Trial Outcomes & Findings for Real-World Outcome of Rheumatoid Arthritis Patients in Korea on Adalimumab (NCT NCT02627924)

Last Updated: 2019-03-22

Results Overview

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 and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were 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.

Recruitment status

COMPLETED

Target enrollment

91 participants

Primary outcome timeframe

Baseline and week 24

Results posted on

2019-03-22

Participant Flow

Ninety-one patients diagnosed with rheumatoid arthritis (RA) were enrolled at nine different sites in Korea.

Participant milestones

Participant milestones
Measure	Adalimumab Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Study STARTED	91
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab n=91 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Age, Continuous	55.7 years STANDARD_DEVIATION 13.3 • n=91 Participants
Sex: Female, Male Female	64 Participants n=91 Participants
Sex: Female, Male Male	27 Participants n=91 Participants
Heath Assessment Questionnaire - Disability Index (HAQ-DI)	1.33 units on a scale STANDARD_DEVIATION 0.73 • n=91 Participants

PRIMARY outcome

Timeframe: Baseline and week 24

Population: Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 24.

Outcome measures

Outcome measures
Measure	Adalimumab n=71 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.	Week 12 Participants who completed the patient treatment satisfaction questionnaire at week 12	Week 24 Participants who completed the patient treatment satisfaction questionnaire at week 24.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24	-0.67 units on a scale Standard Deviation 0.67	—	—

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 12.

Outcome measures

Outcome measures
Measure	Adalimumab n=79 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.	Week 12 Participants who completed the patient treatment satisfaction questionnaire at week 12	Week 24 Participants who completed the patient treatment satisfaction questionnaire at week 24.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12	-0.46 units on a scale Standard Deviation 0.60	—	—

SECONDARY outcome

Timeframe: Baseline, week 12 and week 24

Population: Participants still receiving adalimumab and with available data at each time point.

Outcome measures

Outcome measures
Measure	Adalimumab n=88 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.	Week 12 Participants who completed the patient treatment satisfaction questionnaire at week 12	Week 24 Participants who completed the patient treatment satisfaction questionnaire at week 24.
Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24 Week 12	65.8 percentage of participants	—	—
Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24 Week 24	77.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, and week 24

Population: Participants still receiving adalimumab and with available data at each time point.

The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included the following subscales: vitality, social functioning, role-emotional, and mental health. Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement.

Outcome measures

Outcome measures
Measure	Adalimumab n=88 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.	Week 12 Participants who completed the patient treatment satisfaction questionnaire at week 12	Week 24 Participants who completed the patient treatment satisfaction questionnaire at week 24.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24 Physical Component Score at Week 12	6.56 units on a scale Standard Deviation 6.98	—	—
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24 Physical Component Score at Week 24	9.51 units on a scale Standard Deviation 7.77	—	—
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24 Mental Component Score at Week 12	5.26 units on a scale Standard Deviation 11.62	—	—
Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24 Mental Component Score at Week 24	6.63 units on a scale Standard Deviation 12.31	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, and week 24

Population: Participants still receiving adalimumab and with available data at each time point.

The EQ-5D-5L descriptive system comprises 5 dimensions of health-related quality of life states (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems') within a particular EQ-5D-3L dimension. The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Adalimumab n=88 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.	Week 12 Participants who completed the patient treatment satisfaction questionnaire at week 12	Week 24 Participants who completed the patient treatment satisfaction questionnaire at week 24.
Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24 Week 12	0.15 units on a scale Standard Deviation 0.24	—	—
Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24 Week 24	0.18 units on a scale Standard Deviation 0.25	—	—

SECONDARY outcome

Timeframe: Baseline, week 12, and week 24

Population: Participants still receiving adalimumab and with available data at each time point. Overall work impairment was only assessed in participants who were employed.

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), overall work 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. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Adalimumab n=88 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.	Week 12 Participants who completed the patient treatment satisfaction questionnaire at week 12	Week 24 Participants who completed the patient treatment satisfaction questionnaire at week 24.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 Overall Work Impairment at Week 12	-19 percent impairment Standard Deviation 32	—	—
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 Overall Work Impairment at Week 24	-25 percent impairment Standard Deviation 31	—	—
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 Activity Impairment at Week 12	-15 percent impairment Standard Deviation 31	—	—
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 Activity Impairment at Week 24	-25 percent impairment Standard Deviation 34	—	—

SECONDARY outcome

Timeframe: Baseline, week 12 and week 24

Population: Participants still receiving adalimumab and with available data at each time point.

Participants were asked to answer the following four questions as either Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied, or Very dissatisfied. Question 1: Satisfaction with RA treatment in improving morning stiffness in and around the joints Question 2: Satisfaction with RA treatment improving mobility Question 3: Satisfaction with RA treatment improving the ability to perform daily living requiring fine motor skills Questions 4: Satisfaction with RA treatment overall