Trial Outcomes & Findings for Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy. (NCT NCT04721821)
NCT ID: NCT04721821
Last Updated: 2024-04-12
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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to (\<=)10 in participants with moderate or high disease activity CDAI greater than (\>) 10 at baseline. Propensity score method was used for analysis of the outcome measure.
COMPLETED
7807 participants
Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
2024-04-12
Participant Flow
Data of participants diagnosed with rheumatoid arthritis (RA), enrolled in Corrona RA registry, initiated tofacitinib or tumor necrosis factor inhibitors (TNFis) on or after 06-November-2012, after failure with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) treatment, were included.
Data was collected retrospectively for observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years). Data from eligible participants for aforesaid observation period were retrieved and observed in this retrospective study from 22-January-2021 to 29-November-2021 (approximately 10 months).
Participant milestones
| Measure |
Tofacitinib (6-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
TNFis (6-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
TNFis (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
989
|
3337
|
805
|
2676
|
|
Overall Study
COMPLETED
|
989
|
3337
|
805
|
2676
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
Baseline characteristics by cohort
| Measure |
Tofacitinib (6-Month Follow-up)
n=989 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
TNFis (6-Month Follow-up)
n=3337 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib (12-Month Follow-up)
n=805 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
TNFis (12-Month Follow-up)
n=2676 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Total
n=7807 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 11.8 • n=987 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
58.4 Years
STANDARD_DEVIATION 12.8 • n=3334 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
59.9 Years
STANDARD_DEVIATION 11.9 • n=803 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
58.9 Years
STANDARD_DEVIATION 12.6 • n=2671 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
59.0 Years
STANDARD_DEVIATION 12.5 • n=7795 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
|
Sex: Female, Male
Female
|
804 Participants
n=987 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
2634 Participants
n=3337 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
651 Participants
n=803 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
2094 Participants
n=2674 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
6183 Participants
n=7801 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
|
Sex: Female, Male
Male
|
183 Participants
n=987 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
703 Participants
n=3337 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
152 Participants
n=803 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
580 Participants
n=2674 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
1618 Participants
n=7801 Participants • "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported.
|
|
Race/Ethnicity, Customized
White
|
846 Participants
n=989 Participants
|
2,716 Participants
n=3337 Participants
|
697 Participants
n=805 Participants
|
2199 Participants
n=2676 Participants
|
6458 Participants
n=7807 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
67 Participants
n=989 Participants
|
272 Participants
n=3337 Participants
|
53 Participants
n=805 Participants
|
192 Participants
n=2676 Participants
|
584 Participants
n=7807 Participants
|
|
Race/Ethnicity, Customized
Black
|
42 Participants
n=989 Participants
|
212 Participants
n=3337 Participants
|
30 Participants
n=805 Participants
|
167 Participants
n=2676 Participants
|
451 Participants
n=7807 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=989 Participants
|
55 Participants
n=3337 Participants
|
6 Participants
n=805 Participants
|
40 Participants
n=2676 Participants
|
107 Participants
n=7807 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=989 Participants
|
50 Participants
n=3337 Participants
|
5 Participants
n=805 Participants
|
44 Participants
n=2676 Participants
|
112 Participants
n=7807 Participants
|
|
Race/Ethnicity, Customized
Missing
|
15 Participants
n=989 Participants
|
32 Participants
n=3337 Participants
|
14 Participants
n=805 Participants
|
34 Participants
n=2676 Participants
|
95 Participants
n=7807 Participants
|
PRIMARY outcome
Timeframe: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to (\<=)10 in participants with moderate or high disease activity CDAI greater than (\>) 10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=502 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=513 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall
|
—
|
—
|
129 Participants
|
140 Participants
|
PRIMARY outcome
Timeframe: Month 6 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity CDAI \>10 at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=228 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=231 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
—
|
—
|
66 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: Month 6 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=469 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=438 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy
|
—
|
—
|
166 Participants
|
154 Participants
|
PRIMARY outcome
Timeframe: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=223 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=222 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy
|
—
|
—
|
59 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=310 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=301 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
|
—
|
—
|
82 Participants
|
82 Participants
|
PRIMARY outcome
Timeframe: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=419 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=417 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall
|
—
|
—
|
104 Participants
|
127 Participants
|
PRIMARY outcome
Timeframe: Month 12 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=180 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=176 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
—
|
—
|
44 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: Month 12 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=362 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=356 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy
|
—
|
—
|
123 Participants
|
129 Participants
|
PRIMARY outcome
Timeframe: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=160 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=165 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
|
—
|
—
|
40 Participants
|
52 Participants
|
PRIMARY outcome
