Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA (NCT NCT03600805)

Last Updated: 2022-03-28

Results Overview

Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (\<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid \[CS\] dose due to GCA or elevation of erythrocyte sedimentation rate \[ESR\] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalization of CRP (to \<10 mg/L, with absence of successive elevations 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

83 participants

Primary outcome timeframe

At Week 52

Results posted on

2022-03-28

Participant Flow

Study was conducted at 48 active centers in 19 countries. A total of 125 participants were screened between 20 November 2018 and 19 March 2020, of whom 42 participants were screen failures. Screen failures were mainly due to not meeting inclusion criteria. A total of 83 participants were enrolled and randomized in the study.

Participants were randomized to 4 treatments arms in 2:1:1:2 ratio by interactive response technology stratified by starting dose of prednisone at Baseline (less than \[\<\] 30 milligrams per day (mg/day) or greater than or equal to \[\>=\] 30 mg/day).

Participant milestones

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.	Placebo+26 Week Taper Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Overall Study STARTED	28	14	14	27
Overall Study Week 52 Analysis Set Population	10	6	7	13
Overall Study COMPLETED	9	6	6	8
Overall Study NOT COMPLETED	19	8	8	19

Reasons for withdrawal

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.	Placebo+26 Week Taper Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Overall Study Adverse Event	2	1	1	7
Overall Study Lack of Efficacy	2	1	0	0
Overall Study Withdrawal by Subject	1	0	0	1
Overall Study Other unspecified	14	6	7	11

Baseline Characteristics

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Total Title n=83 Participants
Age, Continuous	71.4 years STANDARD_DEVIATION 7.7 • n=5 Participants	69.5 years STANDARD_DEVIATION 5.4 • n=7 Participants	67.1 years STANDARD_DEVIATION 7.9 • n=5 Participants	73.4 years STANDARD_DEVIATION 8.6 • n=4 Participants	71.0 years STANDARD_DEVIATION 7.9 • n=21 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	23 Participants n=4 Participants	67 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	25 Participants n=4 Participants	72 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Week 52

Population: Analysis was performed on Week 52 analysis set population that included randomized participants who had opportunity to complete the 52-week treatment period (randomized prior to October 16th, 2019).

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=10 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.	Placebo+26 Week Taper n=6 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=7 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=13 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Percentage of Participants Who Achieved Sustained Disease Remission at Week 52	30.0 percentage of participants	0 percentage of participants	42.9 percentage of participants	46.2 percentage of participants

PRIMARY outcome

Timeframe: At Week 24

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

Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP \<10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalization of CRP (to \<10 mg/L, with an absence of successive elevations to \>=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Percentage of Participants Who Achieved Sustained Disease Remission at Week 24	39.3 percentage of participants	7.1 percentage of participants	42.9 percentage of participants	48.1 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: Analysis was performed on Week 52 analysis set.

Disease remission was defined as resolution of signs and symptoms of GCA, 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 corticosteroid (CS) due to active GCA 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.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=10 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.	Placebo+26 Week Taper n=6 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=7 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=13 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set	7 Participants	3 Participants	4 Participants	7 Participants

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 GCA, 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 GCA 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.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population	16 Participants	6 Participants	9 Participants	15 Participants

SECONDARY outcome

Timeframe: From Week 12 through Week 52

Population: Analysis was performed on Week 52 analysis set.

Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 52 were reported.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=10 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.	Placebo+26 Week Taper n=6 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=7 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=13 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set	7 Participants	3 Participants	4 Participants	7 Participants

SECONDARY outcome

Timeframe: From Week 12 through Week 24

Population: Analysis was performed on ITT population.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population	21 Participants	7 Participants	10 Participants	15 Participants

SECONDARY outcome

Timeframe: From Week 12 through Week 52

Population: Analysis was performed on Week 52 analysis set.

Normalization 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

Outcome measures
Measure	Placebo+52 Week Taper n=10 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.	Placebo+26 Week Taper n=6 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=7 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=13 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set	6 Participants	3 Participants	5 Participants	8 Participants

SECONDARY outcome

Timeframe: From Week 12 through Week 24

Population: Analysis was performed on ITT population.

Normalization 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

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population	20 Participants	4 Participants	11 Participants	17 Participants

SECONDARY outcome

Timeframe: From Week 12 through Week 52

Population: Analysis was performed on Week 52 analysis set.

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 might include the use of 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 GCA.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=10 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.	Placebo+26 Week Taper n=6 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=7 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=13 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set	6 Participants	2 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: From Week 12 through Week 24

Population: Analysis was performed on ITT population.

Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as participants who did not take rescue therapy from Week 12 through Week 24 and might include the use of 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 AE not related to GCA.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population	18 Participants	5 Participants	7 Participants	13 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Analysis was performed on ITT population.

