Trial Outcomes & Findings for Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan (NCT NCT02616380)

NCT ID: NCT02616380

Last Updated: 2019-03-14

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: 100 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2019-03-14

Participant Flow

One hundred participants with rheumatoid arthritis (RA) were enrolled at 7 sites in Taiwan.

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	100
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Adalimumab Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Overall Study Lost to Follow-up	1
Overall Study Other	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Adalimumab n=100 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Age, Continuous	54.0 years STANDARD_DEVIATION 12.2 • n=100 Participants
Sex: Female, Male Female	87 Participants n=100 Participants
Sex: Female, Male Male	13 Participants n=100 Participants
Heath Assessment Questionnaire - Disability Index	1.06 units on a scale STANDARD_DEVIATION 0.72 • n=100 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.

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.

Outcome measures

Measure	Adalimumab n=94 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24	-0.44 units on a scale Standard Deviation 0.59

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

Measure	Adalimumab n=97 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
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	8.09 units on a scale Standard Deviation 7.13
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	5.72 units on a scale Standard Deviation 5.78
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	3.67 units on a scale Standard Deviation 7.94
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	5.85 units on a scale Standard Deviation 7.99

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, self-care, 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

Measure	Adalimumab n=97 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24 12 weeks	0.23 units on a scale Standard Deviation 0.30
Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24 24 weeks	0.33 units on a scale Standard Deviation 0.38

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

Measure	Adalimumab n=97 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 Overall Work Impairment at Week 12	-18 percent impairment Standard Deviation 23
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 Overall Work Impairment at Week 24	-19 percent impairment Standard Deviation 23
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 Activity Impairment at Week 12	-14 percent impairment Standard Deviation 22
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24 Activity Impairment at Week 24	-24 percent impairment Standard Deviation 25

SECONDARY outcome

Timeframe: Week 0 and Week 12

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

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.

Outcome measures

Measure	Adalimumab n=96 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Change From Baseline in HAQ DI Score at Week 12	-0.34 units on a scale Standard Deviation 0.46

SECONDARY outcome

Timeframe: Baseline, week 12 and week 24

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

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.

A clinically meaningful improvement was defined as an improvement of -0.22 points or greater in the HAQ-DI score.

Outcome measures

Measure	Adalimumab n=97 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24 Week 24	59.6 percentage of participants
Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24 Week 12	60.4 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: All enrolled participants

The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

Outcome measures

Measure	Adalimumab n=100 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Any healthcare professional	99 Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Rheumatologist	97 Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Traditional medicine	7 Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Orthopaedist	5 Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Rehabilitation medicine	5 Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Family medicine	3 Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Internist	2 Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Emergency department	1 Participants
Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis Other	11 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: All enrolled participants

The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

Outcome measures

Measure	Adalimumab n=100 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Any Procedure	95 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Blood Sample Taken	87 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Chest X-Ray	27 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Urine Test	11 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Liverfunction Test	11 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Electroardiogram	9 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Hand X-Ray	5 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Spine X-Ray	4 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Bone Scan	3 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Shoulder X-Ray	1 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Knee X-Ray	1 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Magnetic Resonance Imaging (MRI)	1 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Endoscopy	1 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Tuberculin Skin Test	1 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Sputum Tests	1 Participants
Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis Other	8 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: All enrolled participants

The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

Outcome measures

Measure	Adalimumab n=100 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis	1 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: All enrolled participants

The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.

Outcome measures

Measure	Adalimumab n=100 Participants Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis Any Concomitant Medication	100 Participants
Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis Disease Modifying Antirheumatic Drug (DMARD)	96 Participants
Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis Non-steroidal Anti-inflammatory Drug (NSAID)	73 Participants
Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis Others	59 Participants

Adverse Events

Adalimumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab n=100 participants at risk Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Injury, poisoning and procedural complications Hip fracture	1.0% 1/100 • Up to 34 weeks The protocol required that all serious adverse events (SAEs) to be actively solicited. Non-serious adverse events were collected as spontaneous reports when the Sponsor was notified.

Other adverse events

Measure	Adalimumab n=100 participants at risk Participants diagnosed with rheumatoid arthritis who were prescribed adalimumab according to their physician's discretion and routine clinical practice.
Immune system disorders Allergic reaction	1.0% 1/100 • Up to 34 weeks The protocol required that all serious adverse events (SAEs) to be actively solicited. Non-serious adverse events were collected as spontaneous reports when the Sponsor was notified.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER