Download PDF
CC BY 4.0 · Glob Med Genet 2023; 10(02): 087-096
DOI: 10.1055/s-0043-1769087
Original Article

Efficacy and Safety Analysis of Combination Therapy Consisting of Intravenous Immunoglobulin and Corticosteroids versus Respective Monotherapies in the Treatment of Relapsed ITP in Adults

Lijun Fang
1   State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China
,
Jing Sun
2   Nanfang Hospital, Southern Medical University, Guangzhou, People's Republic of China
,
Yongqiang Zhao
3   Peking Union Medical College Hospital, Beijing, People's Republic of China
,
Ming Hou
4   Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China
,
Depei Wu
5   The First Affiliated Hospital of Soochow University, Suzhou, People's Republic of China
,
Yunfei Chen
1   State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China
,
Renchi Yang
1   State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China
,
Lei Zhang
1   State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, People's Republic of China
6   Tianjin Institutes of Health Science, Tianjin, People's Republic of China
› Author Affiliations Funding This work was supported by grants from National Key Research and Development Program of China (2019YFA0110802), National Natural Science Foundation of China (Nos.82104618, 82270152, 8197012), CAMS Innovation Fund for Medical Sciences (CIFMS) (2022-I2M-2-003, 2020-I2M-C&T-B-086), and Haihe Laboratory of Cell Ecosystem Innovation Fund (22HHXBSS00022).
› Further Information
Also available at
   Permissions and Reprints

Abstract

Objective In this study, we aimed to evaluate the efficacy and safety of combination therapy, consisting of intravenous immunoglobulin (IVIg) and corticosteroids, in comparison to respective monotherapies in the treatment of relapsed immune thrombocytopenia (ITP) in adults.

Methods A retrospective analysis of clinical data was conducted on 205 adult patients with relapsed ITP who received first-line combination therapy or monotherapy in multiple centers across China from January 2010 to December 2022. The study evaluated the patients' clinical characteristics, efficacy, and safety.

Results We found that the proportion of patients with platelet counts in complete response was significantly higher in the combination group (71.83%) compared with the IVIg group (43.48%) and the corticosteroids group (23.08%). The mean PLTmax in the combination group (178 × 109/L) was significantly higher than that in the IVIg group (109 × 109/L) and the corticosteroids group (76 × 109/L). Additionally, the average time for platelet counts to reach 30 × 109/L, 50 × 109/L, and 100 × 109/L in the combination group was significantly shorter than in the monotherapy groups. The proportion curves for reaching these platelet counts during treatment were also significantly different from those in the monotherapy groups. However, there were no significant differences in the effective rate, clinical characteristics, and adverse events among the three groups.

Conclusion We concluded that combining IVIg and corticosteroids was a more effective and faster treatment for relapsed ITP in adults than using either therapy alone. The findings of this study provided clinical evidence and reference for the use of first-line combination therapy in the treatment of relapsed ITP in adults.

Keywords

primary immune thrombocytopenia - adult relapse - first-line drugs - combination therapy


Publication History

Article published online:
23 May 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • Reference