Cumulative dose of CS used for GCA disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, CS used in rescue therapy and the use of commercial prednisone (an excess of \<=100 mg of prednisone during the study treatment period employed to manage AE not related to GCA). 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

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Total Cumulative Corticosteroid (Including Prednisone) Dose	2577.3 milligrams Standard Deviation 1018.3	2270.7 milligrams Standard Deviation 1418.0	2177.1 milligrams Standard Deviation 1326.7	1643.1 milligrams Standard Deviation 967.3

SECONDARY outcome

Timeframe: Up to Week 52

Population: Analysis was performed on ITT population.

Time to first GCA flare was defined as the duration (in days) from randomization to first GCA 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 GCA or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. 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

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Time to First Giant Cell Arteritis Disease Flare	NA days Interval 141.0 to Median and upper limit of 95% confidence interval (CI) was not estimable due to very low number of participants with the events.	170.00 days Interval 85.0 to Upper limit of 95% CI was not estimable due to very low number of participants with the events.	NA days Interval 58.0 to Median and upper limit of 95% CI was not estimable due to very low number of participants with the events.	NA days Interval 77.0 to Median and upper limit of 95% CI was not estimable due to very low number of participants with the events.

SECONDARY outcome

Timeframe: At Week 24

Population: Analysis was performed on ITT population.

GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 24 are reported in this outcome measure (OM). 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. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population Cumulative worsening score	29.2 units on a scale Standard Deviation 30.8	30.7 units on a scale Standard Deviation 33.2	55.1 units on a scale Standard Deviation 43.1	31.0 units on a scale Standard Deviation 42.9
Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population Aggregate improvement score	-21.6 units on a scale Standard Deviation 54.8	-13.4 units on a scale Standard Deviation 44.3	14.2 units on a scale Standard Deviation 55.0	-3.3 units on a scale Standard Deviation 43.4

SECONDARY outcome

Timeframe: At Week 52

Population: Analysis was performed on Week 52 analysis set. 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: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this OM. 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. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=10 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.	Placebo+26 Week Taper n=6 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=6 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=11 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52 Cumulative worsening score	73.0 units on a scale Standard Deviation 50.3	84.7 units on a scale Standard Deviation 33.4	77.2 units on a scale Standard Deviation 41.7	52.8 units on a scale Standard Deviation 39.0
Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52 Aggregate improvement score	-19.5 units on a scale Standard Deviation 65.0	31.2 units on a scale Standard Deviation 54.7	23.7 units on a scale Standard Deviation 31.9	-0.5 units on a scale Standard Deviation 51.5

SECONDARY outcome

Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose (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 adverse event (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 SC IMP +60 days).

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TEAE	24 Participants	14 Participants	13 Participants	22 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any treatment emergent SAE	2 Participants	3 Participants	2 Participants	7 Participants

SECONDARY outcome

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

Population: Analyzed on PK analysis 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 arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=14 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.	Placebo+26 Week Taper n=26 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Baseline	0.00 nanograms per milliliter Standard Deviation 0.00	0.00 nanograms per milliliter Standard Deviation 0.00	—	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 2	2099.29 nanograms per milliliter Standard Deviation 3114.92	5400.82 nanograms per milliliter Standard Deviation 4124.63	—	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 4	4644.71 nanograms per milliliter Standard Deviation 5994.17	11640.98 nanograms per milliliter Standard Deviation 8574.00	—	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 12	8371.33 nanograms per milliliter Standard Deviation 7608.42	27586.00 nanograms per milliliter Standard Deviation 17496.07	—	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 16	8111.08 nanograms per milliliter Standard Deviation 5962.56	28911.88 nanograms per milliliter Standard Deviation 20821.06	—	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 24	12926.67 nanograms per milliliter Standard Deviation 9509.92	35451.74 nanograms per milliliter Standard Deviation 23953.29	—	—
Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab Week 52	19780.00 nanograms per milliliter Standard Deviation 21829.95	46766.67 nanograms per milliliter Standard Deviation 21172.15	—	—

SECONDARY outcome

Timeframe: post-dose at Week 24

Population: Analysis was performed on PK analysis 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 arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol.

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

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=11 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.	Placebo+26 Week Taper n=13 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24	25255.45 nanograms per milliliter Standard Deviation 17510.38	44551.54 nanograms per milliliter Standard Deviation 28298.62	—	—

SECONDARY outcome

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

Population: Analysis was performed on ADA population that included 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 non-missing ADA result in the ADA assay following the first dose of IMP.

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 SC IMP + 60 days). Titer values were categorized as low (titer \<1,000); moderate (1,000\<= titer \<=10,000) and high (titer \>10,000).

