Relationship between response to lusutrombopag and splenic volume

Uojima, Haruki; Arase, Yoshitaka; Itokawa, Norio; Atsukawa, Masanori; Satoh, Takashi; Miyazaki, Kôji; Hidaka, Hiroyoshi; Sung, Ji Hyun; Kako, Makoto; Tsuruya, Kota; Kagawa, Tatehiro; Iwakiri, Katsuhiko; Horie, Ryouichi; Koizumi, Wasaburo

doi:10.3748/wjg.v24.i46.5271

Cited by 23 publications

(25 citation statements)

References 26 publications

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“…Nevertheless, despite the differences in characteristics between patients enrolled in the clinical trials compared with the present surveillance, it is reassuring that the present results confirm the safety and effectiveness of lusutrombopag, and further validate the results of the clinical trials . These interim results are also consistent with other recent reports of the safety and effectiveness of lusutrombopag in both treatment‐naïve and retreatment patients …”

Section: Discussionsupporting

confidence: 92%

“…[7][8][9] These interim results are also consistent with other recent reports of the safety and effectiveness of lusutrombopag in both treatmentnaïve and retreatment patients. [14][15][16] Lusutrombopag is currently the only thrombopoietin receptor agonist with available postmarketing surveillance data for treatment of patients with CLD and thrombocytopenia undergoing invasive procedures. Another agent, avatrombopag, was approved in the USA in May 2018, but no real-world surveillance data have yet been reported.…”

Section: Discussionmentioning

confidence: 99%

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Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance

Sasaki

Shiino

Imawari

et al. 2019

Hepatology Research

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Aim Lusutrombopag is approved for the treatment of thrombocytopenia in chronic liver disease patients undergoing invasive procedures. This real‐world surveillance assesses the safety and effectiveness of lusutrombopag in Japan. Methods This ongoing, multicenter, prospective, real‐world surveillance is collecting data from case report forms between October 2016 and May 2021. Interim data up to September 2018 were used to evaluate safety (adverse events and adverse drug reactions [ADRs]) and effectiveness (proportion of patients avoiding preoperative platelet transfusion and change in platelet count from baseline). Results The safety analysis set included 331 patients. The mean baseline platelet count was 46.2 ± 13.7 × 109/L. Of 377 invasive procedures, radiofrequency ablation (110 procedures, 29.2%) was the most frequent. The mean time from starting lusutrombopag treatment to invasive procedure was 12.3 days. Incidences of serious adverse events and ADRs were 8.76% and 3.32%, respectively. Six cases (1.81%) of portal vein thrombosis were considered serious adverse events; of these, four cases (1.21%) were classified as serious ADRs. Of 300 patients who underwent an invasive procedure (excluding those with platelet transfusion refractoriness), 282 (94.0%) avoided preoperative platelet transfusion. In patients with platelet measurements before and after lusutrombopag administration who did not undergo platelet transfusion, the mean maximum change in platelet count from baseline was 41.7 ± 31.4 × 109/L (range, −6 to 276; n = 286). All patients receiving second (n = 20) and third (n = 1) treatments avoided preoperative platelet transfusion without developing any ADRs. Conclusions This real‐world surveillance further supports the safety and effectiveness of lusutrombopag in patients with chronic liver disease undergoing invasive procedures.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance

Sasaki

Shiino

Imawari

et al. 2019

Hepatology Research

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“…In our study, a baseline platelet count of < 30 × 10 3 /μL was the only significant factor preventing platelet counts from reaching 50 × 10 3 /μL with lusutrombopag treatment. While it is true that splenomegaly may prevent the improvement of thrombocytopenia as reported by Uojima et al, 9 patients with advanced splenomegaly often experience severe thrombocytopenia from the outset. The level of elevation of platelets is limited.…”

Section: Discussionmentioning

confidence: 89%

“…4 However, patients who undergo transfusions can face certain complications including febrile nonhemolytic allergic reactions or infections. 9 As such, we conducted this study to assess whether splenomegaly is indeed associated with the insufficient improvement of platelet counts after either platelet transfusion or lusutrombopag administration. Recently, however, it was suggested that splenomegaly may prevent the improvement of thrombocytopenia in patients administered with lusutrombopag.…”

