Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to learn how different types of medicines may improve disease activity in people with rheumatoid arthritis (RA). RA is a kind of joint disease that causes pain and swelling. The study will look at data from a large, US-based group of RA patients who have taken the below medicines: * Tofacitinib * Abatacept * Tocilizumab or sarilumab The study will compare clinical disease activity scores of patients on the different medicines taken. The study will also decide whether some patient traits or disease factors play a role in how medicines may improve disease activity.
Interventions
DRUGtofacitinib
New index treatment of tofacitinib
DRUGtumor necrosis factor inhibitors (TNFi)
New index treatment of TNFi
DRUGabatacept
New index treatment of abatacept
DRUGtocilizumab or sarilumab
New index treatment of tocilizumab or sarilumab
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years on the cohort entry date. 2. Diagnosed with rheumatoid arthritis (RA) at any time prior to cohort entry date: 1. At least two RA diagnosis codes at least 30 days apart, each coming from an encounter with a rheumatologist; 2. At least one inpatient visit with a RA diagnosis code; 3. At least two outpatient records with a RA diagnosis code at least 30 days apart and within a year, regardless of physician specialty; or 4. At least one outpatient record with an RA diagnosis and a prescription or fill for a disease modifying anti-rheumatic drug (DMARD) from a specified list and does not have any of the non-RA conditions for which those drugs may also be prescribed. 3. Initiation of specified biologic or targeted synthetic molecule DMARDs of interest for treatment of RA (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept, tocilizumab, or sarilumab). 4. At least 180 days of baseline data available prior to and including the cohort entry date. 5. At least one Clinical Disease Activity Index (CDAI) score in 45 days prior to and including the cohort entry date (baseline).
Exclusion criteria
1. Patients diagnosed with concomitant indications for tofacitinib \[psoriatic arthritis (PsA), UC, and polyarticular course juvenile idiopathic arthritis (pcJIA)\] at any time prior to cohort entry date, determined by at least two (2) diagnosis codes at least 30 days apart and prior to baseline. 2. Patients with \>1 b/tsDMARD (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept tocilizumab, or sarilumab) prescribed on index date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Low Disease Activity (LDA) or Remission Based on Clinical Disease Activity Index (CDAI) at 6-Months Follow-up: Tofacitinib vs. TNFi | During 6 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: swollen joint counts (SJC) and tender/painful joint counts (TJC) (score range from 0 to 28, higher scores = worse condition), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA) (assessed on 0-10 centimeter \[cm)\] visual analog scale \[VAS\]; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. Inverse probability of treatment weighting (IPTW) using stabilized weights to adjust for baseline confounders, was used for analysis. |
| Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. TNFi | During 12 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. |
| Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. Abatacept | During 6 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. |
| Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept | During 12 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. |
| Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. IL-6 | During 6 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) | CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis. |
| Incident Rate of Low Disease Activity or Remission Based on CDAI at Month 12: Tofacitinib vs. IL-6, IPTW | During 12 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months) | CDAI was a simplified index for assessing disease activity comprising of the SJC, tender/painful joint counts TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to 10 in participants with moderate or high disease activity CDAI greater than 10 at baseline. IPTW method was used for analysis of this outcome measure. |
Countries
United States
Participant flow
Recruitment details
Eligible retrospective data retrieved from US based OM1 PremiOM™ Rheumatoid Arthritis (RA)dataset (OM1, Inc., Boston, MA) from 1 Jan 2013 to 13 Mar 2024 (approximately 11.2 years). Dataset included participants diagnosed with RA in routine clinical care among network of rheumatologists across US. Participants who initiated treatment with tofacitinib or comparator (tumor necrosis factor inhibitor \[TNFi\], abatacept, interleukin 6 \[IL-6\]) were assigned to respective reporting groups for analysis.
Pre-assignment details
Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months).
