Trial Outcomes & Findings for To Estimate the Efficacy of Treatment With TNFi as Monotherapy or Combination Therapy With MTX and Compare and Contrast Efficacy With Tofacitinib as Monotherapy and Combination Therapy in a Real World Setting. (NCT NCT05576051)
NCT ID: NCT05576051
Last Updated: 2025-12-23
Results Overview
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
COMPLETED
9159 participants
At month 6 follow up visit
2025-12-23
Participant Flow
Data from greater than (\>) 5500 participants who initiated Tumor Necrosis Factor Inhibitor (TNFi) initiation as combination with Methotrexate (MTX) and \>2000 participants who initiated TNFi initiations as monotherapy; \> 500 participants who initiated Tofacitinib initiations as monotherapy or as combination with MTX were observed in this non-interventional observational study.
Participants diagnosed with rheumatoid arthritis (RA), enrolled in Corrona US-based observational RA registry were included in this study.
Participant milestones
| Measure |
All Tumor Necrosis Factor Inhibitor (TNFi) Initiators Combination
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFi Initiators Monotherapy
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
TNFi Initiators After 11/6/2012 Combination
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
TNFi Initiators After 11/6/2012 Monotherapy
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
Tofacitinib Initiators Combination
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
Tofacitinib Initiators Monotherapy
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5077
|
2275
|
987
|
494
|
124
|
202
|
|
Overall Study
COMPLETED
|
4215
|
1724
|
825
|
394
|
86
|
147
|
|
Overall Study
NOT COMPLETED
|
862
|
551
|
162
|
100
|
38
|
55
|
Reasons for withdrawal
| Measure |
All Tumor Necrosis Factor Inhibitor (TNFi) Initiators Combination
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFi Initiators Monotherapy
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
TNFi Initiators After 11/6/2012 Combination
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
TNFi Initiators After 11/6/2012 Monotherapy
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
Tofacitinib Initiators Combination
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
Tofacitinib Initiators Monotherapy
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
543
|
343
|
108
|
72
|
28
|
50
|
|
Overall Study
Safety
|
78
|
74
|
16
|
14
|
4
|
5
|
|
Overall Study
Efficacy + Safety
|
10
|
7
|
3
|
0
|
0
|
0
|
|
Overall Study
Other
|
231
|
127
|
35
|
14
|
6
|
0
|
Baseline Characteristics
Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
Baseline characteristics by cohort
| Measure |
All TNFi Initiators Combination
n=4056 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFi Initiators Monotherapy
n=1716 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
TNFi Initiators After 11/6/2012 Combination
n=838 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
TNFi Initiators After 11/6/2012 Monotherapy
n=406 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
Tofacitinib Initiators Combination
n=96 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
Tofacitinib Initiators Monotherapy
n=145 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
Total
n=7257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
All TNFi initiators combination
|
56 Years
n=4056 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
—
|
—
|
—
|
—
|
—
|
56 Years
n=4056 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
|
Age, Continuous
All TNFi initiators monotherapy
|
—
|
55 Years
n=1716 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
—
|
—
|
—
|
—
|
55 Years
n=1716 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
|
Age, Continuous
TNFi initiators after 11/6/2012 combination
|
—
|
—
|
58 Years
n=838 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
—
|
—
|
—
|
58 Years
n=838 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
|
Age, Continuous
TNFi initiators after 11/6/2012 monotherapy
|
—
|
—
|
—
|
55 Years
n=406 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
—
|
—
|
55 Years
n=406 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
|
Age, Continuous
Tofacitinib initiators combination
|
—
|
—
|
—
|
—
|
59 Years
n=96 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
—
|
59 Years
n=96 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
|
Age, Continuous
Tofacitinib initiators monotherapy
|
—
|
—
|
—
|
—
|
—
|
59 Years
n=145 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
59 Years
n=145 Participants • Here, "Number Analyzed" signifies number of participants evaluable for specified arms.
