Trial Outcomes & Findings for A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis (NCT NCT06418529)
NCT ID: NCT06418529
Last Updated: 2025-07-31
Results Overview
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.
COMPLETED
21340 participants
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)
2025-07-31
Participant Flow
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.
Retrospective data retrieved, were assembled in this study from 15-May-2024 to 19-July-2024 (approximately 2 months).
Participant milestones
| Measure |
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 targeted synthetic/biologic (ts/b)DMARD, (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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3681
|
11667
|
3528
|
2464
|
|
Overall Study
COMPLETED
|
3681
|
11667
|
3528
|
2464
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Tofacitinib
n=3681 Participants
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.
|
TNFi
n=11667 Participants
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.
|
Abatacept
n=3528 Participants
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.
|
IL-6
n=2464 Participants
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.
|
Total
n=21340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.9 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
61.1 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
60.5 Years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
59.4 Years
STANDARD_DEVIATION 13.32 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2997 Participants
n=5 Participants
|
9171 Participants
n=7 Participants
|
2,898 Participants
n=5 Participants
|
1,982 Participants
n=4 Participants
|
17048 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
684 Participants
n=5 Participants
|
2496 Participants
n=7 Participants
|
630 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
4292 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
210 Participants
n=5 Participants
|
639 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
1155 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3182 Participants
n=5 Participants
|
10026 Participants
n=7 Participants
|
3,091 Participants
n=5 Participants
|
2151 Participants
n=4 Participants
|
18450 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
289 Participants
n=5 Participants
|
1002 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
1735 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
330 Participants
n=5 Participants
|
1131 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
2048 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
2776 Participants
n=5 Participants
|
8436 Participants
n=7 Participants
|
2659 Participants
n=5 Participants
|
1855 Participants
n=4 Participants
|
15726 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
412 Participants
n=5 Participants
|
1362 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
2397 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
163 Participants
n=5 Participants
|
738 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
1169 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=3681 Participants
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.
|
TNFi
n=11667 Participants
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.
|
|---|---|---|
|
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
|
471.9 Events per 1000 person years
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=3681 Participants
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.
|
TNFi
n=11667 Participants
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.
|
|---|---|---|
|
Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. TNFi
|
185.5 Events per 1000 person years
|
200.4 Events per 1000 person years
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=3681 Participants
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.
|
TNFi
n=3528 Participants
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.
|
|---|---|---|
|
Incidence Rate of LDA or Remission Based on CDAI at 6-Months Follow-up: Tofacitinib vs. Abatacept
|
421.1 Events per 1000 person years
|
486.6 Events per 1000 person years
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=3681 Participants
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.
|
TNFi
n=3528 Participants
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.
|
|---|---|---|
|
Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept
|
185.2 Events per 1000 person years
|
203.1 Events per 1000 person years
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=3681 Participants
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.
|
TNFi
n=2464 Participants
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.
|
|---|---|---|
|
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
|
436.3 Events per 1000 person years
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib
n=3681 Participants
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.
|
TNFi
n=2464 Participants
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.
|
|---|---|---|
|
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
|
181.7 Events per 1000 person years
|
Adverse Events
Tofacitinib
TNFi
Abatacept
IL-6
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER