Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica (NCT NCT03600818)

NCT ID: NCT03600818

Last Updated: 2022-06-10

Results Overview

Sustained remission was defined as meeting all of the following parameters: achievement of disease remission (defined as resolution of signs and symptoms of polymyalgia rheumatica \[PMR\], and normalization of C-reactive protein \[CRP\] {less than \[\<\]10 milligrams per liter \[mg/L\]}) not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active PMR plus an increase in corticosteroid \[CS\] dose due to PMR or elevation of erythrocyte sedimentation rate \[ESR\] attributable to active PMR plus an increase in CS dose due to PMR) from Week 12 through Week 52, sustained reduction of CRP (to \<10 mg/L, with absence of successive elevations to greater than or equal to \[\>=\]10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 118 participants
• Primary outcome timeframe: At Week 52
• Results posted on: 2022-06-10

Participant Flow

The study was conducted at 78 active centers (randomized at least 1 participant) in 17 countries. A total of 196 participants were screened between 09 October 2018 and 19 March 2020, of whom 78 were screen failures. Screen failures were mainly due to not meeting inclusion criteria.

Participants were randomized to two treatment groups in a 1:1 ratio by interactive response technology. A total of 118 participants were enrolled and randomized in the study.

Participant milestones

Measure	Placebo+52 Week Taper Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Overall Study STARTED	58	60
Overall Study Safety Population	58	59
Overall Study COMPLETED	36	42
Overall Study NOT COMPLETED	22	18

Reasons for withdrawal

Measure	Placebo+52 Week Taper Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Overall Study Adverse Event	4	7
Overall Study Lack of Efficacy	9	4
Overall Study Withdrawal by Subject	4	3
Overall Study Other-unspecified	5	3
Overall Study Randomized and not treated	0	1

Baseline Characteristics

Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Baseline characteristics by cohort

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=60 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.	Total Title n=118 Participants
Age, Continuous	69.1 Years STANDARD_DEVIATION 8.5 • n=5 Participants	68.8 Years STANDARD_DEVIATION 7.8 • n=7 Participants	68.9 Years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	45 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 52

Population: Analysis was performed on intent-to-treat (ITT) population that included all participants who were allocated to a randomized treatment group, and were analyzed according to the treatment group allocated by randomization.

Sustained remission was defined as meeting all of the following parameters: achievement of disease remission (defined as resolution of signs and symptoms of polymyalgia rheumatica [PMR], and normalization of C-reactive protein [CRP] {less than [<]10 milligrams per liter [mg/L]}) not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active PMR plus an increase in corticosteroid [CS] dose due to PMR or elevation of erythrocyte sedimentation rate [ESR] attributable to active PMR plus an increase in CS dose due to PMR) from Week 12 through Week 52, sustained reduction of CRP (to <10 mg/L, with absence of successive elevations to greater than or equal to [>=]10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=60 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Percentage of Participants Achieving Sustained Remission at Week 52	10.3 percentage of participants	28.3 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Cumulative dose of CS used for PMR disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, add-on prednisone, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=59 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Total Cumulative Corticosteroid Dose	2235.8 milligrams Standard Deviation 839.4	1039.5 milligrams Standard Deviation 612.2

SECONDARY outcome

Timeframe: Up to Week 12

Population: Analysis was performed on ITT population.

Disease remission was defined as resolution of signs and symptoms of PMR, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active PMR prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. During the initial 12 weeks of prednisone taper, treatment for one flare before Week 12 was permitted if it was successfully treated with a low dose (<=5 mg/day) prednisone add-on taper regimen (completed prior to Week 12) and provided that all other sustained remission parameters were met.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=60 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants Who Achieved Disease Remission up to Week 12	22 Participants	28 Participants

SECONDARY outcome

Timeframe: From Week 12 Through Week 52

Population: Analysis was performed on ITT population.

Disease flare was defined as either recurrence of signs and symptoms attributable to active PMR plus an increase in CS dose due to PMR, or elevation of ESR attributable to active PMR plus an increase in CS dose due to PMR.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=60 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Absence of Disease Flare From Week 12 Through Week 52	19 Participants	33 Participants

SECONDARY outcome

Timeframe: From Week 12 through Week 52

Population: Analysis was performed on ITT population.

Normalization (sustained reduction) of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=60 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Sustained Reduction of CRP From Week 12 Through Week 52	26 Participants	40 Participants

SECONDARY outcome

Timeframe: From Week 12 through Week 52

Population: Analysis was performed on ITT population.

Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to PMR.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=60 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52	14 Participants	30 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Analysis was performed on ITT population.

