Giant Cell Arteritis
Conditions
Keywords
GCA, ain457, Secukinumab, Subcutaneous, Vessel Inflammation, corticosteroid tapering, newly diagnosed or relapsing giant cell arteritis, prednisolone taper regimen, escape
Brief summary
This study was designed to evaluate the efficacy and safety of secukinumab compared to placebo to maintain disease remission up to 28 weeks including corticosteroid tapering, as well as up to 1 year (52 weeks) in patients with newly diagnosed or relapsing giant cell arteritis (GCA) who were naïve to biological therapy.
Detailed description
This randomized, parallel-group, double-blind, placebo-controlled, multicenter, Phase II study was designed to evaluate the efficacy of secukinumab compared to placebo in combination with a 26-week prednisolone taper regimen in terms of sustained remission in patients with newly diagnosed or relapsing Giant Cell Arteritis (GCA) who were naïve to biological therapy. The study consisted of a Screening Period of up to 6 weeks (maximum duration), a 52-week Treatment Period and an 8-week Safety Follow-up Period Patients who did not achieve remission by Week 12, experienced a flare after remission or could not adhere to the prednisolone taper regimen entered escape. Upon entering escape, patients received prednisolone at a dose determined by the physician's clinical judgment and continued to receive secukinumab or placebo in a blinded manner. Safety evaluation was included in all visits including two safety follow-up visits performed 8 and 12 weeks after the last study drug administration.
Interventions
Secukinumab 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.
DRUGPrednisolone
Prednisolone was provided as tablets (1 mg, 5 mg, 10 mg, 20 mg tablets) for daily administration as tapered regimen from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 (last dose)
DRUGPlacebo
Placebo 300 mg was administered by subcutaneous (s.c.) injections using 1 mL pre-filled syringes (PFSs) throughout the study.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of GCA classified according to the following criteria: * Age at onset of disease ≥ 50 years. * History of ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L. * Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication) AND/OR symptoms of polymyalgia rheumatica (PMR) defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness * Temporal artery biopsy revealing features of GCA AND/OR * evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography-computed tomography (PET CT), or ultrasound Patients with new onset GCA or relapsing GCA (Definition new onset: diagnosis of GCA within 6 weeks of Baseline Visit; Definition relapsing GCA: diagnosis of GCA (in accordance with inclusion criterion no. 4) \> 6 weeks before Baseline Visit and in the meantime achieved remission (absence of signs and symptoms attributable to GCA and normalization of ESR (\< 30 mm/hr) and CRP (\<10.0mg/L) included) including previous treatment with ≥ 25 mg/day prednisolone equivalent for ≥ 2 weeks.) Active disease as defined by the presence of signs and symptoms of GCA (cranial or PMR) and elevated ESR ≥ 30 mm/hr, or CRP ≥ 10 mg/L, attributed to active GCA within 6 weeks of Baseline. Prednisolone dose of 25-60 mg/day at Baseline.
Exclusion criteria
Previous exposure to secukinumab or other biologic drug directly targeting Interleukin(IL)-17 or IL-17 receptor. Patients treated with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g. anti-CD3, anti-CD4, anti-CD5 or anti-CD19). Patients who have previously been treated with any biologic agent including but not limited to tocilizumab, sirukumab, abatacept, or tumor necrosis factor alpha (TNFα) inhibitors (infliximab, adalimumab, etanercept, certolizumab, golimumab). Patients who have previously been treated with tofacitinib or baricitinib. Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to Baseline. Patients treated with cyclophosphamide, tacrolimus or everolimus within 6 months prior to Baseline. Patients treated with hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine or mycophenolate mofetil within 4 weeks of Baseline. Patients treated with leflunomide within 8 weeks of Baseline unless a cholestyramine washout has been performed in which case the patient must be treated within 4 weeks of Baseline. Patients treated with an alkylating agent except for cyclophosphamide as mentioned above. Patients requiring systemic chronic glucocorticoid therapy for any other reason than GCA. Chronic systemic glucocorticoid therapy over the last 4 years or longer; or inability, in the opinion of the investigator, to withdraw glucocorticoid therapy through protocol-defined taper regimen due to suspected or established adrenal insufficiency. Patients requiring chronic (i.e. not occasional prn) high potency opioid analgesics for pain management. Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunosuppressed the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy. History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum creatinine level exceeding 1.8 mg/dL (159.12 μmol/L). Screening total white blood cell (WBC) count \< 3000/μL, or platelets \< 100 000/μL or neutrophils \< 1500/μL or hemoglobin \< 8.3 g/dL (83 g/L). Major ischemic event, unrelated to GCA, within 12 weeks of screening. Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening or randomization. Life vaccinations within 6 weeks prior to Baseline or planned vaccination during study participation until 12 weeks after last study treatment administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Sustained Remission Until Week 28 | Until week 28 | Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First GCA Flare After Clinical Remission | Up to Week 52 (included) | Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare. For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase. Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time. |
| Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | from Baseline to week 28, from baseline to week 52 weeks | Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted. |
| Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | Until Week 52 | Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. |
| Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 19, Week 28, Week 52 | Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52. Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 \[last dose\]. |
| Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. |
| Percentage of Participants in Remission at Week 12 | Week 12 | Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. |
| Change From Baseline in FACIT-Fatigue Scale | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue). |
| Change From Baseline in Short-Form (SF)-36 Questionnaire | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores. |
| Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, & anxiety/depression). Items are rated either no problem, slight problems, moderate problems, severe problems, or extreme problems/unable. A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the best possible health state & 0 represents the worst possible health state. The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows weighting by the patient of health states & generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Baseline, Week 28, Week 52 | ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. |
| Change From Baseline in C-Reactive Protein (CRP) Level | Baseline, Week 28, Week 52 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. |
Countries
Germany
Participant flow
Recruitment details
Participants took part in 11 investigative sites in 1 country.
