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High-dose dexamethasone therapy as the initial treatment for idiopathic thrombocytopenic purpura

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Abstract

There is a controversy which short term high dose dexamethasone therapy (HDD) or standard dose prednisolone therapy as the initial treatment leads to long term efficacy in idiopathic thrombocytopenic purpura (ITP) patients. We conducted a multicenter, prospective trial to determine the efficacy and safety of short-term HDD in ITP patients aged 18–80 years with platelet counts of < 20 × 109/l, or < 50 × 109/l and bleeding symptoms. The primary endpoints are the proportion of complete response (CR) plus partial response (R) on day 180 after the completion of the 46-day HDD. Twenty-three patients were enrolled. Test for Helicobacter pylori (H. pylori) was positive for 6 patients and negative for 17 patients. In positive patients, 5 were received successful H. pylori eradication therapy. The proportion of CR + R was 60.9% (14/23) with 90% confidence interval of 41.7–77.8%. For patients with positive H. pylori and successful eradication, the proportion of CR + R was 80.0% (4/5). There was one grade 4 adverse event. Although we have enrolled relatively old, severe ITP patients with a median age of 63 years in this study, the efficacy was comparable to the reported clinical trials with HDD therapy.

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References

  1. Fujimura K, Miyakawa Y, Kurata Y, Kuwana M, Tomiyama Y. Murata M (2012) Reference guide for management of adult idiopathic thrombocytopenic purpura (ITP) 2012 version. Rinsho Ketsueki Nihon Rinsho Ketsueki Gakkai/Japan Society of Clinical Hematology. 2012;53:433–42.

    Google Scholar 

  2. Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA, et al. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117:4190–207.

    Article  CAS  Google Scholar 

  3. Fujimura K, Miyakawa Y, Kurata Y, Kuwana M, Tomiyama Y, Murata M. Reference guide for management of adult idiopathic thrombocytopenic purpura (ITP) 2012 version. Rinsho Ketsueki. 2012;53:433–42.

    PubMed  Google Scholar 

  4. Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, et al. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007;109:1401–7.

    Article  CAS  Google Scholar 

  5. Stasi R, Stipa E, Masi M, Cecconi M, Scimò MT, Oliva F, et al. Long-term observation of 208 adults with chronic idiopathic thrombocytopenic purpura. Am J Med. 1995;98:436–42.

    Article  CAS  Google Scholar 

  6. Zimmer J, Andres E, Noel E, Koumarianou A, Blickle J-F, Maloisel F. Current management of adult idiopathic thrombocytopenic purpura in practice: a cohort study of 201 patients from a single center. Clin Lab Haematol. 2004;26:137–42.

    Article  CAS  Google Scholar 

  7. Cheng Y, Wong RSM, Soo YOY, Chui CH, Lau FY, Chan NPH, et al. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003;349:831–6.

    Article  CAS  Google Scholar 

  8. Mashhadi MA, Kaykhaei MA, Sepehri Z, Miri-Moghaddam E. Single course of high dose dexamethasone is more effective than conventional prednisolone therapy in the treatment of primary newly diagnosed immune thrombocytopenia. DARU J Pharm Sci. 2012;20:7.

    Article  CAS  Google Scholar 

  9. Sakamoto K, Nakasone H, Tsurumi S, Sasaki K, Mitani K, Kida M, et al. Prednisone versus high-dose dexamethasone for untreated primary immune thrombocytopenia. A retrospective study of the Japan Hematology and Oncology Clinical Study Group. J Thromb Thrombolysis. 2014;37:279–86.

    Article  CAS  Google Scholar 

  10. Nakazaki K, Hosoi M, Hangaishi A, Ichikawa M, Nannya Y, Kurokawa M. Comparison between pulsed high-dose dexamethasone and daily corticosteroid therapy for adult primary immune thrombocytopenia: a retrospective study. Intern Med. 2012;51:859–63.

    Article  CAS  Google Scholar 

  11. Takase K, Kada A, Iwasaki H, Yoshida I, Sawamura M, Yoshio N, et al. High-dose dexamethasone therapy as the initial treatment for idiopathic thrombocytopenic purpura: protocol for a multicenter, open-label single arm trial. Acta Med Okayama. 2018;72:197–201.

    CAS  PubMed  Google Scholar 

  12. Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113:2386–93.

    Article  CAS  Google Scholar 

  13. Portielje JEA. Morbidity and mortality in adults with idiopathic thrombocytopenic purpura. Blood. 2001;97:2549–54.

    Article  CAS  Google Scholar 

  14. Japan Intractable Diseases Information Center.Survey on blood coagulation disorders; 2019. https://www.nanbyou.or.jp/entry/303. Accessed 24 July 2019 (in Japanese).

  15. Al-Samkari H, Kuter DJ. Thrombopoietin level predicts response to treatment with eltrombopag and romiplostim in immune thrombocytopenia. Am J Hematol. 2018;93:1501–8.

    Article  CAS  Google Scholar 

  16. Wei Y, Ji X-B, Wang Y-W, Wang J-X, Yang E-Q, Wang Z-C, et al. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood. 2016;127:296–302 (quiz 370).

    Article  CAS  Google Scholar 

  17. Suzuki T, Matsushima M, Masui A, Watanabe K-I, Takagi A, Ogawa Y, et al. Effect of Helicobacter pylori eradication in patients with chronic idiopathic thrombocytopenic purpura—a randomized controlled trial. Am J Gastroenterol. 2005;100:1265–70.

    Article  Google Scholar 

  18. Tsutsumi Y, Kanamori H, Yamato H, Ehira N, Kawamura T, Umehara S, et al. Randomized study of Helicobacter pylori eradication therapy and proton pump inhibitor monotherapy for idiopathic thrombocytopenic purpura. Ann Hematol. 2005;84:807–11.

    Article  CAS  Google Scholar 

  19. Li C-X, Liu D-J, Pan C-Q, Sang X-F, Li X. Effect of Helicobacter pylori eradication on childhood acute idiopathic thrombocytopenic purpura. Nan Fang Yi Ke Da Xue Xue Bao. 2009;29:1243–4.

    PubMed  Google Scholar 

  20. Treepongkaruna S, Sirachainan N, Kanjanapongkul S, Winaichatsak A, Sirithorn S, Sumritsopak R, et al. Absence of platelet recovery following Helicobacter pylori eradication in childhood chronic idiopathic thrombocytopenic purpura: a multi-center randomized controlled trial. Pediatr Blood Cancer. 2009;53:72–7.

    Article  Google Scholar 

  21. Tang Y, Wang S-C, Wang L-J, Liu Y, Wang H-Y, Wang Z-J. Clinical significance of Helicobacter pylori in children with idiopathic thrombocytopenic purpura. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2013;21:419–21.

    PubMed  Google Scholar 

  22. Brito HSH, Braga JAP, Loggetto SR, Machado RS, Granato CFH, Kawakami E. Helicobacter pylori infection and immune thrombocytopenic purpura in children and adolescents: a randomized controlled trial. Platelets. 2015;26:336–41.

    Article  CAS  Google Scholar 

  23. Kuwana M, Kurata Y, Fujimura K, Fujisawa K, Wada H, Nagasawa T, et al. Preliminary laboratory based diagnostic criteria for immune thrombocytopenic purpura: evaluation by multi-center prospective study. J Thromb Haemost. 2006;4:1936–43.

    Article  CAS  Google Scholar 

  24. Choi PY-I, Roncolato F, Badoux X, Ramanathan S, Ho S-J, Chong BH. A novel triple therapy for ITP using high-dose dexamethasone, low-dose rituximab, and cyclosporine (TT4). Blood. 2015;126:500–3.

    Article  CAS  Google Scholar 

  25. Gomez-Almaguer D, Herrera-Rojas MA, Jaime-Perez JC, Gomez-De Leon A, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, et al. Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune thrombocytopenia in adults. Blood. 2014;123:3906–8.

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The authors are grateful to all the patients, their families, nurses and physicians who participated in this study. The authors would also like to show our appreciation to the independent monitoring committee members.

Funding

This study is supported by Grant-in-Aid for Clinical Research from the National Hospital Organization.

