Rheumatoid Arthritis
Conditions
Brief summary
To estimate the efficacy of treatment with TNFi as monotherapy or combination therapy with MTX and compare and contrast efficacy with Tofacitinib as monotherapy and combination therapy in a real world setting.
Interventions
OTHERpatterns of use of combination therapy and monotherapy
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* RA patients in Corrona initiating a TNFi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in Corrona with no prior use of Tofacitinib
Exclusion criteria
* Patients with no history of cDMARD but history of 1+ biologics - these cases will be excluded from analyses * Patients using combination therapy with a cDMARD other than MTX will be excluded * Patients using combination therapy of MTX and another cDMARD will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | At month 6 follow up visit | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported. |
| CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | At month 6 follow up visit | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported. |
| CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | At month 6 follow up visit | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported. |
| CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | At month 6 follow up visit | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported. |
| Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX | At month 6 follow up visit | mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function). |
| Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function). |
| Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function). |
| Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | At month 6 follow up visit | mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function). |
| Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | At month 6 follow up visit | mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function). |
| CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | At month 6 follow up visit | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported. |
| Number of Participants According to Line of Therapy at TNFi Initiation | At baseline | Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of 1st line, 2nd line, 3rd line, and 4th line of therapy was reported in this outcome measure. |
| Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | At baseline | Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at TNFi initiation after 11/6/2012 was reported in this outcome measure. |
| Number of Participants According to Line of Therapy at Tofacitinib Initiation | At baseline | Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at tofacitinib initiation was reported in this outcome measure. |
| Median CDAI Score at Baseline- TNFi Initiator | At baseline | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi Initiator. |
| Median CDAI Score at Baseline- Tofacitinib Initiator | At baseline | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of Tofacitinib Initiator. |
| Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012 | At baseline | CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi initiator after 11-6-2012. |
| Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | At baseline | Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at TNFi initiation was reported in this outcome measure. Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. |
| Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | At baseline | Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy (LOT): prior use of at least one biologic) use at TNFi initiation after 11/6/2012 was reported in this outcome measure. |
| Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | At baseline | Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at tofacitinib initiation was reported in this outcome measure. |
| Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | At month 6 follow up visit | mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function). |
Countries
United States
Participant flow
Recruitment details
Data from greater than (\>) 5500 participants who initiated Tumor Necrosis Factor Inhibitor (TNFi) initiation as combination with Methotrexate (MTX) and \>2000 participants who initiated TNFi initiations as monotherapy; \> 500 participants who initiated Tofacitinib initiations as monotherapy or as combination with MTX were observed in this non-interventional observational study.
Pre-assignment details
Participants diagnosed with rheumatoid arthritis (RA), enrolled in Corrona US-based observational RA registry were included in this study.
Participants by arm
| Arm | Count |
|---|---|
| All TNFi Initiators Combination Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015. | 4,056 |
| All TNFi Initiators Monotherapy Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015. | 1,716 |
| TNFi Initiators After 11/6/2012 Combination Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015. | 838 |
| TNFi Initiators After 11/6/2012 Monotherapy Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015. | 406 |
| Tofacitinib Initiators Combination Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015. | 96 |
| Tofacitinib Initiators Monotherapy Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015. | 145 |
| Total | 7,257 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Efficacy + Safety | 10 | 7 | 3 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 543 | 343 | 108 | 72 | 28 | 50 |
| Overall Study | Other | 231 | 127 | 35 | 14 | 6 | 0 |
| Overall Study | Safety | 78 | 74 | 16 | 14 | 4 | 5 |
Baseline characteristics
| Characteristic | All TNFi Initiators Combination | Total | All TNFi Initiators Monotherapy | TNFi Initiators After 11/6/2012 Combination | TNFi Initiators After 11/6/2012 Monotherapy | Tofacitinib Initiators Combination | Tofacitinib Initiators Monotherapy |
|---|---|---|---|---|---|---|---|
| Age, Continuous All TNFi initiators combination | 56 Years | 56 Years | — | — | — | — | — |