Pre-assignment details
The screening period began once patients had signed the study informed consent. Screening evaluations were performed up to 6 weeks before the beginning of the Treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab Participants received secukinumab at a dose of 300 milligrams (mg) as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. | 27 |
| Placebo Participants received placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to week 48 along with a 26-week prednisolone tapering regimen. | 25 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 2 | 4 |
| Overall Study | Subject decision | 2 | 3 |
Baseline characteristics
| Characteristic | Secukinumab | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 76.4 years STANDARD_DEVIATION 5.31 | 69.6 years STANDARD_DEVIATION 8.02 | 73.1 years STANDARD_DEVIATION 7.52 |
| Race/Ethnicity, Customized White | 27 Participants | 25 Participants | 52 Participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 27 | 1 / 25 | 2 / 52 |
| other Total, other adverse events | 25 / 27 | 23 / 25 | 48 / 52 |
| serious Total, serious adverse events | 6 / 27 | 11 / 25 | 17 / 52 |
Outcome results
Primary
Percentage of Participants in Sustained Remission Until Week 28
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
Time frame: Until week 28
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Percentage of Participants in Sustained Remission Until Week 28 | 19 Participants |
| Placebo | Percentage of Participants in Sustained Remission Until Week 28 | 6 Participants |
Comparison: Odds Ratio95% CI: [3.54, 26.29]
Secondary
Change From Baseline in C-Reactive Protein (CRP) Level
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 28, Week 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from Baseline at each visit is calculated only for subjects with a value at Baseline and the particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab | Change From Baseline in C-Reactive Protein (CRP) Level | Week 28 (n = 23, 19) | 4.426 mg/L | Standard Deviation 9.6836 |
| Secukinumab | Change From Baseline in C-Reactive Protein (CRP) Level | Week 52 (n = 21, 16) | -1.433 mg/L | Standard Deviation 8.7909 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Level | Week 28 (n = 23, 19) | 5.216 mg/L | Standard Deviation 8.982 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Level | Week 52 (n = 21, 16) | 4.650 mg/L | Standard Deviation 14.3691 |
Secondary
Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire
EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, & anxiety/depression). Items are rated either no problem, slight problems, moderate problems, severe problems, or extreme problems/unable. A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the best possible health state & 0 represents the worst possible health state. The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows weighting by the patient of health states & generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 4 (n = 27, 23) | 11.26 scores on a scale | Standard Deviation 16.819 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 8 (n = 26, 21) | 5.58 scores on a scale | Standard Deviation 16.65 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 12 (n = 25, 20) | 4.64 scores on a scale | Standard Deviation 19.598 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 16 (n = 25, 20) | 7.000 scores on a scale | Standard Deviation 19.53 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 20 (n = 24, 20) | 7.88 scores on a scale | Standard Deviation 19.077 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 24 (n = 23, 20) | 5.39 scores on a scale | Standard Deviation 17.598 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 28 (n = 23, 19) | 4.43 scores on a scale | Standard Deviation 17.84 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | WEQ-5D-5L VAS: Week 36 (n = 21, 19) | 6.90 scores on a scale | Standard Deviation 17.972 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 44 (n = 21, 16) | 6.38 scores on a scale | Standard Deviation 19.505 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 52 (n = 21, 16) | 11.62 scores on a scale | Standard Deviation 16.877 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 4 (n = 27, 23) | 0.0166 scores on a scale | Standard Deviation 0.19559 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 8 (n = 26, 21) | -0.0034 scores on a scale | Standard Deviation 