Ankylosing Spondylitis
Conditions
Keywords
Daily practice, Humira, Efficacy, Safety, Ankylosing spondylitis
Brief summary
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.
Detailed description
This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy. Participants started treatment with adalimumab under normal clinical settings in Germany. Enrolled participants were followed during adalimumab therapy . Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4). 2. Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs). 3. No contraindications for anti-tumor necrosis factors (TNF) therapy.
Exclusion criteria
1\. Participants who do not meet the above listed inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06\*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0). |
| Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0). |
| Number of Participants With Drug-Related Adverse Events (AEs) | From signing of informed consent up to 24 months | An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Erythrocyte Sedimentation Rate (ESR) | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. |
| Mean Plasma Concentrations of C-Reactive Protein (CRP) | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. |
| Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | The BAS-G was a participant-reported instrument with two items. In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months. Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect). The mean of the two scores was the total BAS-G score and the MCID was 1.5. |
| Mean Global Assessment of Disease Activity Score | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity. It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status. |
| Mean Participant Fatigue Score | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms). |
| Percentage of Participants With Morning Stiffness | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit. |
| Mean Duration of Morning Stiffness | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours. Data are reported as the mean duration of morning stiffness ± standard deviation. |
| Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | At 3, 6, 9, 12, 18, and 24 months | This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain. To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain. |
| Percentage of Participants Achieving ASAS Partial Remission Criteria | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains. |
| Mean Participant Pain Score | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms). |
| Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | — |
| Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | — |
| Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | — |
| Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | — |
| Percentage of Participants on Adalimumab Monotherapy | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | — |
| Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | — |
| Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period. |
| Mean Equivalent Dose of Prednisolone | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products. |
| Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed. |
| Mean Number of Involved Peripheral Joints | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination. Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints. |
| Percentage of Participants With Extraspinal Manifestations | At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months | Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ankylosing Spondylitis Participants with ankylosing spondylitis | 4,681 |
| Total | 4,681 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ADR and Lack of Effectiveness | 39 |
| Overall Study | Adverse Drug Reaction (ADR) | 261 |
| Overall Study | Lack of Efficacy | 514 |
| Overall Study | Lost to Follow-up | 1,634 |
| Overall Study | Reasons not Evaluated | 271 |
Baseline characteristics
| Characteristic | Ankylosing Spondylitis |
|---|---|
| Age, Continuous | 43.1 Years STANDARD_DEVIATION 12.1 |
| Duration of Ankylosing Spondylitis (AS) Symptoms | 14.4 Years STANDARD_DEVIATION 10.8 |
| Gender Female | 1620 Participants |
| Gender Male | 3060 Participants |
| Human Leukocyte Antigen (HLA) B27 Positive Status | 84.4 Percentage of participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1,099 / 4,681 |
| serious Total, serious adverse events | 141 / 4,681 |
Outcome results
Primary
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06\*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | Baseline | 5.5 BASDAI score | Standard Deviation 1.9 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | Change from Baseline at Month 3 (N=3575) | -2.0 BASDAI score | Standard Deviation 2 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | Change from Baseline at Month 6 (N=3181) | -2.1 BASDAI score | Standard Deviation 2.1 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | Change from Baseline at Month 9 (N=2828) | -2.2 BASDAI score | Standard Deviation 2.2 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | Change from Baseline at Month 12 (N=2585) | -2.3 BASDAI score | Standard Deviation 2.2 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | Change from Baseline at Month 18 (N=2169) | -2.3 BASDAI score | Standard Deviation 2.3 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | Change from Baseline at Month 24 (N=1799) | -2.3 BASDAI score | Standard Deviation 2.3 |
Primary
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Baseline | 4.9 BASFI score | Standard Deviation 2.4 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Change from Baseline at Month 3 (N=3565) | -1.4 BASFI score | Standard Deviation 1.9 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Change from Baseline at Month 6 (N=3180) | -1.5 BASFI score | Standard Deviation 2 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Change from Baseline at Month 9 (N=2821) | -1.6 BASFI score | Standard Deviation 2.1 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Change from Baseline at Month 12 (N=2572) | -1.6 BASFI score | Standard Deviation 2.1 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Change from Baseline at Month 18 (N=2160) | -1.7 BASFI score | Standard Deviation 2.2 |
| Ankylosing Spondylitis | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | Change from Baseline at Month 24 (N=1793) | -1.7 BASFI score | Standard Deviation 2.2 |
Primary
Number of Participants With Drug-Related Adverse Events (AEs)
An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.
Time frame: From signing of informed consent up to 24 months
Population: Safety analysis set: Participants who received at least one dose of adalimumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ankylosing Spondylitis | Number of Participants With Drug-Related Adverse Events (AEs) | 1099 Participants |
Secondary
Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score
The BAS-G was a participant-reported instrument with two items. In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months. Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect). The mean of the two scores was the total BAS-G score and the MCID was 1.5.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score | Baseline | 6.7 BAS-G score | Standard Deviation 2 |
| Ankylosing Spondylitis | Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score | At Month 3 (N=3562) | 4.8 BAS-G score | Standard Deviation 2.2 |
| Ankylosing Spondylitis | Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score | At Month 6 (N=3178) | 4.1 BAS-G score | Standard Deviation 2.4 |
| Ankylosing Spondylitis | Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score | At Month 9 (N=2832) | 3.8 BAS-G score | Standard Deviation 2.4 |
| Ankylosing Spondylitis | Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score | At Month 12 (N=2574) | 3.6 BAS-G score | Standard Deviation 2.4 |
| Ankylosing Spondylitis | Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score | At Month 18 (N=2162) | 3.5 BAS-G score | Standard Deviation 2.4 |
| Ankylosing Spondylitis | Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score | At Month 24 (N=1796) | 3.4 BAS-G score | Standard Deviation 2.4 |
Secondary
Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | Baseline | 16.0 Days | Standard Deviation 14.7 |
| Ankylosing Spondylitis | Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 3 (N=3521) | 15.1 Days | Standard Deviation 12.6 |
| Ankylosing Spondylitis | Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 6 (N=3134) | 16.3 Days | Standard Deviation 21.5 |
| Ankylosing Spondylitis | Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 9 (N=2798) | 17.2 Days | Standard Deviation 26.4 |
| Ankylosing Spondylitis | Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 12 (N=2538) | 18.8 Days | Standard Deviation 33.9 |
| Ankylosing Spondylitis | Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 18 (N=2133) | 17.7 Days | Standard Deviation 12.4 |
| Ankylosing Spondylitis | Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 24 (N=1762) | 15.3 Days | Standard Deviation 11.9 |
Secondary
Mean Duration of Morning Stiffness
Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours. Data are reported as the mean duration of morning stiffness ± standard deviation.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Duration of Morning Stiffness | Baseline | 56.7 minutes | Standard Deviation 34.5 |
| Ankylosing Spondylitis | Mean Duration of Morning Stiffness | At Month 3 (N=3582) | 33.5 minutes | Standard Deviation 30.7 |
| Ankylosing Spondylitis | Mean Duration of Morning Stiffness | At Month 6 (N=3186) | 31.3 minutes | Standard Deviation 30 |
| Ankylosing Spondylitis | Mean Duration of Morning Stiffness | At Month 9 (N=2835) | 29.6 minutes | Standard Deviation 28.7 |
| Ankylosing Spondylitis | Mean Duration of Morning Stiffness | At Month 12 (N=2589) | 28.6 minutes | Standard Deviation 28.2 |
| Ankylosing Spondylitis | Mean Duration of Morning Stiffness | At Month 18 (N=2173) | 27.7 minutes | Standard Deviation 27.4 |
| Ankylosing Spondylitis | Mean Duration of Morning Stiffness | At Month 24 (N=1802) | 27.4 minutes | Standard Deviation 27 |
Secondary
Mean Equivalent Dose of Prednisolone
The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Equivalent Dose of Prednisolone | At Month 9 (N=2848) | 6.4 mg/day | Standard Deviation 6.1 |
| Ankylosing Spondylitis | Mean Equivalent Dose of Prednisolone | At Month 12 (N=2598) | 7.2 mg/day | Standard Deviation 14.9 |
| Ankylosing Spondylitis | Mean Equivalent Dose of Prednisolone | At Month 18 (N=2179) | 6.0 mg/day | Standard Deviation 7 |
| Ankylosing Spondylitis | Mean Equivalent Dose of Prednisolone | Baseline | 10.5 mg/day | Standard Deviation 15.2 |
| Ankylosing Spondylitis | Mean Equivalent Dose of Prednisolone | At Month 3 (N=3591) | 6.6 mg/day | Standard Deviation 5 |
| Ankylosing Spondylitis | Mean Equivalent Dose of Prednisolone | At Month 6 (N=3202) | 6.8 mg/day | Standard Deviation 6.6 |
| Ankylosing Spondylitis | Mean Equivalent Dose of Prednisolone | At Month 24 (N=1816) | 5.6 mg/day | Standard Deviation 3.8 |
Secondary
Mean Erythrocyte Sedimentation Rate (ESR)
Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Erythrocyte Sedimentation Rate (ESR) | Baseline | 26.8 mm/hour | Standard Deviation 21.6 |
| Ankylosing Spondylitis | Mean Erythrocyte Sedimentation Rate (ESR) | At Month 3 (N=3231) | 12.9 mm/hour | Standard Deviation 14.1 |
| Ankylosing Spondylitis | Mean Erythrocyte Sedimentation Rate (ESR) | At Month 6 (N=2888) | 13.3 mm/hour | Standard Deviation 15.1 |
| Ankylosing Spondylitis | Mean Erythrocyte Sedimentation Rate (ESR) | At Month 9 (N=2540) | 13.6 mm/hour | Standard Deviation 15.3 |
| Ankylosing Spondylitis | Mean Erythrocyte Sedimentation Rate (ESR) | At Month 12 (N=2288) | 13.3 mm/hour | Standard Deviation 14.1 |
| Ankylosing Spondylitis | Mean Erythrocyte Sedimentation Rate (ESR) | At Month 18 (N=1932) | 13.3 mm/hour | Standard Deviation 13.6 |
| Ankylosing Spondylitis | Mean Erythrocyte Sedimentation Rate (ESR) | At Month 24 (N=1627) | 14.0 mm/hour | Standard Deviation 13.7 |
Secondary
Mean Global Assessment of Disease Activity Score
Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity. It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Global Assessment of Disease Activity Score | Baseline | 6.5 Score on scale | Standard Deviation 1.7 |
| Ankylosing Spondylitis | Mean Global Assessment of Disease Activity Score | At Month 3 (N=3574) | 3.1 Score on scale | Standard Deviation 2.1 |
| Ankylosing Spondylitis | Mean Global Assessment of Disease Activity Score | At Month 6 (N=3174) | 2.8 Score on scale | Standard Deviation 2.1 |
| Ankylosing Spondylitis | Mean Global Assessment of Disease Activity Score | At Month 9 (N=2831) | 2.6 Score on scale | Standard Deviation 2 |
| Ankylosing Spondylitis | Mean Global Assessment of Disease Activity Score | At Month 12 (N=2574) | 2.4 Score on scale | Standard Deviation 1.9 |
| Ankylosing Spondylitis | Mean Global Assessment of Disease Activity Score | At Month 18 (N=2161) | 2.3 Score on scale | Standard Deviation 1.9 |
| Ankylosing Spondylitis | Mean Global Assessment of Disease Activity Score | At Month 24 (N=1805) | 2.2 Score on scale | Standard Deviation 1.9 |
Secondary
Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months | Baseline | 48.0 Days | Standard Deviation 69.1 |
| Ankylosing Spondylitis | Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 3 (N=2082) | 52.2 Days | Standard Deviation 74.3 |
| Ankylosing Spondylitis | Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 6 (N=1870) | 56.0 Days | Standard Deviation 85.7 |
| Ankylosing Spondylitis | Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 9 (N=1673) | 50.5 Days | Standard Deviation 81.7 |
| Ankylosing Spondylitis | Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 12 (N=1549) | 48.0 Days | Standard Deviation 80.1 |
| Ankylosing Spondylitis | Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 18 (N=1331) | 35.3 Days | Standard Deviation 61.4 |
| Ankylosing Spondylitis | Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 24 (N=1105) | 35.4 Days | Standard Deviation 61.3 |
Secondary
Mean Number of Involved Peripheral Joints
Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination. Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | TJC at Baseline | 3.1 Joints | Standard Deviation 7.2 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | TJC at Month 3 (N=3576) | 1.8 Joints | Standard Deviation 6 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | TJC at Month 6 (N=3172) | 1.6 Joints | Standard Deviation 5.6 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | TJC at Month 9 (N=2821) | 1.6 Joints | Standard Deviation 5.7 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | TJC at Month 12 (N=2583) | 1.5 Joints | Standard Deviation 6.1 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | TJC at Month 18 (N=2162) | 1.5 Joints | Standard Deviation 5.4 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | TJC at Month 24 (N=1804) | 1.2 Joints | Standard Deviation 5 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | SJC at Baseline | 1.3 Joints | Standard Deviation 4.5 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | SJC at Month 3 (N=3576) | 0.7 Joints | Standard Deviation 3.4 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | SJC at Month 6 (N=3172) | 0.6 Joints | Standard Deviation 3 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | SJC at Month 9 (N=2821) | 0.5 Joints | Standard Deviation 2.9 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | SJC at Month 12 (N=2583) | 0.4 Joints | Standard Deviation 2.3 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | SJC at Month 18 (N=2162) | 0.5 Joints | Standard Deviation 3.1 |
| Ankylosing Spondylitis | Mean Number of Involved Peripheral Joints | SJC at Month 24 (N=1804) | 0.4 Joints | Standard Deviation 2.3 |
