Trial Outcomes & Findings for A Study To Investigate And Describe The Treatment Patterns And Effect Of Tofacitinib Indicators For Patients With Rheumatoid Arthritis (NCT NCT04721808)
NCT ID: NCT04721808
Last Updated: 2023-09-29
Results Overview
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count and swollen joint count (both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a visual analog scale (VAS) from 0 to 100 millimeter (mm); higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; between \>10 and \<=22 indicated moderate disease activity and \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
COMPLETED
1712 participants
At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)
2023-09-29
Participant Flow
Participants with a diagnosis of rheumatoid arthritis enrolled in Corrona Rheumatoid Arthritis (RA) Registry who initiated tofacitinib (tofa) on or after 06-Nov-2012 and had a 6-month follow-up visit or 12-month follow-up visit on or before 31-Jan-2021 were observed retrospectively in this study. Data was retrieved and analyzed during approximately 10 months of this observational retrospective study.
Participant milestones
| Measure |
Tofacitinib Initiators
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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|---|---|
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Overall Study
STARTED
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1712
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Overall Study
COMPLETED
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1712
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
Baseline characteristics by cohort
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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Age, Continuous
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59.99 Years
STANDARD_DEVIATION 12.08 • n=1708 Participants • Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Sex: Female, Male
Female
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1386 Participants
n=1709 Participants • Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic
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Sex: Female, Male
Male
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323 Participants
n=1709 Participants • Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic
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Race/Ethnicity, Customized
White
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1424 Participants
n=1674 Participants • Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Race/Ethnicity, Customized
Hispanic
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125 Participants
n=1674 Participants • Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Race/Ethnicity, Customized
Black
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79 Participants
n=1674 Participants • Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Race/Ethnicity, Customized
Asian
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25 Participants
n=1674 Participants • Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Race/Ethnicity, Customized
Other
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21 Participants
n=1674 Participants • Here, 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Type of Insurance
None
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18 Participants
n=1712 Participants
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Number of Participants According to Type of Insurance
Private
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1166 Participants
n=1712 Participants
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Number of Participants According to Type of Insurance
Medicare
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701 Participants
n=1712 Participants
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Number of Participants According to Type of Insurance
Medicaid
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109 Participants
n=1712 Participants
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Number of Participants According to Their Final Education
Primary
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50 Participants
n=1667 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Their Final Education
High School
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667 Participants
n=1667 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Their Final Education
College/University
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940 Participants
n=1667 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Their Final Education
Other
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10 Participants
n=1667 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Their Work Status
Full Time
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544 Participants
n=1670 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Their Work Status
Part Time
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124 Participants
n=1670 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Their Work Status
Disabled
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340 Participants
n=1670 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Their Work Status
Retired
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522 Participants
n=1670 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Their Work Status
Other
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140 Participants
n=1670 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Smoking Status
Never
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835 Participants
n=1687 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Smoking Status
Previous
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523 Participants
n=1687 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants According to Smoking Status
Current
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329 Participants
n=1687 Participants • Here 'Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Weight
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183.24 Pounds
STANDARD_DEVIATION 46.62 • n=1711 Participants • Here Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Body Mass Index
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30.45 Kilograms per meter square (Kg/m^2)
STANDARD_DEVIATION 7.38 • n=1680 Participants • Here Number Analyzed' signifies participants evaluable for this baseline characteristic.
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Number of Participants With History of Comorbidities
Cardiovascular disease
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718 Participants
n=1712 Participants • Here Number Analyzed' signifies participants evaluable for specific categories in this baseline characteristic.
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Number of Participants With History of Comorbidities
Malignancy
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219 Participants
n=1712 Participants • Here Number Analyzed' signifies participants evaluable for specific categories in this baseline characteristic.
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Number of Participants With History of Comorbidities
Hypertension
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607 Participants
n=1712 Participants • Here Number Analyzed' signifies participants evaluable for specific categories in this baseline characteristic.
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Number of Participants With History of Comorbidities
Diabetes
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192 Participants
n=1710 Participants • Here Number Analyzed' signifies participants evaluable for specific categories in this baseline characteristic.
