Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia.
Previous observational studies suggest that rituximab may be useful in the treatment of primary immune thrombocytopenia (ITP). This randomized trial investigated rituximab efficacy in previously untreated adult ITP patients with a platelet count of 20 x 10(9)/L or less. One hundred three patients were randomly assigned to receive 40 mg/d dexamethasone for 4 days with or without 375 mg/m(2) rituximab weekly for 4 weeks. Patients who were refractory to dexamethasone alone received salvage therapy with dexamethasone plus rituximab. Sustained response (ie, platelet count > or = 50 x 10(9)/L at month 6 after treatment initiation), evaluable in 101 patients, was greater in patients treated with dexamethasone plus rituximab (n = 49) than in those treated with dexamethasone alone (n = 52; 63% vs 36%, P = .004, 95% confidence interval [95% CI], 0.079-0.455). Patients in the experimental arm showed increased incidences of grade 3 to 4 adverse events (10% vs 2%, P = .082, 95% CI, -0.010 to 0.175), but incidences of serious adverse events were similar in both arms (6% vs 2%, P = .284, 95% CI, -0.035 to 0.119). Dexamethasone plus rituximab was an effective salvage therapy in 56% of patients refractory to dexamethasone. The combination of dexamethasone and rituximab improved platelet counts compared with dexamethasone alone. Thus, combination therapy may represent an effective treatment option before splenectomy. This study is registered at http://clinicaltrials.gov as NCT00770562.
Department of Hematology Dipartimento Ricerche Mediche Morfologiche, Azienda Ospedaliero Universitaria S Maria della Misericordia, Udine, Italy. zaja.francesco@aoud.sanita.fvg.it
Francesco
F
Zaja
Michele
M
Baccarani
Patrizio
P
Mazza
Monica
M
Bocchia
Luigi
L
Gugliotta
Alfonso
A
Zaccaria
Nicola
N
Vianelli
Marzia
M
Defina
Alessia
A
Tieghi
Sergio
S
Amadori
Selenia
S
Campagna
Felicetto
F
Ferrara
Emanuele
E
Angelucci
Emilio
E
Usala
Silvia
S
Cantoni
Giuseppe
G
Visani
Antonella
A
Fornaro
Rita
R
Rizzi
Valerio
V
De Stefano
Francesco
F
Casulli
Marta Lisa
ML
Battista
Miriam
M
Isola
Franca
F
Soldano
Enrica
E
Gamba
Renato
R
Fanin
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000097:blood / Q000188:drug therapy*; D000069283:Rituximab; D016879:Salvage Therapy / Q000379:methods*; D013997:Time Factors
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D003907:Dexamethasone