Secondary
Mean Participant Fatigue Score
Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Participant Fatigue Score | Baseline | 5.9 Score on scale | Standard Deviation 2.3 |
| Ankylosing Spondylitis | Mean Participant Fatigue Score | At Month 3 (N=3585) | 4.3 Score on scale | Standard Deviation 2.5 |
| Ankylosing Spondylitis | Mean Participant Fatigue Score | At Month 6 (N=3189) | 4.2 Score on scale | Standard Deviation 2.5 |
| Ankylosing Spondylitis | Mean Participant Fatigue Score | At Month 9 (N=2837) | 4.0 Score on scale | Standard Deviation 2.5 |
| Ankylosing Spondylitis | Mean Participant Fatigue Score | At Month 12 (N=2591) | 3.9 Score on scale | Standard Deviation 2.5 |
| Ankylosing Spondylitis | Mean Participant Fatigue Score | At Month 18 (N=2174) | 3.8 Score on scale | Standard Deviation 2.4 |
| Ankylosing Spondylitis | Mean Participant Fatigue Score | At Month 24 (N=1803) | 3.8 Score on scale | Standard Deviation 2.5 |
Secondary
Mean Participant Pain Score
Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Participant Pain Score | Baseline | 6.7 Score on scale | Standard Deviation 2.3 |
| Ankylosing Spondylitis | Mean Participant Pain Score | At Month 3 (N=3586) | 4.0 Score on scale | Standard Deviation 2.6 |
| Ankylosing Spondylitis | Mean Participant Pain Score | At Month 6 (N=3191) | 3.9 Score on scale | Standard Deviation 2.6 |
| Ankylosing Spondylitis | Mean Participant Pain Score | At Month 9 (N=2839) | 3.8 Score on scale | Standard Deviation 2.6 |
| Ankylosing Spondylitis | Mean Participant Pain Score | At Month 12 (N=2589) | 3.7 Score on scale | Standard Deviation 2.5 |
| Ankylosing Spondylitis | Mean Participant Pain Score | At Month 18 (N=2173) | 3.5 Score on scale | Standard Deviation 2.5 |
| Ankylosing Spondylitis | Mean Participant Pain Score | At Month 24 (N=1804) | 3.5 Score on scale | Standard Deviation 2.5 |
Secondary
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ankylosing Spondylitis | Mean Plasma Concentrations of C-Reactive Protein (CRP) | Baseline | 17.1 mg/L | Standard Deviation 21.8 |
| Ankylosing Spondylitis | Mean Plasma Concentrations of C-Reactive Protein (CRP) | At Month 3 (N=3277) | 6.2 mg/L | Standard Deviation 11 |
| Ankylosing Spondylitis | Mean Plasma Concentrations of C-Reactive Protein (CRP) | At Month 6 (N=2934) | 6.5 mg/L | Standard Deviation 13.4 |
| Ankylosing Spondylitis | Mean Plasma Concentrations of C-Reactive Protein (CRP) | At Month 9 (N=2601) | 6.3 mg/L | Standard Deviation 11.9 |
| Ankylosing Spondylitis | Mean Plasma Concentrations of C-Reactive Protein (CRP) | At Month 12 (N=2344) | 6.0 mg/L | Standard Deviation 11.9 |
| Ankylosing Spondylitis | Mean Plasma Concentrations of C-Reactive Protein (CRP) | At Month 18 (N=2004) | 5.5 mg/L | Standard Deviation 9.1 |
| Ankylosing Spondylitis | Mean Plasma Concentrations of C-Reactive Protein (CRP) | At Month 24 (N=1687) | 5.8 mg/L | Standard Deviation 9.5 |
Secondary
Percentage of Participants Achieving ASAS Partial Remission Criteria
This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants Achieving ASAS Partial Remission Criteria | Baseline | 1.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving ASAS Partial Remission Criteria | Month 3 (N=3537) | 17.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving ASAS Partial Remission Criteria | Month 6 (N=3128) | 21.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving ASAS Partial Remission Criteria | Month 9 (N=2785) | 23.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving ASAS Partial Remission Criteria | Month 12 (N=2535) | 23.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving ASAS Partial Remission Criteria | Month 18 (N=2132) | 24.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving ASAS Partial Remission Criteria | Month 24 (N=1782) | 26.8 Percentage of participants |
Secondary
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria
This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain. To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain.
Time frame: At 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 20 Improvement at Month 3 | 57.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 20 Improvement at Month 6 (N=2989) | 63.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 20 Improvement at Month 9 (N=2661) | 64.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 20 Improvement at Month 12 (N=2419) | 65.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 20 Improvement at Month 18 (N=2030) | 66.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 20 Improvement at Month 24 (N=1688) | 67.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 40 Improvement at Month 3 | 36.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 40 Improvement at Month 6 (N=2989) | 40.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 40 Improvement at Month 9 (N=2661) | 42.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 40 Improvement at Month 12 (N=2419) | 43.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 40 Improvement at Month 18 (N=2030) | 45.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria | ASAS 40 Improvement at Month 24 (N=1688) | 46.8 Percentage of participants |
