Ankylosing Spondylitis
Conditions
Keywords
Ankylosing spondylitis, ASDAS inactive disease, secukinumab, ASDAS
Brief summary
This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis
Detailed description
The study used a multicenter design which included an initial 16 week open-label period (Treatment Period 1) followed by a randomized, double-blind, parallel-group period (Treatment Period 2), 1. Screening: A Screening Period took place over 2 separate visits, with the first visit used to assess eligibility and to washout prohibited medications (up to 11 weeks). The second Screening Visit, which occurred at a minimum of 2 weeks prior to the Baseline Visit for all patients, was used to further assess eligibility and to initiate patients on the sensor actigraphy device and morning sleep questionnaires which collected data over the 2-week Screening Period to establish Baseline data. Note: Patients who did not require a washout, and who satisfied all inclusion and none of the exclusion criteria at the first Screening Visit, could initiate the second Screening Visit 1 (SV1) week after their first Screening Visit. 2. Treatment Period 1: Patients who met all of the inclusion criteria and none of the exclusion criteria had a Baseline Visit performed to start Treatment Period 1. During this 16-week period, all patients received open-label secukinumab 150 mg (1 x 1.0mL subcutaneously \[s.c.\]) at Baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16, patients were placed into 1 of the following groups: 1. Responders (Rs): Patients who achieved ASDAS inactive disease (total score \< 1.3) at both Week 12 and Week 16 and who achieved a decrease (improvement) from Baseline in total ASDAS score at both Week 12 and Week 16. 2. Inadequate responders (IRs): Patients who had active disease, defined as an ASDAS total score of ≥ 1.3 at either Week 12 or Week 16, and who achieved a decrease (improvement) from Baseline in total ASDAS score at both Week 12 and Week 16. 3. Nonresponders: Patients who exhibited no change or an increase (worsening) from Baseline in total ASDAS score at either Week 12 or Week 16. Note: To minimize patient burden, at the Week 16 Visit, the hs-CRP measurement that is part of the ASDAS calculation was imputed from the Week 12 hs-CRP results to allow for assignment into the groups above. Historically, hs-CRP levels have varied little between Week 12 and Week 16 or in previous studies of secukinumab in active AS. 1\. Treatment Period 2: Upon completion of the Week 16 visit, 1. Responders entered Treatment Period 2 and continued to receive secukinumab 150 mg every 4 weeks through Week 48 as well as 1 matched placebo dose (s.c. injection) to maintain the integrity of the blind for the randomized IR group. 2. Inadequate responders entered Treatment Period 2 and were randomized (1:1, double blinded) to secukinumab 300 mg or secukinumab 150 mg every 4 weeks through Week 48. Patients knew that they were on secukinumab, but were blinded to dose, so they did not know whether they were receiving 150 mg or 300 mg. 3. Nonresponders were discontinued from the study at Week 16. The only condition that was placed on enrollment targets was that no less than 60% of patients (162 patients) were tumor necrosis factor alpha (TNFα) inhibitor naive (or, no more than 40% of patients were TNF-IR). In theory the percentage of TNFα inhibitor naive patients could have reached 100%, although that was not anticipated. Patients could discontinue the study at any time. If rescue treatment with prohibited medications (as described in Section 9.4.7) occurred, patients were discontinued from the study and were to return for an End of Study Visit. The End of Study Visit was scheduled approximately 4 weeks after the last study treatment and was performed before any new treatment was initiated. After the End of Study Visit, any serious adverse events (SAEs) that occurred in the following 30 days were required to be reported.
Interventions
DRUG150 mg open-label secukinumab
All patients in Treatment Period 1 received 150 mg s.c. injection open-label secukinumab.
DRUG150 mg double-blinded secukinumab
Treatment Period 2 Patients who achieved responder status entered Treatment Period 2 and continued to receive 150 mg s.c. (1 s.c. injection of secukinumab 150 mg)
DRUG300 mg double-blinded secukinumab
Treatment Period 2 300 mg (2 s.c. injections of the 150 mg dose)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients and Investigators will be blinded to the secukinumab dose during Treatment Period 2.