| Age, Continuous All TNFi initiators monotherapy | — | 55 Years | 55 Years | — | — | — | — |
| Age, Continuous TNFi initiators after 11/6/2012 combination | — | 58 Years | — | 58 Years | — | — | — |
| Age, Continuous TNFi initiators after 11/6/2012 monotherapy | — | 55 Years | — | — | 55 Years | — | — |
| Age, Continuous Tofacitinib initiators combination | — | 59 Years | — | — | — | 59 Years | — |
| Age, Continuous Tofacitinib initiators monotherapy | — | 59 Years | — | — | — | — | 59 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 256 Participants | 485 Participants | 110 Participants | 71 Participants | 28 Participants | 6 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3800 Participants | 6772 Participants | 1606 Participants | 767 Participants | 378 Participants | 90 Participants | 131 Participants |
| History of cancer excluding nonmelanoma skin cancer | 194 Participants | 341 Participants | 84 Participants | 32 Participants | 14 Participants | 6 Participants | 11 Participants |
| History of Cardiovascular disease | 306 Participants | 570 Participants | 139 Participants | 69 Participants | 32 Participants | 8 Participants | 16 Participants |
| History of Diabetes | 300 Participants | 588 Participants | 150 Participants | 74 Participants | 39 Participants | 9 Participants | 16 Participants |
| Insurance Medicaid | 242 Participants | 442 Participants | 110 Participants | 45 Participants | 32 Participants | 5 Participants | 8 Participants |
| Insurance Medicare | 1054 Participants | 1946 Participants | 454 Participants | 237 Participants | 114 Participants | 38 Participants | 49 Participants |
| Insurance None | 96 Participants | 186 Participants | 42 Participants | 28 Participants | 20 Participants | 0 Participants | 0 Participants |
| Insurance Private | 3059 Participants | 5431 Participants | 1293 Participants | 609 Participants | 296 Participants | 62 Participants | 112 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants | 87 Participants | 14 Participants | 16 Participants | 5 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 268 Participants | 461 Participants | 98 Participants | 56 Participants | 28 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 349 Participants | 654 Participants | 150 Participants | 91 Participants | 38 Participants | 7 Participants | 19 Participants |
| Race (NIH/OMB) White | 3389 Participants | 6055 Participants | 1454 Participants | 675 Participants | 335 Participants | 84 Participants | 118 Participants |
| Sex: Female, Male Female | 3121 Participants | 5652 Participants | 1354 Participants | 653 Participants | 330 Participants | 76 Participants | 118 Participants |
| Sex: Female, Male Male | 935 Participants | 1605 Participants | 362 Participants | 185 Participants | 76 Participants | 20 Participants | 27 Participants |
| Smoker Current smoker | 787 Participants | 1397 Participants | 327 Participants | 172 Participants | 77 Participants | 13 Participants | 21 Participants |
| Smoker Never smoker | 2084 Participants | 3658 Participants | 864 Participants | 388 Participants | 195 Participants | 49 Participants | 78 Participants |
| Smoker Previous smoker | 1163 Participants | 2149 Participants | 514 Participants | 267 Participants | 127 Participants | 33 Participants | 45 Participants |
| Smoker Unknown or not reported | 22 Participants | 53 Participants | 11 Participants | 11 Participants | 7 Participants | 1 Participants | 1 Participants |
| Work Status Disabled | 884 Participants | 1563 Participants | 345 Participants | 191 Participants | 79 Participants | 24 Participants | 40 Participants |
| Work Status Full Time | 1697 Participants | 2920 Participants | 672 Participants | 331 Participants | 150 Participants | 29 Participants | 41 Participants |
| Work Status Part time | 412 Participants | 722 Participants | 160 Participants | 89 Participants | 44 Participants | 7 Participants | 10 Participants |
| Work Status Retired | 526 Participants | 1055 Participants | 298 Participants | 110 Participants | 73 Participants | 15 Participants | 33 Participants |
| Work Status Student | 73 Participants | 177 Participants | 34 Participants | 45 Participants | 20 Participants | 1 Participants | 4 Participants |
| Work Status Unknown or not reported | 40 Participants | 80 Participants | 17 Participants | 10 Participants | 5 Participants | 3 Participants | 5 Participants |
| Work Status Work at home | 424 Participants | 740 Participants | 190 Participants | 62 Participants | 35 Participants | 17 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed (n) signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators Combination | Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | All | 18.1 Units on a scale | Standard Deviation 15.1 |
| Tofacitinib Initiators Combination | Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | Non-switchers | 16.6 Units on a scale | Standard Deviation 14.3 |
| Tofacitinib Initiators Monotherapy | Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | All | 17 Units on a scale | Standard Deviation 13.4 |
| Tofacitinib Initiators Monotherapy | Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) | Non-switchers | 14.6 Units on a scale | Standard Deviation 11.6 |
Secondary
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | All | 13.9 Units on a scale | Standard Deviation 12.5 |
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | Non-switchers | 13 Units on a scale | Standard Deviation 11.8 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | Non-switchers | 16.6 Units on a scale | Standard Deviation 14.3 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | All | 18.1 Units on a scale | Standard Deviation 15.1 |
Secondary
CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | All | 16.5 Units on a scale | Standard Deviation 13.8 |
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | Non-switchers | 14.9 Units on a scale | Standard Deviation 13 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | All | 18.1 Units on a scale | Standard Deviation 15.1 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | Non-switchers | 16.6 Units on a scale | Standard Deviation 14.3 |
Secondary
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | All | 13.9 Units on a scale | Standard Deviation 12.5 |
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | Non-switchers | 13 Units on a scale | Standard Deviation 11.8 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | All | 17 Units on a scale | Standard Deviation 13.4 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | Non-switchers | 14.6 Units on a scale | Standard Deviation 11.6 |
Secondary
CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | All | 16.5 Units on a scale | Standard Deviation 13.8 |
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | Non-switchers | 14.9 Units on a scale | Standard Deviation 13 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | All | 17 Units on a scale | Standard Deviation 13.4 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | Non-switchers | 14.6 Units on a scale | Standard Deviation 11.6 |
Secondary
CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, n signifies number of participants evaluable for specified rows. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for CDAI score outcome measure as CDAI score data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | All | 13.9 Units on a scale | Standard Deviation 12.5 |
| Tofacitinib Initiators Combination | CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | Non-switchers | 13 Units on a scale | Standard Deviation 11.8 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | All | 16.5 Units on a scale | Standard Deviation 13.8 |
| Tofacitinib Initiators Monotherapy | CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX | Non-switchers | 14.9 Units on a scale | Standard Deviation 13 |
Secondary
Median CDAI Score at Baseline- TNFi Initiator
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi Initiator.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib Initiators Combination | Median CDAI Score at Baseline- TNFi Initiator | 18.6 Units on a scale |
| Tofacitinib Initiators Monotherapy | Median CDAI Score at Baseline- TNFi Initiator | 19.7 Units on a scale |
p-value: 0.278Mixed model linear regression
Secondary
Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi initiator after 11-6-2012.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib Initiators Combination | Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012 | 19.5 Units on a scale |
| Tofacitinib Initiators Monotherapy | Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012 | 21 Units on a scale |
p-value: 0.987Mixed model linear regression
Secondary
Median CDAI Score at Baseline- Tofacitinib Initiator
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of Tofacitinib Initiator.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tofacitinib Initiators Combination | Median CDAI Score at Baseline- Tofacitinib Initiator | 22.1 Units on a scale |
| Tofacitinib Initiators Monotherapy | Median CDAI Score at Baseline- Tofacitinib Initiator | 19 Units on a scale |
p-value: 0.131Mixed model linear regression
Secondary
Number of Participants According to Line of Therapy at TNFi Initiation
Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of 1st line, 2nd line, 3rd line, and 4th line of therapy was reported in this outcome measure.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation | 3rd line | 1088 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation | 4th line | 656 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation | Missing | 1021 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation | 1st line | 203 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation | 2nd line | 2109 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation | 2nd line | 616 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation | 1st line | 89 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation | 4th line | 430 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation | 3rd line | 581 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation | Missing | 559 Participants |
Secondary
Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012
Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at TNFi initiation after 11/6/2012 was reported in this outcome measure.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | 2nd line | 388 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | 4th line | 184 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | 3rd line | 212 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | Missing | 149 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | 1st line | 54 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | Missing | 0 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | 1st line | 361 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | 2nd line | 123 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | 3rd line | 118 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 | 4th line | 143 Participants |
Secondary
Number of Participants According to Line of Therapy at Tofacitinib Initiation
Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at tofacitinib initiation was reported in this outcome measure.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at Tofacitinib Initiation | 4th line | 67 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at Tofacitinib Initiation | 2nd line | 12 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at Tofacitinib Initiation | 3rd line | 11 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at Tofacitinib Initiation | Missing | 28 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Line of Therapy at Tofacitinib Initiation | 1st line | 6 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at Tofacitinib Initiation | Missing | 57 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at Tofacitinib Initiation | 3rd line | 22 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at Tofacitinib Initiation | 1st line | 12 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at Tofacitinib Initiation | 4th line | 99 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Line of Therapy at Tofacitinib Initiation | 2nd line | 12 Participants |