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Number of Participants With History of Comorbidities
Osteoporosis
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59 Participants
n=1604 Participants • Here Number Analyzed' signifies participants evaluable for specific categories in this baseline characteristic.
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Number of Participants With History of Comorbidities
Fibromyalgia
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134 Participants
n=1709 Participants • Here Number Analyzed' signifies participants evaluable for specific categories in this baseline characteristic.
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Number of Participants With History of Comorbidities
Depression
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305 Participants
n=1710 Participants • Here Number Analyzed' signifies participants evaluable for specific categories in this baseline characteristic.
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PRIMARY outcome
Timeframe: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count and swollen joint count (both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a visual analog scale (VAS) from 0 to 100 millimeter (mm); higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; between \>10 and \<=22 indicated moderate disease activity and \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1211 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators
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30.1 Percentage of participants
Interval 27.5 to 32.7
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Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators
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29.5 Percentage of participants
Interval 25.8 to 33.6
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Percentage of Participants Who Achieved Low Disease Activity (LDA) (Clinical Disease Activity Index [CDAI] <=10) at 6 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators
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30.4 Percentage of participants
Interval 27.1 to 34.0
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PRIMARY outcome
Timeframe: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: tender joint count (TJC) and swollen joint count (\[SJC\] both out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=905 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators
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31.9 Percentage of participants
Interval 29.0 to 35.0
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy
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33.1 Percentage of participants
Interval 28.5 to 37.9
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy
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31.1 Percentage of participants
Interval 27.3 to 35.2
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PRIMARY outcome
Timeframe: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI=composite index for assessing disease activity (DA) based on summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate DA and score \>22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any disease modifying antirheumatic drug \[DMARD\]) and by each line of therapy, second line: participants with prior use of at least 1 conventional synthetic (cs) DMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1183 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy
Overall tofacitinib therapy
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29.9 Percentage of participants
Interval 27.4 to 32.6
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy
Second line therapy
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35.7 Percentage of participants
Interval 28.5 to 43.6
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy
Third line therapy
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37.4 Percentage of participants
Interval 31.4 to 43.9
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Line of Therapy
Fourth line therapy
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26.7 Percentage of participants
Interval 23.7 to 29.9
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PRIMARY outcome
Timeframe: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI=composite index for assessing DA based on numerical summation of four components: TJC and SJC (both out of 28 evaluated joints), patient global assessment of DA and physician global assessment of DA, both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score range: 0 to 76 where lower scores=lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate DA and score \>22 indicated high DA. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy, second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.
Outcome measures
| Measure |
Tofacitinib Initiators
n=885 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy
Overall tofacitinib therapy
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31.9 Percentage of participants
Interval 28.9 to 35.0
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy
Second line therapy
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39.4 Percentage of participants
Interval 30.7 to 48.9
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy
Third line therapy
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39.0 Percentage of participants
Interval 31.7 to 46.8
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Line of Therapy
Fourth line therapy
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28.8 Percentage of participants
Interval 25.3 to 32.5
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PRIMARY outcome
Timeframe: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg twice daily (BID) or 11 mg once daily (QD).
Outcome measures
| Measure |
Tofacitinib Initiators
n=1005 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose
Tofacitinib 5 mg BID
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30.0 Percentage of participants
Interval 26.2 to 34.1
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Tofa Dose
Tofacitinib 11 mg QD
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34.6 Percentage of participants
Interval 30.5 to 39.0
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PRIMARY outcome
Timeframe: At 12 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by dose of tofacitinib at initiation i.e. 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=751 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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|---|---|
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose
Tofacitinib 5 mg dose
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34.0 Percentage of participants
Interval 29.5 to 38.7
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Tofa Dose
Tofacitinib 11 mg dose
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35.4 Percentage of participants
Interval 30.5 to 40.6
|
PRIMARY outcome
Timeframe: At 6 months after initiation of tofacitinib (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020).