0.19972 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 12 (n = 25, 20) | 0.0016 scores on a scale | Standard Deviation 0.16236 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 16 (n = 25, 20) | 0.0186 scores on a scale | Standard Deviation 0.14639 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 20 (n = 24, 20) | 0.0210 scores on a scale | Standard Deviation 0.13308 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 24 (n = 23, 20) | 0.0402 scores on a scale | Standard Deviation 0.12427 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 28 (n = 23, 19) | -0.0002 scores on a scale | Standard Deviation 0.06695 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 36 (n = 21, 19) | 0.0063 scores on a scale | Standard Deviation 0.06432 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 44 (n = 21, 16) | -0.0119 scores on a scale | Standard Deviation 0.08525 |
| Secukinumab | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 52 (n = 21, 16) | -0.0076 scores on a scale | Standard Deviation 0.11997 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 36 (n = 21, 19) | -0.0155 scores on a scale | Standard Deviation 0.13186 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 4 (n = 27, 23) | 1.87 scores on a scale | Standard Deviation 21.467 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 4 (n = 27, 23) | -0.0702 scores on a scale | Standard Deviation 0.21239 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 8 (n = 26, 21) | 5.52 scores on a scale | Standard Deviation 29.646 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 24 (n = 23, 20) | -0.0444 scores on a scale | Standard Deviation 0.20875 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 12 (n = 25, 20) | 3.30 scores on a scale | Standard Deviation 22.85 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 8 (n = 26, 21) | 0.0087 scores on a scale | Standard Deviation 0.9869 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 16 (n = 25, 20) | 4.40 scores on a scale | Standard Deviation 27.354 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 52 (n = 21, 16) | 0.0205 scores on a scale | Standard Deviation 0.09403 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 20 (n = 24, 20) | 6.30 scores on a scale | Standard Deviation 25.041 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 12 (n = 25, 20) | -0.0122 scores on a scale | Standard Deviation 0.15686 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 24 (n = 23, 20) | -1.00 scores on a scale | Standard Deviation 29.902 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 28 (n = 23, 19) | 0.0240 scores on a scale | Standard Deviation 0.13458 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 28 (n = 23, 19) | 10.37 scores on a scale | Standard Deviation 21.67 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 16 (n = 25, 20) | -0.0196 scores on a scale | Standard Deviation 0.19789 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | WEQ-5D-5L VAS: Week 36 (n = 21, 19) | 5.32 scores on a scale | Standard Deviation 28.825 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 44 (n = 21, 16) | 0.0090 scores on a scale | Standard Deviation 0.13033 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 44 (n = 21, 16) | 12.69 scores on a scale | Standard Deviation 21.941 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L utility index: Week 20 (n = 24, 20) | 0.0221 scores on a scale | Standard Deviation 0.16759 |
| Placebo | Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire | EQ-5D-5L VAS: Week 52 (n = 21, 16) | 10.81 scores on a scale | Standard Deviation 24.109 |
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Baseline, Week 28, Week 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from Baseline at each visit is calculated only for subjects with a value at Baseline and the particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Week 28 (n = 23, 18) | 4.043 mm/hr | Standard Deviation 16.1934 |
| Secukinumab | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Week 52 (n = 21, 16) | -3.286 mm/hr | Standard Deviation 10.6167 |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Week 28 (n = 23, 18) | 14.667 mm/hr | Standard Deviation 23.9141 |
| Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Week 52 (n = 21, 16) | 10.000 mm/hr | Standard Deviation 14.8728 |
Secondary
Change From Baseline in FACIT-Fatigue Scale
Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue).
