Comparative Effectiveness of New Initiators of Tofacitinib and Other Biologic/Targeted Synthetic DMARDs in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 21,340
- 试验地点
- 1
- 主要终点
- Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years on the cohort entry date.
- •Diagnosed with rheumatoid arthritis (RA) at any time prior to cohort entry date:
- •At least two RA diagnosis codes at least 30 days apart, each coming from an encounter with a rheumatologist;
- •At least one inpatient visit with a RA diagnosis code;
- •At least two outpatient records with a RA diagnosis code at least 30 days apart and within a year, regardless of physician specialty; or
- •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.
- •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).
- •At least 180 days of baseline data available prior to and including the cohort entry date.
- •At least one Clinical Disease Activity Index (CDAI) score in 45 days prior to and including the cohort entry date (baseline).
排除标准
- •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.
- •Patients with >1 b/tsDMARD (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept tocilizumab, or sarilumab) prescribed on index date.
研究组 & 干预措施
rheumatoid arthritis
Patients diagnosed with rheumatoid arthritis
干预措施: tofacitinib (Drug)
rheumatoid arthritis
Patients diagnosed with rheumatoid arthritis
干预措施: tumor necrosis factor inhibitors (TNFi) (Drug)
rheumatoid arthritis
Patients diagnosed with rheumatoid arthritis
干预措施: abatacept (Drug)
rheumatoid arthritis
Patients diagnosed with rheumatoid arthritis
干预措施: tocilizumab or sarilumab (Drug)
结局指标
主要结局
Incidence Rate of LDA or Remission Based on CDAI at 12-Months Follow-up: Tofacitinib vs. Abatacept
时间窗: 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
时间窗: 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
时间窗: 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.
Incidence Rate of Low Disease Activity (LDA) or Remission Based on Clinical Disease Activity Index (CDAI) at 6-Months Follow-up: Tofacitinib vs. TNFi
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点