Outcome measures
| Measure |
Tofacitinib Initiators
n=1211 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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|---|---|
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation
Initiation period: 2012-2014
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25.4 Percentage of participants
Interval 21.1 to 30.4
|
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation
Initiation period: 2015-2017
|
30.1 Percentage of participants
Interval 26.3 to 34.1
|
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 6 Months: by Time Periods of Initiation
Initiation period: 2018-2020
|
34.5 Percentage of participants
Interval 29.7 to 39.6
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PRIMARY outcome
Timeframe: At 12 months after tofacitinib initiation (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=10 indicated LDA; score between \>10 and \<=22 indicated moderate disease activity and score \>22 indicated high disease activity. In this outcome measure, data is reported by year of tofacitinib initiation (2012-2014, 2015-2017, 2018-2020).
Outcome measures
| Measure |
Tofacitinib Initiators
n=905 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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|---|---|
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Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation
Initiation period: 2012-2014
|
29.7 Percentage of participants
Interval 24.6 to 35.5
|
|
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation
Initiation period: 2015-2017
|
32.9 Percentage of participants
Interval 28.5 to 37.6
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|
Percentage of Participants Who Achieved LDA (CDAI <=10) at 12 Months: by Time Periods of Initiation
Initiation period: 2018-2020
|
32.7 Percentage of participants
Interval 26.9 to 39.1
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SECONDARY outcome
Timeframe: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=2.8 indicated remission. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1601 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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|---|---|
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Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 6
|
8.9 Percentage of participants
Interval 7.6 to 10.4
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 6
|
8.8 Percentage of participants
Interval 6.9 to 11.1
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 6
|
9.1 Percentage of participants
Interval 7.3 to 11.1
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 12
|
10.1 Percentage of participants
Interval 8.5 to 11.9
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 12
|
9.6 Percentage of participants
Interval 7.3 to 12.4
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 12
|
10.4 Percentage of participants
Interval 8.4 to 12.9
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
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|---|---|
|
Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 6
|
-3.47 Units on a scale
Standard Deviation 13.11
|
|
Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 6
|
-2.96 Units on a scale
Standard Deviation 13.37
|
|
Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 6
|
-3.86 Units on a scale
Standard Deviation 12.90
|
|
Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 12
|
-3.46 Units on a scale
Standard Deviation 13.47
|
|
Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 12
|
-3.18 Units on a scale
Standard Deviation 13.76
|
|
Change From Baseline in CDAI at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 12
|
-3.67 Units on a scale
Standard Deviation 13.26
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category.
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. 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. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score=sum of domain scores and divided by number of domains answered. Total scores range from 0 to 3 where 0=least difficulty and 3=extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 6
|
-0.04 Units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 6
|
-0.03 Units on a scale
Standard Deviation 0.49
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 6
|
-0.06 Units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 12
|
-0.06 Units on a scale
Standard Deviation 0.51
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 12
|
-0.04 Units on a scale
Standard Deviation 0.50
|
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 12
|
-0.07 Units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 6
|
-5.72 Units on a scale
Standard Deviation 28.64
|
|
Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 6
|
-4.92 Units on a scale
Standard Deviation 30.18
|
|
Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 6
|
-6.35 Units on a scale
Standard Deviation 27.37
|
|
Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 12
|
-5.69 Units on a scale
Standard Deviation 28.16
|
|
Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 12
|
-4.18 Units on a scale
Standard Deviation 28.09
|
|
Change From Baseline in Participant Pain Visual Analog Scale (VAS) Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 12
|
-6.84 Units on a scale
Standard Deviation 28.18
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for overall tofa initiators and participants who initiated tofacitinib as either monotherapy or as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 6
|
-3.84 Units on a scale
Standard Deviation 26.06
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 6
|
-2.37 Units on a scale
Standard Deviation 26.40
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 6
|
-4.97 Units on a scale
Standard Deviation 25.74
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 12
|
-3.36 Units on a scale
Standard Deviation 26.26
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 12
|
-2.49 Units on a scale
Standard Deviation 24.85
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 12
|
-4.01 Units on a scale
Standard Deviation 27.28
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1634 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 6
|
21.4 Percentage of participants
Interval 19.5 to 23.5
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 6
|
20.8 Percentage of participants
Interval 18.0 to 23.9
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 6
|
21.9 Percentage of participants
Interval 19.4 to 24.7
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 12
|
22.4 Percentage of participants
Interval 20.2 to 24.8
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 12
|
21.2 Percentage of participants
Interval 18.0 to 24.9
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 12
|
23.3 Percentage of participants
Interval 20.3 to 26.6
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1634 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 6
|
11.4 Percentage of participants
Interval 9.9 to 13.0
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 6
|
11.2 Percentage of participants
Interval 9.1 to 13.7
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 6
|
11.5 Percentage of participants
Interval 9.6 to 13.8
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 12
|
10.4 Percentage of participants
Interval 8.8 to 12.2
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 12
|
9.6 Percentage of participants
Interval 7.4 to 12.4
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 12
|
11.0 Percentage of participants
Interval 8.9 to 13.6
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1634 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 6
|
5.3 Percentage of participants
Interval 4.3 to 6.5
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 6
|
5.0 Percentage of participants
Interval 3.6 to 6.8
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 6
|
5.5 Percentage of participants
Interval 4.2 to 7.2
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Overall tofacitinib initiators: At Month 12
|
5.0 Percentage of participants
Interval 3.9 to 6.4
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib monotherapy initiators: At Month 12
|
5.7 Percentage of participants
Interval 4.0 to 8.0
|
|
Percentage of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy Initiators
Tofacitinib combination therapy initiators: At Month 12
|
4.4 Percentage of participants
Interval 3.1 to 6.2
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. Components included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and patient's global assessment (PtGA) recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\]), higher scores=more disease activity. DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28)+0.28\*sqrt (SJC28)+0.70\*ln (ESR \[mm/hour\]+0.014\*PtGA \[mm\]; where, ln=natural logarithm, sqrt=square root of. Total score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \<=3.2 indicated LDA or remission. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy, participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1463 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Overall tofacitinib initiators: At Month 6
|
13.7 Percentage of participants
Interval 12.1 to 15.6
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Tofacitinib monotherapy initiators: At Month 6
|
13.7 Percentage of participants
Interval 11.2 to 16.5
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Tofacitinib combination therapy initiators: At Month 6
|
13.8 Percentage of participants
Interval 11.6 to 16.3
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Overall tofacitinib initiators: At Month 12
|
15.5 Percentage of participants
Interval 13.4 to 17.7
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Tofacitinib monotherapy initiators: At Month 12
|
16.4 Percentage of participants
Interval 13.4 to 20.0
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by Disease Activity Score in 28 Joints (DAS28) (Erythrocyte Sedimentation Rate [ESR]) <= 3.2 at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Tofacitinib combination therapy: At Month 12
|
14.7 Percentage of participants
Interval 12.2 to 17.7
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as \<=20 mm on 100 mm VAS scale in those participants who had pain \>20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported separately for overall number of participants who initiated tofacitinib as either monotherapy or as combination therapy (i.e. tofacitinib in combination with methotrexate, arava, azulfidine, plaquenil, or cyclosporine), participants who initiated tofacitinib as monotherapy and participants who initiated tofacitinib as combination therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1355 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Overall tofacitinib initiators: At Month 6
|
18.7 Percentage of participants
Interval 16.8 to 20.9
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Tofacitinib monotherapy initiators: At Month 6
|
18.3 Percentage of participants
Interval 15.3 to 21.6
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Tofacitinib combination therapy initiators: At Month 6
|
19.1 Percentage of participants
Interval 16.5 to 22.0
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Overall tofacitinib initiators: At Month 12
|
19.0 Percentage of participants
Interval 16.7 to 21.5
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Tofacitinib monotherapy initiators: At Month 12
|
17.5 Percentage of participants
Interval 14.2 to 21.4
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Overall Tofa Initiators, Monotherapy and Combination Therapy
Tofacitinib combination therapy initiators: At Month 12
|
20.1 Percentage of participants
Interval 17.1 to 23.6
|
SECONDARY outcome
Timeframe: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=2.8 indicated remission. Data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy (first line: no prior use of any DMARD) and by each line of therapy including second line: participants with prior use of at least 1 csDMARD and no prior use of any biologic; third line: participants with prior use of any csDMARDs and 1 biologic and fourth line: participants with prior use of any csDMARDs and more than 2 biologics.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1565 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
8.9 Percentage of participants
Interval 7.6 to 10.5
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
13.6 Percentage of participants
Interval 9.6 to 18.9
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
10.3 Percentage of participants
Interval 7.4 to 14.3
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
