Trial Outcomes & Findings for Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice (NCT NCT01078090)
NCT ID: NCT01078090
Last Updated: 2014-05-08
Results Overview
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Recruitment status
COMPLETED
Target enrollment
5745 participants
Primary outcome timeframe
Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Results posted on
2014-05-08
Participant Flow
Participant milestones
| Measure |
Rheumatoid Arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
|---|---|
|
Overall Study
STARTED
|
5745
|
|
Overall Study
COMPLETED
|
1152
|
|
Overall Study
NOT COMPLETED
|
4593
|
Reasons for withdrawal
| Measure |
Rheumatoid Arthritis
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2363
|
|
Overall Study
Adverse drug reaction (ADR)
|
453
|
|
Overall Study
Lack of Efficacy
|
1193
|
|
Overall Study
ADR and lack of efficacy
|
61
|
|
Overall Study
Other
|
523
|
Baseline Characteristics
Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice
Baseline characteristics by cohort
| Measure |
Rheumatoid Arthritis
n=5745 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Gender
Female
|
4428 participants
n=5 Participants
|
|
Gender
Male
|
1315 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
5745 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28
Month 3 (n=3918)
|
-1.6 units on a scale
Standard Deviation 1.3
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Change From Baseline in Disease Activity Score (DAS) 28
Month 6 (n=3347)
|
-1.8 units on a scale
Standard Deviation 1.4
|
—
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—
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—
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—
|
—
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—
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—
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—
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—
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Change From Baseline in Disease Activity Score (DAS) 28
Month 12 (n=2872)
|
-2.0 units on a scale
Standard Deviation 1.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Disease Activity Score (DAS) 28
Month 18 (n=2397)
|
-2.1 units on a scale
Standard Deviation 1.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Disease Activity Score (DAS) 28
Month 24 (n=2099)
|
-2.2 units on a scale
Standard Deviation 1.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Disease Activity Score (DAS) 28
Month 30 (n=1810)
|
-2.3 units on a scale
Standard Deviation 1.5
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Disease Activity Score (DAS) 28
Month 36 (n=1564)
|
-2.3 units on a scale
Standard Deviation 1.5
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Disease Activity Score (DAS) 28
Month 48 (n=1261)
|
-2.3 units on a scale
Standard Deviation 1.5
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Change From Baseline in Disease Activity Score (DAS) 28
Month 60 (n=934)
|
-2.4 units on a scale
Standard Deviation 1.5
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Clinical remission is defined as a DAS28 score of \< 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale \[VAS\] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants in DAS28 Remission
Month 24 (n=2099)
|
23.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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|
Percentage of Participants in DAS28 Remission
Month 3 (n=3918)
|
12.8 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants in DAS28 Remission
Month 6 (n=3347)
|
16.9 percentage of participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants in DAS28 Remission
Month 12 (n=2872)
|
19.4 percentage of participants
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants in DAS28 Remission
Month 18 (n=2397)
|
23.0 percentage of participants
|
—
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—
|
—
|
—
|
—
|
—
|
—
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—
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—
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Percentage of Participants in DAS28 Remission
Month 30 (n=1810)
|
24.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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Percentage of Participants in DAS28 Remission
Month 36 (n=1564)
|
24.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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Percentage of Participants in DAS28 Remission
Month 48 (n=1261)
|
24.7 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants in DAS28 Remission
Month 60 (n=934)
|
25.6 percentage of participants
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale \[VAS\] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Significant Therapeutic Response
Month 3 (n=3918)
|
40.8 percentage of participants
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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Percentage of Participants With a Significant Therapeutic Response
Month 6 (n=3347)
|
50.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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|
Percentage of Participants With a Significant Therapeutic Response
Month 12 (n=2872)
|
53.6 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Percentage of Participants With a Significant Therapeutic Response
Month 18 (n=2397)
|
58.7 percentage of participants
|
—
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—
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—
|
—
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—
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—
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—
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—
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—
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Percentage of Participants With a Significant Therapeutic Response
Month 24 (n=2099)
|
60.3 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants With a Significant Therapeutic Response
Month 30 (n=1810)
|
63.3 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants With a Significant Therapeutic Response
Month 36 (n=1564)
|
64.6 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Percentage of Participants With a Significant Therapeutic Response
Month 48 (n=1261)
|
64.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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|
Percentage of Participants With a Significant Therapeutic Response
Month 60 (n=934)
|
65.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS) participants with available data at each time point.
Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 \>3.2 to ≤5.1; High disease activity as a DAS28 \>5.1. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale \[VAS\] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
n=3918 Participants
3 months after inclusion
|
Month 6
n=3347 Participants
6 months after inclusion
|
Month 12
n=2872 Participants
12 months after inclusion
|
Month 18
n=2397 Participants
18 months after inclusion
|
Month 24
n=2099 Participants
24 months after inclusion
|
Month 30
n=1810 Participants
30 months after inclusion
|
Month 36
n=1564 Participants
36 months after inclusion
|
Month 48
n=1261 Participants
48 months after inclusion
|
Month 60
n=934 Participants
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Low, Moderate and High Disease Activity
Low disease activity
|
0.0 percentage of participants
|
23.9 percentage of participants
|
29.8 percentage of participants
|
33.0 percentage of participants
|
38.7 percentage of participants
|
38.5 percentage of participants
|
41.5 percentage of participants
|
40.5 percentage of participants
|
40.7 percentage of participants
|
41.9 percentage of participants
|
|
Percentage of Participants With Low, Moderate and High Disease Activity
Moderate disease activity
|
26.1 percentage of participants
|
45.9 percentage of participants
|
46.6 percentage of participants
|
46.6 percentage of participants
|
43.6 percentage of participants
|
45.0 percentage of participants
|
43.6 percentage of participants
|
45.3 percentage of participants
|
45.4 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants With Low, Moderate and High Disease Activity
High disease activity
|
73.9 percentage of participants
|
30.2 percentage of participants
|
23.6 percentage of participants
|
20.3 percentage of participants
|
17.7 percentage of participants
|
16.5 percentage of participants
|
14.9 percentage of participants
|
14.3 percentage of participants
|
13.9 percentage of participants
|
12.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 0 (n=4400)
|
34.5 mm/hour
Standard Deviation 23.1
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 3 (n=4083)
|
24.7 mm/hour
Standard Deviation 20.4
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 6 (n=3467)
|
23.8 mm/hour
Standard Deviation 19.9
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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Erythrocyte Sedimentation Rate (ESR) Over Time
Month 12 (n=2966)
|
22.8 mm/hour
Standard Deviation 18.9
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Erythrocyte Sedimentation Rate (ESR) Over Time
Month 18 (n=2472)
|
22.0 mm/hour
Standard Deviation 18.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 24 (n=2156)
|
21.6 mm/hour
Standard Deviation 17.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 30 (n=1860)
|
21.4 mm/hour
Standard Deviation 18.1
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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|
Erythrocyte Sedimentation Rate (ESR) Over Time
Month 36 (n=1685)
|
20.9 mm/hour
Standard Deviation 17.5
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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Erythrocyte Sedimentation Rate (ESR) Over Time
Month 48 (n=1341)
|
21.5 mm/hour
Standard Deviation 17.8
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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Erythrocyte Sedimentation Rate (ESR) Over Time
Month 60 (n=998)
|
21.2 mm/hour
Standard Deviation 17.6
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
C-Reactive Protein (CRP) Levels Over Time
Month 0 (n=3852)
|
33.7 mg/L
Standard Deviation 63.8
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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|
C-Reactive Protein (CRP) Levels Over Time
Month 3 (n=3209)
|
19.8 mg/L
Standard Deviation 56.3
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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C-Reactive Protein (CRP) Levels Over Time
Month 6 (n=2671)
|
16.1 mg/L
Standard Deviation 29.9
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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C-Reactive Protein (CRP) Levels Over Time
Month 12 (n=2192)
|
17.0 mg/L
Standard Deviation 89.8
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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C-Reactive Protein (CRP) Levels Over Time
Month 18 (n=1770)
|
14.9 mg/L
Standard Deviation 68.0
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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C-Reactive Protein (CRP) Levels Over Time
Month 24 (n=1573)
|
12.3 mg/L
Standard Deviation 27.3
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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C-Reactive Protein (CRP) Levels Over Time
Month 30 (n=1355)
|
12.0 mg/L
Standard Deviation 26.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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C-Reactive Protein (CRP) Levels Over Time
Month 36 (n=1211)
|
11.0 mg/L
Standard Deviation 22.8
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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|
C-Reactive Protein (CRP) Levels Over Time
Month 48 (n=1000)
|
11.6 mg/L
Standard Deviation 27.8
|
—
|
—
|
—
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—
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—
|
—
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—
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—
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—
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|
C-Reactive Protein (CRP) Levels Over Time
Month 60 (n=756)
|
9.2 mg/L
Standard Deviation 16.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tender Joint Count (TJC) Over Time
Month 0 (n=4400)
|
12.3 tender joints
Standard Deviation 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 3 (n=4165)