|
|
Sex: Female, Male
Female
|
3121 Participants
n=4056 Participants
|
1354 Participants
n=1716 Participants
|
653 Participants
n=838 Participants
|
330 Participants
n=406 Participants
|
76 Participants
n=96 Participants
|
118 Participants
n=145 Participants
|
5652 Participants
n=7257 Participants
|
|
Sex: Female, Male
Male
|
935 Participants
n=4056 Participants
|
362 Participants
n=1716 Participants
|
185 Participants
n=838 Participants
|
76 Participants
n=406 Participants
|
20 Participants
n=96 Participants
|
27 Participants
n=145 Participants
|
1605 Participants
n=7257 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
256 Participants
n=4056 Participants
|
110 Participants
n=1716 Participants
|
71 Participants
n=838 Participants
|
28 Participants
n=406 Participants
|
6 Participants
n=96 Participants
|
14 Participants
n=145 Participants
|
485 Participants
n=7257 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=4056 Participants
|
0 Participants
n=1716 Participants
|
0 Participants
n=838 Participants
|
0 Participants
n=406 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=7257 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3800 Participants
n=4056 Participants
|
1606 Participants
n=1716 Participants
|
767 Participants
n=838 Participants
|
378 Participants
n=406 Participants
|
90 Participants
n=96 Participants
|
131 Participants
n=145 Participants
|
6772 Participants
n=7257 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4056 Participants
|
0 Participants
n=1716 Participants
|
0 Participants
n=838 Participants
|
0 Participants
n=406 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=7257 Participants
|
|
Race (NIH/OMB)
Asian
|
50 Participants
n=4056 Participants
|
14 Participants
n=1716 Participants
|
16 Participants
n=838 Participants
|
5 Participants
n=406 Participants
|
1 Participants
n=96 Participants
|
1 Participants
n=145 Participants
|
87 Participants
n=7257 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4056 Participants
|
0 Participants
n=1716 Participants
|
0 Participants
n=838 Participants
|
0 Participants
n=406 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=7257 Participants
|
|
Race (NIH/OMB)
Black or African American
|
268 Participants
n=4056 Participants
|
98 Participants
n=1716 Participants
|
56 Participants
n=838 Participants
|
28 Participants
n=406 Participants
|
4 Participants
n=96 Participants
|
7 Participants
n=145 Participants
|
461 Participants
n=7257 Participants
|
|
Race (NIH/OMB)
White
|
3389 Participants
n=4056 Participants
|
1454 Participants
n=1716 Participants
|
675 Participants
n=838 Participants
|
335 Participants
n=406 Participants
|
84 Participants
n=96 Participants
|
118 Participants
n=145 Participants
|
6055 Participants
n=7257 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4056 Participants
|
0 Participants
n=1716 Participants
|
0 Participants
n=838 Participants
|
0 Participants
n=406 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=7257 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
349 Participants
n=4056 Participants
|
150 Participants
n=1716 Participants
|
91 Participants
n=838 Participants
|
38 Participants
n=406 Participants
|
7 Participants
n=96 Participants
|
19 Participants
n=145 Participants
|
654 Participants
n=7257 Participants
|
|
History of Cardiovascular disease
|
306 Participants
n=4056 Participants
|
139 Participants
n=1716 Participants
|
69 Participants
n=838 Participants
|
32 Participants
n=406 Participants
|
8 Participants
n=96 Participants
|
16 Participants
n=145 Participants
|
570 Participants
n=7257 Participants
|
|
History of cancer excluding nonmelanoma skin cancer
|
194 Participants
n=4056 Participants
|
84 Participants
n=1716 Participants
|
32 Participants
n=838 Participants
|
14 Participants
n=406 Participants
|
6 Participants
n=96 Participants
|
11 Participants
n=145 Participants
|
341 Participants
n=7257 Participants
|
|
History of Diabetes
|
300 Participants
n=4056 Participants
|
150 Participants
