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    Home > Active Ingredient News > Blood System > Lancet Haematol: All-trans retinoic acid increased dose dexamethasone can be used as the first-line treatment for patients with newly diagnosed immune thrombocytopenia

    Lancet Haematol: All-trans retinoic acid increased dose dexamethasone can be used as the first-line treatment for patients with newly diagnosed immune thrombocytopenia

    • Last Update: 2022-01-08
    • Source: Internet
    • Author: User
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    Dose dexamethasone is immune standard initial treatment of thrombocytopenia, but there are still many patients relapse, there remains a need for further treatment, while the all-trans retinoic acid has been shown to regulate the immune response and promote platelet production
    .
    Recently, a multicenter, open-label, randomized, controlled, phase 2 trial was published in the journal Lancet Haematol, aiming to evaluate
    all-trans retinoic acid with increased dose dexamethasone as the first-line treatment for patients with newly diagnosed immune thrombocytopenia The activity and safety
    .

    Dose dexamethasone is immune standard initial treatment of thrombocytopenia, but there are still many patients relapse, there remains a need for further treatment, while the all-trans retinoic acid has been shown to regulate the immune response and promote platelet production
    .
    Recently, a multicenter, open-label, randomized, controlled, phase 2 trial was published in the journal Lancet Haematol, aiming to evaluate
    all-trans retinoic acid with increased dose dexamethasone as the first-line treatment for patients with newly diagnosed immune thrombocytopenia The activity and safety
    .
    Immune all-trans retinoic acid increases the dose of dexamethasone as a first-line treatment for patients with newly diagnosed immune thrombocytopenia in activity and safety
    .
    diagnosis

    Figure 1: Experimental flowchart

    Figure 1: Experimental flowchart Figure 1: Experimental flowchart Figure 1: Experimental flowchart

    Table 1: Baseline and clinical characteristics of the intent-to-treat population

    Table 1: Baseline and clinical characteristics of the intention-to-treat population Table 1: Baseline and clinical characteristics of the intention-to-treat population

    The experiment was conducted in six different tertiary medical centers in China.
    Eligible participants were adults (age> 18 years old) with newly diagnosed, newly diagnosed, primary immune thrombocytopenia, and platelet counts below 30 × 10
    9 platelets/L or platelet count below 50 × 10 9 platelets/L and clinically significant bleeding
    .
    The researchers randomly assigned (1:1) participants to receive all-trans retinoic acid (10 mg orally twice a day for 12 weeks) plus high-dose dexamethasone (40 mg/day intravenously for 4 consecutive days) or alone Use high doses of dexamethasone

    .
    If the patient does not respond on day 14, repeat the course of dexamethasone for 4 days
    .
    The primary endpoint is a 6-month continuous response, defined as a platelet count maintained at least 30 × 10
    9 platelets per liter , and at least 2 times the baseline count, and no bleeding.
    At this time, emergency medicine is not required

    .
    The primary endpoint was analyzed by intention-to-treat and safety was assessed in all participants who received at least one dose of the study drug

    .
    The trial has been registered with ClinicalTrials.
    gov, NCT04217148, and is now complete

    .

    The experiment was conducted in six different tertiary medical centers in China.
    Eligible participants were adults (age> 18 years old) with newly diagnosed, newly diagnosed, primary immune thrombocytopenia, and platelet counts below 30 × 10
    9 platelets/L or platelet count below 50 × 10 9 platelets/L and clinically significant bleeding
    .
    The researchers randomly assigned (1:1) participants to receive all-trans retinoic acid (10 mg orally twice a day for 12 weeks) plus high-dose dexamethasone (40 mg/day intravenously for 4 consecutive days) or alone Use high doses of dexamethasone

    .
    9 9 If the patient does not respond on day 14, repeat the course of dexamethasone for 4 days
    .
    The primary endpoint is a 6-month continuous response, defined as a platelet count maintained at least 30 × 10
    9 platelets per liter , and at least 2 times the baseline count, and no bleeding.
    At this time, emergency medicine is not required

    .
    The primary endpoint was analyzed by intention-to-treat and safety was assessed in all participants who received at least one dose of the study drug

    .
    The trial has been registered with ClinicalTrials.
    gov, NCT04217148, and is now complete

    .
    9

    Figure 2: Patients with an initial response (A) and patients with an initial complete response (B)
    .
    The patient’s response duration (relapse time) response duration (or recurrence time) is defined as a platelet count lower than 30×10⁹ platelets per L, a platelet count lower than 2 times the baseline count, or bleeding after the reaction

    .

    Figure 2: Patients with an initial response (A) and patients with an initial complete response (B)
    .
    The patient’s response duration (relapse time) response duration (or recurrence time) is defined as a platelet count lower than 30×10⁹ platelets per L, a platelet count lower than 2 times the baseline count, or bleeding after the reaction

    .
    Figure 2: Patients with an initial response (A) and patients with an initial complete response (B)
    .
    The patient’s response duration (relapse time) response duration (or recurrence time) is defined as a platelet count lower than 30×10⁹ platelets per L, a platelet count lower than 2 times the baseline count, or bleeding after the reaction

    .



