Trial Outcomes & Findings for An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY) (NCT NCT02451839)
NCT ID: NCT02451839
Last Updated: 2019-06-19
Results Overview
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
COMPLETED
168 participants
Baseline, Month 6
2019-06-19
Participant Flow
Of the 168 recruited participants, 4 withdrew or were withdrawn prior to baseline measures being completed (164 participants had baseline World Health Organization Disability Assessment Schedule \[WHODAS\] data recorded).
Participant milestones
| Measure |
Crohn's Disease
Participants with Crohn's disease. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
Rheumatoid Arthritis
Participants with rheumatoid arthritis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
Psoriasis
Participants with psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|---|---|
|
Overall Study
STARTED
|
72
|
59
|
37
|
|
Overall Study
Baseline WHODAS Data Recorded
|
70
|
57
|
37
|
|
Overall Study
COMPLETED
|
44
|
40
|
30
|
|
Overall Study
NOT COMPLETED
|
28
|
19
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants with baseline and Month 6 assessments in each of the indication categories.
Baseline characteristics by cohort
| Measure |
All Indications
n=164 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Age, Continuous
|
45.7 years
n=164 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=164 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=164 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=164 Participants
|
|
Race/Ethnicity, Customized
European
|
145 Participants
n=164 Participants
|
|
Race/Ethnicity, Customized
Maori
|
7 Participants
n=164 Participants
|
|
Race/Ethnicity, Customized
Other (Not Specified)
|
4 Participants
n=164 Participants
|
|
Race/Ethnicity, Customized
Pacific Peoples
|
3 Participants
n=164 Participants
|
|
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Response Score
All Indications
|
15.2 units on a scale
STANDARD_DEVIATION 9.1 • n=114 Participants • Participants with baseline and Month 6 assessments in each of the indication categories.
|
|
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Response Score
Crohn's disease
|
13.2 units on a scale
STANDARD_DEVIATION 7.3 • n=44 Participants • Participants with baseline and Month 6 assessments in each of the indication categories.
|
|
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Response Score
Rheumatoid arthritis
|
17.9 units on a scale
STANDARD_DEVIATION 8.1 • n=40 Participants • Participants with baseline and Month 6 assessments in each of the indication categories.
|
|
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Response Score
Psoriasis
|
14.4 units on a scale
STANDARD_DEVIATION 11.7 • n=30 Participants • Participants with baseline and Month 6 assessments in each of the indication categories.
|
|
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) V2.0: Absenteeism
|
14.7 percentage of work time missed
STANDARD_DEVIATION 30.0 • n=68 Participants • Participants with a baseline and Month 6 assessment.
|
|
WPAI-GH v2.0: Presenteeism
|
39.7 percentage impairment time
STANDARD_DEVIATION 28.8 • n=71 Participants • Participants with a baseline and Month 6 assessment.
|
|
WPAI-GH v2.0: Work Productivity Loss
|
29.4 percentage overall work impairment
STANDARD_DEVIATION 22.5 • n=68 Participants • Participants with a baseline and Month 6 assessment.
|
|
WPAI-GH v2.0: Activity Impairment
|
51.9 percentage of activity impairment
STANDARD_DEVIATION 28.1 • n=114 Participants • Participants with a baseline and Month 6 assessment.
|
|
Kessler Psychological Distress Scale (K10)
|
23.0 units on a scale
STANDARD_DEVIATION 8.2 • n=114 Participants • Participants with a baseline and Month 6 assessment.
|
|
Flourishing Scale
|
45.0 units on a scale
STANDARD_DEVIATION 9.0 • n=114 Participants • Participants with a baseline and Month 6 assessment.
|
|
Subjective Vitality Scale
|
25.4 units on a scale
STANDARD_DEVIATION 7.4 • n=113 Participants • Participants with a baseline and Month 6 assessment.
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
|
1.9 units on a scale
STANDARD_DEVIATION 0.6 • n=40 Participants • Participants with rheumatoid arthritis and a baseline and Month 6 assessment.
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
|
36.1 units on a scale
STANDARD_DEVIATION 9.7 • n=43 Participants • Participants with Crohn's disease and baseline and Month 6 assessments.
|
|
Dermatology Life Quality Index (DLQI) Score
|
15.8 units on a scale
STANDARD_DEVIATION 7.5 • n=30 Participants • Participants with psoriasis and a baseline and Month 6 assessment.
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Outcome measures
| Measure |
All Indications
n=114 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications
|
7.9 units on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline, Month 2Population: Participants with baseline and Month 2 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Outcome measures
| Measure |
All Indications
n=130 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications
|
5.7 units on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Participants with baseline and Month 4 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Outcome measures
| Measure |
All Indications
n=115 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications
|
7.1 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with Crohn's disease and baseline and Month 6 assessments.
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Outcome measures
| Measure |
All Indications
n=44 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease
|
6.3 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with psoriasis and baseline and Month 6 assessments.
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Outcome measures
| Measure |
All Indications
n=30 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis
|
8.1 units on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with rheumatoid arthritis and baseline and Month 6 assessments.
WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.
Outcome measures
| Measure |
All Indications
n=40 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis
|
9.5 units on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Outcome measures
| Measure |
All Indications
n=68 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism
|
10.6 percentage of work time missed
Standard Deviation 34.7
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Outcome measures
| Measure |
All Indications
n=71 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism
|
18.0 percentage impairment time
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Outcome measures
| Measure |
All Indications
n=68 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss
|
9.7 percentage overall work impairment
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.