n=1716 Participants
|
74 Participants
n=838 Participants
|
39 Participants
n=406 Participants
|
9 Participants
n=96 Participants
|
16 Participants
n=145 Participants
|
588 Participants
n=7257 Participants
|
|
Smoker
Never smoker
|
2084 Participants
n=4056 Participants
|
864 Participants
n=1716 Participants
|
388 Participants
n=838 Participants
|
195 Participants
n=406 Participants
|
49 Participants
n=96 Participants
|
78 Participants
n=145 Participants
|
3658 Participants
n=7257 Participants
|
|
Smoker
Previous smoker
|
1163 Participants
n=4056 Participants
|
514 Participants
n=1716 Participants
|
267 Participants
n=838 Participants
|
127 Participants
n=406 Participants
|
33 Participants
n=96 Participants
|
45 Participants
n=145 Participants
|
2149 Participants
n=7257 Participants
|
|
Smoker
Current smoker
|
787 Participants
n=4056 Participants
|
327 Participants
n=1716 Participants
|
172 Participants
n=838 Participants
|
77 Participants
n=406 Participants
|
13 Participants
n=96 Participants
|
21 Participants
n=145 Participants
|
1397 Participants
n=7257 Participants
|
|
Smoker
Unknown or not reported
|
22 Participants
n=4056 Participants
|
11 Participants
n=1716 Participants
|
11 Participants
n=838 Participants
|
7 Participants
n=406 Participants
|
1 Participants
n=96 Participants
|
1 Participants
n=145 Participants
|
53 Participants
n=7257 Participants
|
|
Work Status
Full Time
|
1697 Participants
n=4056 Participants
|
672 Participants
n=1716 Participants
|
331 Participants
n=838 Participants
|
150 Participants
n=406 Participants
|
29 Participants
n=96 Participants
|
41 Participants
n=145 Participants
|
2920 Participants
n=7257 Participants
|
|
Work Status
Part time
|
412 Participants
n=4056 Participants
|
160 Participants
n=1716 Participants
|
89 Participants
n=838 Participants
|
44 Participants
n=406 Participants
|
7 Participants
n=96 Participants
|
10 Participants
n=145 Participants
|
722 Participants
n=7257 Participants
|
|
Work Status
Work at home
|
424 Participants
n=4056 Participants
|
190 Participants
n=1716 Participants
|
62 Participants
n=838 Participants
|
35 Participants
n=406 Participants
|
17 Participants
n=96 Participants
|
12 Participants
n=145 Participants
|
740 Participants
n=7257 Participants
|
|
Work Status
Student
|
73 Participants
n=4056 Participants
|
34 Participants
n=1716 Participants
|
45 Participants
n=838 Participants
|
20 Participants
n=406 Participants
|
1 Participants
n=96 Participants
|
4 Participants
n=145 Participants
|
177 Participants
n=7257 Participants
|
|
Work Status
Retired
|
526 Participants
n=4056 Participants
|
298 Participants
n=1716 Participants
|
110 Participants
n=838 Participants
|
73 Participants
n=406 Participants
|
15 Participants
n=96 Participants
|
33 Participants
n=145 Participants
|
1055 Participants
n=7257 Participants
|
|
Work Status
Disabled
|
884 Participants
n=4056 Participants
|
345 Participants
n=1716 Participants
|
191 Participants
n=838 Participants
|
79 Participants
n=406 Participants
|
24 Participants
n=96 Participants
|
40 Participants
n=145 Participants
|
1563 Participants
n=7257 Participants
|
|
Work Status
Unknown or not reported
|
40 Participants
n=4056 Participants
|
17 Participants
n=1716 Participants
|
10 Participants
n=838 Participants
|
5 Participants
n=406 Participants
|
3 Participants
n=96 Participants
|
5 Participants
n=145 Participants
|
80 Participants
n=7257 Participants
|
|
Insurance
None
|
96 Participants
n=4056 Participants
|
42 Participants
n=1716 Participants
|
28 Participants
n=838 Participants
|
20 Participants
n=406 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=145 Participants
|
186 Participants
n=7257 Participants
|
|
Insurance
Private
|
3059 Participants
n=4056 Participants
|
1293 Participants
n=1716 Participants
|
609 Participants
n=838 Participants
|
296 Participants
n=406 Participants
|
62 Participants
n=96 Participants
|
112 Participants
n=145 Participants
|
5431 Participants
n=7257 Participants
|
|
Insurance
Medicaid
|
242 Participants
n=4056 Participants
|
110 Participants
n=1716 Participants
|
45 Participants
n=838 Participants
|
32 Participants
n=406 Participants
|
5 Participants
n=96 Participants
|
8 Participants
n=145 Participants
|
442 Participants
n=7257 Participants
|
|
Insurance
Medicare
|
1054 Participants
n=4056 Participants
|
454 Participants
n=1716 Participants
|
237 Participants
n=838 Participants
|
114 Participants
n=406 Participants
|
38 Participants
n=96 Participants
|
49 Participants
n=145 Participants
|
1946 Participants
n=7257 Participants
|
PRIMARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed (n)" signifies number of participants evaluable for specified rows.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=96 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=145 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)
All
|
18.1 Units on a scale
Standard Deviation 15.1
|
17 Units on a scale
Standard Deviation 13.4
|
|
Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)
Non-switchers
|
16.6 Units on a scale
Standard Deviation 14.3
|
14.6 Units on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "n" signifies number of participants evaluable for specified rows. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for CDAI score outcome measure as CDAI score data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=4056 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=1716 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX
Non-switchers
|
13 Units on a scale
Standard Deviation 11.8
|
14.9 Units on a scale
Standard Deviation 13
|
|
CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX
All
|
13.9 Units on a scale
Standard Deviation 12.5
|
16.5 Units on a scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=4056 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=145 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
Non-switchers
|
13 Units on a scale
Standard Deviation 11.8
|
14.6 Units on a scale
Standard Deviation 11.6
|
|
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
All
|
13.9 Units on a scale
Standard Deviation 12.5
|
17 Units on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=1716 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=96 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
All
|
16.5 Units on a scale
Standard Deviation 13.8
|
18.1 Units on a scale
Standard Deviation 15.1
|
|
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
Non-switchers
|
14.9 Units on a scale
Standard Deviation 13
|
16.6 Units on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=4056 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=96 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
Non-switchers
|
13 Units on a scale
Standard Deviation 11.8
|
16.6 Units on a scale
Standard Deviation 14.3
|
|
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
All
|
13.9 Units on a scale
Standard Deviation 12.5
|
18.1 Units on a scale
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=1716 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=145 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
All
|
16.5 Units on a scale
Standard Deviation 13.8
|
17 Units on a scale
Standard Deviation 13.4
|
|
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
Non-switchers
|
14.9 Units on a scale
Standard Deviation 13
|
14.6 Units on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed (N)" signifies number of participants evaluable for this outcome measure.
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Outcome measures
| Measure |
All TNFi Initiators Combination
n=90 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=135 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX
|
19 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "N" signifies number of participants evaluable for this outcome measure. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for mACR20 outcome measure as mACR20 data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms.
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Outcome measures
| Measure |
All TNFi Initiators Combination
n=4013 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=1683 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX
|
1224 Participants
|
394 Participants
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Outcome measures
| Measure |
All TNFi Initiators Combination
n=4013 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=135 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
|
1224 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Outcome measures
| Measure |
All TNFi Initiators Combination
n=1683 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=135 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
|
394 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Outcome measures
| Measure |
All TNFi Initiators Combination
n=4013 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=90 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
|
1224 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: At month 6 follow up visitPopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Outcome measures
| Measure |
All TNFi Initiators Combination
n=1683 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=90 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
|
394 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of 1st line, 2nd line, 3rd line, and 4th line of therapy was reported in this outcome measure.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=5077 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=2275 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants According to Line of Therapy at TNFi Initiation
1st line
|
203 Participants
|
89 Participants
|
|
Number of Participants According to Line of Therapy at TNFi Initiation
3rd line
|
1088 Participants
|
581 Participants
|
|
Number of Participants According to Line of Therapy at TNFi Initiation
Missing
|
1021 Participants
|
559 Participants
|
|
Number of Participants According to Line of Therapy at TNFi Initiation
4th line
|
656 Participants
|
430 Participants
|
|
Number of Participants According to Line of Therapy at TNFi Initiation
2nd line
|
2109 Participants
|
616 Participants
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at TNFi initiation after 11/6/2012 was reported in this outcome measure.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=987 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=745 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012
1st line
|
54 Participants
|
361 Participants
|
|
Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012
2nd line
|
388 Participants
|
123 Participants
|
|
Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012
3rd line
|
212 Participants
|
118 Participants
|
|
Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012
4th line
|
184 Participants
|
143 Participants
|
|
Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012
Missing
|
149 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at tofacitinib initiation was reported in this outcome measure.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=124 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=202 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants According to Line of Therapy at Tofacitinib Initiation
1st line
|
6 Participants
|
12 Participants
|
|
Number of Participants According to Line of Therapy at Tofacitinib Initiation
3rd line
|
11 Participants
|
22 Participants
|
|
Number of Participants According to Line of Therapy at Tofacitinib Initiation
4th line
|
67 Participants
|
99 Participants
|
|
Number of Participants According to Line of Therapy at Tofacitinib Initiation
Missing
|
28 Participants
|
57 Participants
|
|
Number of Participants According to Line of Therapy at Tofacitinib Initiation
2nd line
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi Initiator.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=4056 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=1716 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Median CDAI Score at Baseline- TNFi Initiator
|
18.6 Units on a scale
Interval 10.1 to 29.3
|
19.7 Units on a scale
Interval 10.5 to 29.9
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of Tofacitinib Initiator.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=96 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=145 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Median CDAI Score at Baseline- Tofacitinib Initiator
|
22.1 Units on a scale
Interval 10.6 to 33.1
|
19 Units on a scale
Interval 10.0 to 28.3
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi initiator after 11-6-2012.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=838 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=406 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012
|
19.5 Units on a scale
Interval 11.5 to 30.5
|
21 Units on a scale
Interval 12.0 to 30.0
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at TNFi initiation was reported in this outcome measure. Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=2341 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=1396 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Abatacept
|
295 Participants
|
265 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Rituximab
|
145 Participants
|
89 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Tocilizumab
|
76 Participants
|
74 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Anakinra
|
85 Participants
|
52 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Infliximab
|
707 Participants
|
434 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Adalimumab
|
975 Participants
|
634 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Etanercept
|
1286 Participants
|
872 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Golimumab
|
7 Participants
|
12 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Certolizumab pegol
|
137 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy (LOT): prior use of at least one biologic) use at TNFi initiation after 11/6/2012 was reported in this outcome measure.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=517 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=331 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Golimumab
|
7 Participants
|
12 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Infliximab
|
147 Participants
|
93 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Etanercept
|
246 Participants
|
194 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Abatacept
|
110 Participants
|
100 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Rituximab
|
42 Participants
|
28 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Anakinra
|
6 Participants
|
7 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Adalimumab
|
233 Participants
|
176 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Certolizumab pegol
|
60 Participants
|
33 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Tocilizumab
|
45 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: At baselinePopulation: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at tofacitinib initiation was reported in this outcome measure.
Outcome measures
| Measure |
All TNFi Initiators Combination
n=110 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
All TNFI Initiators Monotherapy
n=187 Participants
Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.
|
|---|---|---|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Golimumab
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Certolizumab pegol
|
29 Participants
|
42 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Abatacept
|
58 Participants
|
105 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Rituximab
|
35 Participants
|
41 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Tocilizumab
|
40 Participants
|
60 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Infliximab
|
41 Participants
|
82 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Adalimumab
|
72 Participants
|
109 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Etanercept
|
61 Participants
|
123 Participants
|
|
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Anakinra
|
6 Participants
|
12 Participants
|
Adverse Events
All TNFi Initiators Combination
All TNFi Initiators Monotherapy
TNFi Initiators After 11/6/2012 Combination
TNFi Initiators After 11/6/2012 Monotherapy
Tofacitinib Initiators Combination
Tofacitinib Initiators Monotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER