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PB2552: VAYHIA: A RANDOMIZED, DOUBLE-BLIND, PHASE III TRIAL TO ASSESS THE EFFICACY AND SAFETY OF IANALUMAB VS PLACEBO IN PATIENTS WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA THAT FAILED ≥1 LINE OF TREATMENT

ABSTRACT:

SUBMITTER: Barcellini W

PROVIDER: S-EPMC10428764 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Venous thromboembolic events during warm autoimmune hemolytic anemia.

Project description:Thrombotic manifestations are a hallmark of many auto-immune diseases (AID), specially of warm autoimmune hemolytic anemia (wAIHA), as 15 to 33% of adults with wAIHA experience venous thromboembolic events (VTE). However, beyond the presence of positive antiphospholipid antibodies and splenectomy, risk factors for developing a VTE during wAIHA have not been clearly identified. The aim of this retrospective study was to characterize VTEs during wAIHA and to identify risk factors for VTE. Forty-eight patients with wAIHA were included, among whom 26 (54%) had secondary wAIHA. Eleven (23%) patients presented at least one VTE, that occurred during an active phase of the disease for 10/11 patients (90%). The frequency of VTE was not different between primary and secondary AIHA (23.7 vs. 19.2%; p = 0.5). The Padua prediction score based on traditional risk factors was not different between patients with and without VTE. On multivariate analysis, total bilirubin ? 40 ?mol/L [odds ratio (OR) = 7.4; p = 0.02] and leucocyte count above 7x10(9)/L (OR = 15.7; p = 0.02) were significantly associated with a higher risk of thrombosis. Antiphospholipid antibodies were screened in 9 out the 11 patients who presented a VTE and were negative. Thus, the frequency of VTE is high (23%) during wAIHA and VTE preferentially occur within the first weeks of diagnosis. As no clinically relevant predictive factors of VTE could be identified, the systematic use of a prophylactic anticoagulation should be recommended in case of active hemolysis and its maintenance after hospital discharge should be considered. The benefit of a systematic screening for VTE and its procedure remain to be determined.

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Ominous comorbidities: Small ventricular septal defect and warm autoimmune hemolytic anemia.

Project description: Not available

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Autoimmune hemolytic anemia.

Project description:The diagnosis of autoimmune hemolytic anemia (AIHA) can be made with a stepwise approach that aims to identify laboratory and clinical evidence of hemolysis and then determine the immune nature of hemolysis with the direct anti-globulin test. Once alternative causes for these findings have been excluded, AIHA is established, and the clinician must search for secondary causes, as well as identify the type of AIHA. Rituximab is now the preferred second-line treatment for primary warm AIHA and first-line treatment for primary cold agglutinin disease (CAD), either as monotherapy or combined with bendamustine. Complement inhibitors have shown utility in stabilizing AIHA patients with acute severe hemolysis. Future prospects are discussed and include the C1s inhibitor BIVV009 (sutimlimab) that is now entering phase 3 studies for CAD.

| S-EPMC6246027 | biostudies-literature

P1533: TRIAL IN PROGRESS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF PARSACLISIB IN PATIENTS WITH PRIMARY WARM AUTOIMMUNE HEMOLYTIC ANEMIA

Project description: Not available

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Warm Autoimmune Hemolytic Anemia as First Presentation of Chronic Myeloid Leukemia: A Case Report.

Project description:IntroductionChronic myeloid leukemia (CML) is a myeloproliferative neoplasm characterized by the Philadelphia chromosome and uncontrolled granulocyte production. While autoimmune hemolytic anemia (AIHA) is commonly associated with lymphoproliferative disorders such as chronic lymphocytic leukemia, its occurrence in CML is rare, with only a few documented cases. Here, we report a case of concurrent chronic-phase CML and AIHA.Case presentationWe present a 34-year-old female diagnosed with warm AIHA as the first presentation of CML. Diagnostic workup, including peripheral smear, revealed hemolysis with elevated lactate dehydrogenase and a positive direct antiglobulin test (DAT), along with a positive Philadelphia chromosome, confirming CML. Steroid therapy successfully managed the AIHA, leading to normalization of hemoglobin levels and subsequent tapering and discontinuation of steroids.ConclusionWhile AIHA is a rare cause of anemia in CML, it should be considered during anemia evaluation, particularly in cases of CML relapse.