Intervention model description
This was a randomized, double-blind, parallel-group, multicenter design which included an initial 16 week open-label period (Treatment Period 1) followed by a randomized, double-blind, parallel-group period (Treatment Period 2),
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Understand and communicate with the investigator, comply with the requirements of the study and give a written, signed and dated informed consent 2. Male or non-pregnant, non-lactating female patients at least 18 years of age 3. Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented radiologic evidence fulfilling the Modified New York criteria for AS 4. Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index (BASDAI) ≥ 4 (0-10) at baseline 5. Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline 6. Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) at baseline 7. Patients should have been on non-steroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications 8. Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2) inhibitors for at least 2 weeks before their Baseline Visit 9. Patients who have been on a tumor necrosis factor alpha (TNFα) inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or had been intolerant upon administration of an anti-TNFα agent Key
Exclusion criteria
1. Total ankylosis of the spine 2. Use of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer. 3. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes. 4. Chest x-ray, computerized tomography (CT) scan, or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician. 5. Previous exposure to secukinumab or any other biologic drug directly targeting Interleukin-17 (IL-17), Interleukin-12/23 (IL-12/23), or the IL-17 receptor, or any other biologic immunomodulating agent, except those targeting TNFα 6. Patients who have taken more than one anti-TNFα agent 7. Any intramuscular or intravenous corticosteroid injection within 2 weeks before baseline 8. Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline 9. Previous treatment with any cell-depleting therapies 10. Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure | Week 52 | Proportion of participants with inadequate response at week 16 who achieved inactive disease at Week 52 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) were utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline, Week 52 | BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating worst problem), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab. |
| Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50) | Baseline, Week 52 | BASDAI-50 represents a change from baseline (improvement) of at least 50% in BASDAI score. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab. |
| The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria) | Week 52 | ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS20 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS20 response is defined as an improvement of ≥20% from baseline and absolute improvement from baseline of at least 1 on a 0-to-10 scale in at least 3 of the following 4 domains: patient global, total back pain, function (BASFI), and inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness). An absence of deterioration from baseline (deterioration defines as ≥20% worsening and absolute worsening of at last 1 on a 0-to-10 scale) in the potential remaining domain. |
| The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale | Baseline, Week 52 | A reduction from baseline in ASDAS score of ≥1.1 was considered a clinically important improvement in disease activity in Ankylosing Spondylitis. In this study, ASDAS is used to estimate the difference in response between 150mg and 300mg of secukinumab. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) wias utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity. |
| The Proportion of Patients Who Achieved an ASAS Partial Remission | Week 52 | The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 0-10. In this study, ASAS partial remission is used to estimate the difference in response between 150mg and 300mg of secukinumab. |
| Change in ASAS - Health Index Over Time | Baseline, Week 52 | The ASAS-HI is a self-administered questionnaire and measures functioning and health over 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. Patients score each item as I agree and I do not agree. In this study, ASAS-HI is used to estimate the difference in response between 150mg and 300mg of secukinumab. Lower score indicating a better health status |
| Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Over Time | Baseline, Week 52 | Fatigue was assessed using the 13-item FACIT-fatigue scale for the assessment of fatigue in cancer patients.24 The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue. |
