Fostamatinib effectiveness and safety for immune thrombocytopenia in clinical practice

Author:

González-López Tomás José1ORCID,Bermejo-Vega Nuria2ORCID,Cardesa-Cabrera Rocío3,Martínez-Robles Violeta4,Aguilar-Monserrate Gerardo5ORCID,Pérez-Segura Gloria6ORCID,Domingo Abel7,Luis-Navarro Josefa8,Lakhwani Sunil9ORCID,Acedo Natalia10,Lozano María Luisa11ORCID,Bernat Silvia12,Torres-Tienza Ana13ORCID,Ruano Ana14,Jarque Isidro15,Galán Pilar13ORCID,Benet Carmen16,Marcellini Shally13,Jimenez-Bárcenas Reyes17ORCID,Martínez-Carballeira Daniel18,De Miguel-Llorente Dunia19,Perona-Blázquez Alvaro20,Gonzalez-Gascón Isabel21ORCID,Lopez-Ansoar Elsa22ORCID,Alonso-Alonso José María23,Bengochea-Casado María Luisa24,Díaz-Gálvez Francisco Javier1,Moretó Ana25,Moreno-Jiménez Gemma26,Hernández-Martin Roberto27,de Cabo Erik28ORCID,Dávila-Valls Julio29ORCID,Cuesta Amalia30,Pastoriza Carmen31,Hermida-Fernández Gerardo Julio1,García Covadonga1,Pozas-Mañas Miguel Angel32,Aguilar Carlos33ORCID,Fernandez-Jimenez Dolores34,Navas-Elorza Begoña35,López-Santamaría Castro Carolina36ORCID,Lorenzo Alvaro37ORCID,Ortín Xavier38,García Marta39,Piernas Sonia40,Díaz-Santa Johana41,Soto Inmaculada18ORCID,Provan Drew42ORCID,García-Donas Gabaldón Gloria43

Affiliation:

1. 1Department of Hematology, Hospital Universitario de Burgos, Burgos, Spain

2. 2Department of Hematology, Complejo Hospitalario Universitario de Cáceres, Cáceres, Spain

3. 3Department of Hematology, Hospital Público Comarcal de La Merced, Seville, Spain

4. 4Department of Hematology, Complejo Asistencial Universitario de León, León, Spain

5. 5Department of Hematology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain

6. 6Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain

7. 7Department of Hematology, Fundació Privada Hospital Asil de Granollers, Barcelona, Spain

8. 8Department of Hematology Hospital General de Riotinto, Minas de Riotinto, Huelva, Spain

9. 9Department of Hematology, Hospital Universitario de Canarias, Universidad de La Laguna, Tenerife, Spain

10. 10Department of Hematology, Hospital Universitario de La Princesa, Madrid, Spain

11. 11Department of Hematology, Hospital General Universitario José María Morales Meseguer, Centro Regional de Hemodonación, Universidad de Murcia, IMIB-Pascual Parrilla, Centro de Investigación Biomédica en Red de Enfermedades Raras- Instituto de Salud Carlos III, Murcia, Spain

12. 12Department of Hematology, Hospital Universitario de La Plana, Villareal, Spain

13. 13Department of Hematology, Complejo Asistencial de Segovia, Segovia, Spain

14. 14Department of Hematology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain

15. 15Department of Hematology, Hospital Universitari i Politècnic La Fe, Valencia, Spain

16. 16Department of Hematology, Hospital Arnau de Vilanova, Valencia, Spain

17. 17Department of Hematology, Hospital de la Serranía de Ronda, Málaga, Spain

18. 18Department of Hematology, Hospital Universitario Central de Asturias, Oviedo, Spain

19. 19Department of Hematology, Hospital Universitario de Guadalajara, Guadalajara, Spain

20. 20Department of Hematology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain

21. 21Department of Hematology, Hospital Universitario Infanta Leonor, Madrid, Spain

22. 22Department of Hematology, Hospital Universitario Álvaro Cunqueiro, Vigo, Spain

23. 23Department of Hematology, Complejo Asistencial de Palencia, Palencia, Spain

24. 24Department of Hematology, Hospital Universitario Severo Ochoa, Leganés, Spain

25. 25Department of Hematology, Hospital Universitario de Cruces, Barakaldo, Spain

26. 26Department of Hematology, Hospital Universitario Ramón y Cajal, Madrid, Spain

27. 27Department of Hematology, Complejo Asistencial de Zamora, Zamora, Spain

28. 28Department of Hematology, Complejo Hospital de El Bierzo, Ponferrada, Spain

29. 29Department of Hematology, Complejo Asistencial de Avila, Avila, Spain

30. 30Department of Hematology, Hospital Sierrallana, Cantabria, Spain

31. 31Department of Hematology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain

32. 32Department of Hematology, Hospital Universitario Río Hortega, Valladolid, Spain

33. 33Department of Hematology, Complejo Asistencial de Soria, Soria, Spain

34. 34Department of Hematology, Hospital Universitario Clínico San Cecilio, Granada, Spain

35. 35Department of Hematology, Hospital Clínico San Carlos, Madrid, Spain

36. 36Department of Hematology, Hospital Universitario de Badajoz, Badajoz, Spain

37. 37Department of Hematology, Hospital Universitario Lucus Augusti, Lugo, Spain

38. 38Department of Hematology, Hospital Verge de la Cinta, Tortosa, Spain

39. 39Department of Hematology, Hospital de Terrassa, Barcelona, Spain

40. 40Department of Hematology, Parc Taulí Hospital Universitari, Sabadell, Spain

41. 41Department of Hematology, Hospital Universitari Doctor Josep Trueta, Girona, Spain

42. 42Department of Haematology, Barts and The London School of Medicine, London, United Kingdom

43. 43Department of Hematology, Hospital Universitario Virgen Macarena, Seville, Spain

Abstract

Abstract Fostamatinib, a recently approved Syk inhibitor used in adult primary immune thrombocytopenia (ITP), has been shown to be safe and effective in this disorder. However, clinical trial results may not be similarly reproduced in clinical practice. Here, 138 patients with ITP (both primary and secondary) from 42 Spanish centers who had been treated with fostamatinib were evaluated prospectively and retrospectively. The median age of our cohort (55.8% women) was 66 years (interquartile range [IQR], 56-80). The median time since ITP diagnosis at fostamatinib initiation was 51 months (IQR, 10-166). The median number of therapies before fostamatinib initiation was 4 (IQR, 2-5), including eltrombopag (76.1%), romiplostim (57.2%), and IV immunoglobulins (44.2%). Fifty-eight patients (42.0%) had signs/symptoms of bleeding in the month before treatment initiation. Seventy-nine percent of patients responded to fostamatinib with 53.6% complete responses (platelet count > 100 × 109/L). Eighty-three patients (60.1%) received fostamatinib monotherapy, achieving a high response rate (85.4%). The proportion of time in response during the 27-month period examined was 83.3%. The median time to platelet response was 11 days (IQR, 7-21). Sixty-seven patients (48.5%) experienced adverse events, mainly grade 1 to 2; the commonest of which were diarrhea (n = 28) and hypertension (n = 21). One patient had deep venous thrombosis, and one patient developed acute myocardial infarction. Fostamatinib was shown to be effective with good safety profile in patients with primary and secondary ITP across a wide age spectrum in this real-world study.

Publisher

American Society of Hematology

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. 2025 update on clinical trials in immune thrombocytopenia;American Journal of Hematology;2024-08-06

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