Timeframe: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI\>10) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI \<=10 in participants with moderate or high disease activity CDAI\>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=234 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=240 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
|
—
|
—
|
57 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=572 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=565 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=686 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=680 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
|
53 Participants
|
61 Participants
|
61 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=259 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=251 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=317 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=311 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
23 Participants
|
24 Participants
|
29 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=474 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=485 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=606 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=604 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
|
55 Participants
|
56 Participants
|
69 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=230 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=236 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=315 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=316 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
|
20 Participants
|
30 Participants
|
28 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI \>2.8) at baseline.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of remission was defined by CDAI (\<=2.8) in those participants with LDA, moderate or high disease activity (CDAI \>2.8) at baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=319 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=317 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=414 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=412 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
|
26 Participants
|
23 Participants
|
34 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
|
-3.29 Units on a scale
Standard Deviation 13.28
|
-4.39 Units on a scale
Standard Deviation 11.82
|
-3.85 Units on a scale
Standard Deviation 12.71
|
-3.98 Units on a scale
Standard Deviation 12.64
|
SECONDARY outcome
Timeframe: Baseline,Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
-3.30 Units on a scale
Standard Deviation 13.68
|
-2.31 Units on a scale
Standard Deviation 12.23
|
-3.43 Units on a scale
Standard Deviation 12.77
|
-2.66 Units on a scale
Standard Deviation 12.59
|
SECONDARY outcome
Timeframe: Baseline, Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
|
-5.07 Units on a scale
Standard Deviation 12.08
|
-3.49 Units on a scale
Standard Deviation 11.76
|
-4.39 Units on a scale
Standard Deviation 12.32
|
-4.36 Units on a scale
Standard Deviation 11.82
|
SECONDARY outcome
Timeframe: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy
|
-3.33 Units on a scale
Standard Deviation 13.51
|
-4.39 Units on a scale
Standard Deviation 10.85
|
-3.26 Units on a scale
Standard Deviation 12.68
|
-3.66 Units on a scale
Standard Deviation 12.41
|
SECONDARY outcome
Timeframe: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy
|
-3.28 Units on a scale
Standard Deviation 12.59
|
-4.29 Units on a scale
Standard Deviation 12.23
|
-3.92 Units on a scale
Standard Deviation 13.20
|
-4.53 Units on a scale
Standard Deviation 11.94
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mACR 20/50/70 response was defined as response greater than or equal to( \>=) 20 percent (%), 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the modified Health Assessment Questionnaire (mHAQ) \[scored from 0 to 3, higher scores indicated worsening of function\]. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=608 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=602 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=731 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=730 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
mACR 20
|
114 Participants
|
109 Participants
|
138 Participants
|
143 Participants
|
|
Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
mACR 50
|
52 Participants
|
63 Participants
|
73 Participants
|
87 Participants
|
|
Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
mACR 70
|
22 Participants
|
33 Participants
|
33 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=272 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=267 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=333 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=328 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
mACR 20
|
46 Participants
|
43 Participants
|
63 Participants
|
56 Participants
|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
mACR 50
|
20 Participants
|
19 Participants
|
38 Participants
|
25 Participants
|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
mACR 70
|
12 Participants
|
8 Participants
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=531 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=533 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=666 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=663 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
mACR 20
|
111 Participants
|
107 Participants
|
137 Participants
|
151 Participants
|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
mACR 50
|
59 Participants
|
59 Participants
|
90 Participants
|
85 Participants
|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
mACR 70
|
34 Participants
|
26 Participants
|
47 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=244 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=244 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=338 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=340 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
mACR 20
|
42 Participants
|
33 Participants
|
66 Participants
|
66 Participants
|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
mACR 50
|
21 Participants
|
19 Participants
|
36 Participants
|
37 Participants
|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
mACR 70
|
12 Participants
|
9 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mACR 20/50/70 response was defined as response \>= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function). Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=341 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=442 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=439 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
mACR 20
|
65 Participants
|
57 Participants
|
91 Participants
|
91 Participants
|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
mACR 50
|
30 Participants
|
32 Participants
|
47 Participants
|
39 Participants
|
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
mACR 70
|
10 Participants
|
14 Participants
|
24 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR \>3.2 at baseline.
DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=265 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=232 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=314 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=279 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
|
44 Participants
|
40 Participants
|
54 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR \>3.2 at baseline.
DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=112 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=108 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=131 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=149 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
14 Participants
|
16 Participants
|
24 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR \>3.2 at baseline.
DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=204 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=205 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=255 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=236 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
|
39 Participants
|
45 Participants
|
62 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR \>3.2 at baseline.
DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=95 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=88 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=129 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=129 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
|
12 Participants
|
17 Participants
|
23 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR \>3.2 at baseline.
DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\*sqrt (PJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR \<= 3.2 = low disease activity, DAS28 ESR \> 3.2 and \<=5.1 = moderate and \>5.1 = high disease activity. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=151 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=143 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=201 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=167 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy
|
24 Participants
|
24 Participants
|
36 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
|
0.98 Units on a scale
Standard Deviation 0.73
|
1.05 Units on a scale
Standard Deviation 0.74
|
1.02 Units on a scale
Standard Deviation 0.71
|
1.06 Units on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
1.06 Units on a scale
Standard Deviation 0.74
|
1.04 Units on a scale
Standard Deviation 0.75
|
1.05 Units on a scale
Standard Deviation 0.72
|
1.10 Units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
|
0.95 Units on a scale
Standard Deviation 0.71
|
0.98 Units on a scale
Standard Deviation 0.73
|
0.92 Units on a scale
Standard Deviation 0.71
|
0.88 Units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
|
1.01 Units on a scale
Standard Deviation 0.72
|
0.99 Units on a scale
Standard Deviation 0.73
|
0.98 Units on a scale
Standard Deviation 0.69
|
1.00 Units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
|
0.99 Units on a scale
Standard Deviation 0.75
|
1.04 Units on a scale
Standard Deviation 0.76
|
1.04 Units on a scale
Standard Deviation 0.70
|
1.10 Units on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=507 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=504 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=614 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=618 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
|
174 Participants
|
135 Participants
|
197 Participants
|
213 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=226 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=221 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=269 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=278 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
73 Participants
|
75 Participants
|
94 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Baseline, Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=429 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=452 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=543 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=539 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
|
129 Participants
|
143 Participants
|
202 Participants
|
197 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=199 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=201 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=269 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=286 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy
|
62 Participants
|
62 Participants
|
97 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
MCID improvement assessed based on HAQ. HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=290 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=281 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=379 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=381 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy
|
94 Participants
|
86 Participants
|
121 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
|
0.52 Units on a scale
Standard Deviation 0.54
|
0.53 Units on a scale
Standard Deviation 0.51
|
0.51 Units on a scale
Standard Deviation 0.50
|
0.53 Units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
0.57 Units on a scale
Standard Deviation 0.55
|
0.55 Units on a scale
Standard Deviation 0.52
|
0.55 Units on a scale
Standard Deviation 0.52
|
0.56 Units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
|
0.48 Units on a scale
Standard Deviation 0.47
|
0.49 Units on a scale
Standard Deviation 0.51
|
0.48 Units on a scale
Standard Deviation 0.48
|
0.44 Units on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
|
0.53 Units on a scale
Standard Deviation 0.52
|
0.49 Units on a scale
Standard Deviation 0.50
|
0.50 Units on a scale
Standard Deviation 0.48
|
0.50 Units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
|
0.51 Units on a scale
Standard Deviation 0.54
|
0.53 Units on a scale
Standard Deviation 0.53
|
0.51 Units on a scale
Standard Deviation 0.49
|
0.56 Units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 millimeter (mm) horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
|
43.22 Millimeter
Standard Deviation 29.02
|
43.45 Millimeter
Standard Deviation 29.22
|
43.61 Millimeter
Standard Deviation 29.07
|
44.33 Millimeter
Standard Deviation 28.80
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
46.91 Millimeter
Standard Deviation 28.38
|
44.21 Millimeter