7.4 Percentage of participants
Interval 6.0 to 9.2
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
10.2 Percentage of participants
Interval 8.6 to 12.1
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
20.9 Percentage of participants
Interval 15.2 to 27.9
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
10.2 Percentage of participants
Interval 6.8 to 15.1
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
7.9 Percentage of participants
Interval 6.2 to 10.0
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1673 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
-3.51 Units on a scale
Standard Deviation 12.95
|
|
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
-4.36 Units on a scale
Standard Deviation 12.31
|
|
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
-4.96 Units on a scale
Standard Deviation 12.61
|
|
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
-2.85 Units on a scale
Standard Deviation 13.08
|
|
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
-3.54 Units on a scale
Standard Deviation 13.41
|
|
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
-4.45 Units on a scale
Standard Deviation 12.71
|
|
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
-4.64 Units on a scale
Standard Deviation 12.37
|
|
Change From Baseline in CDAI at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
-3.03 Units on a scale
Standard Deviation 13.73
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. 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. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1673 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
-0.05 Units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
-0.05 Units on a scale
Standard Deviation 0.52
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
-0.07 Units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
-0.04 Units on a scale
Standard Deviation 0.47
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
-0.06 Units on a scale
Standard Deviation 0.51
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
-0.06 Units on a scale
Standard Deviation 0.52
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
-0.07 Units on a scale
Standard Deviation 0.49
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
-0.06 Units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1673 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
-5.71 Units on a scale
Standard Deviation 28.49
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
-8.03 Units on a scale
Standard Deviation 29.83
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
-7.30 Units on a scale
Standard Deviation 28.73
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
-4.77 Units on a scale
Standard Deviation 28.02
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
-5.91 Units on a scale
Standard Deviation 28.03
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
-7.09 Units on a scale
Standard Deviation 29.14
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
-8.18 Units on a scale
Standard Deviation 26.49
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
-5.17 Units on a scale
Standard Deviation 28.06
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1673 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
-3.53 Units on a scale
Standard Deviation 25.17
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
-4.03 Units on a scale
Standard Deviation 25.98
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
-6.73 Units on a scale
Standard Deviation 26.14
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
-3.70 Units on a scale
Standard Deviation 28.02
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
-3.63 Units on a scale
Standard Deviation 26.29
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
-5.46 Units on a scale
Standard Deviation 26.16
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
0.28 Units on a scale
Standard Deviation 24.23
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
-4.31 Units on a scale
Standard Deviation 26.69
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1596 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
21.3 Percentage of participants
Interval 19.4 to 23.4
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
25.0 Percentage of participants
Interval 19.7 to 31.1
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
24.5 Percentage of participants
Interval 20.1 to 29.6
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
19.4 Percentage of participants
Interval 17.1 to 21.9
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
22.4 Percentage of participants
Interval 20.2 to 24.9
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
25.5 Percentage of participants
Interval 19.3 to 32.8
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
26.9 Percentage of participants
Interval 21.5 to 33.0
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
20.5 Percentage of participants
Interval 17.9 to 23.5
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1596 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
11.3 Percentage of participants
Interval 9.9 to 13.0
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
12.3 Percentage of participants
Interval 8.5 to 17.3
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
14.3 Percentage of participants
Interval 10.9 to 18.7
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
10.2 Percentage of participants
Interval 8.5 to 12.2
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
10.7 Percentage of participants
Interval 9.1 to 12.6
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
15.5 Percentage of participants
Interval 10.7 to 22.0
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
12.3 Percentage of participants
Interval 8.7 to 17.3
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
9.2 Percentage of participants
Interval 7.4 to 11.4
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1596 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
5.1 Percentage of participants
Interval 4.2 to 6.3
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
6.8 Percentage of participants
Interval 4.2 to 11.0
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
7.6 Percentage of participants
Interval 5.2 to 11.2
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
4.0 Percentage of participants
