Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Multicenter study
Brief summary
This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).
Interventions
None listed
Sponsors
Veeda Clinical Research
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with ongoing HUMIRA (adalimumab) treatment who have been prescribed HUMIRA (adalimumab) within local reimbursement guidelines. * Patients must be willing to consent to data being collected and provided to Abbott Laboratories.
Exclusion criteria
* Contraindications according to the summary of product characteristics. * Patients who are actually followed in the ReAlise registry (M03-634 NCT00234884).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Parameter: Change From Baseline in CRP Over Time | Baseline, Months 3, 6, 12, 24, 60 | — |
| Inflammatory Parameter: Change From Baseline in ESR Over Time | Baseline, Months 3, 6, 12, 24, 60 | — |
| Change From Baseline in Physician's Assessment of Disease Activity Over Time | Baseline, Months 3, 6, 12, 24, 60 | Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity. |
| Change From Baseline in Tender Joints Over Time | Baseline, Months 3, 6, 12, 24, 60 | A total of 28 joints were assessed for tenderness. |
| Change From Baseline in Swollen Joints Over Time | Baseline, Months 3, 6, 12, 24, 60 | A total of 28 joints were assessed for swelling. |
| Physical Function: Change From Baseline in HAQ% Over Time | Baseline, Months 3, 6, 12, 24, 60 | The HAQ score measures quality of life in terms of physical function and consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement. |
| Change From Baseline in DAS28 Over Time: RA Participants | Baseline, Months 3, 6, 12, 24, 60 | The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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. |
| DAS28 Category Over Time: RA Participants | Baseline, Months 3, 6, 12, 24, 60 | The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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. |
| BSA With PsA Over Time: PsA Participants | Baseline, Months 3, 6, 12, 24, 60 | — |
| Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Baseline, Months 3, 6, 12, 24, 60 | Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days. |
| Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Baseline, Months 3, 6, 12, 24, 60 | Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days. |
| Change From Baseline in BASDAI Over Time: AS Participants | Baseline, Months 3, 6, 12, 24, 60 | BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms. |
| Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | up to 60 months | An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified. |
Participant flow
Pre-assignment details
A total of 5940 participants (2845 with rheumatoid arthritis \[RA\], 1128 with psoriatic arthritis \[PsA\], and 1967 with ankylosing spondylitis \[AS\]) were enrolled. Twenty of these participants were younger than 18 years old (9 RA participants, 1 PsA participant, and 10 AS participants); these participants were not included in any analysis.
Participants by arm
| Arm | Count |
|---|---|
| Participants With RA Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. | 2,836 |
| Participants With PsA Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. | 1,127 |
| Participants With AS Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines. | 1,957 |
| Total | 5,920 |
Baseline characteristics
| Characteristic | Participants With PsA | Participants With RA | Participants With AS | Total |
|---|---|---|---|---|
| Age, Continuous | 49.52 years STANDARD_DEVIATION 12.36 | 56.64 years STANDARD_DEVIATION 12.96 | 43.62 years STANDARD_DEVIATION 12.47 | 50.98 years STANDARD_DEVIATION 13.95 |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS Participants | — | — | 6.2 units on a scale STANDARD_DEVIATION 1.9 | 6.2 units on a scale STANDARD_DEVIATION 1.9 |
| Body Surface Area (BSA) with PsA 11% to 20% of BSA | 134 Participants | — | — | 134 Participants |
| Body Surface Area (BSA) with PsA > 20% of BSA | 85 Participants | — | — | 85 Participants |
| Body Surface Area (BSA) with PsA < 3% of BSA | 353 Participants | — | — | 353 Participants |
| Body Surface Area (BSA) with PsA 3% to 10% of BSA | 211 Participants | — | — | 211 Participants |
| DAS28 Category < 2.6 | — | 16 Participants | — | 16 Participants |
| DAS28 Category ≥ 2.6 to ≤ 3.2 | — | 4 Participants | — | 4 Participants |
| DAS28 Category > 3.2 | — | 363 Participants | — | 363 Participants |
