Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies · Source last updated 2014-09-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline to Week 264
What was measured
Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" \[symptom-free and no arthritis symptoms\], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
Analysis population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Groups in this outcome
Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Tocilizumab
2067
Reported measurements
ACR20 Week 48: Maintained 24 weeks (n=1937)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
41.2
Not reported
Not reported
Not reported
Not reported
ACR20 Week 96: Maintained 24 weeks (n=1745)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
53.0
Not reported
Not reported
Not reported
Not reported
ACR20 Week 96: Maintained 48 weeks (n=1745)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
43.0
Not reported
Not reported
Not reported
Not reported
ACR20 Week 144: Maintained 24 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
56.3
Not reported
Not reported
Not reported
Not reported
ACR20 Week 144: Maintained 48 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
48.7
Not reported
Not reported
Not reported
Not reported
ACR20 Week 144: Maintained 96 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
35.6
Not reported
Not reported
Not reported
Not reported
ACR20 Week 192: Maintained 24 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
60.0
Not reported
Not reported
Not reported
Not reported
ACR20 Week 192: Maintained 48 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
52.3
Not reported
Not reported
Not reported
Not reported
ACR20 Week 192: Maintained 96 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
41.3
Not reported
Not reported
Not reported
Not reported
ACR20 Week 192: Maintained 144 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
31.8
Not reported
Not reported
Not reported
Not reported
ACR20 Week 264: Maintained 24 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
63.0
Not reported
Not reported
Not reported
Not reported
ACR20 Week 264: Maintained 48 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
54.7
Not reported
Not reported
Not reported
Not reported
ACR20 Week 264: Maintained 96 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
46.2
Not reported
Not reported
Not reported
Not reported
ACR20 Week 264: Maintained 144 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
38.7
Not reported
Not reported
Not reported
Not reported
ACR20 Week 264: Maintained 192 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
32.6
Not reported
Not reported
Not reported
Not reported
ACR50 Week 48: Maintained 24 weeks (n=1937)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
20.7
Not reported
Not reported
Not reported
Not reported
ACR50 Week 96: Maintained 24 weeks (n=1745)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
32.0
Not reported
Not reported
Not reported
Not reported
ACR50 Week 96: Maintained 48 weeks (n=1745)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
22.8
Not reported
Not reported
Not reported
Not reported
ACR50 Week 144: Maintained 24 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
36.9
Not reported
Not reported
Not reported
Not reported
ACR50 Week 144: Maintained 48 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
28.4
Not reported
Not reported
Not reported
Not reported
ACR50 Week 144: Maintained 96 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
18.1
Not reported
Not reported
Not reported
Not reported
ACR50 Week 192: Maintained 24 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
39.8
Not reported
Not reported
Not reported
Not reported
ACR50 Week 192: Maintained 48 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
33.0
Not reported
Not reported
Not reported
Not reported
ACR50 Week 192: Maintained 96 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
22.7
Not reported
Not reported
Not reported
Not reported
ACR50 Week 192: Maintained 144 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
15.9
Not reported
Not reported
Not reported
Not reported
ACR50 Week 264: Maintained 24 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
42.3
Not reported
Not reported
Not reported
Not reported
ACR50 Week 264: Maintained 48 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
34.7
Not reported
Not reported
Not reported
Not reported
ACR50 Week 264: Maintained 96 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
27.6
Not reported
Not reported
Not reported
Not reported
ACR50 Week 264: Maintained 144 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
21.7
Not reported
Not reported
Not reported
Not reported
ACR50 Week 264: Maintained 192 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
16.6
Not reported
Not reported
Not reported
Not reported
ACR70 Week 48: Maintained 24 weeks (n=1937)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
8.5
Not reported
Not reported
Not reported
Not reported
ACR70 Week 96: Maintained 24 weeks (n=1745)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
16.2
Not reported
Not reported
Not reported
Not reported
ACR70 Week 96: Maintained 48 weeks (n=1745)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
11.2
Not reported
Not reported
Not reported
Not reported
ACR70 Week 144: Maintained 4 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
20.9
Not reported
Not reported
Not reported
Not reported
ACR70 Week 144: Maintained 48 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
15.0
Not reported
Not reported
Not reported
Not reported
ACR70 Week 144: Maintained 96 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
8.7
Not reported
Not reported
Not reported
Not reported
ACR70 Week 192: Maintained 24 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
22.9
Not reported
Not reported
Not reported
Not reported
ACR70 Week 192: Maintained 48 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
17.6
Not reported
Not reported
Not reported
Not reported
ACR70 Week 192: Maintained 96 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
11.4
Not reported
Not reported
Not reported
Not reported
ACR70 Week 192: Maintained 144 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
7.3
Not reported
Not reported
Not reported
Not reported
ACR70 Week 264: Maintained 24 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
24.9
Not reported
Not reported
Not reported
Not reported
ACR70 Week 264: Maintained 48 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
19.7
Not reported
Not reported
Not reported
Not reported
ACR70 Week 264: Maintained 96 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
14.4
Not reported
Not reported
Not reported
Not reported
ACR70 Week 264: Maintained 144 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
11.0
Not reported
Not reported
Not reported
Not reported
ACR70 Week 264: Maintained 192 weeks (n=1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
7.7
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
41.2
title
ACR20 Week 48: Maintained 24 weeks (n=1937)
categories
measurements
group Id
OG000
value
53.0
title
ACR20 Week 96: Maintained 24 weeks (n=1745)
categories
measurements
group Id
OG000
value
43.0
title
ACR20 Week 96: Maintained 48 weeks (n=1745)
categories
measurements
group Id
OG000
value
56.3
title
ACR20 Week 144: Maintained 24 weeks (n=1615)
categories
measurements
group Id
OG000
value
48.7
title
ACR20 Week 144: Maintained 48 weeks (n=1615)
categories
measurements
group Id
OG000
value
35.6
title
ACR20 Week 144: Maintained 96 weeks (n=1615)
categories
measurements
group Id
OG000
value
60.0
title
ACR20 Week 192: Maintained 24 weeks (n=1514)
categories
measurements
group Id
OG000
value
52.3
title
ACR20 Week 192: Maintained 48 weeks (n=1514)
categories
measurements
group Id
OG000
value
41.3
title
ACR20 Week 192: Maintained 96 weeks (n=1514)
categories
measurements
group Id
OG000
value
31.8
title
ACR20 Week 192: Maintained 144 weeks (n=1514)
categories
measurements
group Id
OG000
value
63.0
title
ACR20 Week 264: Maintained 24 weeks (n=1358)
categories
measurements
group Id
OG000
value
54.7
title
ACR20 Week 264: Maintained 48 weeks (n=1358)
denoms
counts
group Id
OG000
value
2067
units
Participants
description
Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" \[symptom-free and no arthritis symptoms\], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
groups
description
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
id
OG000
title
Tocilizumab
param Type
NUMBER
population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
time Frame
Baseline to Week 264
title
Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264
Triangle