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib Participants diagnosed with RA and who initiated treatment with tofacitinib, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. | 3,681 |
| TNFi Participants diagnosed with RA and who initiated treatment with TNFi, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. | 11,667 |
| Abatacept Participants diagnosed with RA and who initiated treatment with abatacept, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. | 3,528 |
| IL-6 Participants diagnosed with RA and who initiated treatment with IL-6, in routine clinical care in a network of rheumatologists across the US were included. Their data was observed from the date after treatment initiation until the occurrence of an outcome or a censoring event: (i) discontinued their index treatment, (ii) switched to a different ts/bDMARD, (iii) were lost to follow-up, or (iv) on the last day of the outcome assessment window for each analysis, whichever occurred first, from 1 January 2013 to 13 March 2024 (approximately 11.2 years). Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months). There was no study intervention administration under this study. | 2,464 |
| Total | 21,340 |
Baseline characteristics
| Characteristic | Tofacitinib | TNFi | Abatacept | IL-6 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 57.9 Years STANDARD_DEVIATION 12.3 | 58.1 Years STANDARD_DEVIATION 13.7 | 61.1 Years STANDARD_DEVIATION 13.1 | 60.5 Years STANDARD_DEVIATION 12.8 | 59.4 Years STANDARD_DEVIATION 13.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 210 Participants | 639 Participants | 172 Participants | 134 Participants | 1155 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3182 Participants | 10026 Participants | 3,091 Participants | 2151 Participants | 18450 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 289 Participants | 1002 Participants | 265 Participants | 179 Participants | 1735 Participants |
| Race/Ethnicity, Customized Race Black | 330 Participants | 1131 Participants | 349 Participants | 238 Participants | 2048 Participants |
| Race/Ethnicity, Customized Race Other | 412 Participants | 1362 Participants | 351 Participants | 272 Participants | 2397 Participants |
| Race/Ethnicity, Customized Race Unknown | 163 Participants | 738 Participants | 169 Participants | 99 Participants | 1169 Participants |
| Race/Ethnicity, Customized Race White | 2776 Participants | 8436 Participants | 2659 Participants | 1855 Participants | 15726 Participants |
| Sex: Female, Male Female | 2997 Participants | 9171 Participants | 2,898 Participants | 1,982 Participants | 17048 Participants |
| Sex: Female, Male Male | 684 Participants | 2496 Participants | 630 Participants | 482 Participants | 4292 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept
CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis.
Time frame: During 12 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)
Population: Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib | Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept | 185.2 Events per 1000 person years |
| TNFi | Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept | 203.1 Events per 1000 person years |
95% CI: [0.79, 1.04]
Primary
Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. TNFi
CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis.
Time frame: During 12 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)
Population: Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib | Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. TNFi | 185.5 Events per 1000 person years |
| TNFi | Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. TNFi | 200.4 Events per 1000 person years |
95% CI: [0.83, 1.07]
Primary
Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. Abatacept
CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis.
Time frame: During 6 month of follow-up post-initiation of tofacitinib or abatacept; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)
Population: Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib | Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. Abatacept | 421.1 Events per 1000 person years |
| TNFi | Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. Abatacept | 486.6 Events per 1000 person years |
95% CI: [0.79, 0.99]
Primary
Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. IL-6
CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (score range from 0 to 28, higher scores = worse condition), PtGA and PGA (assessed on 0-10 cm) VAS; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. IPTW using stabilized weights to adjust for baseline confounders, was used for analysis.
Time frame: During 6 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)
Population: Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib | Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. IL-6 | 401.7 Events per 1000 person years |
| TNFi | Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. IL-6 | 436.3 Events per 1000 person years |
95% CI: [0.81, 1.05]
Primary
Incidence Rate of Low Disease Activity (LDA) or Remission Based on Clinical Disease Activity Index (CDAI) at 6-Months Follow-up: Tofacitinib vs. TNFi
CDAI is a simplified index for assessing disease activity. CDAI is the numerical sum of 4 outcome parameters: swollen joint counts (SJC) and tender/painful joint counts (TJC) (score range from 0 to 28, higher scores = worse condition), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA) (assessed on 0-10 centimeter \[cm)\] visual analog scale \[VAS\]; higher scores = greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. LDA was defined as CDAI score of 2.9 to 10.0 and remission was defined as CDAI score of 0.0 to 2.8. Incidence rate was defined as the number of events (LDA or remission based on CDAI score) divided by the Participant-Year, multiplied by 1000. Inverse probability of treatment weighting (IPTW) using stabilized weights to adjust for baseline confounders, was used for analysis.
Time frame: During 6 month of follow-up post-initiation of tofacitinib or TNFi; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)
Population: Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib | Incidence Rate of Low Disease Activity (LDA) or Remission Based on Clinical Disease Activity Index (CDAI) at 6-Months Follow-up: Tofacitinib vs. TNFi | 426.8 Events per 1000 person years |
| TNFi | Incidence Rate of Low Disease Activity (LDA) or Remission Based on Clinical Disease Activity Index (CDAI) at 6-Months Follow-up: Tofacitinib vs. TNFi | 471.9 Events per 1000 person years |
95% CI: [0.85, 1.05]
Primary
Incident Rate of Low Disease Activity or Remission Based on CDAI at Month 12: Tofacitinib vs. IL-6, IPTW
CDAI was a simplified index for assessing disease activity comprising of the SJC, tender/painful joint counts TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to 10 in participants with moderate or high disease activity CDAI greater than 10 at baseline. IPTW method was used for analysis of this outcome measure.
Time frame: During 12 month of follow-up post-initiation of tofacitinib or IL-6; retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months)
Population: Analysis population included all eligible participants whose data were retrieved from dataset and observed in this retrospective observational study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib | Incident Rate of Low Disease Activity or Remission Based on CDAI at Month 12: Tofacitinib vs. IL-6, IPTW | 177.7 Events per 1000 person years |
| TNFi | Incident Rate of Low Disease Activity or Remission Based on CDAI at Month 12: Tofacitinib vs. IL-6, IPTW | 181.7 Events per 1000 person years |
95% CI: [0.79, 1.09]