Telitacicept for the Treatment of Refractory RA

Prior treatment

• Subjects who have received live virus vaccines within 4 weeks prior to enrollment in the study
• Subjects who have participated in any other investigational drug trial within 12 weeks prior to the start of this study
• Subjects in the active phase of herpes zoster infection, or those who have experienced severe infections (requiring intravenous antibiotics or hospitalization) within 12 weeks prior to the start of the study medication

Other illness

• Subjects with other autoimmune diseases
• Subjects with a history of malignancy (or less than 5 years since clinical remission)
• Subjects allergic to talizumab or any excipients
• Subjects with active hepatitis or a history of severe liver disease at screening
• Subjects with other conditions deemed unsuitable for enrollment by the investigator

Lab values

• Subjects with severe and poorly controlled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematological, or neurological diseases, or laboratory abnormalities that, in the opinion of the investigator, pose unacceptable risks for participation in the study

Other

• Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period

• Fulfill the classification criteria of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
• Refractory RA definition: Insufficient response to a combination of at least two adequate doses of csDMARDs followed by bDMARDs (including but not limited to tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors, T-cell costimulation molecule inhibitors, B-cell targeted drugs) or tsDMARDs (including but not limited to JAK inhibitors) for 12 weeks, with stable drug dosage for at least 6 weeks
• For patients treated with glucocorticoid therapy, they must have been on a stable dose of prednisone or prednisone equivalent ≤ 10 mg/day for at least 4 weeks before enrollment
• For patients treated with non-steroidal anti-inflammatory drugs, they must have been on a stable dose for at least 2 weeks before screening and enrollment
• ① Age \> 18 years and \< 70 years; ② Absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 3 times the upper limit of normal, total bilirubin within 1.5 times the upper limit of normal, serum creatinine clearance rate \> 60 ml/min; ③ Voluntarily sign the informed consent form