Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis

Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.

Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.

WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.

WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.

WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.

WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.

The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best).

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, a DAS28 score < 3.2 indicates low disease activity, and a DAS28 score < 2.6 indicates clinical remission.

Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.

The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions):

• agility/mobility
• self-care
• usual activities
• pain, bodily discomfort
• anxiety, depression

For each dimension the patient is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3).

EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine."

Participants self-reported the number of physician visits they had in the past 6 months.

Participants self-reported the number of hospitalizations they had in the past 6 months.

Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.

Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days.

Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain).

Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly).

Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others.

Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options:

• Considerably better
• Better
• About the same
• Worse
• Noticeably worse