Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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])

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

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

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.

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.

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.

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.