Interval 3.0 to 5.4
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
5.1 Percentage of participants
Interval 4.0 to 6.5
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
6.2 Percentage of participants
Interval 3.4 to 11.2
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
5.7 Percentage of participants
Interval 3.4 to 9.6
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
4.7 Percentage of participants
Interval 3.5 to 6.4
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*ln (ESR \[mm/hour\] + 0.014\*PtGA \[mm\]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of \<=3.2 indicated LDA or remission. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1431 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
13.8 Percentage of participants
Interval 12.1 to 15.7
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
18.0 Percentage of participants
Interval 13.1 to 24.1
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
18.6 Percentage of participants
Interval 14.4 to 23.7
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
11.5 Percentage of participants
Interval 9.6 to 13.6
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
15.4 Percentage of participants
Interval 13.3 to 17.7
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
22.4 Percentage of participants
Interval 16.3 to 29.9
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
25.0 Percentage of participants
Interval 19.3 to 31.7
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
11.4 Percentage of participants
Interval 9.3 to 13.9
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as \<=20 mm on 100 mm VAS scale in those participants who had pain \>20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for overall tofacitinib initiators who initiated tofacitinib as first, second, third or fourth line of therapy and by each line of therapy including second line, third line and fourth line of therapy.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1324 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 6
|
18.6 Percentage of participants
Interval 16.6 to 20.8
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 6
|
26.6 Percentage of participants
Interval 20.3 to 34.0
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 6
|
22.7 Percentage of participants
Interval 18.0 to 28.3
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 6
|
16.0 Percentage of participants
Interval 13.8 to 18.6
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Overall tofacitinib therapy: At Month 12
|
19.0 Percentage of participants
Interval 16.7 to 21.6
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Second line therapy: At Month 12
|
34.2 Percentage of participants
Interval 26.0 to 43.5
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Third line therapy: At Month 12
|
22.8 Percentage of participants
Interval 17.2 to 29.5
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Line of Therapy
Fourth line therapy: At Month 12
|
15.7 Percentage of participants
Interval 13.1 to 18.6
|
SECONDARY outcome
Timeframe: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=2.8 indicated remission. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1345 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
9.5 Percentage of participants
Interval 7.5 to 11.9
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
10.3 Percentage of participants
Interval 8.2 to 12.9
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
11.2 Percentage of participants
Interval 8.8 to 14.1
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
10.3 Percentage of participants
Interval 7.9 to 13.4
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1445 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
-3.97 Units on a scale
Standard Deviation 13.47
|
|
Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
-3.43 Units on a scale
Standard Deviation 12.35
|
|
Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
-4.40 Units on a scale
Standard Deviation 13.73
|
|
Change From Baseline in CDAI at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
-2.77 Units on a scale
Standard Deviation 13.28
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. 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. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1445 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
-0.07 Units on a scale
Standard Deviation 0.49
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
-0.03 Units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
-0.09 Units on a scale
Standard Deviation 0.51
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
-0.03 Units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1445 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
-5.93 Units on a scale
Standard Deviation 29.01
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
-6.53 Units on a scale
Standard Deviation 28.58
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
-8.02 Units on a scale
Standard Deviation 27.96
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
-3.79 Units on a scale
Standard Deviation 28.81
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1445 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
-3.89 Units on a scale
Standard Deviation 27.17
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg: At Month 6
|
-3.65 Units on a scale
Standard Deviation 24.79
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
-3.52 Units on a scale
Standard Deviation 26.12
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg: At Month 12
|
-2.84 Units on a scale
Standard Deviation 26.98
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1373 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
23.4 Percentage of participants
Interval 20.4 to 26.6
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
21.4 Percentage of participants
Interval 18.4 to 24.7
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
24.2 Percentage of participants
Interval 20.9 to 27.9
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
22.1 Percentage of participants
Interval 18.6 to 26.1
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1373 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
13.0 Percentage of participants
Interval 10.7 to 15.7
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
11.7 Percentage of participants
Interval 9.4 to 14.4
