Clinical Efficacy of Telitacicept in Sjögren's Disease With Interstitial Lung Disease

Korábbi kezelés

• Concomitant Autoimmune Diseases: Diagnosis of other systemic autoimmune diseases besides Sjögren's Syndrome, such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Mixed Connective Tissue Disease (MCTD), or ANCA-associated vasculitis. (Note: Secondary Sjögren's Syndrome is not excluded on this basis alone, but the primary condition must be considered).
• Prior/Concomitant Medications:
  • Use of rituximab, belimumab, TNF inhibitors (e.g., etanercept, adalimumab), or ther biologic agents (e.g., IL-6, IL-17, IL-23 inhibitors) within 3 months prior to screening.
  • Participation in another interventional clinical trial (receiving investigational drug or device) within 4 weeks prior to screening.
• Special Populations:
  • Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use highly effective contraceptive methods from screening until at least 3 months after the last dose of study drug.
  • Patients planning to undergo major surgery during the study period.

Más betegség

• Allergy: Known allergy or hypersensitivity to Telitacicept or any of its excipients.
• Significant Organ Diseases or Comorbidities:
  • Cardiovascular: Myocardial infarction or unstable angina within the past 6 months; uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg); pulmonary arterial hypertension with evidence of right heart failure.
  • Respiratory: Presence of other significant lung diseases (e.g., COPD, asthma, pulmonary embolism, active pulmonary tuberculosis).
  • Gastrointestinal: Active peptic ulcer, gastrointestinal bleeding, or pancreatitis.
  • Malignancy: History of any malignancy within the past 5 years (excluding successfully treated basal cell carcinoma of the skin or in-situ cervical carcinoma).
  • Psychiatric: Severe mental illness (e.g., severe depression, schizophrenia) or cognitive impairment that may interfere with compliance.
• Active Infection:
  • Presence of an active infection requiring systemic anti-infective treatment at screening.
  • Active tuberculosis (positive T-SPOT.TB or TST with chest X-ray/CT findings suggestive of active disease).
  • Positive HIV antibody. Positive Hepatitis B surface antigen (HBsAg), or positive Hepatitis B core antibody (HBcAb) with detectable HBV DNA.
  • Positive Hepatitis C antibody with detectable HCV RNA.
• Other Situations:
  • Inability to cooperate with pulmonary function tests (e.g., due to severe cognitive impairment or dyspnea).
  • Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study (e.g., poor compliance, inability to understand study procedures).

Laborértékek

• Laboratory Abnormalities (at Screening):
  • Hematology:
  • Hemoglobin (Hb) < 85 g/L. White Blood Cell count (WBC) < 3.0 × 10\^9/L. Neutrophil count (NEUT) < 1.5 × 10\^9/L. Platelet count (PLT) < 80 × 10\^9/L.
  • Liver Function:
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 2.5 × the upper limit of normal (ULN).
  • Total bilirubin (TBIL) > 1.5 × ULN.
  • Kidney Function:
  • Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m². Or serum creatinine (Cr) > 1.5 × ULN.

• Age 18 to 70 years, male or female.
• Diagnosis of primary Sjögren's Syndrome meeting the 2016 ACR/EULAR classification criteria.
• Confirmed diagnosis of Interstitial Lung Disease by High-Resolution Computed Tomography (HRCT).
• Stable doses of corticosteroids and immunosuppressants (e.g., mycophenolate mofetil) for at least 1 week prior to enrollment.
• Willing and able to provide written informed consent