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

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

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

The experiment was conducted in six different tertiary medical centers in China.

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)

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)

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

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

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.

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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