Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al. 's study found that approximately 55% of patients treated with prednisolone monotherapy experienced recurrence at 36 months. The overall response rate of second-line treatment with rituximab is 70-80%, but the recurrence rate reaches 50%. The response rates of other immunosuppressants, such as cyclosporine, cyclophosphamide, and azathioprine, are relatively low, approximately 30-50%. Patients with chronic hemolysis have recurrent episodes, which affect their survival and quality of life. New treatment methods need to be explored.
Age ≥18 years old, gender not limited.
Primary wAIHA with a clear diagnosis.
Patients who have relapsed or are refractory after at least second-line treatment (previous treatments include at least two types of glucocorticoids, CD20 monoclonal antibodies or other immunosuppressants). Refractory is defined as failure to achieve partial remission after 6 months of treatment with a stable dose of immunosuppressants.
The infusion of CD20 monoclonal antibody should be at least three months apart. If taking immunosuppressants such as cyclosporine and sirolimus, the medication should be discontinued for at least one month.
(1) Those with impaired functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency.
Parallel
enatumab
DrugThe recommended subcutaneous injection dose of this product is as follows: an incremental dose of 12mg on day 1, an incremental dose of 32mg on day 4, an initial treatment dose of 38mg on day 8, and subsequent treatment doses of 38mg in weeks 4 and 6.
overall response rate (ORR)
The overall response rate (ORR) and complete response rate (CRR) at 3 months. The overall response rate (ORR) is defined as the ratio of patients achieving complete response (CR) plus partial response (PR)
The incidence and severity of adverse events
Safety analyses include assessments of the incidence and severity of adverse events; all adverse events that occurred or worsened during the treatment period will be reported, as well as adverse events that occurred later but are considered by the investigator to be related to the trial drug.
Click on the lead sponsor to view all of their trials.
Bing Han
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