    Between January 1, 2020 and June 30, 2020, 132 patients were randomly assigned to all-trans retinoic acid plus high-dose dexamethasone (n=66) or high-dose dexamethasone alone (n= 66)
    .
    Three patients did not receive the assigned treatment, leaving 129 in the safety analysis

    .
    At 6 months, the proportion of participants in the all-trans retinoic acid plus high-dose dexamethasone group (45 [68%] of 66 people) was significantly higher than that of the high-dose dexamethasone monotherapy group (27 of 66 people).
    [41%]) There was a sustained response (OR 3.
    095, 95% CI 1.
    516-6.
    318; p=0.
    0017)

    .
    The most common adverse events in the combination group were dry skin (31 [48%] of 64 patients), headache (12 [19%]) and insomnia (12 [19%]), and insomnia (10 [15%]) 65 patients) and anxiety or mood disorders (8 [12%]) were in the monotherapy group

    .
    Both treatments were well tolerated, and no adverse events of grade 4 or more occurred

    .
    There were no treatment-related deaths

    .



    Between January 1, 2020 and June 30, 2020, 132 patients were randomly assigned to all-trans retinoic acid plus high-dose dexamethasone (n=66) or high-dose dexamethasone alone (n= 66)
    .
    Three patients did not receive the assigned treatment, leaving 129 in the safety analysis

    .
    At 6 months, the proportion of participants in the all-trans retinoic acid plus high-dose dexamethasone group (45 [68%] of 66 people) was significantly higher than that of the high-dose dexamethasone monotherapy group (27 of 66 people).
    [41%]) There was a sustained response (OR 3.
    095, 95% CI 1.
    516-6.
    318; p=0.
    0017)

    .
    The most common adverse events in the combination group were dry skin (31 [48%] of 64 patients), headache (12 [19%]) and insomnia (12 [19%]), and insomnia (10 [15%]) 65 patients) and anxiety or mood disorders (8 [12%]) were in the monotherapy group

    .
    Both treatments were well tolerated, and no adverse events of grade 4 or more occurred

    .
    There were no treatment-related deaths

    .

    Table 2: Adverse events in the safety analysis.


    In general, the study shows that the combination of all-trans retinoic acid and high-dose dexamethasone is safe and effective in newly diagnosed patients with primary immune thrombocytopenia.
    Provides a continuous response

    .
    This program represents a potential first-line treatment in this situation, but further research is needed to verify its effectiveness and safety

    .

    Table 2: Adverse events in the safety analysis set Table 2: Adverse events in the safety analysis set

    Overall, the study showed that the combination of all-trans retinoic acid and high-dose dexamethasone is effective in newly diagnosed primary immune thrombocytopenia It is safe and effective in patients with symptoms, and provides a continuous response
    .
    This program represents a potential first-line treatment in this situation, but further research is needed to verify its effectiveness and safety

    .
    Overall, studies have shown that the combination of all-trans retinoic acid and high-dose dexamethasone is safe and effective in newly diagnosed patients with primary immune thrombocytopenia, providing a sustained response
    .
    This program represents a potential first-line treatment in this situation, but further research is needed to verify its effectiveness and safety

    .

    Original source:

    Original source:

    Huang QS, Liu Y, Wang JB, Peng J, Hou M, Liu H, Feng R, Wang JW, Xu LP, Wang Y, Huang XJ, Zhang XH.
    All-trans retinoic acid plus high-dose dexamethasone as first-line treatment for patients with newly diagnosed immune thrombocytopenia: a multicentre, open-label, randomised, controlled, phase 2 trial.
    Lancet Haematol.
    2021 Oct;8(10):e688-e699.
    doi: 10.
    1016/S2352-3026(21)00240 -4.
    PMID: 34560012.

    Huang QS, Liu Y, Wang JB, Peng J, Hou M, Liu H, Feng R, Wang JW, Xu LP, Wang Y, Huang XJ, Zhang XH.
    All-trans retinoic acid plus high-dose dexamethasone as first-line treatment for patients with newly diagnosed immune thrombocytopenia: a multicentre, open-label, randomised, controlled, phase 2 trial.
    Lancet Haematol.
    2021 Oct;8(10):e688-e699.
    doi: 10.
    1016/S2352-3026(21)00240 -4.
    PMID: 34560012.
    Huang QS, Liu Y, Wang JB, Peng J, Hou M, Liu H, Feng R, Wang JW, Xu LP, Wang Y, Huang XJ, Zhang XH.
    All-trans retinoic acid plus high -dose dexamethasone as first-line treatment for patients with newly diagnosed immune thrombocytopenia: a multicentre, open-label, randomised, controlled, phase 2 trial.
    Lancet Haematol.
    2021 Oct;8(10):e688-e699.
    doi: 10.
    1016/S2352-3026(21)00240-4.
    PMID: 34560012.
    All-trans retinoic acid plus high-dose dexamethasone as first-line treatment for patients with newly diagnosed immune thrombocytopenia: a multicentre, open-label, randomised, controlled, phase 2 trial.


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