Author information

Author notes

  1. Ken Takase and Hirokazu Nagai contributed equally to this study.

Authors and Affiliations

  1. Department of Hematology, National Hospital Organization Kyushu Medical Center, 1-8-1 Jigyohama, Chuo-ku, Fukuoka, 810-8563, Japan

    Ken Takase & Hiromi Iwasaki

  2. Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan

    Hirokazu Nagai & Hiroatsu Iida

  3. Department of Hematology, National Hospital Organization Hiroshimanishi Medical Center, Otake, Japan

    Moe Kadono & Yoshiaki Kuroda

  4. Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan

    Takanori Yoshioka

  5. Department of Hematology, National Hospital Organization Kanazawa Medical Center, Kanazawa, Japan

    Nobuyuki Yoshio

  6. Department of Hematology, National Hospital Organization Matsumoto Medical Center, Matsumoto Hospital, Matsumoto, Nagano, Japan

    Yukio Hirabayashi

  7. Department of Hematology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Hiroshima, Japan

    Takuo Ito

  8. Department of Clinical Research, National Hospital Organization Shibukawa Medical Center, Shibukawa, Gunma, Japan

    Morio Sawamura

  9. Division of Hematology, Department of Internal Medicine, Division of Transfusion Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan

    Akihiro Yokoyama

  10. Department of Hematology, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan

    Shinichiro Yoshida

  11. Department of Hematology, National Hospital Organization Mito Medical Center, Ibaraki, Japan

    Ikuyo Tsutsumi

  12. Department of Hematology, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan

    Maki Otsuka

  13. Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan

    Youko Suehiro

  14. Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan

    Michihiro Hidaka

  15. Department of Hematology and Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan

    Isao Yoshida

  16. Department of Hematology, National Hospital Organization Sendai Medical Center, Sendai, Japan

    Hisayuki Yokoyama

  17. Department of Internal Medicine, National Hospital Organization Tsuruga Medical Center, Tsuruga, Japan

    Hitoshi Inoue

  18. Department of Hematology, National Hospital Organization Nishibeppu National Hospital, Beppu, Japan

    Maki Nakayama

  19. Department of Hematology, National Hospital Organization Himeji Medical Center, Himeji, Hyogo, Japan

    Terutoshi Hishita

  20. Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan

    Akiko Kada & Akiko M. Saito

Authors
  1. Ken Takase
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  2. Hirokazu Nagai
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  3. Moe Kadono
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  24. Yoshiaki Kuroda
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Contributions

KT designed this study and drafted this article. AMS performed data management and monitoring of this study. AK was responsible for the statistical analysis. KT, HN, MK, TY, NY, YH, TI, MS, AY, SY, IT, MO, YS, MH, IY, HY, HI, HI, MN, TH, HI and YK have contributed to data collection and interpretation. All authors wrote and approved the manuscript. KT and HN contributed equally to this study.

Corresponding author

Correspondence to Ken Takase.

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Conflict of interest

HN reports grants and personal fees from Janssen Pharmaceutical K.K., Mundipharma K.K., Celgene Corporation, Bayer Yakuhin Ltd., Takeda Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Esai Co., Ltd., Bristol-Myers Squibb, Ono Pharmaceutical Co., Ltd., Gilead Sciences Inc., Zenyaku Kogyo Co., Ltd., AstraZeneca plc., and SymBio Pharmaceuticals Limited, outside the submitted work; grants from Abbvie G.K., Solasia Pharma K.K., HUYA Bioscience International, Otsuka Pharmaceutical Co., Ltd., and IQVIA service Japan K.K., outside the submitted work; personal fees from Roche Ltd., Sanofi K.K., outside the submitted work. HY reports grants from Astellas, outside the submitted work. AK reports personal fees from Bayer Yakuhin, Ltd. for a member of independent data monitoring committee of clinical trials, outside the submitted work. All other authors have nothing to disclose.

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Appendix

Appendix

See Table 4.

Table 4 Response at 46 + 180 days by factors
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Takase, K., Nagai, H., Kadono, M. et al. High-dose dexamethasone therapy as the initial treatment for idiopathic thrombocytopenic purpura. Int J Hematol 111, 388–395 (2020). https://doi.org/10.1007/s12185-019-02808-6

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  • DOI: https://doi.org/10.1007/s12185-019-02808-6

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