Trial results for a study comparing tofacitinib to other advanced treatments for rheumatoid arthritis were posted on ClinicalTrials.gov on 2025-07-31. The study found that tofacitinib had an incidence rate of 421.1 events per 1000 person years for low disease activity or remission at 6 months, compared to 486.6 events per 1000 person years for abatacept, with a Hazard Ratio of 0.88 (95% CI: 0.79 to 0.99).
Background
The study aimed to understand the effectiveness of tofacitinib when compared to other advanced treatments in patients with rheumatoid arthritis (RA). RA is a type of joint disease that causes pain and swelling.
Trial design
This study (NCT06418529) was a large, completed study that enrolled 21,340 participants with rheumatoid arthritis. The study compared clinical disease activity scores of patients on tofacitinib against those on tumor necrosis factor inhibitors (TNFi), abatacept, and tocilizumab or sarilumab (IL-6 inhibitors). The purpose was to assess how different medicines improve disease activity and whether patient traits or disease factors influence treatment response.
Key results
The study evaluated the incidence rate of low disease activity (LDA) or remission based on the Clinical Disease Activity Index (CDAI) at 6-months and 12-months follow-up for tofacitinib compared to other advanced treatments.
- Tofacitinib vs. Tumor Necrosis Factor Inhibitors (TNFi):
- At 6-months follow-up, tofacitinib had an incidence rate of 426.8 events per 1000 person years for LDA or remission, compared to 471.9 events per 1000 person years for TNFi. The Hazard Ratio (HR) was 0.94 (95.0% CI: 0.85 to 1.05).
- At 12-months follow-up, tofacitinib had an incidence rate of 185.5 events per 1000 person years for LDA or remission, compared to 200.4 events per 1000 person years for TNFi. The Hazard Ratio (HR) was 0.94 (95.0% CI: 0.83 to 1.07).
- Tofacitinib vs. Abatacept:
- At 6-months follow-up, tofacitinib had an incidence rate of 421.1 events per 1000 person years for LDA or remission, compared to 486.6 events per 1000 person years for abatacept. The Hazard Ratio (HR) was 0.88 (95.0% CI: 0.79 to 0.99).
- At 12-months follow-up, tofacitinib had an incidence rate of 185.2 events per 1000 person years for LDA or remission, compared to 203.1 events per 1000 person years for abatacept. The Hazard Ratio (HR) was 0.91 (95.0% CI: 0.79 to 1.04).
- Tofacitinib vs. IL-6 Inhibitors (Tocilizumab or Sarilumab):
- At 6-months follow-up, tofacitinib had an incidence rate of 401.7 events per 1000 person years for LDA or remission, compared to 436.3 events per 1000 person years for IL-6 inhibitors. The Hazard Ratio (HR) was 0.92 (95.0% CI: 0.81 to 1.05).
- At 12-months follow-up, tofacitinib had an incidence rate of 177.7 events per 1000 person years for LDA or remission, compared to 181.7 events per 1000 person years for IL-6 inhibitors. The Hazard Ratio (HR) was 0.93 (95.0% CI: 0.79 to 1.09).
What this means
The results indicate that tofacitinib generally showed similar or slightly lower incidence rates of achieving low disease activity or remission compared to TNFi and IL-6 inhibitors over 6 and 12 months. Notably, at 6 months, tofacitinib demonstrated a statistically significantly lower incidence rate of low disease activity or remission compared to abatacept, as indicated by the Hazard Ratio of 0.88 with a 95% confidence interval that did not cross 1. For other comparisons, the confidence intervals for the Hazard Ratios crossed 1, suggesting no statistically significant difference or a trend towards similar outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06418529, titled "A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis," were posted on 2025-07-31 on clinicaltrials.gov.