|
6.4 tender joints
Standard Deviation 6.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 6 (n=3568)
|
5.4 tender joints
Standard Deviation 6.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 12 (n=3026)
|
4.9 tender joints
Standard Deviation 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 18 (n=2533)
|
4.4 tender joints
Standard Deviation 5.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 24 (n=2224)
|
4.2 tender joints
Standard Deviation 5.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 30 (n=1939)
|
4.1 tender joints
Standard Deviation 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 36 (n=1681)
|
4.0 tender joints
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 48 (n=1373)
|
3.9 tender joints
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tender Joint Count (TJC) Over Time
Month 60 (n=1029)
|
3.9 tender joints
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Swollen Joint Count (SJC) Over Time
Month 0 (n=4400)
|
9.5 swollen joints
Standard Deviation 6.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 3 (n=4165)
|
4.7 swollen joints
Standard Deviation 5.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 6 (n=3568)
|
3.9 swollen joints
Standard Deviation 4.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 12 (n=3026)
|
3.5 swollen joints
Standard Deviation 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 18 (n=2533)
|
3.1 swollen joints
Standard Deviation 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 24 (n=2224)
|
2.7 swollen joints
Standard Deviation 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 30 (n=1939)
|
2.7 swollen joints
Standard Deviation 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 36 (n=1681)
|
2.7 swollen joints
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 48 (n=1373)
|
2.4 swollen joints
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Swollen Joint Count (SJC) Over Time
Month 60 (n=1029)
|
2.3 swollen joints
Standard Deviation 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 0 (n=4360)
|
57.7 units on a scale
Standard Deviation 23.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 3 (n=4075)
|
65.1 units on a scale
Standard Deviation 23.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 6 (n=3498)
|
67.1 units on a scale
Standard Deviation 23.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 12 (n=2978)
|
68.3 units on a scale
Standard Deviation 23.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 18 (n=2493)
|
69.4 units on a scale
Standard Deviation 23.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 24 (n=2194)
|
69.9 units on a scale
Standard Deviation 23.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 30 (n=1908)
|
70.1 units on a scale
Standard Deviation 23.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 36 (n=1715)
|
70.4 units on a scale
Standard Deviation 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 48 (n=1394)
|
70.0 units on a scale
Standard Deviation 23.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hannover Functional Questionnaire (FFbH) Over Time
Month 60 (n=1048)
|
69.9 units on a scale
Standard Deviation 24.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Patients Global Assessment of Disease Activity Over Time
Month 0 (n=4400)
|
6.6 cm
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 3 (n=4076)
|
4.8 cm
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 6 (n=3483)
|
4.5 cm
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 12 (n=2968)
|
4.3 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 18 (n=2489)
|
4.1 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 24 (n=2196)
|
4.1 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 30 (n=1903)
|
4.0 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 36 (n=1712)
|
3.9 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 48 (n=1386)
|
3.9 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patients Global Assessment of Disease Activity Over Time
Month 60 (n=1047)
|
3.9 cm
Standard Deviation 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Participants Assessment of Pain Over Time
Month 0 (n=4388)
|
6.8 cm
Standard Deviation 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 3 (n=4079)
|
4.7 cm
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 6 (n=3484)
|
4.3 cm
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 12 (n=2966)
|
4.1 cm
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 18 (n=2491)
|
3.9 cm
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 24 (n=2190)
|
3.9 cm
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 30 (n=1904)
|
3.8 cm
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 36 (n=1712)
|
3.7 cm
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 48 (n=1383)
|
3.8 cm
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Pain Over Time
Month 60 (n=1048)
|
3.7 cm
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Participants Assessment of Fatigue Over Time
Month 0 (n=4389)
|
6.0 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 3 (n=4076)
|
4.5 cm
Standard Deviation 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 6 (n=3491)
|
4.2 cm
Standard Deviation 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 12 (n=2950)
|
4.0 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 18 (n=2491)
|
3.8 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 24 (n=2188)
|
3.8 cm
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 30 (n=1906)
|
3.7 cm
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 36 (n=1706)
|
3.6 cm
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 48 (n=1381)
|
3.6 cm
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Participants Assessment of Fatigue Over Time
Month 60 (n=1039)
|
3.6 cm
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 6, 18, 24, and 30Population: Full analysis set (FAS) participants with available data at each time point.
Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4315 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
n=3428 Participants
3 months after inclusion
|
Month 6
n=2387 Participants
6 months after inclusion
|
Month 12
n=2150 Participants
12 months after inclusion
|
Month 18
n=1860 Participants
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Impairment in Daily Activities
7 to 14 days of impairment
|
28.0 percentage of participants
|
16.1 percentage of participants
|
13.4 percentage of participants
|
13.1 percentage of participants
|
12.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Impairment in Daily Activities
No days of impairment
|
17.9 percentage of participants
|
38.8 percentage of participants
|
45.8 percentage of participants
|
44.5 percentage of participants
|
45.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Impairment in Daily Activities
Less than 7 days of impairment
|
28.2 percentage of participants
|
34.7 percentage of participants
|
33.5 percentage of participants
|
35.3 percentage of participants
|
36.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Impairment in Daily Activities
More than 14 days of impairment
|
25.9 percentage of participants
|
10.4 percentage of participants
|
7.2 percentage of participants
|
7.1 percentage of participants
|
6.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set participants who were employed and with available data at each time point (indicated by n)
Participants reported the number of days they had missed from work in the prior 6 months due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 0 (n=1503)
|
51.0 days
Standard Deviation 78.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 6 (n=1173)
|
11.6 days
Standard Deviation 35.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 12 (n=1016)
|
8.6 days
Standard Deviation 30.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 18 (n=840)
|
6.8 days
Standard Deviation 26.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 24 (n=744)
|
4.9 days
Standard Deviation 19.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 30 (n=637)
|
5.2 days
Standard Deviation 19.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 36 (n=566)
|
5.2 days
Standard Deviation 21.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 48 (n=452)
|
4.8 days
Standard Deviation 23.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Days Missed From Work Due to Rheumatoid Arthritis
Month 60 (n=339)
|
1.8 days
Standard Deviation 9.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set participants who were employed and with available data at each time point (indicated by n)
The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
3 months after inclusion
|
Month 6
6 months after inclusion
|
Month 12
12 months after inclusion
|
Month 18
18 months after inclusion
|
Month 24
24 months after inclusion
|
Month 30
30 months after inclusion
|
Month 36
36 months after inclusion
|
Month 48
48 months after inclusion
|
Month 60
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With In-patient Hospitalization
Month 0 (n=4341)
|
27.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 6 (n=3401)
|
10.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 12 (n=2924)
|
7.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 18 (n=2467)
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 24 (n=2177)
|
6.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 30 (n=1900)
|
5.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 36 (n=1706)
|
6.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 48 (n=1370)
|
5.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With In-patient Hospitalization
Month 60 (n=1037)
|
5.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. "n" indicates the number of participants with available data at each time point.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=4400 Participants
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
Month 3
n=4229 Participants
3 months after inclusion
|
Month 6
n=3611 Participants
6 months after inclusion
|
Month 12
n=3067 Participants
12 months after inclusion
|
Month 18
n=2569 Participants
18 months after inclusion
|
Month 24
n=2250 Participants
24 months after inclusion
|
Month 30
n=1966 Participants
30 months after inclusion
|
Month 36
n=1772 Participants
36 months after inclusion
|
Month 48
n=1435 Participants
48 months after inclusion
|
Month 60
n=1079 Participants
60 months after inclusion
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Systemic glucocorticoids
|
85.6 percentage of participants
|
78.1 percentage of participants
|
75.4 percentage of participants
|
73.1 percentage of participants
|
70.1 percentage of participants
|
68.6 percentage of participants
|
64.5 percentage of participants
|
63.1 percentage of participants
|
59.4 percentage of participants
|
58.1 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Methotrexate
|
54.0 percentage of participants
|
51.9 percentage of participants
|
52.2 percentage of participants
|
54.4 percentage of participants
|
53.9 percentage of participants
|
54.8 percentage of participants
|
55.3 percentage of participants
|
54.9 percentage of participants
|
53.7 percentage of participants
|
54.6 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Sulfasalazin
|
6.1 percentage of participants
|
3.9 percentage of participants
|
3.4 percentage of participants
|
3.0 percentage of participants
|
2.6 percentage of participants
|
2.4 percentage of participants
|
2.1 percentage of participants
|
2.5 percentage of participants
|
2.2 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Hydroxychloroquine/Chloroquine
|
4.0 percentage of participants
|
2.6 percentage of participants
|
2.0 percentage of participants
|
1.6 percentage of participants
|
1.5 percentage of participants
|
2.0 percentage of participants
|
1.6 percentage of participants
|
1.6 percentage of participants
|
1.6 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Leflunomide
|
20.7 percentage of participants
|
15.9 percentage of participants
|
13.6 percentage of participants
|
13.3 percentage of participants
|
12.4 percentage of participants
|
11.6 percentage of participants
|
11.9 percentage of participants
|
10.8 percentage of participants
|
9.6 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Other disease-modifying antirheumatic drug
|
5.9 percentage of participants
|
3.2 percentage of participants
|
2.6 percentage of participants
|
2.9 percentage of participants
|
2.5 percentage of participants
|
2.7 percentage of participants
|
2.2 percentage of participants
|
2.2 percentage of participants
|
1.7 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Analgesics
|
26.9 percentage of participants
|
19.1 percentage of participants
|
17.4 percentage of participants
|
17.1 percentage of participants
|
16.2 percentage of participants
|
16.4 percentage of participants
|
14.1 percentage of participants
|
14.8 percentage of participants
|
14.7 percentage of participants
|
14.2 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Non-steroidal anti-inflammatory drug
|
44.7 percentage of participants
|
36.7 percentage of participants
|
36.3 percentage of participants
|
36.3 percentage of participants
|
37.2 percentage of participants
|
37.2 percentage of participants
|
36.8 percentage of participants
|
35.9 percentage of participants
|
35.1 percentage of participants
|
35.4 percentage of participants
|
|
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Cyclo-oxygenase 2 (COX-2) Inhibitors
|
20.0 percentage of participants
|
15.8 percentage of participants
|
14.5 percentage of participants
|
12.8 percentage of participants
|
11.4 percentage of participants
|
11.1 percentage of participants
|
10.6 percentage of participants
|
10.2 percentage of participants
|
10.2 percentage of participants
|
9.8 percentage of participants
|
Adverse Events
Rheumatoid Arthritis
Serious events: 163 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rheumatoid Arthritis
n=5745 participants at risk
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.16%
9/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Sepsis
|
0.16%
9/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Arthritis bacterial