Secondary
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at tofacitinib initiation was reported in this outcome measure.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Etanercept | 61 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Abatacept | 58 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Golimumab | 0 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Rituximab | 35 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Infliximab | 41 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Tocilizumab | 40 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Certolizumab pegol | 29 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Anakinra | 6 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Adalimumab | 72 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Anakinra | 12 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Adalimumab | 109 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Etanercept | 123 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Infliximab | 82 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Golimumab | 0 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Certolizumab pegol | 42 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Abatacept | 105 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Rituximab | 41 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation | Tocilizumab | 60 Participants |
Secondary
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at TNFi initiation was reported in this outcome measure. Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Adalimumab | 975 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Etanercept | 1286 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Infliximab | 707 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Golimumab | 7 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Certolizumab pegol | 137 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Abatacept | 295 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Rituximab | 145 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Tocilizumab | 76 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Anakinra | 85 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Tocilizumab | 74 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Abatacept | 265 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Etanercept | 872 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Adalimumab | 634 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Infliximab | 434 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Rituximab | 89 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Golimumab | 12 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Anakinra | 52 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation | Certolizumab pegol | 99 Participants |
Secondary
Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012
Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy (LOT): prior use of at least one biologic) use at TNFi initiation after 11/6/2012 was reported in this outcome measure.
Time frame: At baseline
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Etanercept | 246 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Abatacept | 110 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Golimumab | 7 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Rituximab | 42 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Infliximab | 147 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Tocilizumab | 45 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Certolizumab pegol | 60 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Anakinra | 6 Participants |
| Tofacitinib Initiators Combination | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Adalimumab | 233 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Anakinra | 7 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Adalimumab | 176 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Etanercept | 194 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Infliximab | 93 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Golimumab | 12 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Certolizumab pegol | 33 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Abatacept | 100 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Rituximab | 28 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 | Tocilizumab | 56 Participants |
Secondary
Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, N signifies number of participants evaluable for this outcome measure. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for mACR20 outcome measure as mACR20 data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX | 1224 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX | 394 Participants |
Secondary
Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | 1224 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX | 19 Participants |
Secondary
Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | 394 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy | 19 Participants |
Secondary
Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | 1224 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX | 28 Participants |
Secondary
Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | 394 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy | 28 Participants |
Secondary
Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX
mACR20 response: \>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).
Time frame: At month 6 follow up visit
Population: Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, Overall number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib Initiators Combination | Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX | 19 Participants |
| Tofacitinib Initiators Monotherapy | Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX | 28 Participants |