Tocilizumab for the Treatment of Refractory Granulomatous Lobular Mastitis

Exclusion Criteria

• •1. Bilateral mastitis occurring simultaneously or sequentially within six months.
• •2. Clinical diagnosis (combined with pathological findings) of periductal mastitis.
• •3. History of lymphoproliferative disorder; or presence of signs or symptoms suggestive of a possible lymphoproliferative disorder (including lymphadenopathy or splenomegaly); or active primary or recurrent malignancy; or clinically significant malignancy with a remission duration of less than 5 years.
• •1. Patients with carcinoma in situ of the cervix may participate if successfully treated with no evidence of recurrence or metastasis for at least 3 years.
• •2. Patients with basal cell or squamous cell carcinoma of the skin may participate if successfully treated with no evidence of recurrence for at least 3 years.
• •4. Patients who are pregnant.
• •5. Current or recent severe viral, bacterial, fungal, or parasitic infection, including but not limited to:
• •1. Symptomatic herpes zoster infection within 12 weeks prior to screening.
• •2. History of disseminated/complicated herpes zoster (e.g., multidermatomal involvement, herpes zoster ophthalmicus, CNS involvement, or postherpetic neuralgia).
• •3. Symptomatic herpes simplex at the time of enrollment.
• •4. Active or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
• •5. Household contact with an individual with active tuberculosis (TB) and not having received appropriate and documented TB prophylaxis.
• •6. Evidence of active TB, or history of active TB without appropriate and documented treatment.
• •7. Clinically significant infection within 4 weeks prior to enrollment, or having received intravenous antibiotic therapy for an infection.
• •8. Any other active or recent infection within 4 weeks prior to enrollment that, in the investigator's judgment, would pose an unacceptable risk to the patient.
• •Note: Recent viral upper respiratory tract infections or uncomplicated urinary tract infections should not be considered clinically significant.
• •6. Patients with hepatic or renal insufficiency, gastrointestinal ulcer, active hepatitis, active rheumatic autoimmune disease, active tuberculosis, or poorly controlled psychiatric disorders.
• •7. Cardiac, pulmonary, hepatic, renal, or coagulation dysfunction that, in the investigator's judgment, makes the patient unsuitable for enrollment.
• •8. History of hypersensitivity to tocilizumab.
• •9. Previous treatment with tocilizumab (a single prior dose may be exempted upon investigator's assessment).
• •10. Any major surgery within 8 weeks prior to screening, or requirement for major surgery during the study period, which, in the investigator's judgment, would pose an unacceptable risk to the patient.
• •11. Presence of the following laboratory abnormalities, or any other laboratory value outside the reference range deemed by the investigator to pose an unacceptable risk for participation:
• •1. AST or ALT ≥ 2 × upper limit of normal (ULN)
• •2. Alkaline phosphatase (ALP) ≥ 2 × ULN
• •3. Total bilirubin (TBL) ≥ 1.5 × ULN
• •4. Hemoglobin \< 9.0 g/dL
• •5. Total white blood cell count \< 2.5 × 10⁹ cells/L
• •6. Neutropenia (absolute neutrophil count \[ANC\] \< 1.2 × 10⁹ cells/L)
• •7. Lymphopenia (lymphocyte count \< 0.75 × 10⁹ cells/L)
• •8. Thrombocytopenia (platelets \< 100 × 10⁹/L)
• •9. Estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m² (based on the CKD-EPI equation) Note: The above abnormalities may be retested during the screening period, with eligibility determined based on the retest results.
• •12. Administration of a live or attenuated vaccine within 6 weeks prior to the first dose, or planned administration during the treatment period or within 6 weeks after the last dose.
• •13. Body weight ≥ 100 kg.