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
12.3 Percentage of participants
Interval 9.8 to 15.2
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
9.7 Percentage of participants
Interval 7.3 to 12.7
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1373 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
5.6 Percentage of participants
Interval 4.1 to 7.6
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
5.3 Percentage of participants
Interval 3.8 to 7.3
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
5.3 Percentage of participants
Interval 3.7 to 7.4
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
4.8 Percentage of participants
Interval 3.2 to 7.2
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*ln (ESR \[mm/hour\] + 0.014\*PtGA \[mm\]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of \<=3.2 indicated LDA or remission. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1233 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
15.5 Percentage of participants
Interval 12.9 to 18.5
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
14.4 Percentage of participants
Interval 11.8 to 17.5
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
15.6 Percentage of participants
Interval 12.7 to 19.0
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
18.2 Percentage of participants
Interval 14.8 to 22.2
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as \<=20 mm on 100 mm VAS scale in those participants who had pain \>20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for participants who administered tofacitinib dose as either 5 mg BID or 11 mg QD.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1130 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 6
|
20.7 Percentage of participants
Interval 17.6 to 24.2
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 6
|
19.4 Percentage of participants
Interval 16.3 to 23.0
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose
Tofacitinib 5 mg BID: At Month 12
|
21.1 Percentage of participants
Interval 17.6 to 25.1
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Tofa Dose
Tofacitinib 11 mg QD: At Month 12
|
19.5 Percentage of participants
Interval 15.9 to 23.8
|
SECONDARY outcome
Timeframe: At Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. A score of \<=2.8 indicated remission. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1601 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
8.2 Percentage of participants
Interval 5.9 to 11.2
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
9.0 Percentage of participants
Interval 7.1 to 11.4
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
9.5 Percentage of participants
Interval 7.2 to 12.4
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
9.4 Percentage of participants
Interval 6.7 to 13.1
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
10.9 Percentage of participants
Interval 8.6 to 13.8
|
|
Percentage of Participants Who Achieved Remission at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
9.2 Percentage of participants
Interval 6.5 to 12.9
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category.
CDAI is a composite index for assessing disease activity based on the numerical summation of four components: TJC (out of 28 evaluated joints) and SJC (out of 28 evaluated joints), patient global assessment of disease activity and physician global assessment of disease activity both measured on a VAS from 0 to 100 mm; higher scores=higher disease activity. CDAI total score ranged from 0 to 76 where lower scores indicated lower disease activity. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
-3.48 Units on a scale
Standard Deviation 14.72
|
|
Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
-3.48 Units on a scale
Standard Deviation 12.52
|
|
Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
-3.44 Units on a scale
Standard Deviation 12.44
|
|
Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
-4.43 Units on a scale
Standard Deviation 15.02
|
|
Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
-3.38 Units on a scale
Standard Deviation 13.14
|
|
Change From Baseline in CDAI at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
-2.59 Units on a scale
Standard Deviation 12.27
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category.
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. 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. Responses in each functional area were scored from 0=no difficulty to 3=inability to perform a task in that area. Total score was computed as the sum of domain scores and divided by the number of domains answered. Total scores range from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher scores indicated worse functioning. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
-0.07 Units on a scale
Standard Deviation 0.47
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
-0.02 Units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
-0.05 Units on a scale
Standard Deviation 0.50
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
-0.12 Units on a scale
Standard Deviation 0.49
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
-0.01 Units on a scale
Standard Deviation 0.51
|
|
Change From Baseline in HAQ Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
-0.07 Units on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
-5.44 Units on a scale
Standard Deviation 29.31
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
-5.13 Units on a scale
Standard Deviation 29.07
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
-6.80 Units on a scale
Standard Deviation 27.42
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
-8.16 Units on a scale
Standard Deviation 28.39
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
-4.48 Units on a scale
Standard Deviation 28.56
|
|
Change From Baseline in Participant Pain VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
-5.27 Units on a scale
Standard Deviation 27.10
|
SECONDARY outcome
Timeframe: Baseline (Corrona visit with first reported use of tofacitinib), Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess the level of fatigue by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Higher scores indicated worsening of fatigue. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1712 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
