Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis. Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.
• Age ≥14 years old, male or female;
• Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;
• Diagnosed as autoimmune encephalitis, diagnostic criteria as follows:
‣ Rapid onset (\<3 months) of at least four of the following six major symptoms:
• Abnormal (mental) behavior or cognitive dysfunction
∙ Speech dysfunction (verbal urgency, hypospeech, mutism)
∙ Seizures
∙ Movement disorders, dyskinesias, or postural rigidity/abnormalities
∙ Decreased level of consciousness
∙ Autonomic dysfunction or central hypoventilation in the presence of one or more of the six major symptoms;
⁃ Positive anti-NMDAR (GluN1) IgG antibody detected in CSF or positive serum and/or cerebrospinal fluid LGI1 antibody; c.Reasonable exclusion of other etiologies and other well-defined encephalitis syndromes (e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary CNS vasculitis, Rasmussen encephalitis);
• Refractory AE: ineffective treatment with steroids and rituximab or other immunosuppressants, post-treatment mRS score≥2 (stable for at least 24 hours);Recurrent AE: at least 2 months after 1st or 2nd line treatment, new symptoms or worsening of existing symptoms (mRS increase\>1); 5)Doses of steroids and other immunosuppressants (e.g. azathioprine, mycophenolate mofetil, cyclophosphamide) should be stabilised for 4 weeks prior to enrolment; 6)Ability to obtain patient or proxy consent; 7)Women of childbearing potential should use effective contraception during treatment or avoid heterosexual intercourse for at least 3 months after the last dose of talitacicept;