Sjögren's disease & overlap diseases

Evaluating the therapeutic potential of tofacitinib in Sjögren’s disease: a comprehensive clinical and immunological assessment

Rheumatology (Oxford)Published Retrospective and prospective cohort studies

Authors' conclusion

Tofacitinib effectively improves disease activity and immune regulation in SjD, and it is associated with suppressing Tfh and Tph cells, suggesting its potential as a treatment option.

Study context

Population
Patients diagnosed with Sjögren's disease (SjD)10 completed Cohort II
Exposure
Oral tofacitinib, before vs after treatment
  • Cohort In = 112
Outcome
Change in disease activity (ESSDAI)
Methodological detailstwo independent cohorts, prospective (Cohort II)
  • Two independent cohorts
  • Prospective (Cohort II)

Main finding

As reported in the abstract

ESSDAI score, Cohort I, before vs after tofacitinib

Cohort I (baseline)

8.00

median · IQR 4.25–15.75

Cohort I (tofacitinib)

6.50

median · IQR 2.25–12.75

P < 0.001

Observational data: associations, not effects.

Further findings

ESSDAI score in Cohort II, vs baseline · sixth month

Significant reduction in ESSDAI scores at the sixth month compared with baseline
P = 0.001
  • Ten patients completed the 12-month treatment period

ESSPRI decrease of at least one point or 15% in Cohort II

Patients achieving a decrease of at least one point or 15% in ESSPRI scores
80% (8/10)

Proportion of Th17 cells in Cohort II

Significant reduction in the proportion of Th17 cells (mean ± SD)
14.84 ± 7.70 vs 7.74 ± 4.24, P = 0.008

Tfh and Tph cells, pSTAT-3 in CD4+ T cells

Decrease in Tfh and Tph cells, along with decreased pSTAT-3 levels in CD4+ T cells and disease activity scores

Safety

Serious adverse events

None observed in the two cohorts
0

Original publication

Evaluating the therapeutic potential of tofacitinib in Sjögren’s disease: a comprehensive clinical and immunological assessment. Rheumatology (Oxford). Published 26 March 2025. doi:10.1093/rheumatology/keaf173

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