Trial Outcomes & Findings for A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis (NCT NCT03765788)

NCT ID: NCT03765788

Last Updated: 2023-08-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: Until week 28
• Results posted on: 2023-08-21

Participant Flow

Participants took part in 11 investigative sites in 1 country.

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	27	25
Overall Study COMPLETED	22	17
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Measure	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.	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.
Overall Study Subject decision	2	3
Overall Study Physician Decision	2	4
Overall Study Death	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis

Baseline characteristics by cohort

Measure	Secukinumab n=27 Participants 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.	Placebo n=25 Participants 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.	Total n=52 Participants Total of all reporting groups
Age, Continuous	76.4 years STANDARD_DEVIATION 5.31 • n=5 Participants	69.6 years STANDARD_DEVIATION 8.02 • n=7 Participants	73.1 years STANDARD_DEVIATION 7.52 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized White	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=25 Participants 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.
Percentage of Participants in Sustained Remission Until Week 28	19 Participants	6 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=25 Participants 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.
Percentage of Participants in Remission at Week 12	22 Participants	12 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=25 Participants 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.
Time to First GCA Flare After Clinical Remission	NA days NA: not enough participants with events to calculate the median \& CI	197.0 days Interval 101.0 to 280.0

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=25 Participants 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.
Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks Baseline to Week 28	2689.70 milligrams Standard Deviation 935.860	2693.74 milligrams Standard Deviation 1241.907
Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks Baseline to Week 52	2841.26 milligrams Standard Deviation 1116.192	3375.58 milligrams Standard Deviation 1720.978

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=25 Participants 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.
Percentage of Participants With GCA Who Had Sustained Remission Until Week 52	16 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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].

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=25 Participants 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.
Number of Participants on Prednisolone Dose ≤ 5mg/Day Week 19 (n = 25, 20)	22 Participants	10 Participants
Number of Participants on Prednisolone Dose ≤ 5mg/Day Week 28 (n = 23, 20)	19 Participants	9 Participants
Number of Participants on Prednisolone Dose ≤ 5mg/Day Week 52 (n = 21, 17)	19 Participants	13 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=23 Participants 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.
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	-3.2 scores on a scale Standard Deviation 18.45
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	2.1 scores on a scale Standard Deviation 18.94
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	-3.1 scores on a scale Standard Deviation 10.81
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	0.7 scores on a scale Standard Deviation 13.97
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	-1.5 scores on a scale Standard Deviation 14.32
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	2.2 scores on a scale Standard Deviation 17.22
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	3.9 scores on a scale Standard Deviation 21.47
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	0.7 scores on a scale Standard Deviation 17.45
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	1.1 scores on a scale Standard Deviation 15.20
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	4.0 scores on a scale Standard Deviation 21.24

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=23 Participants 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.
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	-0.5 scores on a scale Standard Deviation 23.58
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	-10.8 scores on a scale Standard Deviation 27.64
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	-11.9 scores on a scale Standard Deviation 31.46
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	-8.8 scores on a scale Standard Deviation 31.43
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	-6.9 scores on a scale Standard Deviation 31.94
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	-7.0 scores on a scale Standard Deviation 30.61
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	-8.0 scores on a scale Standard Deviation 31.31
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	-8.6 scores on a scale Standard Deviation 29.90
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	-9.4 scores on a scale Standard Deviation 30.58
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	-15.9 scores on a scale Standard Deviation 24.04

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=23 Participants 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.
Change From Baseline in FACIT-Fatigue Scale Week 4 (n = 27, 23)	2.11 scores on a scale Standard Deviation 9.613	-0.96 scores on a scale Standard Deviation 7.358
Change From Baseline in FACIT-Fatigue Scale Week 8 (n = 26, 21)	2.19 scores on a scale Standard Deviation 10.190	0.81 scores on a scale Standard Deviation 7.498
Change From Baseline in FACIT-Fatigue Scale Week 12 (n = 25, 20)	0.96 scores on a scale Standard Deviation 11.175	-0.25 scores on a scale Standard Deviation 10.047
Change From Baseline in FACIT-Fatigue Scale Week 16 (n = 25, 20)	2.12 scores on a scale Standard Deviation 8.876	-0.36 scores on a scale Standard Deviation 8.884
Change From Baseline in FACIT-Fatigue Scale Week 20 (n =24, 20)	3.42 scores on a scale Standard Deviation 8.617	0.05 scores on a scale Standard Deviation 10.318
Change From Baseline in FACIT-Fatigue Scale Week 24 (n = 23, 20)	2.91 scores on a scale Standard Deviation 10.409	-3.10 scores on a scale Standard Deviation 11.281
Change From Baseline in FACIT-Fatigue Scale Week 28 (n = 23, 19)	3.61 scores on a scale Standard Deviation 11.044	0.42 scores on a scale Standard Deviation 9.203
Change From Baseline in FACIT-Fatigue Scale Week 36 (n = 21, 19)	3.90 scores on a scale Standard Deviation 7.245	1.84 scores on a scale Standard Deviation 8.719
Change From Baseline in FACIT-Fatigue Scale Week 44 (n = 21, 16)	2.67 scores on a scale Standard Deviation 5.986	0.31 scores on a scale Standard Deviation 10.928
Change From Baseline in FACIT-Fatigue Scale Week 52 (n = 21, 16)	3.19 scores on a scale Standard Deviation 7.033	0.19 scores on a scale Standard Deviation 8.848

