Lupus & antiphospholipid syndrome
Pharmacokinetics, effectiveness, tolerability and effect on quality of life of open-label tofacitinib for the treatment of moderately active mucocutaneous manifestations of SLE: results of a 76-week phase II study
Authors' conclusion
Tofacitinib in patients with SLE with active MC manifestations showed good effectiveness by week 4 as well as tolerability at exposure comparable to those with other rheumatic diseases.
Study context
- Population
- Young adults with SLE and active mucocutaneous manifestations (CLASI-A Scores >8)10 female
- Participants
- 11 adults
- Outcome
- Partial response of mucocutaneous (MC) activity (CLASI-PR), defined as <20% improvement of CLASI-A Score from baseline, ITT
- Follow-up
- Week 8
Methodological detailsintention-to-treat analysis
- Intention-to-treat analysis
Main finding
As reported in the abstract
CLASI-PR (<20% improvement of CLASI-A from baseline)
CLASI-PR achieved at week 8
73%
8/11
Further findings
CLASI-PR · week 24
- CLASI-PR achieved at week 24
- 82%
- Intention-to-treat analysis
CLASI-PR · week 72
- CLASI-PR achieved at week 72
- 100%
- Intention-to-treat analysis
CLASI-A Score, mean±SD (baseline/week 8/week 24/week 72)
- CLASI-A Scores significantly decreased from baseline
- 16.55±8.03/8.64±7.8/8.82+7 .9/7+9.7; p<0.001
CLASI-CR (CLASI-A=0) · from week 8
- CLASI-CR achieved
- <10% (1/11)
Skindex-29 quality of life (QoL) Scores (baseline/week 4/week 24/week 72)
- Skindex-29 Scores improved significantly as early as week 4
- 37.6±24.16/26.1±23.58/24.3±28.67/25.5±30.71; p=0.009
Safety
Adverse events (AEs) · 629 patient-weeks of follow-up
- AEs reported
- 73
- None considered severe or led to study discontinuation
Serious AEs
- Serious AEs (pelvic inflammatory disease, appendicitis and migraine with aura)
- 3
- No major cardiovascular events, malignancies or death
Original publication
Pharmacokinetics, effectiveness, tolerability and effect on quality of life of open-label tofacitinib for the treatment of moderately active mucocutaneous manifestations of SLE: results of a 76-week phase II study. Lupus Sci Med. Published 29 October 2025. doi:10.
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