Introduction 5 23 10 5 12 23 9 17 23 14 5 11 19 4 8 9 18 20 22 Materials and methods 9 2 9 9 9 9 9 9 Before starting treatment, all patients signed an informed consent authorization. The procedures done in this protocol were in accordance with the Helsinki Declaration of 1975. The protocol was approved by the Ethics Committee of the participating hospitals. Results 1 9 Table 1 Patient characteristics and outcomes Patient/age/gender a Previous treatments 9 9 Time to response (weeks) Response type SR 1/42/F 37 P, S, Az, D, IFN 3.0 146 24 CR Yes 2/43/F 84 P, S, Az, D, IFN, V 5.0 123 24 CR Yes 3/30/F 48 P, S, Az, D, IFN, V 12.5 34. 5 16 MR Yes b 38 P, S, Az, D, IFN 24.4 78 16 b b 5/70/M 60 P, Az, D, V 7.8 NR NR NR No 6/43/F 96 P, S, Az, D, IFN, V 10.1 37.7 8 MR Yes 7/53/F 96 P, S, Az, D, IFN, V 12.5 54 12 PR Yes 8/36/F 264 P, S, Az, D, IFN, V, OE, IVIg 5.0 30.6 4 MR Yes 9/17/F 38 P, S, Az, D, IFN, V, OE 6.5 129 4 CR Yes 10/57/F 26 P, Az, D 8.3 64 8 PR Yes 11/36/F 25 P, S, Az, D, IFN, V 7.0 49 20 MR No 12/63/F 120 P, Az, D, V 26.3 NR NR NR No 13/53/F 348 P, De, D, S, Az 22.0 112 8 CR Yes 14/22/F 266 P, S, D, IFN, IVIg 12.6 67 12 PR No 15/56/F 137 P, D, S, Az 18.4 223 4 CR Yes 16/35/F 38 P, D, Az, S 23.2 11.4 0 NR No 17/52/F 41 P, D, S 16.5 51.9 4 PR Yes 18/24/F 60 O, D, S 24.0 NR NR NR No PC P S Az D IFN V De OE a b 9 1 1 9 9 2 Fig. 1 time 0 Diamonds ovals triangles  Fig. 2 9 a 9 b  p 3 Fig. 3 CR PR MR  4 9 Fig. 4 squares diamonds triangles  Discussion 6 13 9 23 10 2 4 8 20 2 2 4 8 Table 2 1 6 18 Reference Number of patients OR (%) CR (%) PR (%) Median time to response (weeks) Mayo clinic 12 50 42 8 ? USA–Italy 57 53 31 22 8 Denmark 35 33 18 15 2–8 Peru 22 68 40 27 ? Mexico 18 56 28 28 14 OR CR PR 1 8 9 2 4 8 9 3 15 9 16 7 2 On the other hand, because of the mechanism of action of rituximab and its interference with the immune system, we searched for possible long-term complications associated with its use, namely, neoplasias, chronic infections, or autoimmune diseases. Immune status is a major concern in patients treated with rituximab being the induction of low CD20+ counts and hypogammaglobulinemia (specifically low levels of immunoglobulin M), two previously reported secondary effects. Although we do not have data about these two immunological variables, the lack of severe infectious diseases during the long-term follow-up of our patients allows us to speculate that no severe immune abnormalities were developed in our series. As we previously stated, during the follow-up period, no associated illnesses or pathological phenomena were observed. To our knowledge, this seems to be the first report about the lack of long-term complications associated with rituximab. In conclusion, rituximab is a long-term, safe, and effective alternative treatment of chronic and refractory ITP patients. Prospective randomized clinical trials are needed to elucidate the efficacy of the drug in comparison to splenectomy in early stages of the disease