Time to first PMR flare was defined as the duration (in days) from randomization to first PMR flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to PMR or elevation of ESR attributable to active PMR plus an increase in CS dose due to PMR. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=60 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Time to First Polymyalgia Rheumatica Flare After Clinical Remission up to Week 52	99.00 days Interval 1.0 to 154.0	NA days Interval 93.0 to At Week 52 the cumulative incidence was less than 50% in the Kaplan-Meier plot. Hence, the upper limit of confidence interval and median value was not reached.

SECONDARY outcome

Timeframe: At Week 52

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: C-GTI and Specific List. C-GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. C-GTI score was sum of 9 domain-specific scores at each visit and Cumulative GTI score was sum of C-GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this outcome measure. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. Negative scores reflect improvement in CS toxicities present from Baseline. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, minimum score implies least toxicity and maximum score implies most toxicity.

Outcome measures

Measure	Placebo+52 Week Taper n=57 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=60 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 52 CWS	57.22 units on a scale Standard Error 6.678	52.32 units on a scale Standard Error 6.507
Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 52 AIS	2.57 units on a scale Standard Error 6.275	-4.02 units on a scale Standard Error 6.115

SECONDARY outcome

Timeframe: From first dose (i.e. Day 1) up to 60 days after last dose date of study drug (i.e. up to Week 60)

Population: Analysis was performed on safety population that included participants who had received at least one dose or part of a dose of IMP and were analyzed according to the treatment actually received.

An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the IMP +60 days).

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=59 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TEAE	49 Participants	56 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAE	12 Participants	8 Participants

SECONDARY outcome

Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

Population: Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant vital sign abnormalities:

Systolic Blood Pressure (SBP): <= 95 mmHg and decrease from baseline (DFB) more than or equal to (>=) 20 mmHg; >= 160 mmHg and increase from baseline (IFB) >= 20 mmHg

Diastolic blood pressure (DBP): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg.

Heart Rate (HR): <= 50 beats per min (bpm) and DFB >=20 bpm; >=120 bpm and IFB >= 20 bpm

Weight: >=5% DFB; >=5% IFB.

TEAE period was defined as the time from the first dose of the IMP to the last dose of the IMP + 60 days.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=58 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period Weight >=5% IFB	9 Participants	12 Participants
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period SBP <=95 mmHg and DFB >=20 mmHg	0 Participants	2 Participants
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period SBP >=160 mmHg and IFB >=20 mmHg	4 Participants	5 Participants
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period DBP <=45 mmHg and DFB >=10 mmHg	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period DBP >=110 mmHg and IFB >=10 mmHg	1 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period HR <=50 bpm and DFB >= 20 bpm	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period HR >=120 bpm and IFB >=20 bpm	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period Weight >=5% DFB	2 Participants	5 Participants

SECONDARY outcome

Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

Population: Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant laboratory abnormalities included:

Hemoglobin (Hb): <= 115 grams per liter (g/L) (Male [M]), <= 95 g/L (Female [F]); >= 185 g/L (M), >= 165 g/L (F); DFB >= 20 g/L .

Hematocrit: <= 0.37 volume/volume (v/v) (M); <= 0.32 v/v (F); >= 0.55 v/v (M); >= 0.5 v/v (F).

Erythrocytes: >=6 Tera/ liter (L).

Platelets: < 100 Giga/L, >= 700 Giga/L.

Leukocytes: < 3.0 Giga/L (Non-Black [NB]); < 2.0 Giga/L (Black [B]), >= 16.0 Giga/L.

Neutrophils: < 1.5 Giga/L (NB); < 1.0 Giga/L (B).

Lymphocytes: > 4.0 Giga/L.

Monocytes: > 0.7 Giga/L.

Basophils: > 0.1 Giga/L.

Eosinophils: > 0.5 Giga/L or > upper limit of normal (ULN) (if ULN >= 0.5 Giga/L).

Outcome measures

Measure	Placebo+52 Week Taper n=57 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=58 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Erythrocytes: >=6 Tera/L	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Hb: <= 115 g/L (M), <= 95 g/L (F)	1 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Hb: >=185 g/L(M), >=165 g/L(F)	0 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Hb: DFB >=20 g/L	3 Participants	2 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Hematocrit: <= 0.37 v/v(M); <=0.32 v/v(F)	1 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Hematocrit: >=0.55 v/v(M); >=0.5 v/v(F)	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Platelets: < 100 Giga/L	0 Participants	2 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Platelets: >= 700 Giga/L	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Leukocytes:<3.0Giga/L(NB);<2.0Giga/L(B)	0 Participants	11 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Leukocytes: >= 16.0 Giga/L.	1 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Neutrophils: < 1.5 Giga/L (NB); < 1.0 Giga/L (B).	0 Participants	18 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Lymphocytes: > 4.0 Giga/L	4 Participants	2 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Monocytes: > 0.7 Giga/L	12 Participants	8 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Basophils: > 0.1 Giga/L.	16 Participants	13 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter Eosinophils:>0.5 Giga/L; >ULN (if ULN>=0.5Giga/L)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

Population: Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant abnormalities:

Glucose: <=3.9 millimoles (mmol)/L and < lower limit of normal (LLN); >=11.1 mmol/L (unfasted [unfas]); >=7 mmol/L (fasted [fas]).