Section: Introductionmentioning

confidence: 99%

“…Recently, however, it was suggested that splenomegaly may prevent the improvement of thrombocytopenia in patients administered with lusutrombopag. 9 As such, we conducted this study to assess whether splenomegaly is indeed associated with the insufficient improvement of platelet counts after either platelet transfusion or lusutrombopag administration.…”

Section: Introductionmentioning

confidence: 99%

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Role of severe thrombocytopenia in preventing platelet count recovery in thrombocytopenic patients with chronic liver disease

Hirooka

Ochi

Hiraoka

et al. 2019

J of Gastro and Hepatol

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Background and Aim Certain thrombocytopenic patients with chronic liver disease have inadequate platelet count recovery after platelet transfusion or lusutrombopag administration. We aimed to identify the reasons for this phenomenon. Methods We investigated 58 and 86 thrombocytopenic patients with chronic liver disease who received lusutrombopag (3 mg orally for up to 7 days) or underwent blood transfusions, respectively. Thirty patients underwent simultaneous hepatic surgery and splenectomy. Factors preventing platelet count recovery above 50 × 103/μL were identified. Results The median patient age was 64 years. Eleven, 78, and 55 patients had hepatitis B, hepatitis C, or another etiology, respectively; 59, 69, and 16 had Child–Pugh classes A, B, and C, respectively. The median spleen volume was 432 mL, and a median of 10 blood units were transfused per patient. The median platelet count rose significantly (from 41.5 × 103/μL to 81.0 × 103/μL) after lusutrombopag administration but not after blood transfusion before invasive procedures. However, maximum platelet counts in patients who underwent splenectomy before platelet transfusion were markedly improved over those who did not. Increasing platelet counts above 50 × 103/μL required baseline platelets > 30 × 103/μL and lusutrombopag administration for all patients. Platelet count recovery was dependent on a spleen volume of < 300 mL and baseline platelets of > 40 × 103/μL in patients who underwent platelet transfusions, while a baseline platelet count of > 30 × 103/μL was required for patients administered with lusutrombopag. Conclusion Neither blood transfusion nor lusutrombopag improves thrombocytopenia in patients with severe conditions; however, the degree of platelet count elevation following lusutrombopag administration is higher than that following blood transfusion.

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Lusutrombopag has slightly stronger effects on patients with mild thrombocytopenia compared with those with severe thrombocytopenia: A multicenter propensity score matching study

Furuichi

Takeuchi

Uojima

et al. 2022

J Hepato Biliary Pancreat

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Background Lusutrombopag effectively increases platelet count in patients with severe thrombocytopenia. However, no multicenter studies analyzing the effects of Lusutrombopag on patients with mild thrombocytopenia (platelet count > 50 000/µL) have been performed. In this study, we aimed to clarify the efficacy of Lusutrombopag on these patients by unifying background factors by propensity score matching. Methods A total of 139 patients with thrombocytopenia were enrolled, and matched for age, sex, etiology, disease, treatment, liver function, renal function, peripheral blood count, and spleen index. The primary endpoint was to compare the increase in platelet count from baseline between the high‐platelet group (>50 000/µL) and the low‐platelet group (<50 000/µL) after Lusutrombopag treatment, using propensity score matching. The secondary endpoint was to clarify platelet transfusion avoidance rate and adverse events, moreover, to identify independent predictors associated with the increase in platelet count. Results The mean increase in platelet count was 67 000/μL vs 48 000/μL in all patients (high‐ vs low‐platelet group, P = .024), and 64 000/μL vs 48 000/μL (P = .12) after propensity score matching. The increase in platelet count and the platelet transfusion avoidance rate tended to be higher in the high‐platelet group. There was no significant difference between adverse events. Predictors associated with an increase in platelet count were sex, estimated glomerular filtration rate, and spleen index by multivariate analysis. Conclusion Lusutrombopag has a little stronger effect in patients with mild thrombocytopenia than those with severe thrombocytopenia and showed a more substantial effect in patients with impaired renal function and small spleen.

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Relationship between response to lusutrombopag and splenic volume

Cited by 23 publications

References 26 publications

Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance

Safety and effectiveness of lusutrombopag in Japanese chronic liver disease patients with thrombocytopenia undergoing invasive procedures: Interim results of a postmarketing surveillance

Role of severe thrombocytopenia in preventing platelet count recovery in thrombocytopenic patients with chronic liver disease

Lusutrombopag has slightly stronger effects on patients with mild thrombocytopenia compared with those with severe thrombocytopenia: A multicenter propensity score matching study

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