Trial Outcomes & Findings for Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China (NCT NCT02668640)

Last Updated: 2019-09-13

Results Overview

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.

Recruitment status

COMPLETED

Target enrollment

55 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2019-09-13

Participant Flow

All participants who received at least one dose of adalimumab during the study

Participant milestones

Participant milestones
Measure	Participants With RA Receiving Adalimumab 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Overall Study STARTED	55
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With RA Receiving Adalimumab 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Overall Study Lost to Follow-up	13
Overall Study Other, not specified	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With RA Receiving Adalimumab n=55 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Age, Continuous	50.0 years STANDARD_DEVIATION 13.4 • n=55 Participants
Sex: Female, Male Female	43 Participants n=55 Participants
Sex: Female, Male Male	12 Participants n=55 Participants
Medical insurance type National/Public insurance	45 Participants n=55 Participants
Medical insurance type Private insurance	2 Participants n=55 Participants
Medical insurance type Employer benefits	1 Participants n=55 Participants
Medical insurance type Other	5 Participants n=55 Participants
Medical insurance type No insurance	1 Participants n=55 Participants
Medical insurance type National/Public insurance and private insurance	1 Participants n=55 Participants
Mean Baseline DAS28 score	6.0 units on a scale STANDARD_DEVIATION 1.4 • n=55 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data

Outcome measures

Outcome measures
Measure	Participants With RA Receiving Adalimumab n=39 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24	-0.3 units on a scale Interval -0.9 to 0.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data

Outcome measures

Outcome measures
Measure	Participants With RA Receiving Adalimumab n=46 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12	-0.2 units on a scale Interval -0.9 to 0.0

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 24

Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data

The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 PCS and MCS scores range from 1-100: higher scores indicate a better state of health and an increase from baseline represents improvement.

Outcome measures

Outcome measures
Measure	Participants With RA Receiving Adalimumab n=54 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 PCS T-Score Week 12	6.50 units on a scale Interval 2.07 to 9.36
Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 MCS T-Score Week 12	0.44 units on a scale Interval -3.49 to 11.0
Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 PCS T-Score Week 24	4.90 units on a scale Interval -2.21 to 11.92
Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 MCS T-Score Week 24	6.01 units on a scale Interval 0.0 to 13.35

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 24

Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data

The EQ-5D-3L measures the participant's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which has three response choices. The responses record three levels of severity ('no problems', 'having some or moderate problems', and 'being unable to do/extreme problems') within a particular EQ-5D-3L dimension. In addition, a 20 cm visual analogue scale (VAS) measures the participant's self-rated current health state on a scale from 0-100, from 0 (worst imaginable health state) to 100 ('best imaginable health state). 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	Participants With RA Receiving Adalimumab n=54 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index Week 24	0.19 units on a scale Interval 0.1 to 0.32
Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index Week 12	0.11 units on a scale Interval 0.07 to 0.26

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 24

Population: Observed population: participants continuing adalimumab treatment after the baseline visit who had at least Baseline data for this endpoint

The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the participant's rheumatoid arthritis impair the productivity while working past seven days from visit). Data were calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent, with higher numbers indicating greater impairment and less productivity. Negative values indicate improvement from baseline.

Outcome measures

Outcome measures
Measure	Participants With RA Receiving Adalimumab n=54 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score Week 12	-58.4 percent impairment Interval -90.0 to -16.7
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score Week 24	-20.0 percent impairment Interval -53.3 to 0.0

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 24

Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data

The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. Activity impairment was calculated via WPAI question 6, the participant's rating of how much rheumatoid arthritis affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely impacted productivity) / 10 \* 100. Negative values indicate improvement from baseline.

Outcome measures

Outcome measures
Measure	Participants With RA Receiving Adalimumab n=54 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score Week 12	-10.0 percent impairment Interval -30.0 to -10.0
Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score Week 24	-20.0 percent impairment Interval -30.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 24

Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.

Outcome measures

Outcome measures
Measure	Participants With RA Receiving Adalimumab n=54 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Week 12	23 Participants
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Week 24	20 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 24

Population: Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response 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 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.

Outcome measures

Outcome measures
Measure	Participants With RA Receiving Adalimumab n=54 Participants 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Week 12	50.0 percentage of participants
Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Week 24	51.3 percentage of participants

Adverse Events

Participants With RA Receiving Adalimumab

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants With RA Receiving Adalimumab n=55 participants at risk 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders Bronchitis	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Other adverse events
Measure	Participants With RA Receiving Adalimumab n=55 participants at risk 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks
Blood and lymphatic system disorders Lymphadenitis	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders Enteritis	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders Injection site hypersensitivity	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders Pyrexia	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders Hepatic function abnormal	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Pharyngitis	5.5% 3/55 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Viral upper respiratory tract infection	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Upper respiratory tract infection	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations Respiratory tract infection	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations White blood cell count decreased	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations Eosinophil count increased	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Hyperlipidaemia	3.6% 2/55 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders Hyperuricaemia	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 3/55 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders Bronchitis	5.5% 3/55 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders Neurodermatitis	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

Additional Information

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