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=23 Participants 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.
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	4.25 scores on a scale Standard Deviation 11.257
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	-1.25 scores on a scale Standard Deviation 4.417
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	0.18 scores on a scale Standard Deviation 4.987
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	-0.38 scores on a scale Standard Deviation 8.750
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	-0.86 scores on a scale Standard Deviation 6.814
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	-0.10 scores on a scale Standard Deviation 6.495
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	-2.11 scores on a scale Standard Deviation 8.667
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	-0.40 scores on a scale Standard Deviation 6.460
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	-1.31 scores on a scale Standard Deviation 6.631
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	-0.36 scores on a scale Standard Deviation 8.065
Change From Baseline in Short-Form (SF)-36 Questionnaire Week 52: PF (n = 21, 16)	2.46 scores on a scale Standard Deviation 4.770	0.12 scores on a scale Standard Deviation 5.696
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	0.49 scores on a scale Standard Deviation 10.616
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	-0.75 scores on a scale Standard Deviation 10.515
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	1.01 scores on a scale Standard Deviation 9.539
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	-1.12 scores on a scale Standard Deviation 8.847
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	-0.45 scores on a scale Standard Deviation 8.163
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	-0.00 scores on a scale Standard Deviation 10.094
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	1.77 scores on a scale Standard Deviation 8.553
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	0.24 scores on a scale Standard Deviation 10.121
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	0.70 scores on a scale Standard Deviation 11.262
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	1.40 scores on a scale Standard Deviation 9.126
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	7.68 scores on a scale Standard Deviation 11.235
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	9.68 scores on a scale Standard Deviation 10.485
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	6.84 scores on a scale Standard Deviation 11.674
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	4.50 scores on a scale Standard Deviation 13.560
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	8.63 scores on a scale Standard Deviation 12.457
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	3.93 scores on a scale Standard Deviation 11.952
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	6.32 scores on a scale Standard Deviation 13.149
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	7.81 scores on a scale Standard Deviation 10.794
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	9.00 scores on a scale Standard Deviation 7.910
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	8.39 scores on a scale Standard Deviation 11.866
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	0.23 scores on a scale Standard Deviation 6.761
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	0.18 scores on a scale Standard Deviation 6.758
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	0.62 scores on a scale Standard Deviation 8.158
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	-0.74 scores on a scale Standard Deviation 7.858
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	-0.38 scores on a scale Standard Deviation 7.933
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	-0.19 scores on a scale Standard Deviation 9.031
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	1.18 scores on a scale Standard Deviation 7.837
Change From Baseline in Short-Form (SF)-36 Questionnaire Week 36:GH (n = 21, 19)	3.42 scores on a scale Standard Deviation 6.680	-0.47 scores on a scale Standard Deviation 7.833
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	-0.30 scores on a scale Standard Deviation 9.597
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	0.15 scores on a scale Standard Deviation 10.277
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	-1.42 scores on a scale Standard Deviation 7.699
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	0.71 scores on a scale Standard Deviation 8.185
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	-0.30 scores on a scale Standard Deviation 9.241
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	-0.45 scores on a scale Standard Deviation 7.847
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	0.45 scores on a scale Standard Deviation 9.652
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	-1.93 scores on a scale Standard Deviation 11.697
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	0.16 scores on a scale Standard Deviation 6.679
Change From Baseline in Short-Form (SF)-36 Questionnaire Week 36: Vitality (n = 21, 19)	7.07 scores on a scale Standard Deviation 7.060	1.41 scores on a scale Standard Deviation 5.635
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	-0.93 scores on a scale Standard Deviation 12.497
Change From Baseline in Short-Form (SF)-36 Questionnaire Week 52: Vitality (n = 21, 16)	7.21 scores on a scale Standard Deviation 8.690	0.37 scores on a scale Standard Deviation 11.474
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	1.74 scores on a scale Standard Deviation 7.499
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	2.63 scores on a scale Standard Deviation 9.979
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	1.76 scores on a scale Standard Deviation 7.325
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	0.75 scores on a scale Standard Deviation 7.325
Change From Baseline in Short-Form (SF)-36 Questionnaire Week 20: SF (n = 24, 20)	4.81 scores on a scale Standard Deviation 10.080	3.51 scores on a scale Standard Deviation 8.150
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	0.00 scores on a scale Standard Deviation 10.912
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	3.17 scores on a scale Standard Deviation 9.631
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	5.01 scores on a scale Standard Deviation 7.285
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	0.63 scores on a scale Standard Deviation 11.561
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	2.82 scores on a scale Standard Deviation 9.681
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	3.48 scores on a scale Standard Deviation 12.985
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	1.99 scores on a scale Standard Deviation 13.239
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	0.52 scores on a scale Standard Deviation 13.188
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	-0.00 scores on a scale Standard Deviation 11.465
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	0.35 scores on a scale Standard Deviation 11.569
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	-1.22 scores on a scale Standard Deviation 16.025
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	1.10 scores on a scale Standard Deviation 11.725
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	0.73 scores on a scale Standard Deviation 16.518
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	3.26 scores on a scale Standard Deviation 16.354
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	0.43 scores on a scale Standard Deviation 19.234
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	0.57 scores on a scale Standard Deviation 8.420
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	1.49 scores on a scale Standard Deviation 6.950
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	4.45 scores on a scale Standard Deviation 7.690
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	5.36 scores on a scale Standard Deviation 6.379
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	6.41 scores on a scale Standard Deviation 7.984
Change From Baseline in Short-Form (SF)-36 Questionnaire Week 24: MH (n = 22, 20)	2.62 scores on a scale Standard Deviation 8.730	2.61 scores on a scale Standard Deviation 13.149
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	6.06 scores on a scale Standard Deviation 7.350
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	5.64 scores on a scale Standard Deviation 8.988
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	1.14 scores on a scale Standard Deviation 11.891

