Daclizumab Research Articles

Delayed onset hypophysitis after therapy with daclizumab for multiple sclerosis – A report of two cases

Daclizumab (DAC), a humanized monoclonal antibody that binds to the interleukin (IL)-2-receptor alpha chain, was approved in May 2016 for treatment of relapsing-remitting multiple sclerosis (RRMS). Approval was suspended in March 2018 after occurrence of severe liver failure and fatal meningoencephalitis in several patients treated with DAC. We report the clinical, laboratory and neuroimaging findings of 2 patients, who developed hypophysitis about 4 months after cessation of therapy with DAC. This report identifies delayed onset hypophysitis as a previously unrecognized severe side effect of DAC, highlighting the importance of continuous pharmacovigilance and patient monitoring even after cessation of DAC therapy.

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Daclizumab induced sarcoidosis

Daclizumab induced sarcoidosis

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Daclizumab: Mechanisms of Action, Therapeutic Efficacy, Adverse Events and Its Uncovering the Potential Role of Innate Immune System Recruitment as a Treatment Strategy for Relapsing Multiple Sclerosis.

Daclizumab (DAC) is a humanized, monoclonal antibody that blocks CD25, a critical element of the high-affinity interleukin-2 receptor (IL-2R). DAC HYP blockade of CD25 inhibits effector T cell activation, regulatory T cell expansion and survival, and activation-induced T-cell apoptosis. Because CD25 blockade reduces IL-2 consumption by effector T cells, it increases IL-2 bioavailability allowing for greater interaction with the intermediate-affinity IL-2R, and therefore drives the expansion of CD56bright natural killer (NK) cells. Furthermore, there appears to be a direct correlation between CD56bright NK cell expansion and DAC HYP efficacy in reducing relapses and MRI evidence of disease activity in patients with RMS in phase II and phase III double-blind, placebo- and active comparator-controlled trials. Therapeutic efficacy was maintained during open-label extension studies. However, treatment was associated with an increased risk of rare adverse events, including cutaneous inflammation, autoimmune hepatitis, central nervous system Drug Reaction with Eosinophilia Systemic Symptoms (DRESS) syndrome, and autoimmune Glial Fibrillary Acidic Protein (GFAP) alpha immunoglobulin-associated encephalitis. As a result, DAC HYP was removed from clinical use in 2018. The lingering importance of DAC is that its use led to a deeper understanding of the underappreciated role of innate immunity in the potential treatment of autoimmune disease.

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▼ Daclizumab withdrawn from the market worldwide

▼ Daclizumab withdrawn from the market worldwide

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Daclizumab

Daclizumab HYP: Another Option in Treating Relapsing Multiple Sclerosis

Daclizumab high-yield process (HYP) is an investigational humanized monoclonal antibody that targets CD25 and modulates interleukin-2 signaling, which

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Daclizumab

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A randomized controlled trial of daclizumab versus anti-thymocyte globulin induction for heart transplantation.

BackgroundThe purpose of this study was to test the efficacy and safety of daclizumab (DZM) versus anti-thymocyte globulin (ATG) as a component of induction therapy in heart transplant recipients.MethodsThirty heart transplant patients were randomized to receive either ATG or DZM during induction therapy. Patients in the DZM group received an initial dose of 2 mg/kg intravenous (IV) at the time of transplant and 1 mg/kg IV on postoperative day 4.DiscussionRecipient, donor, and intraoperative variables did not differ significantly between groups. The cost of induction therapy, total drug cost, and hospital ward costs were significantly less for the DZM group. Average absolute lymphocyte and platelet counts were significantly higher in the DZM group. There were no significant differences in the incidence of rejection, infection, malignancy, or steroid-induced diabetes. One year survival was excellent in both groups (87%, P = 0.1). Daclizumab is a safe component of induction therapy in heart transplantation.