Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate

Inclusion criteria

• 1. Diagnosed with systemic sclerosis (SSc) according to the 2013 ACR/EULAR classification criteria 2. Classified as having diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy and Medsger 3. Disease duration of ≤ 36 months, calculated from the onset of the first non-Raynaud's phenomenon manifestation.

• Modified Rodnan Skin Score (mRSS) between 10 and 45 at the time of screening.

• Concurrent use of calcium channel blockers and phosphodiesterase-5 inhibitors for the treatment of Raynaud's phenomenon or digital ulcers was permitted.

• Subjects were aged 18 years and older

Exclusion criteria

• 1. Presence of a rheumatic disease other than systemic sclerosis, except for fibromyalgia or scleroderma-associated myopathy.

• Evidence of any active infection, including active tuberculosis 3. Abnormal laboratory values at screening, including:
• Hemoglobin <9 g/dL
• White blood cell count <3.0 × 10⁹/L
• Absolute neutrophil count <1.2 × 10⁹/L
• Platelet count <100 × 10⁹/L
• Absolute lymphocyte count <0.75 × 10⁹/L
• ALT or AST >3× the upper limit of normal (ULN)
• Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²

• Pulmonary function showing forced vital capacity (FVC) ≤ 50% predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% predicted.

• History of major surgery (including joint surgery) within 8 weeks prior to the screening visit.

• Use of oral corticosteroids 7. Diagnosis of latent TB at or within 30 days of screening. 8. Positive hepatitis B surface antigen or anti HCV test at or within 30 days of screening.

• Pregnant or breastfeeding women, females of childbearing potential who were unwilling or unable to use highly effective contraception during the study 10. History or evidence of malignancy 11. Receipt of a live or attenuated vaccine within 6 weeks prior to baseline