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab n=27 Participants 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.	Placebo n=23 Participants 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.
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	1.87 scores on a scale Standard Deviation 21.467
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 16.650	5.52 scores on a scale Standard Deviation 29.646
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	3.30 scores on a scale Standard Deviation 22.850
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 19.530	4.40 scores on a scale Standard Deviation 27.354
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	6.30 scores on a scale Standard Deviation 25.041
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	-1.00 scores on a scale Standard Deviation 29.902
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 17.840	10.37 scores on a scale Standard Deviation 21.670
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	5.32 scores on a scale Standard Deviation 28.825
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	12.69 scores on a scale Standard Deviation 21.941
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	10.81 scores on a scale Standard Deviation 24.109
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	-0.0702 scores on a scale Standard Deviation 0.21239
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	0.0087 scores on a scale Standard Deviation 0.9869
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	-0.0122 scores on a scale Standard Deviation 0.15686
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	-0.0196 scores on a scale Standard Deviation 0.19789
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	0.0221 scores on a scale Standard Deviation 0.16759
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	-0.0444 scores on a scale Standard Deviation 0.20875
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	0.0240 scores on a scale Standard Deviation 0.13458
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	-0.0155 scores on a scale Standard Deviation 0.13186
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	0.0090 scores on a scale Standard Deviation 0.13033
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	0.0205 scores on a scale Standard Deviation 0.09403

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab n=23 Participants 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.	Placebo n=18 Participants 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.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Week 28 (n = 23, 18)	4.043 mm/hr Standard Deviation 16.1934	14.667 mm/hr Standard Deviation 23.9141
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Week 52 (n = 21, 16)	-3.286 mm/hr Standard Deviation 10.6167	10.000 mm/hr Standard Deviation 14.8728

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Secukinumab n=23 Participants 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.	Placebo n=19 Participants 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.
Change From Baseline in C-Reactive Protein (CRP) Level Week 28 (n = 23, 19)	4.426 mg/L Standard Deviation 9.6836	5.216 mg/L Standard Deviation 8.9820
Change From Baseline in C-Reactive Protein (CRP) Level Week 52 (n = 21, 16)	-1.433 mg/L Standard Deviation 8.7909	4.650 mg/L Standard Deviation 14.3691

Adverse Events

Secukinumab

Serious events: 6 serious events

Other events: 25 other events

Deaths: 1 deaths

Placebo

Serious events: 11 serious events

Other events: 23 other events

Deaths: 1 deaths

All Participants

Serious events: 17 serious events

Other events: 48 other events

Deaths: 2 deaths

Serious adverse events

Measure	Secukinumab n=27 participants at risk 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.	Placebo n=25 participants at risk 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.	All Participants n=52 participants at risk All participants who participated in the study.
Cardiac disorders Atrial fibrillation	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Cardiac disorders Atrial tachycardia	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Cardiac disorders Cardiac failure	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Cardiac disorders Tachyarrhythmia	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Gastrointestinal disorders Faecaloma	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Gastrointestinal disorders Melaena	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Gastrointestinal disorders Noninfective sialoadenitis	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
General disorders General physical health deterioration	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
General disorders Pyrexia	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Arthritis bacterial	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Erysipelas	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Urinary tract infection	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Face injury	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Fall	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Pelvic fracture	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Investigations Inflammatory marker increased	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Metabolism and nutrition disorders Fluid retention	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Musculoskeletal and connective tissue disorders Spinal stenosis	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Cerebrovascular accident	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Dizziness	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Facial paralysis	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Intracranial aneurysm	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Neurological symptom	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Syncope	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Vascular disorders Deep vein thrombosis	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Vascular disorders Haematoma	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	1.9% 1/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.

Other adverse events

Measure	Secukinumab n=27 participants at risk 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.	Placebo n=25 participants at risk 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.	All Participants n=52 participants at risk All participants who participated in the study.
Endocrine disorders Cushingoid	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Eye disorders Glaucoma	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	7.7% 4/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Eye disorders Vision blurred	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Gastrointestinal disorders Dental caries	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Gastrointestinal disorders Diarrhoea	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	7.7% 4/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Gastrointestinal disorders Nausea	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
General disorders Fatigue	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
General disorders Oedema peripheral	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	16.0% 4/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	11.5% 6/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Gastroenteritis	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Nasopharyngitis	18.5% 5/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	20.0% 5/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	19.2% 10/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Oral candidiasis	14.8% 4/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	9.6% 5/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Respiratory tract infection	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Rhinitis	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Infections and infestations Urinary tract infection	14.8% 4/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	11.5% 6/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Bone contusion	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Fall	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Rib fracture	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Skin laceration	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Injury, poisoning and procedural complications Tooth fracture	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Investigations Blood pressure increased	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Investigations C-reactive protein increased	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Investigations Gamma-glutamyltransferase increased	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Metabolism and nutrition disorders Diabetes mellitus	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 3/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	12.0% 3/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	11.5% 6/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	20.0% 5/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	9.6% 5/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Musculoskeletal and connective tissue disorders Bursitis	11.1% 3/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	7.7% 4/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	14.8% 4/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	9.6% 5/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	11.1% 3/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	9.6% 5/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Dizziness	11.1% 3/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Headache	14.8% 4/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	12.0% 3/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	13.5% 7/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Polyneuropathy	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Sciatica	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Nervous system disorders Tension headache	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Skin and subcutaneous tissue disorders Alopecia	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	4.0% 1/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Skin and subcutaneous tissue disorders Rash	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	7.7% 4/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Skin and subcutaneous tissue disorders Skin ulcer	7.4% 2/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	0.00% 0/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	3.8% 2/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Vascular disorders Giant cell arteritis	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	8.0% 2/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	5.8% 3/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Vascular disorders Haematoma	3.7% 1/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	12.0% 3/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	7.7% 4/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.
Vascular disorders Hypertension	22.2% 6/27 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	32.0% 8/25 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.	26.9% 14/52 • Adverse Events were reported from first dose of study treatment and co-administered Prednisolone treatment until end of treatment (48 weeks) plus 4 weeks (52 weeks). The mean/standard deviation exposure to the study treatment was 49.5 (9.6) weeks for secukinumab and 46.9 (12.6) weeks for placebo. The mean/standard deviation exposure to the co-administered prednisolone treatment was 307 (9.6) weeks for secukinumab and 43.2 (12.2) weeks for placebo. Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days post treatment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER