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Estudio primario

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Rituximab Produces Long-Term Responses in Immune Thrombocytopenic Purpura (ITP).

Revista Blood
Año 2015
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ITP in adults is an autoimmune disease characterized by antibody-mediated thrombocytopenia. A significant number of patients relapse after initial therapy with prednisone and splenectomy when necessary, and require other therapy for continuing thrombocytopenia. Rituximab, an anti-CD20 chimeric monoclonal antibody has been utilized in ITP refractory to other modes of treatment (Feurestein, M., et al. The use of Rituximab in 28 patients with immune thrombocytopenic purpura (ITP). Proc. Am. Soc. Clin. Onc. 22:187, 2003). We report on the long-term responses possible in ITP treated with Rituximab. Twenty-two patients with ITP refractory to initial conventional therapies with platelet counts <30,000/ul were treated with Rituximab 375 mg/m2 IV weekly x4. Responses were characterized as partial response (PR; platelets >50,000/ul but <150,000/ul) and complete response (platelets >150,000/ul). Patient characteristics included 5 males and 17 females with ages 24–83 years (median 58). Twenty had undergone splenectomy. Thirteen patients (59%) responded to Rituximab. Six responses were PR with durations lasting 2, 2, 3, 3, 4, and 6 months. Continuing Rituximab monthly after initial therapy of 4 weeks did not produce improved platelet counts in patients who failed Rituximab or who achieved PR. Seven responses were CR with durations of 12, 20+, 25+, 29+, 38+, 40+, and 48+ months. The one patient who relapsed at 12 months was retreated with Rituximab but did not respond. There was no correlation between response and age, sex, or duration of ITP. Neither of the patients who declined prior splenectomy responded. There were no serious complications of Rituximab infusions. Twenty-five percent of patients had mild first infusion reactions. Rituximab can produce long-term CR in 27% of patients with ITP refractory to initial therapy.

Estudio primario

No clasificado

Rituximab Treatment in Childhood Chronic Immune Thrombocytopenic Purpura (ITP).

Revista Blood
Año 2015

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Abstract 4461 Background Immune thrombocytopenic purpura (ITP) is characterized by mucocutaneous purpura and thrombocytopenia caused by circulating anti-platelet auto-antibodies. ITP is usually self-limited in children, but around 20% of patients will develop chronic ITP. The conventional treatments for children chronic ITP include intravenous immunoglobulin (IVIG), corticosteroid therapy, anti-D immune globulin, or splenectomy. Some children with chronic ITP are refractory to these treatments and nowadays begun to try new treatment agents such as rituximab. Rituximab as a monoclonal antibody to CD-20, has shown promising reports to these patients with refractory chronic ITP in adults groups and a few children groups. We investigated this study to evaluate the efficacy of rituximab for childhood chronic ITP in Korea.Methods We reviewed the questionnaires and medical records about the clinical progresses and results in thirteen children from eight clinical institutes, retrospectively. Complete response (CR) was considered if the platelet count was > 100,000/uL.Results Thirteen patients with chronic thrombocytopenia who had been treated with rituximab were investigated. Two patients were lost to follow-up after rituximab. Finally eleven patients were evaluated including one patient with Evans syndrome. Median age was 6.5 year (range, 0.5 ∼ 15.4). Median platelet count at baseline was 13,700/uL (3,000∼46,000). All patients had been treated with conventional therapy including IVIG and steroids. One had done splenectomy. Median follow-up duration was 2.8 years (1.1-5.9). Among 11 patients, CR was achieved in 3 patients (27%). Their platelet count prior to rituximab were < 10,000/uL. They were treated as the regimen of 375 mg/m2/dose weekly for 4 doses. Time from the first rituximab dose to achievement of complete response was 3.9, 4.9 and 5.7 weeks respectively. One patient who was relapsed 6months after the first course of rituximab was received second course of rituximab using the same regimen and achieved a new CR at 9.3 weeks after. There were no reports about severe complication or interruption of medication.Conclusions Therefore, we suggest that rituximab is effective treatment choice in childhood refractory chronic ITP and well tolerated.Disclosures: No relevant conflicts of interest to declare.

Estudio primario

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Rituximab Induces High Response Rate and Prolonged Remission in Chronic Idiopathic Thrombocytopenic Purpura (ITP): A Retrospective Analysis

Revista Blood
Año 2015
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BACKGROUND: Rituximab is a chimeric monoclonal antibody targeting CD 20+ B lymphocytes (Rastetter et al, 2004). Combination of rituximab with conventional chemotherapeutic agents has become the mainstay of treatment for B-cell Non-Hodgkin’s Lymphomas. The role of rituximab in treatment of immune mediated disorders is currently under investigation. Earlier studies have reported significant responses to rituximab in chronic idiopathic thrombocytopenic purpura patients, who are refractory to steroids and in some cases to splenectomy. (Cooper et al, 2004). METHODS: We retrospectively reviewed charts of 15 patients who received rituximab treatment for chronic ITP. All patients had clinical features consistent with chronic ITP and no other etiology was discovered to cause thrombocytopenia; diagnosis of ITP was confirmed by bone marrow examination in 8 patients. Previous treatments for patients in our series included: prednisone (80%), splenectomy (53%), Rho D immune globulin (40%), IV immunoglobulin (33%), danazole (27%), and vincristine (20%). Rituximab dose was 325mg/m2 for all patients, although the number of treatments varied between patients (Table 1). Complete or partial responses to therapy were defined as follows: Platelet count ≥ 150x10(9)/L at 12 weeks following first infusion was a complete response (CR). Platelet count 50–149x10(9)/L at 12 weeks following first infusion was a partial response (PR). Platelet count < 50x10(9)/L was defined as no response (NR). Response at the 12 week interval was not possible in 2 patients; therefore response was defined at the 8 week interval (Table 1). RESULTS: Patient demographics consist of 5:10 male to female ratio with mean age=49.7, median age= 46 and age range=19–83. 10 patients attained a complete response, 3 patients attained a partial response, and 2 patients failed to show any response to treatment. It was possible to follow 12 patients in our series for a sustained duration of rituximab response; 9 patients (75%) showed a response of >6 months in this group. The most significant factor associated with response to rituximab was age, independent of all other variables when logistic regression analysis was utilized (p=0.003, α=0.05, df=1). Additionally, bivariate analysis was significant for age and number of days lapsed (following first infusion) until platelets increase ≥ 100x10(9)/L and was independent of baseline platelet count (p=0.047, α=0.05, df=1). CONCLUSION: Rituximab has shown significant activity in our series of ITP patients, with an overall response rate of 93%. Our results indicate a direct relationship between younger age and response. The availability of this agent provides another treatment option for chronic ITP, short of splenectomy. Guidelines for ITP may need further modification in view of the promising results with rituximab therapy.

Estudio primario

No clasificado

Rituximab in the Treatment of Adults with Chronic Idiopathic Thrombocytopenic Purpura (ITP) and Autoimmune Hemolytic Anemia (AIHA).

Revista Blood
Año 2015
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Corticosteroids have been the first line of treatment of ITP since 1950, however some patients do not respond to this treatment (refractory) and some will relapse after its discontinuation. For such patients second line treatments were introduced. Some patients will continue to be refractory to this treatment and need other therapy modality.Rituximab is a chimeric monoclonal antibody directed against the CD20 antigen exposing B Lymphocytes, causing its depletion. This could alter the production of auto-antibodies in some Auto-Immune diseases and thus could be used in their treatment. Few medical centers had reported using Rituximab in the treatment of refractory (ITP) and (AIHA), yet its definite role could not be determined, and here we share our experience.Patients with documented diagnosis of ITP or AIHA who were refractory to at least two lines of therapy including steroids were offered to receive Rituximab (375mg/m2 weekly for 4 weeks). 15 patients were enrolled, 10 with ITP, 4 with AIHA, 1 with Coombs negative Hemolytic anemia, and 1 with pure red cell aplasia. One had both ITP and AIHA. 10 were females and 5 males. 5 were &gt;60 years old and 10 were &lt; 60 years old. 2 out of the 10 patients with ITP had also Chronic Lymphocytic Leukemia (CLL). Duration of follow up ranged from 2 months to 17 months (average 7 mos). Of the 10 patients with refractory ITP treated with Rituximab overall response was 60%. 4 were NR (no response), 2 were MR (minimal response: Platelets increased to &lt;50000), 2 were PR (Partial response: Platelets increased to &lt;100000) and 2 were complete response (Platelets became normal). 3 patients of 6 with Hemolytic anemia or PRC aplasia had NR, 1 had MR (Hct &lt;30), and 2 had partial response (Hct 30–35). No complete response was observed in this group. In 3 patients with hemolytic anemia and CLL 1 had MR, 1 had PR and 1 had NR. 2 patients with hemolytic anemia who had NR died as a complication of their disease (one with septic shock and one with severe autoimmune flare up). Only one patient with refractory ITP had mild allergic side effects and did not complete 4 doses. No Rituximab related mortality was observed. CONCLUSION: Rituximab therapy had a variable but valuable effect in the treatment of patients with chronic refractory ITP and refractory/ relapsed AIHA. Overall response in our group reached 60%. No clinical or laboratory parameters were found to predict response, although there was a suggestion that males, younger age, and no history of splenectomy have a better chance of response. As we lack an effective alternative treatment in chronic refractory ITP and AIHA, Rituximab use could be a valid option in view of its mild toxicity. Further follow up of our patients and input from other institutions in this regard are needed.

Estudio primario

No clasificado

The Use of Anti-CD20 Chimeric Monoclonal Antibody, Rituximab in Adult Patients with Treatment Refractory Immune Thrombocytopenia

Revista Blood
Año 2015
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INTRODUCTION: Approximately 20–30% of treated patients with immune thrombocytopenia (IT) will become resistant to standard therapy. Rituximab has been reported to be effective in nearly 50% of such patients. The following report describes our experience using rituximab as both a splenectomy-sparing and salvage intervention in a heterogenous group of IT patients. PATIENTS AND METHODS: 11 patients were evaluated retrospectively. Their characteristics were as follows: median age of 44 (range 20–79); 6 were female; median IT duration was 2.8 yrs (range 1mo-17yrs); median number of prior treatments was 3 (range 1–8); all patients had received steroids and most, high dose immunoglobulin. Other treatments included anti-RhD, vincristine, danazol, cyclophosphamide, staphylococcal protein-A column, plasmapheresis, mycophenolate mofetil, cyclosporine and autologous stem cell transplantation (ASCT). 6 patients (55%) had been splenectomized. 8 patients had primary idiopathic thrombocytopenic purpura (ITP) including 2 cases of Evan’s syndrome (ES) and 3 had secondary IT associated with antiphospholipid antibody syndrome (APS), cutaneous panniculitis-like T-cell lymphoma and chronic lymphocytic leukemia (CLL). The planned treatment was rituximab 375 mg/m2 i.v. weekly x 4. A complete response (CR) was defined as a rise in platelet count >100 X 109/L for greater than 3 months, partial response (PR) was defined as a rise in platelet count >50 X 109/L and no response (NR) was defined as no change or a rise < 50 X109/L. RESULTS: All patients received the 4 doses of rituximab except 1 patient who achieved CR after 1 dose. Of the 8 primary ITP patients 6 (75%) attained CR, 1 had a transient PR and 1 a NR. All 3 patients with secondary IT reached CR. Overall, 91% of patients responded and 81% had CR. 1 ITP patient was spared a splenectomy and remains in CR at 7 mos. 5 of 6 (83%) splenectomized ITP patients reached CR and the 6th had a brief PR and failed to respond to retreatment. 4 of 5 splenectomized patients remain in CR at 3, 3, 32 and 34 mos, respectively. The last patient is a 44 y/o M with ES for 17 yrs who attained a transient CR with stable hemolysis but relapsed and was retreated 6 mos later with a sustained CR for nearly 3 years while maintained on intermittent rituximab therapy. Notably, he has experienced hypogammaglobulinemia with recurrent pneumonia. The 5th splenectomized patient reaching CR was a 35 y/o M with ES refractory to extensive pretreatment including ASCT and had a transient PR only after rituximab. He was retreated 4 mos later and reached a sustained CR 3 mos from last dose but died from hepatic failure characterized by marked cholestasis with loss of bile ducts of unclear etiology but possibly drug related. Among those with secondary IT is a 27 y/o F with APS who responded after 1 rituximab dose and remains in CR at 12 mos. Both cases of CLL and T-cell lymphoma remain untreated for their primary disease and continue in CR at 6 and 22 mos, respectively. No characteristic predicting response was identified. Rituximab therapy was well tolerated with limited infusional reaction, fatigue and headache occurring in 3 of 10 patients. CONCLUSION: In contrast to published reports, 81% of our refractory IT patients treated with rituximab had durable responses. Furthermore, it appears retreatment and maintenance therapy may be effective in refractory IT at the expense of possibly an increased risk for infection.

