Trial reportLupus science & medicine2025
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.
Trial report in Lupus science & medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Can Phagocytosis, Neutrophil Extracellular Traps, and IFN-α Production in Systemic Lupus Erythematosus Be Simultaneously Modulated? A Pharmacological Perspective.International journal of molecular sciences · 2026Review
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Authors and funding
12 authors.
Funding
Abstract
objectiveTo investigate the pharmacokinetics, effectiveness, safety and tolerability of tofacitinib in young adults with active mucocutaneous (MC) SLE manifestations.
methodsPatients with SLE and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity (CLASI-A) Scores >8 newly received open-label tofacitinib from baseline to week (week) 72. Intensive pharmacokinetics sampling was done at the end of week 1, and safety was assessed throughout the study. The primary effectiveness endpoint was partial response of MC activity defined as <20% improvement of the CLASI-A Score from baseline (CLASI-PR) at week 8 in intention-to-treat analysis; secondary and other endpoints included MC complete response (CLASI-CR; CLASI-A=0) and quality of life (QoL) as measured by Skindex-29.
resultsSubjects were 11 patients (female patients: 10, mean±SD age: 23.0±5.87 years) with moderate to severe MC manifestations (CLASI-A=16.6±8.03). The pharmacokinetics of tofacitinib was comparable to that seen in juvenile and adult arthritis. During 629 patient-weeks of follow-up, 73 adverse events (AEs) were reported, none of which were considered severe or led to study discontinuation. There were three serious AEs (pelvic inflammatory disease, appendicitis and migraine with aura) but no major cardiovascular events, malignancies or death. In intention-to-treat analysis, at week 8 CLASI-PR was achieved in 73% (8/11) of subjects, in 82% at week 24 and 100% at week 72, respectively. Although CLASI-A Scores significantly decreased from baseline (baseline/week 8/week 24/week 72=16.55±8.03/8.64±7.8/8.82+7 .9/7+9.7; p<0.001), CLASI-CR was achieved by only <10% (1/11), starting week 8. Skindex-29 Scores improved significantly as early as week 4 (baseline/week 4/week 24/week 72= 37.6±24.16/26.1±23.58/24.3±28.67/25.5±30.71; p=0.009).
conclusionTofacitinib 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. Tofacitinib was associated with significant improvement of QoL due to rapid improvement of MC inflammation. Observed safety and pharmacokinetics were comparable to observations in juvenile and adult arthritis.
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