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 4 (n = 27, 23) | 2.11 scores on a scale | Standard Deviation 9.613 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 8 (n = 26, 21) | 2.19 scores on a scale | Standard Deviation 10.19 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 12 (n = 25, 20) | 0.96 scores on a scale | Standard Deviation 11.175 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 16 (n = 25, 20) | 2.12 scores on a scale | Standard Deviation 8.876 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 20 (n =24, 20) | 3.42 scores on a scale | Standard Deviation 8.617 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 24 (n = 23, 20) | 2.91 scores on a scale | Standard Deviation 10.409 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 28 (n = 23, 19) | 3.61 scores on a scale | Standard Deviation 11.044 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 36 (n = 21, 19) | 3.90 scores on a scale | Standard Deviation 7.245 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 44 (n = 21, 16) | 2.67 scores on a scale | Standard Deviation 5.986 |
| Secukinumab | Change From Baseline in FACIT-Fatigue Scale | Week 52 (n = 21, 16) | 3.19 scores on a scale | Standard Deviation 7.033 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 36 (n = 21, 19) | 1.84 scores on a scale | Standard Deviation 8.719 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 4 (n = 27, 23) | -0.96 scores on a scale | Standard Deviation 7.358 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 24 (n = 23, 20) | -3.10 scores on a scale | Standard Deviation 11.281 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 8 (n = 26, 21) | 0.81 scores on a scale | Standard Deviation 7.498 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 52 (n = 21, 16) | 0.19 scores on a scale | Standard Deviation 8.848 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 12 (n = 25, 20) | -0.25 scores on a scale | Standard Deviation 10.047 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 28 (n = 23, 19) | 0.42 scores on a scale | Standard Deviation 9.203 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 16 (n = 25, 20) | -0.36 scores on a scale | Standard Deviation 8.884 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 44 (n = 21, 16) | 0.31 scores on a scale | Standard Deviation 10.928 |
| Placebo | Change From Baseline in FACIT-Fatigue Scale | Week 20 (n =24, 20) | 0.05 scores on a scale | Standard Deviation 10.318 |
Secondary
Change From Baseline in Short-Form (SF)-36 Questionnaire
Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Bodily Pain (BP) (n = 27, 23) | 8.03 scores on a scale | Standard Deviation 13.272 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: PF (n = 26 ,21) | -0.44 scores on a scale | Standard Deviation 8.849 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: PF (n = 25, 20) | 0.38 scores on a scale | Standard Deviation 6.322 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: PF (n = 25, 20) | -0.00 scores on a scale | Standard Deviation 8.646 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: PF (n = 24, 20) | 0.80 scores on a scale | Standard Deviation 8.098 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: PF (n = 22, 20) | 0.52 scores on a scale | Standard Deviation 5.702 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: PF (n = 23, 19) | 1.25 scores on a scale | Standard Deviation 5.276 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: PF (n = 21, 19) | 1.37 scores on a scale | Standard Deviation 5.778 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: PF (n = 21, 16) | 1.00 scores on a scale | Standard Deviation 6.674 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: PF (n = 21, 16) | 2.46 scores on a scale | Standard Deviation 4.77 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Role-Physical (R-P) (n =27, 23) | 3.49 scores on a scale | Standard Deviation 7.886 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: R-P (n =26, 21) | 3.80 scores on a scale | Standard Deviation 9.628 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: R-P (n = 25, 20) | 3.32 scores on a scale | Standard Deviation 9.3301 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: R-P (n = 25, 20) | 4.58 scores on a scale | Standard Deviation 8.947 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: R-P (n = 24, 20) | 4.40 scores on a scale | Standard Deviation 9.538 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: R-P (n = 22, 20) | 3.37 scores on a scale | Standard Deviation 7.458 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: R-P (n = 23, 19) | 5.96 scores on a scale | Standard Deviation 10.034 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: R-P (n = 21, 19) | 5.99 scores on a scale | Standard Deviation 6.444 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: R-P (n = 21, 16) | 5.13 scores on a scale | Standard Deviation 6.515 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: R-P (n = 21, 16) | 6.20 scores on a scale | Standard Deviation 6.659 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Physical Functioning (PF) (n = 27, 23) | 0.14 scores on a scale | Standard Deviation 7.562 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: BP (n = 26, 21 | 5.80 scores on a scale | Standard Deviation 14.475 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: BP (n = 25, 20) | 6.92 scores on a scale | Standard Deviation 13.426 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: BP (n = 25, 20) | 7.69 scores on a scale | Standard Deviation 14.841 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: BP (n = 24, 20) | 6.10 scores on a scale | Standard Deviation 14.072 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: BP (n = 22, 20) | 5.97 scores on a scale | Standard Deviation 12.689 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: BP (n = 23, 19) | 6.47 scores on a scale | Standard Deviation 12.643 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: BP (n = 21, 19) | 7.20 scores on a scale | Standard Deviation 13.724 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: BP (n = 21, 16) | 8.01 scores on a scale | Standard Deviation 15.378 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: BP (n = 21, 16) | 5.49 scores on a scale | Standard Deviation 12.328 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: General Health (GH) ( n = 27, 23) | 3.49 scores on a scale | Standard Deviation 9.207 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: GH (n = 26, 21) | 2.74 scores on a scale | Standard Deviation 8.119 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: GH (n = 25, 20 | 2.22 scores on a scale | Standard Deviation 7.383 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: GH (n = 25, 20) | 2.28 scores on a scale | Standard Deviation 8.235 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: GH (n = 24, 20) | 4.50 scores on a scale | Standard Deviation 6.774 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: GH (n = 22, 20) | 2.85 scores on a scale | Standard Deviation 7.149 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: GH (n = 23, 19) | 3.53 scores on a scale | Standard Deviation 7.285 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36:GH (n = 21, 19) | 3.42 scores on a scale | Standard Deviation 6.68 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: GH (n = 21, 16) | 1.02 scores on a scale | Standard Deviation 8.127 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: GH (n = 21, 16) | 3.03 scores on a scale | Standard Deviation 6.733 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Vitality (n = 27, 23) | 4.07 scores on a scale | Standard Deviation 8.607 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: Vitality (n = 26, 21) | 2.17 scores on a scale | Standard Deviation 7.952 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: Vitality (n = 25, 20) | 3.57 scores on a scale | Standard Deviation 7.477 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: Vitality (n = 25, 20) | 4.28 scores on a scale | Standard Deviation 7.431 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: Vitality (n = 24, 20) | 4.70 scores on a scale | Standard Deviation 8.445 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: Vitality (n = 22, 20) | 3.78 scores on a scale | Standard Deviation 7.112 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: Vitality (n = 23, 19) | 6.20 scores on a scale | Standard Deviation 7.489 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: Vitality (n = 21, 16) | 7.21 scores on a scale | Standard Deviation 8.69 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: Vitality (n = 21, 19) | 7.07 scores on a scale | Standard Deviation 7.06 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: Vitality (n = 21, 16) | 6.08 scores on a scale | Standard Deviation 8.375 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Social Functioning (SF) (n = 27, 23) | 3.71 scores on a scale | Standard Deviation 7.939 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: SF (n = 26, 21) | 4.82 scores on a scale | Standard Deviation 8.327 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: SF (n = 25, 20) | 4.01 scores on a scale | Standard Deviation 9.154 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: SF (n = 25, 20) | 5.21 scores on a scale | Standard Deviation 11.069 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: SF (n = 24, 20) | 4.81 scores on a scale | Standard Deviation 10.08 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: SF (n = 22, 20) | 4.56 scores on a scale | Standard Deviation 8.602 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: SF (n = 23, 19) | 3.49 scores on a scale | Standard Deviation 8.476 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: SF (n = 21, 19) | 7.16 scores on a scale | Standard Deviation 10.703 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: SF (n = 21, 16) | 6.45 scores on a scale | Standard Deviation 8.988 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: SF (n = 21, 16) | 7.16 scores on a scale | Standard Deviation 8.621 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Role-Emotional (RE) (n = 27, 23) | -0.77 scores on a scale | Standard Deviation 12.454 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: RE (n = 26, 21) | 3.08 scores on a scale | Standard Deviation 11.457 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: RE (n = 25, 20) | -0.42 scores on a scale | Standard Deviation 12.076 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: RE (n = 25, 20) | 3.76 scores on a scale | Standard Deviation 10.586 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: RE (n = 24, 20) | 3.48 scores on a scale | Standard Deviation 11.058 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: RE (n = 22, 20) | 2.85 scores on a scale | Standard Deviation 11.753 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: RE (n = 23, 19) | 3.63 scores on a scale | Standard Deviation 11.853 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: RE (n = 21, 19) | 5.47 scores on a scale | Standard Deviation 10.066 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: RE (n = 21, 16) | 4.15 scores on a scale | Standard Deviation 12.293 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: RE (n = 21, 16) | 6.14 scores on a scale | Standard Deviation 11.385 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Mental Health (MH) (n = 27, 23) | 3.0 scores on a scale | Standard Deviation 8.514 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: MH (n = 26, 21) | 2.82 scores on a scale | Standard Deviation 10.643 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: MH (n = 25, 20) | 3.14 scores on a scale | Standard Deviation 10.786 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: MH (n = 25, 20) | 4.29 scores on a scale | Standard Deviation 8.337 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: MH (n = 24, 20) | 3.49 scores on a scale | Standard Deviation 10.926 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: MH (n = 22, 20) | 2.62 scores on a scale | Standard Deviation 8.73 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: MH (n = 21, 16) | 4.11 scores on a scale | Standard Deviation 8.969 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: MH (n = 23, 19) | 2.84 scores on a scale | Standard Deviation 9.816 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: MH (n = 21, 19) | 5.98 scores on a scale | Standard Deviation 8.111 |
| Secukinumab | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: MH (n = 21, 16) | 5.73 scores on a scale | Standard Deviation 7.473 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: MH (n = 21, 16) | 4.25 scores on a scale | Standard Deviation 11.257 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Physical Functioning (PF) (n = 27, 23) | -1.25 scores on a scale | Standard Deviation 4.417 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Vitality (n = 27, 23) | -1.42 scores on a scale | Standard Deviation 7.699 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: PF (n = 26 ,21) | 0.18 scores on a scale | Standard Deviation 4.987 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Role-Emotional (RE) (n = 27, 23) | 3.48 scores on a scale | Standard Deviation 12.985 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: PF (n = 25, 20) | -0.38 scores on a scale | Standard Deviation 8.75 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: Vitality (n = 26, 21) | 0.71 scores on a scale | Standard Deviation 8.185 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: PF (n = 25, 20) | -0.86 scores on a scale | Standard Deviation 6.814 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Mental Health (MH) (n = 27, 23) | 0.57 scores on a scale | Standard Deviation 8.42 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: PF (n = 24, 20) | -0.10 scores on a scale | Standard Deviation 6.495 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: Vitality (n = 25, 20) | -0.30 scores on a scale | Standard Deviation 9.241 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: PF (n = 22, 20) | -2.11 scores on a scale | Standard Deviation 8.667 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: RE (n = 26, 21) | 1.99 scores on a scale | Standard Deviation 13.239 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: PF (n = 23, 19) | -0.40 scores on a scale | Standard Deviation 6.46 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: Vitality (n = 25, 20) | -0.45 scores on a scale | Standard Deviation 7.847 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: PF (n = 21, 19) | -1.31 scores on a scale | Standard Deviation 6.631 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: MH (n = 22, 20) | 2.61 scores on a scale | Standard Deviation 13.149 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: PF (n = 21, 16) | -0.36 scores on a scale | Standard Deviation 8.065 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: Vitality (n = 24, 20) | 0.45 scores on a scale | Standard Deviation 9.652 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: PF (n = 21, 16) | 0.12 scores on a scale | Standard Deviation 5.696 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: RE (n = 25, 20) | 0.52 scores on a scale | Standard Deviation 13.188 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Role-Physical (R-P) (n =27, 23) | 0.49 scores on a scale | Standard Deviation 10.616 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: Vitality (n = 22, 20) | -1.93 scores on a scale | Standard Deviation 11.697 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: R-P (n =26, 21) | -0.75 scores on a scale | Standard Deviation 10.515 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: MH (n = 26, 21) | 1.49 scores on a scale | Standard Deviation 6.95 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: R-P (n = 25, 20) | 1.01 scores on a scale | Standard Deviation 9.539 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: Vitality (n = 23, 19) | 0.16 scores on a scale | Standard Deviation 6.679 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: R-P (n = 25, 20) | -1.12 scores on a scale | Standard Deviation 8.847 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: RE (n = 25, 20) | -0.00 scores on a scale | Standard Deviation 11.465 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: R-P (n = 24, 20) | -0.45 scores on a scale | Standard Deviation 8.163 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: MH (n = 21, 19) | 5.64 scores on a scale | Standard Deviation 8.988 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: R-P (n = 22, 20) | -0.00 scores on a scale | Standard Deviation 10.094 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: Vitality (n = 21, 19) | 1.41 scores on a scale | Standard Deviation 5.635 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: R-P (n = 23, 19) | 1.77 scores on a scale | Standard Deviation 8.553 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: RE (n = 24, 20) | 0.35 scores on a scale | Standard Deviation 11.569 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: R-P (n = 21, 19) | 0.24 scores on a scale | Standard Deviation 10.121 