Tofacitinib Plus Imatinib in Moderate-to-Severe Palmoplantar Pustulosis

Proportion of Participants Achieving PPPASI 90 Response at Week 16

PPPASI 90 response is defined as at least 90% improvement from baseline in the Palmoplantar Pustulosis Area and Severity Index (PPPASI) score. Participants who discontinue study treatment or receive prohibited concomitant therapy prior to Week 16 will be considered non-responders.

Proportion of Participants Achieving PPPASI 100 Response at Week 16

PPPASI 100 response is defined as complete clearance (100% improvement from baseline) in the Palmoplantar Pustulosis Area and Severity Index (PPPASI) score at Week 16.

Proportion of Participants Achieving at Least 4-Point Improvement in Palmoplantar Pain NRS Score at Week 16

The Palmoplantar Pain Numeric Rating Scale (NRS) is an 11-point scale (0 = no pain, 10 = worst possible pain) used to assess pain intensity on the palms and soles. Response is defined as a ≥4-point improvement from baseline.

Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on quality of life over the past week. Total score ranges from 0 to 30, with higher scores indicating greater impairment. A negative change indicates improvement.

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Treatment-emergent adverse events are defined as any adverse event that occurs after the first dose of study treatment up to 28 days after the last dose. All TEAEs will be summarized by system organ class and preferred term.

Proportion of Participants Achieving PPPASI 50/75/90/100 Response at Various Time Points

Exploratory analysis of PPPASI response rates at intermediate and follow-up time points. PPPASI response is defined as the percentage improvement from baseline in Palmoplantar Pustulosis Area and Severity Index score. Safety Issue

Change from Baseline in EQ-5D-5L Health Status Score

The EQ-5D-5L is a standardized instrument for measuring health-related quality of life. It comprises a descriptive system (5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analog scale (0-100).

Change from Baseline in Palmoplantar Itch NRS Score

The Palmoplantar Itch Numeric Rating Scale (NRS) is an 11-point scale (0 = no itch, 10 = worst imaginable itch) used to assess itch intensity on the palms and soles.

Change from Baseline in Serum Biomarker Levels

Exploratory analysis of changes in serum biomarkers associated with palmoplantar pustulosis pathogenesis, including but not limited to IL-17, IL-22, IL-36, and stem cell factor (SCF).