| Disease Activity Score for 28 Joints (DAS28): RA Participants | — | 5.04 score on a scale STANDARD_DEVIATION 1.21 | — | 5.04 score on a scale STANDARD_DEVIATION 1.21 |
| Health Assessment Questionnaire (HAQ%) | 41.01 percentage of maximum HAQ score STANDARD_DEVIATION 18.65 | 47.80 percentage of maximum HAQ score STANDARD_DEVIATION 19.22 | 40.80 percentage of maximum HAQ score STANDARD_DEVIATION 24.57 | 46.00 percentage of maximum HAQ score STANDARD_DEVIATION 19.43 |
| Inflammatory Parameter: C-Reactive Protein (CRP) | 2.53 mg/dL STANDARD_DEVIATION 6.9 | 3.68 mg/dL STANDARD_DEVIATION 8.44 | 3.24 mg/dL STANDARD_DEVIATION 19.11 | 3.32 mg/dL STANDARD_DEVIATION 12.59 |
| Inflammatory Parameter: Erythrocyte Sedimentation Rate (ESR) | 18.87 mm/hour STANDARD_DEVIATION 18.45 | 27.58 mm/hour STANDARD_DEVIATION 21.84 | 21.09 mm/hour STANDARD_DEVIATION 19.23 | 24.08 mm/hour STANDARD_DEVIATION 20.84 |
| Patient's Numerical Rating Scale for Oligarticular PsA Participants | 6.6 units on a scale STANDARD_DEVIATION 2 | — | — | 6.6 units on a scale STANDARD_DEVIATION 2 |
| Physician's Assessment of Disease Activity | 54.58 units on a scale STANDARD_DEVIATION 22.59 | 58.47 units on a scale STANDARD_DEVIATION 22.93 | 59.21 units on a scale STANDARD_DEVIATION 25.32 | 57.96 units on a scale STANDARD_DEVIATION 23.73 |
| Physician's Numerical Rating Scale for Oligoarticular PsA Participants | 6.2 units on a scale STANDARD_DEVIATION 2 | — | — | 6.2 units on a scale STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex/Gender, Customized Female | 523 Participants | 2004 Participants | 903 Participants | 3430 Participants |
| Sex/Gender, Customized Male | 591 Participants | 787 Participants | 1033 Participants | 2411 Participants |
| Sex/Gender, Customized Missing | 13 Participants | 45 Participants | 21 Participants | 79 Participants |
| Swollen Joints | 7.46 swollen joints STANDARD_DEVIATION 5.37 | 10.79 swollen joints STANDARD_DEVIATION 7.18 | 1.44 swollen joints STANDARD_DEVIATION 3.21 | 8.18 swollen joints STANDARD_DEVIATION 7.17 |
| Tender Joints | 10.47 tender joints STANDARD_DEVIATION 8.34 | 13.73 tender joints STANDARD_DEVIATION 8.9 | 2.40 tender joints STANDARD_DEVIATION 4.31 | 10.67 tender joints STANDARD_DEVIATION 9.16 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 54 / 5,920 |
| other Total, other adverse events | 0 / 5,920 |
| serious Total, serious adverse events | 934 / 5,920 |
Outcome results
Primary
BSA With PsA Over Time: PsA Participants
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All PsA participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 3: < 3% of BSA | 398 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 3: 3% to 10% of BSA | 97 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 3: 11% to 20% of BSA | 32 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 3: > 20% of BSA | 11 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 6: < 3% of BSA | 378 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 6: 3% to 10% of BSA | 59 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 6: 11% to 20% of BSA | 24 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 6: > 20% of BSA | 10 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 12: < 3% of BSA | 356 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 12: 3% to 10% of BSA | 41 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 12: 11% to 20% of BSA | 27 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 12: > 20% of BSA | 2 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 24: < 3% of BSA | 298 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 24: 3% to 10% of BSA | 38 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 24: 11% to 20% of BSA | 9 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 24: > 20% of BSA | 7 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 60: < 3% of BSA | 195 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 60: 3% to 10% of BSA | 15 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 60: 11% to 20% of BSA | 1 Participants |
| Participants With RA | BSA With PsA Over Time: PsA Participants | Month 60: > 20% of BSA | 1 Participants |
Primary
Change From Baseline in BASDAI Over Time: AS Participants
BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Change From Baseline in BASDAI Over Time: AS Participants | Month 6 | -3.2 score on a scale | Standard Deviation 2.4 |
| Participants With RA | Change From Baseline in BASDAI Over Time: AS Participants | Month 12 | -3.4 score on a scale | Standard Deviation 2.5 |