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: Vitality (n = 21, 16) | -0.93 scores on a scale | Standard Deviation 12.497 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: R-P (n = 21, 16) | 0.70 scores on a scale | Standard Deviation 11.262 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: Vitality (n = 21, 16) | 0.37 scores on a scale | Standard Deviation 11.474 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: R-P (n = 21, 16) | 1.40 scores on a scale | Standard Deviation 9.126 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: MH (n = 25, 20) | 4.45 scores on a scale | Standard Deviation 7.69 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Bodily Pain (BP) (n = 27, 23) | 7.68 scores on a scale | Standard Deviation 11.235 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: Social Functioning (SF) (n = 27, 23) | 1.74 scores on a scale | Standard Deviation 7.499 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: BP (n = 26, 21 | 9.68 scores on a scale | Standard Deviation 10.485 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: RE (n = 22, 20) | -1.22 scores on a scale | Standard Deviation 16.025 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: BP (n = 25, 20) | 6.84 scores on a scale | Standard Deviation 11.674 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: SF (n = 26, 21) | 2.63 scores on a scale | Standard Deviation 9.979 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: BP (n = 25, 20) | 4.50 scores on a scale | Standard Deviation 13.56 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: MH (n = 21, 16) | 1.14 scores on a scale | Standard Deviation 11.891 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: BP (n = 24, 20) | 8.63 scores on a scale | Standard Deviation 12.457 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: SF (n = 25, 20) | 1.76 scores on a scale | Standard Deviation 7.325 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: BP (n = 22, 20) | 3.93 scores on a scale | Standard Deviation 11.952 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: RE (n = 23, 19) | 1.10 scores on a scale | Standard Deviation 11.725 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: BP (n = 23, 19) | 6.32 scores on a scale | Standard Deviation 13.149 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: SF (n = 25, 20) | 0.75 scores on a scale | Standard Deviation 7.325 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: BP (n = 21, 19) | 7.81 scores on a scale | Standard Deviation 10.794 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: MH (n = 25, 20) | 5.36 scores on a scale | Standard Deviation 6.379 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: BP (n = 21, 16) | 9.00 scores on a scale | Standard Deviation 7.91 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: SF (n = 24, 20) | 3.51 scores on a scale | Standard Deviation 8.15 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: BP (n = 21, 16) | 8.39 scores on a scale | Standard Deviation 11.866 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: RE (n = 21, 19) | 0.73 scores on a scale | Standard Deviation 16.518 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 4: General Health (GH) ( n = 27, 23) | 0.23 scores on a scale | Standard Deviation 6.761 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: SF (n = 22, 20) | 0.00 scores on a scale | Standard Deviation 10.912 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 8: GH (n = 26, 21) | 0.18 scores on a scale | Standard Deviation 6.758 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: MH (n = 23, 19) | 6.06 scores on a scale | Standard Deviation 7.35 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 12: GH (n = 25, 20 | 0.62 scores on a scale | Standard Deviation 8.158 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: SF (n = 23, 19) | 3.17 scores on a scale | Standard Deviation 9.631 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 16: GH (n = 25, 20) | -0.74 scores on a scale | Standard Deviation 7.858 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: RE (n = 21, 16) | 3.26 scores on a scale | Standard Deviation 16.354 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: GH (n = 24, 20) | -0.38 scores on a scale | Standard Deviation 7.933 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36: SF (n = 21, 19) | 5.01 scores on a scale | Standard Deviation 7.285 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 24: GH (n = 22, 20) | -0.19 scores on a scale | Standard Deviation 9.031 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 20: MH (n = 24, 20) | 6.41 scores on a scale | Standard Deviation 7.984 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 28: GH (n = 23, 19) | 1.18 scores on a scale | Standard Deviation 7.837 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: SF (n = 21, 16) | 0.63 scores on a scale | Standard Deviation 11.561 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 36:GH (n = 21, 19) | -0.47 scores on a scale | Standard Deviation 7.833 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: RE (n = 21, 16) | 0.43 scores on a scale | Standard Deviation 19.234 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 44: GH (n = 21, 16) | -0.30 scores on a scale | Standard Deviation 9.597 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: SF (n = 21, 16) | 2.82 scores on a scale | Standard Deviation 9.681 |
| Placebo | Change From Baseline in Short-Form (SF)-36 Questionnaire | Week 52: GH (n = 21, 16) | 0.15 scores on a scale | Standard Deviation 10.277 |
Secondary
Number of Participants on Prednisolone Dose ≤ 5mg/Day
Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52. Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 \[last dose\].
