CPI Combination Therapy for Autoimmune Encephalitis

Last updated: June 26, 2025
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Completed

Phase

N/A

Condition

Memory Loss

Treatment

IVIG, High-dose glucocorticoid

Plasma exchange

intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP)

Clinical Study ID

NCT03542279
AE-CPI
  • Ages 14-65
  • All Genders

Study Summary

Corticosteroids, intravenous immunoglobulin (IVIG), and plasma exchange (PE) are the first-line therapies for autoimmune encephalitis (AE) patients, but optimal first-line treatment strategy for different AE patients remains undetermined. The study is to compare the efficacy between pulse corticosteroid plus PE initially followed by IVIG (CPI therapy) and pulse corticosteroid plus IVIG followed by PE two weeks later (CIP therapy) in patients with severe antibody-associated autoimmune encephalitis (AE).

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. 14-65 years old;

  2. met all the three following diagnostic criteria of AE: (i) subacute onset (rapidprogress of less than 3 months) of working memory deficits, altered mental status,or psychiatric symptoms; (ii) at least one of the followings: new focal CNSfindings, seizures not explained by a previously known disease, cerebrospinal fluid (CSF) pleocytosis (white blood cell count 5 cells/mm3), magnetic resonance imaging (MRI) features suggestive of encephalitis, and (iii) reasonable exclusion ofalternative causes;

  3. the presence of antibody against neuronal surface antigen in serum or CSF indicatinga positive diagnosis of AE using a cell-based assay;

  4. critically ill with a modified Rankin scale (mRS) score of 4 to 5;

  5. within 3 months of onset;

  6. no immunotherapy previously.

Exclusion

Exclusion criteria:

  1. relative contraindications of TPE treatment: serious underlying diseases such assevere active hemorrhage, disseminated intravascular coagulation, severe hypotensionor shock, unstable cardiac failure, cerebral herniation, severe infection or otherendangered conditions;

  2. allergic to immunoglobulin;

  3. contraindications of glucocorticoid therapy: glucocorticoid allergy, active gastricor duodenal ulcer, severe osteoporosis, diabetes, hypertension after recentgastrointestinal anastomosis, and serious infection that cannot be controlled byantibiotics;

  4. serious underlying diseases, such as cardiac dysfunction, arrhythmia, andcoagulation disorders;

  5. premorbid mRS ≥ 3.

Study Design

Total Participants: 70
Treatment Group(s): 4
Primary Treatment: IVIG, High-dose glucocorticoid
Phase:
Study Start date:
November 25, 2020
Estimated Completion Date:
September 12, 2024

Study Description

Patients with AE will be randomly divided into the CPI and CIP group according to the random table. All patients will receive tumour screening, symptomatic supportive treatment, and immunotherapy. The immunotherapy includes intravenous methylprednisolone (IVMP), intravenous immunoglobulin (IVIG; 0.4 g/kg/d for each course for 5 d), PE and immunosuppressants. Patients in the CPI group received IVMP and PE treatment without delay, followed by IVIG immediately after PE treatment. Patients in the CIP group were given IVMP and IVIG and IVMP immediately, followed by PE at least 2 weeks after IVIG treatment. The patients received long-term immunotherapy involving a combination of oral corticosteroids and immunosuppressants (such as mycophenolate mofetil at a dose of 1-2g/d) for 6-12 months if no contraindications. The primary outcome is the proportion of patients achieving functional improvement [a decrease of at least 1 point in modified Rankin Scale (mRS) score] at 3 months after immunotherapy.

Connect with a study center

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing 100053
    China

    Site Not Available

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