| Participants With RA | Change From Baseline in BASDAI Over Time: AS Participants | Month 24 | -3.1 score on a scale | Standard Deviation 2.5 |
| Participants With RA | Change From Baseline in BASDAI Over Time: AS Participants | Month 60 | -3.3 score on a scale | Standard Deviation 2.8 |
| Participants With RA | Change From Baseline in BASDAI Over Time: AS Participants | Month 3 | -3.1 score on a scale | Standard Deviation 2.4 |
Primary
Change From Baseline in DAS28 Over Time: RA Participants
The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All RA participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Change From Baseline in DAS28 Over Time: RA Participants | Month 6 | -2.01 score on a scale | Standard Deviation 1.55 |
| Participants With RA | Change From Baseline in DAS28 Over Time: RA Participants | Month 3 | -1.77 score on a scale | Standard Deviation 1.21 |
| Participants With RA | Change From Baseline in DAS28 Over Time: RA Participants | Month 12 | -2.38 score on a scale | Standard Deviation 1.29 |
| Participants With RA | Change From Baseline in DAS28 Over Time: RA Participants | Month 60 | -2.53 score on a scale | Standard Deviation 1.44 |
| Participants With RA | Change From Baseline in DAS28 Over Time: RA Participants | Month 24 | -2.29 score on a scale | Standard Deviation 1.49 |
Primary
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 6 | -3.8 units on a scale | Standard Deviation 2.7 |
| Participants With RA | Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 12 | -2.8 units on a scale | Standard Deviation 5.7 |
| Participants With RA | Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 24 | -4.1 units on a scale | Standard Deviation 2.8 |
| Participants With RA | Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 60 | -5.3 units on a scale | Standard Deviation 2.4 |
| Participants With RA | Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 3 | -3.4 units on a scale | Standard Deviation 2.4 |
Primary
Change From Baseline in Physician's Assessment of Disease Activity Over Time
Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 60 | -44.2 units on a scale | Standard Deviation 27.3 |
| Participants With RA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 12 | -40.4 units on a scale | Standard Deviation 27.2 |
| Participants With RA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 6 | -38.6 units on a scale | Standard Deviation 26.4 |
| Participants With RA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 3 | -34.4 units on a scale | Standard Deviation 24.7 |
| Participants With RA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 24 | -42.4 units on a scale | Standard Deviation 26.9 |
| Participants With PsA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 3 | -36.2 units on a scale | Standard Deviation 24.8 |
| Participants With PsA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 60 | -44.8 units on a scale | Standard Deviation 29.3 |
| Participants With PsA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 24 | -42.2 units on a scale | Standard Deviation 27.2 |
| Participants With PsA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 12 | -43.2 units on a scale | Standard Deviation 26.6 |
| Participants With PsA | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 6 | -40.2 units on a scale | Standard Deviation 25.6 |
| Participants With AS | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 60 | -50.2 units on a scale | Standard Deviation 29.9 |
| Participants With AS | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 6 | -44.5 units on a scale | Standard Deviation 28.7 |
| Participants With AS | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 12 | -46.6 units on a scale | Standard Deviation 28.7 |
| Participants With AS | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 24 | -46.6 units on a scale | Standard Deviation 28.7 |
| Participants With AS | Change From Baseline in Physician's Assessment of Disease Activity Over Time | Month 3 | -40.2 units on a scale | Standard Deviation 28.4 |
Primary
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 3 | -3.8 units on a scale | Standard Deviation 2.3 |
| Participants With RA | Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 6 | -4.3 units on a scale | Standard Deviation 2.6 |
| Participants With RA | Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 12 | -3.3 units on a scale | Standard Deviation 4.5 |