Estudio primario

No clasificado

Earlier Administration of Rituximab Allows Higher Rate of Long-Lasting Response in Adult Patients with Autoimmune Thrombocytopenia

Revista Blood
Año 2015
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BACKGROUND: Previous reports highlighted the potential short and mid-term therapeutic activity and safety of rituximab in adult patients with autoimmune thrombocytopenias. OBJECTIVES: Primary objectives of this study were to evaluate the long-term efficacy and toxicity profile. Patients and methods From October 1999 to April 2005, 37 adults patients, median age 54 years, with active and symptomatic autoimmune thrombocytopenias (30 idiopathic thrombocytopenic purpura, 1 idiopathic thrombocytopenia and neutropenia, 4 thrombocytopenia and concomitant undifferentiated connective tissue disease, 2 thrombocytopenia and concomitant B-cell lymphoprolipherative disorders) that had relapsed or were refractory to at least a full course of steroid therapy received weekly infusions of rituximab 375 mg/m2 for 4 weeks. The median interval from diagnosis to rituximab was 34 months (1–264 months) and the platelets median count was 11 x 109/L. The following parameters of efficacy and toxicity were considered: rate of complete and partial response, time to initial and maximum response, relapse rate, relapse free survival, treatment free survival, short and long-term toxicity. The possible prognostic influence of some clinical and laboratory parameters on the patients outcome were also analyzed. RESULTS: Complete and partial response (platelets count ≥ 100 x 109/L and ≥ 50 x 109/L) were 20/37 (54%) and 7/37 (19%), respectively. In most of the patients the time to initial and maximum response was prompt, already before the second administration of rituximab. The median period of observation from treatment was 22 months (1–48 months). Nine out 27 responding patients relapsed; 18/37 patients (49%) remained relapse free and 20/37 (54%) did not necessitated further therapy. A shorter interval period from the time of diagnosis and rituximab administration (≤ vs > 36 months) was associated with a lower relapse free survival (p= 0.03). During the period of rituximab administration, 2 patients experienced short term toxicity with one case of serum sickness syndrome; no infectious or other significant long term toxic complications were documented.. CONCLUSION: Rituximab administration may allow to achieve long-lasting remission in nearly 50% of patients suffering from autoimmune thrombocytopenia with good toxic profile. The possibility to achieved long lasting response appeared related with an earlier timing of administration.

Estudio primario

No clasificado

Treatment of Refractory Chronic Immune Thrombocytopaenic Purpura (ITP) with Rituximab: Report of a Cases Series

Revista Blood
Año 2015
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PURPOSE: To describe the response rates and time to treatment failure in patients with chronic refractory ITP treated with Rituximab. METHODS: Fourteen consecutive patients with chronic refractory ITP, who didn’t achieve a response to first- and second-line treatments (including splenectomy), were recruited between November 2001 and May 2004. Rituximab was administered at 375 mg/m2 iv weekly’ 4 and all patients were pre-medicated with Diphenhydramine (30 mg single dose) and Hydrocortisone (100 mg IV single dose). The first response assessment was performed at week 4, using the following criteria: complete response, platelet count > 100 x 109/L; partial response, platelet count > 50 x 109/L; minimal response, platelet count persisted below 50 x 109/L but without bleeding or need for platelet transfusion; and no response if the platelet count did not change, or the patients required platelet transfusion or remained symptomatic. The response was considered sustained if it persisted for at least 6 months. RESULTS: The age range was 17–70 years; the baseline platelet count range was 3–37 x 109/L. Five patients achieved a complete response, four patients a partial response, four a minimal response and one no response. The time to response was from 4–32 weeks and 10 patients showed a sustained response. No patients with a response showed bleeding and no patients required the use of other drugs. CONCLUSIONS: These results suggest that Rituximab should have a significant therapeutic effect and an acceptable safety profile in patients with refractory chronic ITP. However, there is a lack of randomized, prospective studies to demonstrate the therapeutic benefit of this treatment.

Estudio primario

No clasificado

Rituximab and three dexamethasone cycles provide responses similar to splenectomy in women and those with immune thrombocytopenia of less than two years duration.