Secondary
Percentage of Participants on Adalimumab Monotherapy
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants on Adalimumab Monotherapy | Baseline | 78.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants on Adalimumab Monotherapy | At Month 3 (N=3591) | 81.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants on Adalimumab Monotherapy | At Month 6 (N=3202) | 82.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants on Adalimumab Monotherapy | At Month 9 (N=2848) | 83.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants on Adalimumab Monotherapy | At Month 12 (N=2598) | 83.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants on Adalimumab Monotherapy | At Month 18 (N=2179) | 83.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants on Adalimumab Monotherapy | At Month 24 (N=1816) | 84.6 Percentage of participants |
Secondary
Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months | Baseline | 45.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months | At Month 3 (N=2082) | 39.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months | At Month 6 (N=1870) | 32.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months | At Month 9 (N=1673) | 26.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months | At Month 12 (N=1549) | 21.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months | At Month 18 (N=1331) | 17.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months | At Month 24 (N=1105) | 14.2 Percentage of participants |
Secondary
Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Methotrexate at Baseline | 13.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Methotrexate at Month 3 (N=3591) | 11.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Methotrexate at Month 6 (N=3202) | 11.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Methotrexate at Month 9 (N=2848) | 11.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Methotrexate at Month 12 (N=2598) | 11.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Methotrexate at Month 18 (N=2179) | 11.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Methotrexate at Month 24 (N=1816) | 11.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Sulfasalazine at Baseline | 7.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Sulfasalazine at Month 3 (N=3591) | 5.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Sulfasalazine at Month 6 (N=3202) | 4.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Sulfasalazine at Month 9 (N=2848) | 3.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Sulfasalazine at Month 12 (N=2598) | 3.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Sulfasalazine at Month 18 (N=2179) | 3.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Sulfasalazine at Month 24 (N=1816) | 3.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Other DMARDs at Baseline | 2.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Other DMARDs at Month 3 (N=3591) | 1.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Other DMARDs at Month 6 (N=3202) | 1.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Other DMARDs at Month 9 (N=2848) | 2.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Other DMARDs at Month 12 (N=2598) | 1.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Other DMARDs at Month 18 (N=2179) | 1.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs) | Other DMARDs at Month 24 (N=1816) | 1.5 Percentage of participants |
Secondary
Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents
Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Systemic Glucocorticoids at Month 18 (N=2179) | 11.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Analgesics at Baseline | 17.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Analgesics at Month 3 (N=3591) | 12.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Analgesics at Month 6 (N=3202) | 11.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Analgesics at Month 9 (N=2848) | 11.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Analgesics at Month 12 (N=2598) | 11.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Analgesics at Month 18 (N=2179) | 10.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Analgesics at Month 24 (N=1816) | 10.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | NSAIDs at Baseline | 52.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | NSAIDs at Month 3 (N=3591) | 36.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | NSAIDs at Month 6 (N=3202) | 33.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | NSAIDs at Month 9 (N=2848) | 31.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | NSAIDs at Month 12 (N=2598) | 30.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | NSAIDs at Month 18 (N=2179) | 31.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | NSAIDs at Month 24 (N=1816) | 30.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | COX-2 Inhibitors at Baseline | 21.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | COX-2 Inhibitors at Month 3 (N=3591) | 16.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | COX-2 Inhibitors at Month 6 (N=3202) | 15.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | COX-2 Inhibitors at Month 9 (N=2848) | 15.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | COX-2 Inhibitors at Month 12 (N=2598) | 14.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | COX-2 Inhibitors at Month 18 (N=2179) | 14.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | COX-2 Inhibitors at Month 24 (N=1816) | 13.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Systemic Glucocorticoids at Baseline | 22.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Systemic Glucocorticoids at Month 3 (N=3591) | 15.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Systemic Glucocorticoids at Month 6 (N=3202) | 13.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Systemic Glucocorticoids at Month 9 (N=2848) | 11.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Systemic Glucocorticoids at Month 12 (N=2598) | 11.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents | Systemic Glucocorticoids at Month 24 (N=1816) | 11.0 Percentage of participants |
Secondary
Percentage of Participants With Extraspinal Manifestations
Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | IBD at Month 12 (N=2603) | 1.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Enthesitis at Baseline | 13.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Enthesitis at Month 3 (N=3616) | 5.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Enthesitis at Month 6 (N=3216) | 3.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Enthesitis at Month 9 (N=2858) | 4.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Enthesitis at Month 12 (N=2603) | 4.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Enthesitis at Month 18 (N=2183) | 3.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Enthesitis at Month 24 (N=1823) | 3.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Dactylitis at Baseline | 5.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Dactylitis at Month 3 (N=3616) | 2.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Dactylitis at Month 6 (N=3216) | 1.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Dactylitis at Month 9 (N=2858) | 1.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Dactylitis at Month 12 (N=2603) | 1.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Dactylitis at Month 18 (N=2183) | 1.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Dactylitis at Month 24 (N=1823) | 1.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Uveitis at Baseline | 3.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Uveitis at Month 3 (N=3616) | 1.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Uveitis at Month 6 (N=3216) | 0.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Uveitis at Month 9 (N=2858) | 0.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Uveitis at Month 12 (N=2603) | 0.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Uveitis at Month 18 (N=2183) | 0.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Uveitis at Month 24 (N=1823) | 0.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Psoriasis at Baseline | 5.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Psoriasis at Month 3 (N=3616) | 2.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Psoriasis at Month 6 (N=3216) | 2.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Psoriasis at Month 9 (N=2858) | 2.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Psoriasis at Month 12 (N=2603) | 2.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Psoriasis at Month 18 (N=2183) | 2.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | Psoriasis at Month 24 (N=1823) | 2.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | IBD at Baseline | 4.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | IBD at Month 3 (N=3616) | 2.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | IBD at Month 6 (N=3216) | 1.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | IBD at Month 9 (N=2858) | 1.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | IBD at Month 18 (N=2183) | 1.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Extraspinal Manifestations | IBD at Month 24 (N=1823) | 1.9 Percentage of participants |