| Participants With RA | Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 24 | -4.0 units on a scale | Standard Deviation 2.6 |
| Participants With RA | Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants | Month 60 | -5.2 units on a scale | Standard Deviation 2.6 |
Primary
Change From Baseline in Swollen Joints Over Time
A total of 28 joints were assessed for swelling.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Change From Baseline in Swollen Joints Over Time | Month 24 | -9.0 swollen joints | Standard Deviation 7.4 |
| Participants With RA | Change From Baseline in Swollen Joints Over Time | Month 12 | -8.5 swollen joints | Standard Deviation 7.3 |
| Participants With RA | Change From Baseline in Swollen Joints Over Time | Month 3 | -7.3 swollen joints | Standard Deviation 6.7 |
| Participants With RA | Change From Baseline in Swollen Joints Over Time | Month 6 | -8.2 swollen joints | Standard Deviation 7.1 |
| Participants With RA | Change From Baseline in Swollen Joints Over Time | Month 60 | -9.4 swollen joints | Standard Deviation 6.7 |
| Participants With PsA | Change From Baseline in Swollen Joints Over Time | Month 12 | -6.5 swollen joints | Standard Deviation 5.4 |
| Participants With PsA | Change From Baseline in Swollen Joints Over Time | Month 3 | -5.6 swollen joints | Standard Deviation 5.7 |
| Participants With PsA | Change From Baseline in Swollen Joints Over Time | Month 6 | -6.1 swollen joints | Standard Deviation 5.2 |
| Participants With PsA | Change From Baseline in Swollen Joints Over Time | Month 24 | -6.5 swollen joints | Standard Deviation 5.8 |
| Participants With PsA | Change From Baseline in Swollen Joints Over Time | Month 60 | -6.8 swollen joints | Standard Deviation 6.4 |
| Participants With AS | Change From Baseline in Swollen Joints Over Time | Month 60 | -1.4 swollen joints | Standard Deviation 2.4 |
| Participants With AS | Change From Baseline in Swollen Joints Over Time | Month 24 | -1.4 swollen joints | Standard Deviation 2.8 |
| Participants With AS | Change From Baseline in Swollen Joints Over Time | Month 3 | -1.3 swollen joints | Standard Deviation 3.1 |
| Participants With AS | Change From Baseline in Swollen Joints Over Time | Month 12 | -1.3 swollen joints | Standard Deviation 2.9 |
| Participants With AS | Change From Baseline in Swollen Joints Over Time | Month 6 | -1.4 swollen joints | Standard Deviation 3.4 |
Primary
Change From Baseline in Tender Joints Over Time
A total of 28 joints were assessed for tenderness.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Change From Baseline in Tender Joints Over Time | Month 60 | -11.2 tender joints | Standard Deviation 8.2 |
| Participants With RA | Change From Baseline in Tender Joints Over Time | Month 12 | -10.2 tender joints | Standard Deviation 8.9 |
| Participants With RA | Change From Baseline in Tender Joints Over Time | Month 6 | -9.4 tender joints | Standard Deviation 8.6 |
| Participants With RA | Change From Baseline in Tender Joints Over Time | Month 24 | -10.4 tender joints | Standard Deviation 8.9 |
| Participants With RA | Change From Baseline in Tender Joints Over Time | Month 3 | -8.5 tender joints | Standard Deviation 8 |
| Participants With PsA | Change From Baseline in Tender Joints Over Time | Month 24 | -7.9 tender joints | Standard Deviation 7.9 |
| Participants With PsA | Change From Baseline in Tender Joints Over Time | Month 60 | -8.3 tender joints | Standard Deviation 8.7 |
| Participants With PsA | Change From Baseline in Tender Joints Over Time | Month 3 | -6.8 tender joints | Standard Deviation 7.8 |
| Participants With PsA | Change From Baseline in Tender Joints Over Time | Month 6 | -7.6 tender joints | Standard Deviation 7.6 |
| Participants With PsA | Change From Baseline in Tender Joints Over Time | Month 12 | -8.0 tender joints | Standard Deviation 7.7 |
| Participants With AS | Change From Baseline in Tender Joints Over Time | Month 3 | -1.6 tender joints | Standard Deviation 3.5 |
| Participants With AS | Change From Baseline in Tender Joints Over Time | Month 24 | -2.0 tender joints | Standard Deviation 3.9 |
| Participants With AS | Change From Baseline in Tender Joints Over Time | Month 12 | -1.9 tender joints | Standard Deviation 4.1 |
| Participants With AS | Change From Baseline in Tender Joints Over Time | Month 60 | -1.9 tender joints | Standard Deviation 3.2 |
| Participants With AS | Change From Baseline in Tender Joints Over Time | Month 6 | -1.9 tender joints | Standard Deviation 4.6 |