Outcome measures

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.	Placebo+26 Week Taper n=13 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=24 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response Treatment-boosted ADA positive participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response Treatment-emergent ADA positive participants	3.8 percentage of participants	0 percentage of participants	7.1 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category.

ESR is a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeters per hour.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Baseline	29.3 millimeters per hour Standard Deviation 27.3	21.9 millimeters per hour Standard Deviation 16.2	24.9 millimeters per hour Standard Deviation 22.0	18.2 millimeters per hour Standard Deviation 16.8
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 2	-1.1 millimeters per hour Standard Deviation 17.9	0.7 millimeters per hour Standard Deviation 11.4	-10.4 millimeters per hour Standard Deviation 16.4	-8.8 millimeters per hour Standard Deviation 12.4
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 4	-4.2 millimeters per hour Standard Deviation 21.4	5.2 millimeters per hour Standard Deviation 19.7	-13.3 millimeters per hour Standard Deviation 22.6	-9.4 millimeters per hour Standard Deviation 15.2
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 8	-2.0 millimeters per hour Standard Deviation 22.7	10.2 millimeters per hour Standard Deviation 12.6	-11.9 millimeters per hour Standard Deviation 18.9	-8.7 millimeters per hour Standard Deviation 16.1
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 12	-1.5 millimeters per hour Standard Deviation 24.9	9.8 millimeters per hour Standard Deviation 13.3	-14.7 millimeters per hour Standard Deviation 19.2	-11.0 millimeters per hour Standard Deviation 14.1
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 16	-4.1 millimeters per hour Standard Deviation 22.7	9.8 millimeters per hour Standard Deviation 16.5	-13.5 millimeters per hour Standard Deviation 18.1	-10.4 millimeters per hour Standard Deviation 12.7
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 20	-6.6 millimeters per hour Standard Deviation 23.7	8.8 millimeters per hour Standard Deviation 14.6	-18.2 millimeters per hour Standard Deviation 23.5	-10.9 millimeters per hour Standard Deviation 12.2
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 24	-4.2 millimeters per hour Standard Deviation 22.0	13.9 millimeters per hour Standard Deviation 16.1	-16.4 millimeters per hour Standard Deviation 25.6	-9.3 millimeters per hour Standard Deviation 11.5
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 32	-7.0 millimeters per hour Standard Deviation 21.3	6.6 millimeters per hour Standard Deviation 16.2	-9.4 millimeters per hour Standard Deviation 18.0	-7.9 millimeters per hour Standard Deviation 10.6
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 40	-1.5 millimeters per hour Standard Deviation 22.3	4.0 millimeters per hour Standard Deviation 18.1	-10.1 millimeters per hour Standard Deviation 25.2	-7.9 millimeters per hour Standard Deviation 8.6
Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 52	-1.0 millimeters per hour Standard Deviation 27.0	-1.4 millimeters per hour Standard Deviation 12.4	-15.2 millimeters per hour Standard Deviation 19.0	-7.0 millimeters per hour Standard Deviation 12.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category.

CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Baseline	10.9 milligrams per liter Standard Deviation 20.0	9.7 milligrams per liter Standard Deviation 18.3	10.1 milligrams per liter Standard Deviation 12.4	3.7 milligrams per liter Standard Deviation 6.2
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 2	0.4 milligrams per liter Standard Deviation 21.0	-1.0 milligrams per liter Standard Deviation 21.2	-3.5 milligrams per liter Standard Deviation 11.2	-2.0 milligrams per liter Standard Deviation 7.6
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 4	-3.6 milligrams per liter Standard Deviation 19.3	-2.2 milligrams per liter Standard Deviation 21.8	-2.6 milligrams per liter Standard Deviation 18.7	-1.9 milligrams per liter Standard Deviation 8.3
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 8	-4.0 milligrams per liter Standard Deviation 19.5	-0.9 milligrams per liter Standard Deviation 17.0	-3.5 milligrams per liter Standard Deviation 11.7	-1.7 milligrams per liter Standard Deviation 5.5
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 12	-4.4 milligrams per liter Standard Deviation 22.0	4.4 milligrams per liter Standard Deviation 18.9	-3.3 milligrams per liter Standard Deviation 17.9	-1.1 milligrams per liter Standard Deviation 8.4
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 16	-4.5 milligrams per liter Standard Deviation 20.7	5.0 milligrams per liter Standard Deviation 23.9	-5.0 milligrams per liter Standard Deviation 14.1	-1.8 milligrams per liter Standard Deviation 3.0
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 20	-4.5 milligrams per liter Standard Deviation 21.1	0.6 milligrams per liter Standard Deviation 17.6	-4.9 milligrams per liter Standard Deviation 13.6	-1.6 milligrams per liter Standard Deviation 2.9
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 24	-4.1 milligrams per liter Standard Deviation 19.5	0.3 milligrams per liter Standard Deviation 32.6	-3.1 milligrams per liter Standard Deviation 18.3	-1.0 milligrams per liter Standard Deviation 4.5
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 32	-5.2 milligrams per liter Standard Deviation 19.6	1.1 milligrams per liter Standard Deviation 35.4	-5.8 milligrams per liter Standard Deviation 17.1	-0.4 milligrams per liter Standard Deviation 6.5
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 40	-1.9 milligrams per liter Standard Deviation 22.3	-9.2 milligrams per liter Standard Deviation 27.0	-2.2 milligrams per liter Standard Deviation 11.1	-2.8 milligrams per liter Standard Deviation 3.5
Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52 Week 52	8.2 milligrams per liter Standard Deviation 27.4	-13.8 milligrams per liter Standard Deviation 37.0	-4.5 milligrams per liter Standard Deviation 5.2	-4.6 milligrams per liter Standard Deviation 4.4