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Clinical severity in adult warm autoimmune hemolytic anemia and its relationship to antibody specificity.

Project description: Not available

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Multifactorial jaundice and pigmented choledocholithiasis secondary to warm autoimmune hemolytic anemia and alcoholic cirrhosis.

Project description:A 67-year-old man with a history of alcoholic cirrhosis presented with acute abdominal pain. His total bilirubin was 43.8 mg/dL and fractionated to a direct bilirubin of 32.7 mg/dL. A warm agglutinin IgG1 antibody was positive, and abdominal magnetic resonance imaging detected an obstructing stone at the level of the sphincter of Oddi. Two pigmented gallstones were removed by endoscopic retrograde cholangiopancreatography. His total bilirubin decreased to 24.6 mg/dL the following day, and he was initiated on 20 mg of prednisone for his autoantibody.

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Fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia: Phase 2, multicenter, open-label study.

Project description:Patients with relapsed warm antibody autoimmune hemolytic anemia (wAIHA) have limited treatment options. Fostamatinib is a potent, orally administered spleen tyrosine kinase inhibitor approved in the United States and Europe for the treatment of adults with chronic immune thrombocytopenia (ITP). This phase 2 study evaluated the response to fostamatinib, administered at 150 mg BID orally with or without food in adults with wAIHA and active hemolysis with hemoglobin (Hgb) <10 g/dL who had failed at least one prior treatment. Hemoglobin levels and safety assessments were performed at visits every 2 weeks. The primary endpoint was Hgb >10 g/dL with an increase of ≥2 g/dL from baseline by week 24 without rescue therapy or red blood cell transfusion. Eleven of 24 (46%) patients achieved the primary endpoint. Increases in median Hgb were detected at week 2 and sustained over time. Median lactate dehydrogenase levels and reticulocyte counts generally declined over time with little change in median haptoglobin levels. The most common adverse events (AEs) were diarrhea (42%), fatigue (42%), hypertension (27%), dizziness (27%), and insomnia (23%). AEs were manageable and consistent with the fostamatinib safety database of over 3900 patients across multiple diseases (rheumatoid arthritis, B-cell lymphoma, COVID-19, and ITP). No new safety signals were detected. Fostamatinib may be a promising therapeutic option for wAIHA. A randomized, double-blind, phase 3 study is nearing completion.

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Efficacy of eculizumab in refractory life-threatening warm autoimmune hemolytic anemia associated with chronic myelomonocytic leukemia.

Project description:Eculizumab may be considered as an emergency therapeutic option in refractory life-threatening warm autoimmune hemolytic anemia especially if direct antiglobulin test is positive for both IgG and C3d and after failure of all conventional treatments.

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Infectious Complications in Autoimmune Hemolytic Anemia.

Project description:Autoimmune hemolytic anemia (AIHA) may be frequently challenged by infectious complications, mainly as a result of immunosuppressive treatments administered. Furthermore, infectious agents are known triggers of AIHA onset and relapse. Although being risk factors for mortality, infections are an underestimated issue in AIHA. This review will collect the available evidence on the frequency and type of infectious complications in AIHA, detailing the risk related to each treatment (i.e., steroids, rituximab, splenectomy, classic immunosuppressive agents, and new target drugs). Moreover, we will briefly discuss the infectious complications in AIHA secondary to other diseases that harbor an intrinsic infectious risk (e.g., primary immunodeficiencies, systemic autoimmune diseases, lymphoproliferative disorders, solid organ and hematopoietic stem cell transplants). Finally, viral and bacterial reactivations during immune suppressive therapies will be discussed, along with suggested screening and prophylactic strategies.

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