Primary
DAS28 Category Over Time: RA Participants
The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All RA participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 3 DAS28 < 2.6 | 106 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 3 DAS28 ≥ 2.6 to ≤ 3.2 | 50 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 3 DAS28 < 3.2 | 118 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 6 DAS28 ≥ 2.6 to ≤ 3.2 | 49 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 6 DAS28 < 3.2 | 97 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 12 DAS28 < 2.6 | 161 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 12 DAS28 ≥ 2.6 to ≤ 3.2 | 56 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 24 DAS28 < 2.6 | 195 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 24 DAS28 ≥ 2.6 to ≤ 3.2 | 60 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 24 DAS28 < 3.2 | 97 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 60 DAS28 < 2.6 | 187 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 60 DAS28 < 3.2 | 72 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 6 DAS28 < 2.6 | 135 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 12 DAS28 < 3.2 | 95 Participants |
| Participants With RA | DAS28 Category Over Time: RA Participants | Month 60 DAS28 ≥ 2.6 to ≤ 3.2 | 75 Participants |
Primary
Inflammatory Parameter: Change From Baseline in CRP Over Time
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 24 | -1.9 mg/dL | Standard Deviation 7 |
| Participants With RA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 12 | -1.9 mg/dL | Standard Deviation 7.3 |
| Participants With RA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 3 | -2.1 mg/dL | Standard Deviation 8 |
| Participants With RA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 6 | -1.9 mg/dL | Standard Deviation 6.7 |
| Participants With RA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 60 | -1.6 mg/dL | Standard Deviation 13.2 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 12 | -1.6 mg/dL | Standard Deviation 5.5 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 3 | -1.6 mg/dL | Standard Deviation 7.1 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 6 | -1.8 mg/dL | Standard Deviation 9 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 24 | -1.2 mg/dL | Standard Deviation 9 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 60 | 0.0 mg/dL | Standard Deviation 13.8 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 60 | -0.7 mg/dL | Standard Deviation 4.6 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 24 | -1.3 mg/dL | Standard Deviation 9.3 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 3 | -2.8 mg/dL | Standard Deviation 25.1 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 12 | -2.7 mg/dL | Standard Deviation 27.5 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in CRP Over Time | Month 6 | -2.6 mg/dL | Standard Deviation 26.1 |
Primary
Inflammatory Parameter: Change From Baseline in ESR Over Time
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 24 | -9.2 mm/hour | Standard Deviation 20.5 |
| Participants With RA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 12 | -8.4 mm/hour | Standard Deviation 19.4 |
| Participants With RA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 3 | -8.3 mm/hour | Standard Deviation 18.3 |
| Participants With RA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 6 | -8.1 mm/hour | Standard Deviation 18.8 |
| Participants With RA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 60 | -8.6 mm/hour | Standard Deviation 19.9 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 12 | -8.7 mm/hour | Standard Deviation 18 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 3 | -7.0 mm/hour | Standard Deviation 17.6 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 6 | -8.1 mm/hour | Standard Deviation 18.8 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 24 | -6.2 mm/hour | Standard Deviation 22.6 |
| Participants With PsA | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 60 | -5.5 mm/hour | Standard Deviation 17.4 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 60 | -9.8 mm/hour | Standard Deviation 19.9 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 24 | -8.6 mm/hour | Standard Deviation 18.8 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 3 | -11.7 mm/hour | Standard Deviation 17.8 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 12 | -10.3 mm/hour | Standard Deviation 18.5 |