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 12, 24, and 52

Population: Analysis was performed on safety population. Here, 'number analyzed' = participants with available data for each specified category.

Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 Baseline	10.91 nanograms per Liter Standard Deviation 12.85	8.74 nanograms per Liter Standard Deviation 5.78	11.03 nanograms per Liter Standard Deviation 15.33	7.71 nanograms per Liter Standard Deviation 7.30
Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 Week 2	2.90 nanograms per Liter Standard Deviation 17.46	3.47 nanograms per Liter Standard Deviation 10.30	31.74 nanograms per Liter Standard Deviation 31.13	117.33 nanograms per Liter Standard Deviation 245.28
Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 Week 12	-0.88 nanograms per Liter Standard Deviation 12.60	5.56 nanograms per Liter Standard Deviation 8.08	52.38 nanograms per Liter Standard Deviation 47.46	81.82 nanograms per Liter Standard Deviation 50.85
Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 Week 24	-1.03 nanograms per Liter Standard Deviation 7.15	5.57 nanograms per Liter Standard Deviation 19.81	53.60 nanograms per Liter Standard Deviation 53.71	69.20 nanograms per Liter Standard Deviation 46.89
Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52 Week 52	0.43 nanograms per Liter Standard Deviation 5.58	2.82 nanograms per Liter Standard Deviation 1.90	42.14 nanograms per Liter Standard Deviation 8.52	33.28 nanograms per Liter Standard Deviation 32.37

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 12, 24, and 52

Population: Analyzed on safety population. Here, 'Number Analyzed'=participants with available data for each specified category and '0' in number analyzed field signifies that no participants were available for assessments at specified time points in the respective arm.

Outcome measures

Outcome measures
Measure	Placebo+52 Week Taper n=28 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.	Placebo+26 Week Taper n=14 Participants Participants received sarilumab-matching placebo 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 150mg q2w+26 Week Taper n=14 Participants Participants received sarilumab 150 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.	Sarilumab 200mg q2w+26 Week Taper n=27 Participants Participants received sarilumab 200 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 26 weeks and prednisone-matching placebo from Week 26 up to Week 52.
Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 Baseline	136.63 nanograms per milliliter Standard Deviation 260.57	54.80 nanograms per milliliter Standard Deviation 18.48	50.05 nanograms per milliliter Standard Deviation 17.84	61.37 nanograms per milliliter Standard Deviation 72.43
Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 Week 2	—	—	212.19 nanograms per milliliter Standard Deviation 51.99	224.87 nanograms per milliliter Standard Deviation 107.43
Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 Week 12	17.67 nanograms per milliliter	—	336.30 nanograms per milliliter Standard Deviation 107.49	427.40 nanograms per milliliter Standard Deviation 124.97
Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 Week 24	-12.72 nanograms per milliliter Standard Deviation 3.97	—	311.88 nanograms per milliliter Standard Deviation 184.32	456.09 nanograms per milliliter Standard Deviation 118.07
Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52 Week 52	-131.47 nanograms per milliliter Standard Deviation 356.65	-9.69 nanograms per milliliter Standard Deviation 11.14	377.23 nanograms per milliliter Standard Deviation 84.99	471.16 nanograms per milliliter Standard Deviation 182.72

Adverse Events

Placebo+52 Week Taper

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo+26 Week Taper

Serious events: 3 serious events

Other events: 13 other events

Deaths: 1 deaths

Sarilumab 150mg q2w+26 Week Taper

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Sarilumab 200mg q2w+26 Week Taper

Serious events: 7 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Email: [email protected]

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