| The Proportion of Participants Who Achieved an ASAS 40 Response | Week 52 | ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS40 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS40 response is defined as a ≥40% improvement in 3 of the 4 domains with an absolute improvement of at least 2 on a 0-to-10 scale, and no worsening in the remaining domain. |
Countries
United States
Participant flow
Recruitment details
322 participants were enrolled at 65 sites in the United States
Pre-assignment details
Of 435 patients screened in the study, 322 (74.0%) completed the Screening phase.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab 150 mg - 150 mg AIN457 150 mg - 150 mg | 322 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1 | Adverse Event | 10 | 0 | 0 | 0 |
| Period 1 | Lack of Efficacy | 15 | 0 | 0 | 0 |
| Period 1 | Lost to Follow-up | 3 | 0 | 0 | 0 |
| Period 1 | Non-compliance with study treatment | 2 | 0 | 0 | 0 |
| Period 1 | Physician Decision | 1 | 0 | 0 | 0 |
| Period 1 | Protocol Violation | 3 | 0 | 0 | 0 |
| Period 1 | Technical problems | 1 | 0 | 0 | 0 |
| Period 1 | Withdrawal by Subject | 8 | 0 | 0 | 0 |
| Period 2 | Adverse Event | 0 | 3 | 5 | 0 |
| Period 2 | Lack of Efficacy | 0 | 6 | 2 | 0 |
| Period 2 | Lost to Follow-up | 0 | 3 | 3 | 0 |
| Period 2 | New therapy for study indication | 0 | 0 | 1 | 0 |
| Period 2 | Physician Decision | 0 | 0 | 1 | 0 |
| Period 2 | Protocol Violation | 0 | 0 | 1 | 0 |
| Period 2 | Technical problem | 0 | 1 | 0 | 0 |
| Period 2 | Withdrawal by Subject | 0 | 3 | 4 | 0 |
Baseline characteristics
| Characteristic | Secukinumab 150 mg - 150 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 39 Participants |
| Age, Categorical Between 18 and 65 years | 283 Participants |
| Age, Continuous | 48.02 Mean STANDARD_DEVIATION 13.692 |
| Race/Ethnicity, Customized Asian | 11 Participants |
| Race/Ethnicity, Customized Black | 18 Participants |
| Race/Ethnicity, Customized Caucasian | 284 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Unknown | 5 Participants |
| Sex: Female, Male Female | 155 Participants |
| Sex: Female, Male Male | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 322 | 0 / 101 | 0 / 105 |
| other Total, other adverse events | 7 / 22 | 50 / 322 | 30 / 101 | 32 / 105 |
| serious Total, serious adverse events | 0 / 22 | 11 / 322 | 7 / 101 | 3 / 105 |
Outcome results
Primary
The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure
Proportion of participants with inadequate response at week 16 who achieved inactive disease at Week 52 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) were utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
Time frame: Week 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization. According to intent-to-treat principle, patients were analyzed according to the treatment they were assigned to during the randomization procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure | 9 Participants |
| Secukinumab 150 mg - 150 mg (IR) | The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure | 7 Participants |
Comparison: Statistical analysis (logistic regression) of ASDAS inactive disease response by visit - in Treatment Period 2 (nonresponder imputation)95% CI: [0.28, 2.25]Regression, Logistic
Secondary
Change in ASAS - Health Index Over Time
The ASAS-HI is a self-administered questionnaire and measures functioning and health over 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. Patients score each item as I agree and I do not agree. In this study, ASAS-HI is used to estimate the difference in response between 150mg and 300mg of secukinumab. Lower score indicating a better health status
Time frame: Baseline, Week 52
Population: FAS for patients with valid assessment for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | Change in ASAS - Health Index Over Time | 0.51 scores on a scale | Standard Error 0.32 |
| Secukinumab 150 mg - 150 mg (IR) | Change in ASAS - Health Index Over Time | 0.38 scores on a scale | Standard Error 0.315 |
Comparison: Statistical analysis of change from Week 16 in ASAS-Health Index using MMRM by visit - in Treatment Period 2 (FAS)95% CI: [-0.74, 1.01]Regression, Logistic
Secondary
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating worst problem), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Time frame: Baseline, Week 52
Population: FAS for patients with valid assessment for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 0.18 Score on a scale | Standard Error 0.191 |
| Secukinumab 150 mg - 150 mg (IR) | Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | -0.05 Score on a scale | Standard Error 0.188 |
Comparison: Statistical analysis of total BASDAI change from Week 16 using MMRM - in Treatment Period 2 (FAS)95% CI: [-0.29, 0.75]Mixed Models Analysis
Secondary
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Over Time
Fatigue was assessed using the 13-item FACIT-fatigue scale for the assessment of fatigue in cancer patients.24 The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.