Standard Deviation 28.90
|
43.99 Millimeter
Standard Deviation 29.28
|
44.89 Millimeter
Standard Deviation 28.54
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
|
42.74 Millimeter
Standard Deviation 28.97
|
42.87 Millimeter
Standard Deviation 29.33
|
42.70 Millimeter
Standard Deviation 29.43
|
41.80 Millimeter
Standard Deviation 28.60
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
|
46.11 Millimeter
Standard Deviation 28.41
|
41.82 Millimeter
Standard Deviation 28.53
|
43.56 Millimeter
Standard Deviation 29.23
|
42.97 Millimeter
Standard Deviation 27.64
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy
|
43.13 Millimeter
Standard Deviation 29.48
|
44.62 Millimeter
Standard Deviation 29.08
|
43.62 Millimeter
Standard Deviation 28.79
|
44.30 Millimeter
Standard Deviation 28.80
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=472 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=476 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=564 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=586 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
|
79 Participants
|
79 Participants
|
98 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=214 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=209 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=261 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=265 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
30 Participants
|
27 Participants
|
43 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=409 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=428 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=524 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=520 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
|
73 Participants
|
71 Participants
|
107 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=186 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=191 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=256 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=258 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
|
28 Participants
|
25 Participants
|
44 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Participants who reported VAS \<= 20 mm were categorized with mild pain and were reported in this outcome measure. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=265 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=265 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=348 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=348 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
|
39 Participants
|
36 Participants
|
62 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
|
46.75 Millimeter
Standard Deviation 30.71
|
46.93 Millimeter
Standard Deviation 29.83
|
46.23 Millimeter
Standard Deviation 29.42
|
48.52 Millimeter
Standard Deviation 30.19
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
48.51 Millimeter
Standard Deviation 29.97
|
48.64 Millimeter
Standard Deviation 31.20
|
48.31 Millimeter
Standard Deviation 29.28
|
45.40 Millimeter
Standard Deviation 29.33
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=536 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
|
46.20 Millimeter
Standard Deviation 29.80
|
46.52 Millimeter
Standard Deviation 30.31
|
46.25 Millimeter
Standard Deviation 30.88
|
44.79 Millimeter
Standard Deviation 29.48
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
|
48.90 Millimeter
Standard Deviation 29.51
|
47.01 Millimeter
Standard Deviation 30.62
|
47.11 Millimeter
Standard Deviation 29.08
|
48.74 Millimeter
Standard Deviation 28.89
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
|
46.75 Millimeter
Standard Deviation 31.10
|
47.62 Millimeter
Standard Deviation 30.17
|
45.06 Millimeter
Standard Deviation 29.00
|
48.02 Millimeter
Standard Deviation 29.41
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=611 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=735 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
|
1.39 Hours
Standard Deviation 2.96
|
1.51 Hours
Standard Deviation 3.26
|
1.39 Hours
Standard Deviation 2.73
|
1.56 Hours
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=277 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=345 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
|
1.62 Hours
Standard Deviation 3.24
|
1.41 Hours
Standard Deviation 3.05
|
1.38 Hours
Standard Deviation 2.60
|
1.48 Hours
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit (for respective arms) post initiation of TNFis during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=670 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
|
1.49 Hours
Standard Deviation 3.30
|
1.48 Hours
Standard Deviation 2.95
|
1.51 Hours
Standard Deviation 3.12
|
1.41 Hours
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=246 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=343 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
|
1.51 Hours
Standard Deviation 3.08
|
1.53 Hours
Standard Deviation 3.39
|
1.29 Hours
Standard Deviation 2.30
|
1.28 Hours
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this studyPopulation: Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms.
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours. Propensity score method was used for analysis of the outcome measure.
Outcome measures
| Measure |
Tofacitinib Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as combination therapy with csDMARDs after 06-November-2012 and had at least 12- month follow-up post initiation, were included in this reporting arm.
|
TNFis Combination Therapy (12-Month Follow-up)
n=344 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as combination therapy with csDMARDs after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm.
|
Tofacitinib Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6- month follow-up post initiation, were included in this reporting arm.
|
TNFis Overall (6-Month Follow-up)
n=443 Participants
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) as monotherapy or combination therapy with csDMARDs after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm.
|
|---|---|---|---|---|
|
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
|
1.39 Hours
Standard Deviation 3.06
|
1.62 Hours
Standard Deviation 3.46
|
1.41 Hours
Standard Deviation 2.69
|
1.46 Hours
Standard Deviation 2.95
|
Adverse Events
Tofacitinib (6 Month Follow-up)
TNFis (6 Month Follow-up)
Tofacitinib (12 Month Follow-up)
TNFis (12 Month Follow-up)
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