High versus standard dose methylprednisolone in the acute phase of idiopathic thrombotic thrombocytopenic purpura: a randomized study

Carlo L. Balduini (1, 2) , Luigi Gugliotta (3) , Mario Luppi (4) , Luca Laurenti (5) , Catherine Klersy (6) , Carla Pieresca (1) , Gerlando Quintini (7) , Francesco Iuliano (8) , Rossana Re (9) , Pierangelo Spedini (10) , Nicola Vianelli (11) , Alfonso Zaccaria (12) , Enrico Maria Pogliani (13) , Roberto Musso (14) , Enrico Bobbio Pallavicini (15) , Giovanni Quarta (16) , Piero Galieni (17) , Alberto Fragasso (18) , Gianluca Casella (1) , Patrizia Noris (1) , Edoardo Ascari (1)

1 Internal Medicine, IRCCS Policlinico San Matteo Foundation
2 Department of Internal Medicine
3 Haematology
4 Haematology, Department of Oncology, Haematology and Respiratory Diseases
5 Haematology, Catholic University
6 Biometry and Clinical Epidemiology
7 Haematology-BMT
8 Haematology
9 Unit of Medicine
10 Haematology and BMT
11 Hematology and Oncology
12 Oncology
13 Haematology-BMT, San Gerardo Hospital
14 Haematology
15 Haematology and Oncology
16 Haematology
17 Haematology
18 Internal Medicine

Therapeutic plasma exchange (PE) is the accepted therapy for thrombotic thrombocytopenic purpura (TTP). Because not all patients achieve remission, other treatment modalities have been used in addition to PE, but no randomized clinical trial evaluated their efficacy. The aim of this multicentric study was to compare the effectiveness of standard- versus high-dose methylprednisolone as an adjunctive treatment to PE in the acute phase of TTP. Sixty patients with idiopathic TTP were randomized to receive methylprednisolone 1 mg/kg/die intravenous or 10 mg/kg/die for 3 days, thereafter, 2.5 mg/kg/die in addition to PE. Both dosages of steroids were well tolerated. At the end of induction therapy (day 23), the percentage of patients failing to achieve complete remission was significantly higher in the standard dose (16 of 30) than in the high-dose group (seven of 30). Also, the number of cases without a good response at day 9 and the number of deaths were higher in the standard-dose arm, but the differences did not reach the statistical significance. Results of present study indicate that the association of PE with high-dose instead of standard-dose steroids reduces the percentage of TTP patients that fail to achieve complete remission.

Mots clés: TTP; Steroids; Plasma exchange; Thrombocytopenia

Carlo L. Balduini, Luigi Gugliotta, Mario Luppi, Luca Laurenti, Catherine Klersy, et al.. High versus standard dose methylprednisolone in the acute phase of idiopathic thrombotic thrombocytopenic purpura: a randomized study. Annals of Hematology, 2009, 89 (6), pp.591-596. ⟨10.1007/s00277-009-0877-5⟩. ⟨hal-00494349⟩