Secondary
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks
The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 0 Days at Baseline | 23.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 0 Days at Month 3 (N=3496) | 47.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 0 Days at Month 6 (N=3121) | 52.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 0 Days at Month 9 (N=2793) | 55.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 0 Days at Month 12 (N=2524) | 57.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 0 Days at Month 18 (N=2130) | 60.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 0 Days at Month 24 (N=1766) | 60.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Less Than 7 Days at Baseline | 28.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Less Than 7 Days at Month 3 (N=3496) | 30.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Less Than 7 Days at Month 6 (N=3121) | 28.5 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Less Than 7 Days at Month 9 (N=2793) | 27.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Less Than 7 Days at Month 12 (N=2524) | 27.2 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Less Than 7 Days at Month 18 (N=2130) | 24.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Less Than 7 Days at Month 24 (N=1766) | 24.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 7 to 14 Days at Baseline | 23.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 7 to 14 Days at Month 3 (N=3496) | 11.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 7 to 14 Days at Month 6 (N=3121) | 9.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 7 to 14 Days at Month 9 (N=2793) | 9.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 7 to 14 Days at Month 12 (N=2524) | 8.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 7 to 14 Days at Month 18 (N=2130) | 8.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | 7 to 14 Days at Month 24 (N=1766) | 8.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Greater Than 14 Days at Baseline | 25.1 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Greater Than 14 Days at Month 3 (N=3496) | 11.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Greater Than 14 Days at Month 6 (N=3121) | 9.0 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Greater Than 14 Days at Month 9 (N=2793) | 7.3 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Greater Than 14 Days at Month 12 (N=2524) | 6.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Greater Than 14 Days at Month 18 (N=2130) | 6.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks | Greater Than 14 Days at Month 24 (N=1766) | 6.1 Percentage of participants |
Secondary
Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | Baseline | 20.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 3 (N=3521) | 18.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 6 (N=3134) | 16.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 9 (N=2798) | 12.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 12 (N=2538) | 8.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 18 (N=2133) | 4.7 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months | At Month 24 (N=1762) | 3.8 Percentage of participants |
Secondary
Percentage of Participants With Morning Stiffness
Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit.
Time frame: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Population: Full analysis set: Participants with adequate data available for evaluation of effectiveness.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ankylosing Spondylitis | Percentage of Participants With Morning Stiffness | Baseline | 95.4 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Morning Stiffness | At Month 3 (N=3582) | 81.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Morning Stiffness | At Month 6 (N=3186) | 79.9 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Morning Stiffness | At Month 9 (N=2835) | 78.8 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Morning Stiffness | At Month 12 (N=2589) | 77.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Morning Stiffness | At Month 18 (N=2173) | 77.6 Percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Morning Stiffness | At Month 24 (N=1802) | 77.8 Percentage of participants |