  • 1 Neunert C, Lim W, Crowther M, Cohen A, Solberg Jr L, Crowther MA. American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 2011; 117 (16) 4190-4207
    CrossrefPubMedSearch in Google Scholar
  • 2 Cuker A, Prak ET, Cines DB. Can immune thrombocytopenia be cured with medical therapy?. Semin Thromb Hemost 2015; 41 (04) 395-404
    Thieme ConnectPubMedSearch in Google Scholar
  • 3 Gernsheimer T, Stratton J, Ballem PJ, Slichter SJ. Mechanisms of response to treatment in autoimmune thrombocytopenic purpura. N Engl J Med 1989; 320 (15) 974-980
    CrossrefPubMedSearch in Google Scholar
  • 4 Aslam R, Burack WR, Segel GB, McVey M, Spence SA, Semple JW. Intravenous immunoglobulin treatment of spleen cells from patients with immune thrombocytopenia significantly increases the percentage of myeloid-derived suppressor cells. Br J Haematol 2018; 181 (02) 262-264
    CrossrefPubMedSearch in Google Scholar
  • 5 Hou Y, Feng Q, Xu M. et al. High-dose dexamethasone corrects impaired myeloid-derived suppressor cell function via Ets1 in immune thrombocytopenia. Blood 2016; 127 (12) 1587-1597
    CrossrefPubMedSearch in Google Scholar
  • 6 Provan D, Arnold DM, Bussel JB. et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv 2019; 3 (22) 3780-3817
    CrossrefPubMedSearch in Google Scholar
  • 7 Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood 2017; 129 (21) 2829-2835
    CrossrefPubMedSearch in Google Scholar
  • 8 Neunert C, Terrell DR, Arnold DM. et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv 2019; 3 (23) 3829-3866
    CrossrefPubMedSearch in Google Scholar
  • 9 Wang L, Xu L, Hao H. et al. First line treatment of adult patients with primary immune thrombocytopenia: a real-world study. Platelets 2020; 31 (01) 55-61
    CrossrefPubMedSearch in Google Scholar
  • 10 Sun L, Wang J, Shao L. et al. Dexamethasone plus oseltamivir versus dexamethasone in treatment-naive primary immune thrombocytopenia: a multicentre, randomised, open-label, phase 2 trial. Lancet Haematol 2021; 8 (04) e289-e298
    CrossrefPubMedSearch in Google Scholar
  • 11 Cheng Y, Wong RS, Soo YO. et al. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med 2003; 349 (09) 831-836
    CrossrefPubMedSearch in Google Scholar
  • 12 Wong RSM, Saleh MN, Khelif A. et al. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood 2017; 130 (23) 2527-2536
    CrossrefPubMedSearch in Google Scholar
  • 13 Li Y, Sun L, Li F. et al. Recombinant thrombopoietin effectively shortens the time to response and increases platelet counts in elderly patients with severe immune thrombocytopenia. J Clin Med 2022; 11 (19) 5763
    CrossrefPubMedSearch in Google Scholar
  • 14 Zhou H, Xu M, Qin P. et al. A multicenter randomized open-label study of rituximab plus rhTPO vs rituximab in corticosteroid-resistant or relapsed ITP. Blood 2015; 125 (10) 1541-1547
    CrossrefPubMedSearch in Google Scholar
  • 15 Beck CE, Nathan PC, Parkin PC, Blanchette VS, Macarthur C. Corticosteroids versus intravenous immune globulin for the treatment of acute immune thrombocytopenic purpura in children: a systematic review and meta-analysis of randomized controlled trials. J Pediatr 2005; 147 (04) 521-527
    CrossrefPubMedSearch in Google Scholar
  • 16 Huang QS, Liu Y, Wang JB. et al. 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; 8 (10) e688-e699
    CrossrefPubMedSearch in Google Scholar
  • 17 Neunert CE, Buchanan GR, Blanchette V. et al. Relationships among bleeding severity, health-related quality of life, and platelet count in children with immune thrombocytopenic purpura. Pediatr Blood Cancer 2009; 53 (04) 652-654
    CrossrefPubMedSearch in Google Scholar
  • 18 Fogarty PF, Tarantino MD, Brainsky A, Signorovitch J, Grotzinger KM. Selective validation of the WHO Bleeding Scale in patients with chronic immune thrombocytopenia. Curr Med Res Opin 2012; 28 (01) 79-87
    CrossrefPubMedSearch in Google Scholar
  • 19 Lyu M, Liu X, Fu R. et al. Clinical significance of ITP-BAT bleeding grading system for patients with immune thrombocytopenia [in Chinese]. Zhonghua Xue Ye Xue Za Zhi 2014; 35 (09) 812-815
    PubMedSearch in Google Scholar
  • 20 Piel-Julian ML, Mahévas M, Germain J. et al; CARMEN investigators group. Risk factors for bleeding, including platelet count threshold, in newly diagnosed immune thrombocytopenia adults. J Thromb Haemost 2018; 16 (09) 1830-1842
    CrossrefPubMedSearch in Google Scholar
  • 21 Hayward CP, Harrison P, Cattaneo M, Ortel TL, Rao AK. Platelet Physiology Subcommittee of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Platelet function analyzer (PFA)-100 closure time in the evaluation of platelet disorders and platelet function. J Thromb Haemost 2006; 4 (02) 312-319
    Search in Google Scholar
  • 22 González-López TJ, Alvarez-Román MT, Pascual C. et al. Eltrombopag safety and efficacy for primary chronic immune thrombocytopenia in clinical practice. Eur J Haematol 2016; 97 (03) 297-302
    CrossrefPubMedSearch in Google Scholar
  • 23 Mazza P, Minoia C, Melpignano A. et al. The use of thrombopoietin-receptor agonists (TPO-RAs) in immune thrombocytopenia (ITP): a “real life” retrospective multicenter experience of the Rete Ematologica Pugliese (REP). Ann Hematol 2016; 95 (02) 239-244
    CrossrefPubMedSearch in Google Scholar
  • 24 Saleh MN, Bussel JB, Cheng G. et al; EXTEND Study Group. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study. Blood 2013; 121 (03) 537-545
    CrossrefPubMedSearch in Google Scholar
  • 25 Choi PY, Merriman E, Bennett A. et al. Consensus guidelines for the management of adult immune thrombocytopenia in Australia and New Zealand. Med J Aust 2022; 216 (01) 43-52
    CrossrefPubMedSearch in Google Scholar
  • 26 Zhu XL, Feng R, Huang QS. et al. Prednisone plus IVIg compared with prednisone or IVIg for immune thrombocytopenia in pregnancy: a national retrospective cohort study. Ther Adv Hematol 2022; 13: 20 406207221095226
    CrossrefPubMedSearch in Google Scholar
  • 27 Cooper N, Kruse A, Kruse C. et al. Immune thrombocytopenia (ITP) World Impact Survey (iWISh): Patient and physician perceptions of diagnosis, signs and symptoms, and treatment. Am J Hematol 2021; 96 (02) 188-198
    CrossrefPubMedSearch in Google Scholar
  • 28 Provan D, Semple JW. Recent advances in the mechanisms and treatment of immune thrombocytopenia. EBioMedicine 2022; 76: 103820
    CrossrefPubMedSearch in Google Scholar