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

Exclusion Criteria

• •1\. Presence of a rheumatic disease other than systemic sclerosis, except for fibromyalgia or scleroderma-associated myopathy.
• •2\. 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
• •4\. Pulmonary function showing forced vital capacity (FVC) ≤ 50% predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% predicted.
• •5\. History of major surgery (including joint surgery) within 8 weeks prior to the screening visit.
• •6\. 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.
• •9\. 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