Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 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
A DAS-28 responder was defined as someone who met the European League Against Rheumatism \[EULAR\] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.
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
Week 48: Maintained response 24 weeks (n=1937)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
67.6
Not reported
Not reported
Not reported
Not reported
Week 96: Maintained response 24 weeks (n=1745)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
72.7
Not reported
Not reported
Not reported
Not reported
Week 96: Maintained response 48 weeks (n=1745)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
63.4
Not reported
Not reported
Not reported
Not reported
Week 144: Maintained response 24 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
73.1
Not reported
Not reported
Not reported
Not reported
Week 144: Maintained response 48 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
64.1
Not reported
Not reported
Not reported
Not reported
Week 144: Maintained response 96 weeks (n=1615)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
52.9
Not reported
Not reported
Not reported
Not reported
Week 192: Maintained response 24 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
73.3
Not reported
Not reported
Not reported
Not reported
Week 192: Maintained response 48 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
64.7
Not reported
Not reported
Not reported
Not reported
Week 192: Maintained response 96 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
53.6
Not reported
Not reported
Not reported
Not reported
Week 192: Maintained response 144 weeks (n=1514)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
45.5
Not reported
Not reported
Not reported
Not reported
Week 264: Maintained response 24 weeks (n = 1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
76.7
Not reported
Not reported
Not reported
Not reported
Week 264: Maintained response 48 weeks (n = 1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
68.6
Not reported
Not reported
Not reported
Not reported
Week 264: Maintained response 96 weeks (n = 1358)
Values in Percentage of participants · Interval/dispersion: Not reported
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tocilizumab
42.1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
67.6
title
Week 48: Maintained response 24 weeks (n=1937)
categories
measurements
group Id
OG000
value
72.7
title
Week 96: Maintained response 24 weeks (n=1745)
categories
measurements
group Id
OG000
value
63.4
title
Week 96: Maintained response 48 weeks (n=1745)
categories
measurements
group Id
OG000
value
73.1
title
Week 144: Maintained response 24 weeks (n=1615)
categories
measurements
group Id
OG000
value
64.1
title
Week 144: Maintained response 48 weeks (n=1615)
categories
measurements
group Id
OG000
value
52.9
title
Week 144: Maintained response 96 weeks (n=1615)
categories
measurements
group Id
OG000
value
73.3
title
Week 192: Maintained response 24 weeks (n=1514)
categories
measurements
group Id
OG000
value
64.7
title
Week 192: Maintained response 48 weeks (n=1514)
categories
measurements
group Id
OG000
value
53.6
title
Week 192: Maintained response 96 weeks (n=1514)
categories
measurements
group Id
OG000
value
45.5
title
Week 192: Maintained response 144 weeks (n=1514)
categories
measurements
group Id
OG000
value
76.7
title
Week 264: Maintained response 24 weeks (n = 1358)
categories
measurements
group Id
OG000
value
68.6
title
Week 264: Maintained response 48 weeks (n = 1358)
denoms
counts
group Id
OG000
value
2067
units
Participants
description
A DAS-28 responder was defined as someone who met the European League Against Rheumatism \[EULAR\] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.
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 a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264
Triangle