Time frame: Week 19, Week 28, Week 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). n represents the number of participants with a value for a specific categorical variable at Week 19, 28 and 52.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Secukinumab | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 19 (n = 25, 20) | 22 Participants |
| Secukinumab | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 28 (n = 23, 20) | 19 Participants |
| Secukinumab | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 52 (n = 21, 17) | 19 Participants |
| Placebo | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 19 (n = 25, 20) | 10 Participants |
| Placebo | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 28 (n = 23, 20) | 9 Participants |
| Placebo | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 52 (n = 21, 17) | 13 Participants |
Secondary
Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)
Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 4 (n = 27, 23) | -15.8 scores on a scale | Standard Deviation 28.17 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 8 (n = 26, 21) | -15.8 scores on a scale | Standard Deviation 27.61 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 12 (n = 25, 20) | -8.0 scores on a scale | Standard Deviation 29.43 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 16 (n = 25, 20) | -18.6 scores on a scale | Standard Deviation 19.39 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 20 (n = 24, 20) | -19.18 scores on a scale | Standard Deviation 30.68 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 24 (n = 23, 20) | -14.9 scores on a scale | Standard Deviation 28.84 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 28 (n = 23, 19) | -14.4 scores on a scale | Standard Deviation 25.46 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 36 (n = 21, 19) | -20.9 scores on a scale | Standard Deviation 22.31 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 44 (n = 21, 16) | -21.7 scores on a scale | Standard Deviation 27.35 |
| Secukinumab | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 52 (n = 21, 16) | -19.2 scores on a scale | Standard Deviation 27.35 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 36 (n = 21, 19) | -8.6 scores on a scale | Standard Deviation 29.9 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 4 (n = 27, 23) | -0.5 scores on a scale | Standard Deviation 23.58 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 24 (n = 23, 20) | -7.0 scores on a scale | Standard Deviation 30.61 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 8 (n = 26, 21) | -10.8 scores on a scale | Standard Deviation 27.64 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 52 (n = 21, 16) | -15.9 scores on a scale | Standard Deviation 24.04 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 12 (n = 25, 20) | -11.9 scores on a scale | Standard Deviation 31.46 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 28 (n = 23, 19) | -8.0 scores on a scale | Standard Deviation 31.31 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 16 (n = 25, 20) | -8.8 scores on a scale | Standard Deviation 31.43 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 44 (n = 21, 16) | -9.4 scores on a scale | Standard Deviation 30.58 |
| Placebo | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Week 20 (n = 24, 20) | -6.9 scores on a scale | Standard Deviation 31.94 |
Secondary
Percentage of Participants in Remission at Week 12
Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
Time frame: Week 12
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Percentage of Participants in Remission at Week 12 | 22 Participants |
| Placebo | Percentage of Participants in Remission at Week 12 | 12 Participants |
Secondary
Percentage of Participants With GCA Who Had Sustained Remission Until Week 52
Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28.
Time frame: Until Week 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | 16 Participants |
| Placebo | Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | 2 Participants |
Secondary
Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)
Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 4 (n = 27, 23) | -4.8 scores on a scale | Standard Deviation 14.43 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 8 (n = 26, 21) | -5.8 scores on a scale | Standard Deviation 12.77 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 12 (n = 25, 20) | -3.4 scores on a scale | Standard Deviation 21.93 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 16 (n = 25, 20) | -4.1 scores on a scale | Standard Deviation 15.62 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 20 (n = 24, 20) | -6.9 scores on a scale | Standard Deviation 14.78 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 24 (n = 23, 20) | -4.3 scores on a scale | Standard Deviation 15.92 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 28 (23, 19) | -5.4 scores on a scale | Standard Deviation 15.61 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 36 (21, 19) | -8.7 scores on a scale | Standard Deviation 18.45 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 44 (n = 21, 16) | -5.5 scores on a scale | Standard Deviation 16.87 |
| Secukinumab | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 52 (n = 21, 16) | -9.5 scores on a scale | Standard Deviation 16.72 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 36 (21, 19) | 0.7 scores on a scale | Standard Deviation 17.45 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 4 (n = 27, 23) | -3.2 scores on a scale | Standard Deviation 18.45 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 24 (n = 23, 20) | 2.2 scores on a scale | Standard Deviation 17.22 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 8 (n = 26, 21) | 2.1 scores on a scale | Standard Deviation 18.94 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 52 (n = 21, 16) | 4.0 scores on a scale | Standard Deviation 21.24 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 12 (n = 25, 20) | -3.1 scores on a scale | Standard Deviation 10.81 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 28 (23, 19) | 3.9 scores on a scale | Standard Deviation 21.47 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 16 (n = 25, 20) | 0.7 scores on a scale | Standard Deviation 13.97 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 44 (n = 21, 16) | 1.1 scores on a scale | Standard Deviation 15.2 |
| Placebo | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Week 20 (n = 24, 20) | -1.5 scores on a scale | Standard Deviation 14.32 |
Secondary
Time to First GCA Flare After Clinical Remission
Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare. For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase. Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time.
Time frame: Up to Week 52 (included)
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Secukinumab | Time to First GCA Flare After Clinical Remission | NA days |
| Placebo | Time to First GCA Flare After Clinical Remission | 197.0 days |
Secondary
Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks
Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted.
Time frame: from Baseline to week 28, from baseline to week 52 weeks
Population: The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Secukinumab | Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Baseline to Week 28 | 2689.70 milligrams | Standard Deviation 935.86 |
| Secukinumab | Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Baseline to Week 52 | 2841.26 milligrams | Standard Deviation 1116.192 |
| Placebo | Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Baseline to Week 28 | 2693.74 milligrams | Standard Deviation 1241.907 |
| Placebo | Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Baseline to Week 52 | 3375.58 milligrams | Standard Deviation 1720.978 |