Outcome measures
| Measure |
All Indications
n=114 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment
|
24.1 percentage of activity impariment
Standard Deviation 34.0
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
The K10 is intended to yield a global measure of distress based on a questionnaire about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. The K10 scale involves 10 questions about emotional states each with a 5-level response scale. Each item is scored from 1=none of the time to 5=all of the time. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.
Outcome measures
| Measure |
All Indications
n=114 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in K10 at Month 6 Across All Indications
|
6.1 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score. Participants are asked to respond to 8 statements using a scale of 1 (strongly disagree) and 7 (strongly agree) for each item. The possible range of scores is from 8 (lowest possible) to 56 (highest possible), with higher scores representing more psychological resources and strengths.
Outcome measures
| Measure |
All Indications
n=114 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in Flourishing Scale at Month 6 Across All Indications
|
-2.3 units on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
The Subjective Vitality Scale assesses the state of feeling alive and alert to having energy available to the self. Patients respond to eight prompts, with a response ranging from 1=strongly disagree to 7=strongly agree. The sum of the scores is calculated with a higher score indicating a better condition. The total score ranges from 8 to 56 with a higher score indicating a better condition.
Outcome measures
| Measure |
All Indications
n=113 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications
|
-5.4 units on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with rheumatoid arthritis baseline and Month 6 assessments.
HAQ-DI measures functional status in rheumatic diseases. It has 20 items, and asks patients to report the degree of difficulty faced in several areas of their life including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities based on the previous week on a scale from 0 (without any difficulty) to 3 (cannot be done at all). It also asks the participant to rate their pain and health in the previous week. Scores on each task are summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).
Outcome measures
| Measure |
All Indications
n=40 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis
|
0.4 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with Crohn's disease and baseline and Month 6 assessments.
The SIBDQ is a simple validated, 10-item questionnaire designed to find out how the patient has been feeling in the previous 2 weeks. QoL is measured in 4 domains: bowel symptoms, emotional health, systemic systems and social function. Participants respond to questions ranging from 1=all of the time to 7=none of the time. Scores are added together, with higher scores indicating a better health-related QoL. Total scores range from 10 (poor QoL) to 70 (good QoL).
Outcome measures
| Measure |
All Indications
n=43 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease
|
-16.3 score on a scale
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Participants with psoriasis and baseline and Month 6 assessments.
The DLQI measures 10 items covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, to determine how much the patients skin problem affected their life in the past week. Participants respond to the questions with 'very much,' 'a lot,' 'a little,' or 'not at all.' The scores are added together, and the impact on QoL is banded as follows: 0-1=no effect on participant's life; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.
Outcome measures
| Measure |
All Indications
n=30 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis
|
11.0 score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Month 6Population: Participants completing the study at 6 months. Per protocol, primary and secondary endpoint data \[other than the endpoints presented in Outcome Measures 4-6 and 14-16\] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
The number of participants at 6 months who remained on adalimumab, having satisfied the requirements for application for renewal of subsidy by special authority.
Outcome measures
| Measure |
All Indications
n=114 Participants
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Number of Participants Remaining on Treatment at Month 6
|
108 Participants
|
Adverse Events
All Indications
Serious adverse events
| Measure |
All Indications
n=164 participants at risk
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Abdominal hernia
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Death
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Non-cardiac chest pain
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Anal abscess
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Appendicitis perforated
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Cellulitis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Sinusitis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Investigations
Haemoglobin decreased
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
Other adverse events
| Measure |
All Indications
n=164 participants at risk
Participants with Crohn's disease, rheumatoid arthritis, or psoriasis. All participants received at least 3 months of treatment with adalimumab. Adalimumab was prescribed by the physician under usual and customary practice and according to the approved adalimumab New Zealand Datasheet.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Cardiac disorders
Palpitations
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Eye disorders
Eye irritation
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Drug intolerance
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Fatigue
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Influenza like illness
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Injection site pain
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Injection site reaction
|
2.4%
4/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Injection site urticaria
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Malaise
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Pain
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
General disorders
Ulcer
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Immune system disorders
Hypersensitivity
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Adenovirus infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Candida infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Folliculitis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Furuncle
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Gastroenteritis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Herpes zoster
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Influenza
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Kidney infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Localised infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Respiratory tract infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Sinusitis
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Tinea pedis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Tooth abscess
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Viral infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Infections and infestations
Wound infection
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Investigations
Liver function test increased
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Investigations
Weight decreased
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Nervous system disorders
Dizziness
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Nervous system disorders
Headache
|
2.4%
4/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Nervous system disorders
Hypoaesthesia
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Nervous system disorders
Migraine
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Nervous system disorders
Sciatica
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Nervous system disorders
Sensory disturbance
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Psychiatric disorders
Anxiety
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Psychiatric disorders
Depression
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Psychiatric disorders
Insomnia
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Psychiatric disorders
Mood altered
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Renal and urinary disorders
Renal colic
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.8%
3/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
2/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Vascular disorders
Hot flush
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Vascular disorders
Hypertension
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
|
Vascular disorders
Hypotension
|
0.61%
1/164 • From the signing of informed consent through Month 6
Per protocol, adverse event data were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.
|
Additional Information
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