 7.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Reimbursement support: score 3 | 0.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Reimbursement support: score 4 | 84.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Financial assistance: score 1 | 4.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Financial assistance: score 2 | 3.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Financial assistance: score 3 | 0.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Financial assistance: score 4 | 90.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Other educational materials: score 1 | 12.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Other educational materials: score 2 | 25.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Other educational materials: score 3 | 0.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Other educational materials: score 4 | 60.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Collection/disposal of sharps container: score 1 | 29.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Collection/disposal of sharps container: score 2 | 22.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Collection/disposal of sharps container: score 3 | 1.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Collection/disposal of sharps container: score 4 | 47.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Starter pack: score 1 | 0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Starter pack: score 2 | 50.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Starter pack: score 3 | 0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 24 | Starter pack: score 4 | 50.0 percentage of participants |
Other Pre-specified
PSP Satisfaction Questionnaire Responses at Week 52
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.
Time frame: Week 52
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Relieves my daily burden: score 2 | 32.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Relieves my daily burden: score 3 | 12.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Is exceptional: score 2 | 42.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | PSP in total: score 4 | 28.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Call center/hotline: score 1 | 27.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Call center/hotline: score 2 | 25.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Call center/hotline: score 3 | 1.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Educational materials about life with RA: score 3 | 0.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Educational materials about life with RA: score 4 | 24.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Educational materials about adalimumab: score 1 | 33.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Educational materials about adalimumab: score 2 | 41.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Educational materials about adalimumab: score 3 | 1.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Educational materials about adalimumab: score 4 | 23.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Reimbursement support: score 2 | 7.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Reimbursement support: score 3 | 0.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Reimbursement support: score 4 | 85.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Financial assistance: score 1 | 4.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Financial assistance: score 2 | 5.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Is exceptional: score 3 | 9.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Is exceptional: score 4 | 26.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | PSP in total: score 1 | 33.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | PSP in total: score 2 | 36.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | PSP in total: score 3 | 1.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Call center/hotline: score 4 | 45.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Educational materials about life with RA: score 1 | 33.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Educational materials about life with RA: score 2 | 41.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Injection guide: score 1 | 38.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Injection guide: score 2 | 37.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Injection guide: score 3 | 0.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Injection guide: score 4 | 23.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Nursing services: score 1 | 22.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Nursing services: score 2 | 15.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Nursing services: score 3 | 1.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Nursing services: score 4 | 60.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Email contact: score 1 | 5.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Email contact: score 2 | 10.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Email contact: score 3 | 0.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Email contact: score 4 | 83.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Refill reminders: score 1 | 20.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Refill reminders: score 2 | 17.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Refill reminders: score 3 | 1.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Refill reminders: score 4 | 60.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Newsletters: score 1 | 13.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Newsletters: score 2 | 20.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Newsletters: score 3 | 1.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Newsletters: score 4 | 64.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Reimbursement support: score 1 | 6.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Financial assistance: score 3 | 1.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Financial assistance: score 4 | 89.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Other educational materials: score 1 | 9.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Other educational materials: score 2 | 26.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Other educational materials: score 3 | 1.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Other educational materials: score 4 | 62.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Collection/disposal of sharps container: score 1 | 28.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Collection/disposal of sharps container: score 2 | 19.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Collection/disposal of sharps container: score 3 | 2.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Collection/disposal of sharps container: score 4 | 49.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Relieves my daily burden: score 1 | 21.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Relieves my daily burden: score 4 | 33.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Is always there for me: score 1 | 28.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Is always there for me: score 2 | 37.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Is always there for me: score 3 | 8.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Is always there for me: score 4 | 26.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Offers real added value service: score 1 | 25.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Offers real added value service: score 2 | 39.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Offers real added value service: score 3 | 9.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Offers real added value service: score 4 | 26.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 52 | Is exceptional: score 1 | 21.6 percentage of participants |
Other Pre-specified
PSP Satisfaction Questionnaire Responses at Week 78
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.
Time frame: Week 78
Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Is exceptional: score 4 | 26.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Nursing services: score 3 | 0.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Relieves my daily burden: score 1 | 22.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Relieves my daily burden: score 2 | 32.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Relieves my daily burden: score 3 | 14.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Relieves my daily burden: score 4 | 30.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Is always there for me: score 1 | 29.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Is always there for me: score 2 | 38.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Is always there for me: score 3 | 7.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Is always there for me: score 4 | 24.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Offers real added value service: score 1 | 25.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Offers real added value service: score 2 | 42.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Offers real added value service: score 3 | 7.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Offers real added value service: score 4 | 24.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Is exceptional: score 1 | 22.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Is exceptional: score 2 | 42.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Is exceptional: score 3 | 9.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | PSP in total: score 1 | 34.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | PSP in total: score 2 | 35.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | PSP in total: score 3 | 1.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | PSP in total: score 4 | 28.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Call center/hotline: score 1 | 27.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Call center/hotline: score 2 | 22.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Call center/hotline: score 3 | 1.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Call center/hotline: score 4 | 48.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Educational materials about life with RA: score 1 | 30.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Educational materials about life with RA: score 2 | 46.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Educational materials about life with RA: score 3 | 1.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Educational materials about life with RA: score 4 | 22.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Educational materials about adalimumab: score 1 | 30.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Educational materials about adalimumab: score 2 | 46.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Educational materials about adalimumab: score 3 | 0.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Educational materials about adalimumab: score 4 | 22.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Injection guide: score 1 | 42.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Injection guide: score 2 | 36.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Injection guide: score 3 | 0.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Injection guide: score 4 | 20.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Nursing services: score 1 | 22.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Nursing services: score 2 | 15.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Nursing services: score 4 | 61.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Email contact: score 1 | 6.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Email contact: score 2 | 9.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Email contact: score 3 | 0.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Email contact: score 4 | 82.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Refill reminders: score 1 | 25.5 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Refill reminders: score 2 | 16.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Refill reminders: score 3 | 1.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Refill reminders: score 4 | 56.7 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Newsletters: score 1 | 11.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Newsletters: score 2 | 19.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Newsletters: score 3 | 1.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Newsletters: score 4 | 67.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Reimbursement support: score 1 | 6.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Reimbursement support: score 2 | 7.4 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Reimbursement support: score 3 | 0.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Reimbursement support: score 4 | 85.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Financial assistance: score 1 | 4.0 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Financial assistance: score 2 | 5.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Financial assistance: score 3 | 0.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Financial assistance: score 4 | 89.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Other educational materials: score 1 | 12.3 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Other educational materials: score 2 | 24.9 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Other educational materials: score 3 | 0.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Other educational materials: score 4 | 62.2 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Collection/disposal of sharps container: score 1 | 31.6 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Collection/disposal of sharps container: score 2 | 19.8 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Collection/disposal of sharps container: score 3 | 2.1 percentage of participants |
| Participants With RA Receiving Adalimumab: PSP User | PSP Satisfaction Questionnaire Responses at Week 78 | Collection/disposal of sharps container: score 4 | 46.5 percentage of participants |