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Oral herpes
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Cellulitis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Endocarditis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Fungal infection
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Herpes zoster
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Infection
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Papilloma virus infection
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Peritoneal tuberculosis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Sinusitis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Tooth infection
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Urinary tract infection
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Urosepsis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Abscess
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Abscess limb
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Abscess neck
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Actinomycosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Bronchopneumonia
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Chronic sinusitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Diverticulitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Empyema
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Hepatitis B
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Intervertebral discitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Liver abscess
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Localized infection
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Neuroborreliosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Orchitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Psoas abscess
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Pyothorax
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Septic shock
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Streptococcal sepsis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Subcutaneous abscess
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Tuberculosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Infections and infestations
Wound infection
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.12%
7/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Surgery
|
0.10%
6/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Synovectomy
|
0.07%
4/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Foot operation
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Arthrodesis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Abscess drainage
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Ankle operation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Bone operation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Breast operation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Bursa removal
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Hemorrhoid operation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Hydrocele operation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Hysterectomy
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Osteosynthesis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Osteotomy
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Prostatic operation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Radiotherapy
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Renal transplant
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Skin graft
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Spinal operation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Stent placement
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Transurethral incision of prostate
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Surgical and medical procedures
Vertebroplasty
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.07%
4/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukemia
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemangioblastoma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangioma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mesenteric neoplasm
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Death
|
0.09%
5/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Impaired healing
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Multi-organ failure
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Inflammation
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Accidental death
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Cardiac death
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Fat necrosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Injection site erythema
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Injection site swelling
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Local swelling
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Peripheral edema
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Pyrexia
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
General disorders
Sudden cardiac death
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Coronary artery disease
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Cardiac failure
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Left ventricular failure
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Myocardial infarction
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Angina unstable
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Dry mouth
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Colitis erosive
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Diarrhea
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Enteritis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Gastritis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Peritonitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Syncope
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Cerebellar infarction
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Coma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Hyperkinesia
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Migraine
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Paraparesis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Paresis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Nervous system disorders
Tremor
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Injury, poisoning and procedural complications
Wound
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Renal and urinary disorders
Renal failure acute
|
0.05%
3/5745 • Adverse events were collected throughout the 60-month period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Renal and urinary disorders
Renal impairment
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Hepatobiliary disorders
Cholangitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Investigations
Transaminases increased
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Investigations
Catheterization cardiac
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Investigations
Platelet count decreased
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Investigations
Weight decreased
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Psychiatric disorders
Sleep disorder
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Psychiatric disorders
Decreased activity
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Psychiatric disorders
Suicide attempt
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Eye disorders
Dry eye
|
0.03%
2/5745 • Adverse events were collected throughout the 60-month period.
|
|
Blood and lymphatic system disorders
Anemia
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Social circumstances
Cardiac assistance device user
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.02%
1/5745 • Adverse events were collected throughout the 60-month period.
|
Other adverse events
| Measure |
Rheumatoid Arthritis
n=5745 participants at risk
Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
58/5745 • Adverse events were collected throughout the 60-month period.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
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