Time frame: Baseline, Week 52
Population: FAS for patients with valid assessment for this endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Over Time | -1.93 Score | Standard Error 0.954 |
| Secukinumab 150 mg - 150 mg (IR) | Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Over Time | -0.92 Score | Standard Error 0.938 |
95% CI: [-3.62, 1.61]Regression, Logistic
Secondary
Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50)
BASDAI-50 represents a change from baseline (improvement) of at least 50% in BASDAI score. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Time frame: Baseline, Week 52
Population: FAS for patients with valid assessment for this endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50) | 11 Participants |
| Secukinumab 150 mg - 150 mg (IR) | Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50) | 9 Participants |
Comparison: Statistical analysis (logistic regression) of BASDAI50 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)95% CI: [0.5, 3.24]Regression, Logistic
Secondary
The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale
A reduction from baseline in ASDAS score of ≥1.1 was considered a clinically important improvement in disease activity in Ankylosing Spondylitis. In this study, ASDAS is used to estimate the difference in response between 150mg and 300mg of secukinumab. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) wias utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
Time frame: Baseline, Week 52
Population: FAS (defined as a patient with inadequte respinse at week 16) for patients with valid assessment for this endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale | 6 Participants |
| Secukinumab 150 mg - 150 mg (IR) | The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale | 3 Participants |
Comparison: Statistical analysis (logistic regression) of reduction in ASDAS \>= 1.1 response by visit - in Treatment Period 2 (nonresponder imputation)95% CI: [0.5, 8.66]Regression, Logistic
Secondary
The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS20 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS20 response is defined as an improvement of ≥20% from baseline and absolute improvement from baseline of at least 1 on a 0-to-10 scale in at least 3 of the following 4 domains: patient global, total back pain, function (BASFI), and inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness). An absence of deterioration from baseline (deterioration defines as ≥20% worsening and absolute worsening of at last 1 on a 0-to-10 scale) in the potential remaining domain.
Time frame: Week 52
Population: FAS for patients with valid assessment for this endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria) | 19 Participants |
| Secukinumab 150 mg - 150 mg (IR) | The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria) | 22 Participants |
Comparison: Statistical analysis (logistic regression) of BASDAI20 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)95% CI: [0.43, 1.73]Regression, Logistic
Secondary
The Proportion of Participants Who Achieved an ASAS 40 Response
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS40 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS40 response is defined as a ≥40% improvement in 3 of the 4 domains with an absolute improvement of at least 2 on a 0-to-10 scale, and no worsening in the remaining domain.
Time frame: Week 52
Population: FAS for patients with valid assessment for this endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | The Proportion of Participants Who Achieved an ASAS 40 Response | 10 Participants |
| Secukinumab 150 mg - 150 mg (IR) | The Proportion of Participants Who Achieved an ASAS 40 Response | 8 Participants |
Comparison: Statistical analysis (logistic regression) of ASAS40 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)95% CI: [0.49, 3.46]Regression, Logistic
Secondary
The Proportion of Patients Who Achieved an ASAS Partial Remission
The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 0-10. In this study, ASAS partial remission is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Time frame: Week 52
Population: FAS for patients with valid assessment for this endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab 150 mg - 300 mg (IR) | The Proportion of Patients Who Achieved an ASAS Partial Remission | 12 Participants |
| Secukinumab 150 mg - 150 mg (IR) | The Proportion of Patients Who Achieved an ASAS Partial Remission | 12 Participants |
Comparison: Statistical analysis (logistic regression) of ASAS partial remission response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)95% CI: [0.44, 2.41]Regression, Logistic