Revista Haematologica
Año 2014
Enlaces Pubmed DOI PubMed Central www.scopus.com

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Adults with newly diagnosed or persistent immunothrombocytopenia frequently relapse upon tapering steroids; adults and children with chronic disease have an even lower likelihood of lasting response. In adults with newly-diagnosed immunothrombocytopenia, two studies showed that dexamethasone 40 mg/day × four days and 4 rituximab infusions were superior to dexamethasone alone. Studies have also shown three cycles of dexamethasone are better than one and patients with persistent/chronic immunothrombocytopenia respond less well to either dexamethasone or rituximab. Therefore, 375 mg/m(2) × 4 rituximab was combined with three 4-day cycles of 28 mg/m(2) (max. 40 mg) dexamethasone at 2-week intervals and explored in 67 ITP patients. Best long-term response was assessed as complete (platelet count ≥ 100 × 10(9)/L) or partial (50-99 × 10(9)/L). Only 5 patients had not been previously treated. Fifty achieved complete (n=43, 64%) or partial (n=7, 10%) responses. Thirty-five of 50 responders maintained treatment-free platelet counts over 50 × 10(9)/L at a median 17 months (range 4-67) projecting 44% event-free survival. Duration of immunothrombocytopenia less than 24 months, achieving complete responses, and being female were associated with better long-term response (P<0.01). Adverse events were generally mild-moderate, but 3 patients developed serum sickness and 2 colitis; there were no sequelae. Dexamethasone could be difficult to tolerate. Fourteen patients became hypogammaglobulinemic and half had increased frequency of minor infections; 9 of 12 evaluable patients recovered their IgG levels. Rituximab combined with three cycles of dexamethasone provides apparently better results to reported findings with rituximab alone, dexamethasone alone, or the combination with one cycle of dexamethasone. The results suggest medical cure may be achievable in immunothrombocytopenia, especially in women and in patients within two years of diagnosis. (clinicaltrials.gov identifier:02050581).

Estudio primario

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Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia.

Revista Blood
Año 2013
Enlaces Pubmed DOI www.scopus.com

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In this study, we report the results from the largest cohort to date of newly diagnosed adult immune thrombocytopenia patients randomized to treatment with dexamethasone alone or in combination with rituximab. Eligible were patients with platelet counts ≤25×10(9)/L or ≤50×10(9)/L with bleeding symptoms. A total of 133 patients were randomly assigned to either dexamethasone 40 mg/day for 4 days (n = 71) or in combination with rituximab 375 mg/m(2) weekly for 4 weeks (n = 62). Patients were allowed supplemental dexamethasone every 1 to 4 weeks for up to 6 cycles. Our primary end point, sustained response (ie, platelets ≥50×10(9)/L) at 6 months follow-up, was reached in 58% of patients in the rituximab + dexamethasone group vs 37% in the dexamethasone group (P = .02). The median follow-up time was 922 days. We found longer time to relapse (P = .03) and longer time to rescue treatment (P = .007) in the rituximab + dexamethasone group. There was an increased incidence of grade 3 to 4 adverse events in the rituximab + dexamethasone group (P = .04). In conclusion, rituximab + dexamethasone induced higher response rates and longer time to relapse than dexamethasone alone. This study is registered at http://clinicaltrials.gov as NCT00909077.

Estudio primario

No clasificado

High response rate to low-dose rituximab plus high-dose dexamethasone as frontline therapy in adult patients with primary immune thrombocytopenia.

Revista European journal of haematology
Año 2013
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UNLABELLED: Corticosteroids as initial therapy for primary immune thrombocytopenia achieve a low rate of sustained remission. METHODS: We prospectively evaluated the efficacy, safety, and response duration of low-dose rituximab plus high-dose dexamethasone as frontline therapy in newly diagnosed primary immune thrombocytopenia patients. One cycle of dexamethasone, 40 mg/d/intravenously for four consecutive days, plus weekly intravenous rituximab, 100 mg for four doses, was delivered. RESULTS: Twenty-one consecutive adults were enrolled. The overall response at day +28 was 90.5%. Complete sustained response at 6 months and relapse rate were 76.2% and 15.8%, respectively, compared with 30% and 62.5% for a historical group who had received standard treatment with prednisone (P = 0.005 and P = 0.004). There was a 9.5% incidence of adverse effects. CONCLUSIONS: The combination of low-dose rituximab and high-dose dexamethasone as frontline therapy for adults with primary immune thrombocytopenia was effective and had a high overall response rate and a low incidence of relapse.