HbA1c: >8%.

Cholesterol: >=7.74 mmol/L.

Triglycerides: >=4.6 mmol/L.

C Reactive Protein (CRP): >2 ULN or >10 mg/L (if ULN not provided).

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=58 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Glucose: <=3.9 mmol/L and < LLN	1 Participants	2 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Glucose: >=11.1 mmol/L (unfas); >=7 mmol/L (fas)	14 Participants	5 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters HbA1c: >8%	4 Participants	2 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Cholesterol: >=7.74 mmol/L	4 Participants	8 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters Triglycerides: >=4.6 mmol/L	1 Participants	3 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters CRP: >2 ULN or >10 mg/L (if ULN not provided)	37 Participants	13 Participants

SECONDARY outcome

Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

Population: Analysis was performed on safety population. Here, 'overall number of participants analyzed'= participants evaluable for this outcome measure.

Criteria for potentially clinically significant abnormalities:

Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline.

Creatinine clearance: >=60 to <90 milliliters per minute (mL/min); >=30 to <60 mL/min ; >=15 to <30 mL/min; <15 mL/min.

Blood urea nitrogen: >=17 mmol/L.

Urate: <120 micromol/L; >408 micromol/L.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=58 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine: >=150 micromol/L (adults)	2 Participants	2 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine: >=30% change from baseline	3 Participants	14 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine: >=100% change from baseline	0 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance: >=60 to <90 mL/min	30 Participants	29 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance: >=30 to <60 mL/min	13 Participants	17 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance: >=15 to <30 mL/min	0 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Creatinine clearance: <15 mL/min	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Blood urea nitrogen: >=17 mmol/L	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Urate: <120 micromol/L	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function Urate: >408 micromol/L	16 Participants	16 Participants

SECONDARY outcome

Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

Population: Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Criteria for potentially clinically significant abnormalities:

Albumin: <= 25 g/L.

Alanine Aminotransferase (ALT): >3 ULN; >5 ULN; >10 ULN.

Aspartate Aminotransferase (AST): >3 ULN; >5 ULN; >10 ULN; >20 ULN.

Alkaline Phosphatase: >1.5 ULN.

Bilirubin: >1.5 ULN; >2 ULN.

ALT and Total Bilirubin: ALT > 3 ULN and Bilirubin > 2 ULN

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=58 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Albumin: <= 25 g/L	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function ALT: >3 ULN	2 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function ALT: >5 ULN	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function ALT: >10 ULN	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function AST: >3 ULN	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function AST: >5 ULN	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function AST: >10 ULN	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function AST: >20 ULN	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Alkaline Phosphatase: >1.5 ULN	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Bilirubin: >1.5 ULN	1 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Bilirubin: >2 ULN	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function ALT > 3 ULN and Bilirubin > 2 ULN	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

Population: Analysis was performed on ADA population which included participants who had received at least one dose or part of a dose of IMP and were analyzed according to the treatment actually received and had at least one post dose evaluable ADA sample.

ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the IMP +60 days).

Outcome measures

Measure	Placebo+52 Week Taper n=55 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=56 Participants Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Number of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response Treatment-boosted ADA	0 Participants	0 Participants
Number of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response Treatment-emergent ADA	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Pre-dose on Week 0 (Baseline), Week 2, 4, 12, 16, 24, and 52

Population: Analyzed on PK population: participants who had received at least one dose or part of a dose of IMP, were analyzed according to the treatment actually received and had at least 1 post-dose non-missing serum sarilumab concentration value. Here, 'number analyzed' = participants with available data for each specified category.

Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arm (Placebo+52 Week Taper) as pre-specified in the protocol.

Outcome measures

Measure	Placebo+52 Week Taper n=58 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Baseline	0.00 nanograms per milliliter (ng/mL) Standard Deviation 0.00	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 2	5209.02 nanograms per milliliter (ng/mL) Standard Deviation 4357.37	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 4	9259.25 nanograms per milliliter (ng/mL) Standard Deviation 7668.95	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 12	17494.20 nanograms per milliliter (ng/mL) Standard Deviation 11146.33	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 16	23082.86 nanograms per milliliter (ng/mL) Standard Deviation 15878.92	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 24	27289.75 nanograms per milliliter (ng/mL) Standard Deviation 17927.73	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 52	27604.95 nanograms per milliliter (ng/mL) Standard Deviation 24880.13	—

SECONDARY outcome

Timeframe: Post-dose at Week 24

Population: Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo arm (Placebo+52 Week Taper) as pre-specified in the protocol.

Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay.

Outcome measures

Measure	Placebo+52 Week Taper n=26 Participants Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24	35757.69 ng/mL Standard Deviation 15353.96	—

Adverse Events

Placebo+52 Week Taper

Serious events: 12 serious events

Other events: 42 other events

Deaths: 0 deaths

Sarilumab 200mg q2w+14 Week Taper

Serious events: 8 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo+52 Week Taper n=58 participants at risk Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=59 participants at risk Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Nervous system disorders Syncope	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Renal and urinary disorders Pollakiuria	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Vascular disorders Aortic Intramural Haematoma	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Vascular disorders Giant Cell Arteritis	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Vascular disorders Hypertensive Emergency	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Vascular disorders Orthostatic Hypotension	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	3.4% 2/59 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Covid-19	3.4% 2/58 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Covid-19 Pneumonia	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Intervertebral Discitis	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Pneumonia	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Urinary Tract Infection Bacterial	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Investigations Alanine Aminotransferase Increased	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Erdheim-Chester Disease	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.

Other adverse events

Measure	Placebo+52 Week Taper n=58 participants at risk Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.	Sarilumab 200mg q2w+14 Week Taper n=59 participants at risk Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.
Blood and lymphatic system disorders Increased Tendency To Bruise	6.9% 4/58 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	6.8% 4/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Blood and lymphatic system disorders Leukopenia	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	6.8% 4/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	11.9% 7/59 • Number of events 9 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Eye disorders Dry Eye	6.9% 4/58 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Gastrointestinal disorders Constipation	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	6.8% 4/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Gastrointestinal disorders Diarrhoea	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	11.9% 7/59 • Number of events 7 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	3.4% 2/58 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
General disorders Fatigue	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
General disorders Injection Site Pruritus	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 7 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
General disorders Oedema Peripheral	8.6% 5/58 • Number of events 5 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Cystitis	5.2% 3/58 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	3.4% 2/59 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Gastroenteritis	5.2% 3/58 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	3.4% 2/59 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Influenza	6.9% 4/58 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Nasopharyngitis	10.3% 6/58 • Number of events 6 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	3.4% 2/59 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	8.6% 5/58 • Number of events 5 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	3.4% 2/59 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Injury, poisoning and procedural complications Accidental Overdose	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Injury, poisoning and procedural complications Fall	10.3% 6/58 • Number of events 6 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Injury, poisoning and procedural complications Limb Injury	5.2% 3/58 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Injury, poisoning and procedural complications Skin Laceration	5.2% 3/58 • Number of events 5 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 3/58 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	15.3% 9/59 • Number of events 11 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Back Pain	3.4% 2/58 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Bursitis	8.6% 5/58 • Number of events 5 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	3.4% 2/59 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	6.8% 4/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Osteoarthritis	8.6% 5/58 • Number of events 6 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	10.2% 6/59 • Number of events 6 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Pain In Extremity	5.2% 3/58 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	5.2% 3/58 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	3.4% 2/59 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Tendonitis	3.4% 2/58 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 5 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Nervous system disorders Cognitive Disorder	6.9% 4/58 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	6.8% 4/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Nervous system disorders Headache	8.6% 5/58 • Number of events 5 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	1.7% 1/59 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Nervous system disorders Sciatica	1.7% 1/58 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Psychiatric disorders Depression	10.3% 6/58 • Number of events 7 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	8.5% 5/59 • Number of events 5 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Psychiatric disorders Insomnia	15.5% 9/58 • Number of events 9 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	10.2% 6/59 • Number of events 6 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Psychiatric disorders Mania	5.2% 3/58 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	3.4% 2/59 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	6.8% 4/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Pruritus	1.7% 1/58 • Number of events 1 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 3 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/58 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	5.1% 3/59 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Skin Striae	6.9% 4/58 • Number of events 4 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	0.00% 0/59 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.
Vascular disorders Hypertension	3.4% 2/58 • Number of events 2 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.	10.2% 6/59 • Number of events 6 • From first dose (i.e., Day 1) of IMP to last dose date of IMP + 60 days (i.e., up to Week 60). Reported AEs were TEAEs that developed/worsened in grade or became serious during TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Analysis was performed on safety population.

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
• Publication restrictions are in place

Restriction type: OTHER