-4.84 Units on a scale
Standard Deviation 26.45
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
-3.04 Units on a scale
Standard Deviation 26.73
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
-4.08 Units on a scale
Standard Deviation 24.74
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
-4.98 Units on a scale
Standard Deviation 25.33
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
-3.08 Units on a scale
Standard Deviation 26.98
|
|
Change From Baseline in Participant Fatigue VAS Score at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
-2.15 Units on a scale
Standard Deviation 25.91
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1634 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
24.3 Percentage of participants
Interval 20.5 to 28.6
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
19.6 Percentage of participants
Interval 16.8 to 22.7
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
21.5 Percentage of participants
Interval 18.1 to 25.3
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
27.3 Percentage of participants
Interval 22.9 to 32.3
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
19.4 Percentage of participants
Interval 16.4 to 22.9
|
|
Percentage of Participants Achieving mACR20 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
22.4 Percentage of participants
Interval 18.2 to 27.3
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1634 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
11.9 Percentage of participants
Interval 9.2 to 15.3
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
10.6 Percentage of participants
Interval 8.6 to 13.2
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
11.9 Percentage of participants
Interval 9.4 to 15.1
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
12.2 Percentage of participants
Interval 9.1 to 16.1
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
10.8 Percentage of participants
Interval 8.5 to 13.6
|
|
Percentage of Participants Achieving mACR50 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
7.8 Percentage of participants
Interval 5.3 to 11.3
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement 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 HAQ (scored from 0 to 3, higher scores indicated worsening of function). In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1634 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
5.3 Percentage of participants
Interval 3.5 to 7.8
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
4.6 Percentage of participants
Interval 3.3 to 6.4
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
6.2 Percentage of participants
Interval 4.4 to 8.6
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
5.8 Percentage of participants
Interval 3.8 to 8.8
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
5.2 Percentage of participants
Interval 3.7 to 7.4
|
|
Percentage of Participants Achieving mACR70 Response at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
3.7 Percentage of participants
Interval 2.1 to 6.5
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm per hour) and PtGA recorded on 100 mm VAS (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\]), higher scores indicated more disease activity. DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*ln (ESR \[mm/hour\] + 0.014\*PtGA \[mm\]; where, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28(ESR) score of \<=3.2 indicated LDA or remission. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1463 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
12.2 Percentage of participants
Interval 9.4 to 15.7
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
14.6 Percentage of participants
Interval 12.0 to 17.6
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
14.0 Percentage of participants
Interval 11.1 to 17.6
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
12.6 Percentage of participants
Interval 9.4 to 16.7
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
16.7 Percentage of participants
Interval 13.6 to 20.2
|
|
Percentage of Participants Achieving Low Disease Activity or Remission Defined by DAS28 ESR <=3.2 at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
16.5 Percentage of participants
Interval 12.7 to 21.3
|
SECONDARY outcome
Timeframe: Month 6 and 12 (from the data retrieved and observed for approximately 10 months of this retrospective study)Population: Analysis population included all eligible participants who initiated tofacitinib on or after November 2012 and had 6 months and 12 months follow-up. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified category.
Participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 mm = no pain and 100 mm = worst possible pain. Higher scores indicated worsening of pain. Mild pain was defined as \<=20 mm on 100 mm VAS scale in those participants who had pain \>20 mm on 100 mm VAS at the initiation visit. In this outcome measure, data is reported for participants who initiated tofacitinib in different initiation years (2012-2014, 2015-2017, 2018-2020), were reported.
Outcome measures
| Measure |
Tofacitinib Initiators
n=1355 Participants
Participants with rheumatoid arthritis enrolled in Corrona RA registry who initiated tofacitinib on or after 06-Nov-2012 and had 6-month or 12-month follow-up visit before 31-Jan-2021 were included in this retrospective cohort study.
|
|---|---|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 6
|
15.8 Percentage of participants
Interval 12.5 to 20.0
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 6
|
19.7 Percentage of participants
Interval 16.6 to 23.1
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 6
|
20.0 Percentage of participants
Interval 16.4 to 24.2
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2012-2014: At Month 12
|
16.7 Percentage of participants
Interval 12.8 to 21.4
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2015-2017: At Month 12
|
20.6 Percentage of participants
Interval 17.1 to 24.5
|
|
Percentage of Participants With Mild Pain at Month 6 and 12: by Time Periods of Initiation
Initiation period: 2018-2020: At Month 12
|
18.9 Percentage of participants
Interval 14.6 to 24.0
|
Adverse Events
Tofacitinib Initiators
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 the 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