| Participants With AS | Inflammatory Parameter: Change From Baseline in ESR Over Time | Month 6 | -10.5 mm/hour | Standard Deviation 19.2 |
Primary
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Time frame: up to 60 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With RA | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any AE (Includes SAEs) | 976 Participants |
| Participants With RA | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any Fatal AE | 41 Participants |
| Participants With RA | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any AE Leading to Study Drug Discontinuation | 577 Participants |
| Participants With RA | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any SAE | 560 Participants |
| Participants With PsA | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any Fatal AE | 4 Participants |
| Participants With PsA | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any AE (Includes SAEs) | 323 Participants |
| Participants With PsA | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any SAE | 164 Participants |
| Participants With PsA | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any AE Leading to Study Drug Discontinuation | 171 Participants |
| Participants With AS | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any SAE | 210 Participants |
| Participants With AS | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any AE Leading to Study Drug Discontinuation | 295 Participants |
| Participants With AS | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any AE (Includes SAEs) | 493 Participants |
| Participants With AS | Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation | Any Fatal AE | 9 Participants |
Primary
Physical Function: Change From Baseline in HAQ% Over Time
The HAQ score measures quality of life in terms of physical function and consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement.
Time frame: Baseline, Months 3, 6, 12, 24, 60
Population: All participants with a Baseline and post-baseline assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With RA | Physical Function: Change From Baseline in HAQ% Over Time | Month 24 | -24.4 percentage of maximum HAQ score | Standard Deviation 21.9 |
| Participants With RA | Physical Function: Change From Baseline in HAQ% Over Time | Month 60 | -25.4 percentage of maximum HAQ score | Standard Deviation 22 |
| Participants With RA | Physical Function: Change From Baseline in HAQ% Over Time | Month 3 | -19.4 percentage of maximum HAQ score | Standard Deviation 18.5 |
| Participants With RA | Physical Function: Change From Baseline in HAQ% Over Time | Month 12 | -22.7 percentage of maximum HAQ score | Standard Deviation 21.2 |
| Participants With RA | Physical Function: Change From Baseline in HAQ% Over Time | Month 6 | -22.9 percentage of maximum HAQ score | Standard Deviation 20 |
| Participants With PsA | Physical Function: Change From Baseline in HAQ% Over Time | Month 3 | -19.1 percentage of maximum HAQ score | Standard Deviation 18.8 |
| Participants With PsA | Physical Function: Change From Baseline in HAQ% Over Time | Month 6 | -23.2 percentage of maximum HAQ score | Standard Deviation 18.7 |
| Participants With PsA | Physical Function: Change From Baseline in HAQ% Over Time | Month 12 | -24.5 percentage of maximum HAQ score | Standard Deviation 19.3 |
| Participants With PsA | Physical Function: Change From Baseline in HAQ% Over Time | Month 24 | -24.5 percentage of maximum HAQ score | Standard Deviation 20.9 |
| Participants With PsA | Physical Function: Change From Baseline in HAQ% Over Time | Month 60 | -27.1 percentage of maximum HAQ score | Standard Deviation 21.8 |
| Participants With AS | Physical Function: Change From Baseline in HAQ% Over Time | Month 12 | -33.4 percentage of maximum HAQ score | Standard Deviation 22.7 |
| Participants With AS | Physical Function: Change From Baseline in HAQ% Over Time | Month 60 | -34.9 percentage of maximum HAQ score | Standard Deviation 24.4 |
| Participants With AS | Physical Function: Change From Baseline in HAQ% Over Time | Month 24 | -32.3 percentage of maximum HAQ score | Standard Deviation 20.7 |
| Participants With AS | Physical Function: Change From Baseline in HAQ% Over Time | Month 3 | -19.6 percentage of maximum HAQ score | Standard Deviation 19.3 |
| Participants With AS | Physical Function: Change From Baseline in HAQ% Over Time | Month 6 | -25.8 percentage of maximum HAQ score | Standard Deviation 21.9 |