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2.
Lancet Haematol ; 8(4): e289-e298, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33770484

RESUMO

BACKGROUND: Primary immune thrombocytopenia is an autoimmune bleeding disorder. Preclinical reports suggest that the sialidase inhibitor oseltamivir induces a platelet response in the treatment of immune thrombocytopenia. This study investigated the activity and safety of dexamethasone plus oseltamivir versus dexamethasone alone as initial treatment in adult patients with primary immune thrombocytopenia. METHODS: This multicentre, randomised, open-label, parallel group, phase 2 trial was done in five tertiary medical hospitals in China. Eligible patients were aged 18 years or older with newly diagnosed, treatment-naive primary immune thrombocytopenia. Participants were randomly assigned (1:1), using block randomisation, to receive either dexamethasone (orally at 40 mg per day for 4 days) plus oseltamivir (orally at 75 mg twice a day for 10 days) or dexamethasone monotherapy (orally at 40 mg a day for 4 days). Patients who did not respond to treatment (platelet counts remained <30 × 109 cells per L or showed bleeding symptoms by day 10) were given an additional cycle of dexamethasone for 4 days in each group. Patients in the dexamethasone plus oseltamivir group who relapsed (platelet counts reduced again to <30 × 109 cells per L) after an initial response were allowed a supplemental course of oseltamivir (75 mg twice a day for 10 days). The coprimary endpoints were 14-day initial overall response and 6-month overall response. Complete response was defined as a platelet count at or above 100 × 109 cells per L and an absence of bleeding. Partial response was defined as a platelet count at or above 30 × 109 cells per L but less than 100 × 109 cells per L and at least a doubling of the baseline platelet count and an absence of bleeding. A response lasting for at least 6 months without any additional primary immune thrombocytopenia-specific intervention was defined as sustained response. All patients who were randomly assigned and received the allocated intervention were included in the modified intention-to-treat population analysis. This study has been completed and is registered with ClinicalTrials.gov, number NCT01965626. FINDINGS: From Feb 1, 2016, to May 1, 2019, 120 patients were screened for eligibility, of whom 24 were ineligible and excluded, 96 were enrolled and randomly assigned to receive dexamethasone plus oseltamivir (n=47) or dexamethasone (n=49), and 90 were included in the modified intention-to-treat analysis. Six patients did not receive the allocated intervention. Patients in the dexamethasone plus oseltamivir group had a significantly higher initial response rate (37 [86%] of 43 patients) than did those in the dexamethasone group (31 [66%] of 47 patients; odds ratio [OR] 3·18; 95 CI% 1·13-9·23; p=0·030) at day 14. The 6-month sustained response rate in the dexamethasone plus oseltamivir group was also significantly higher than that in the dexamethasone group (23 [53%] vs 14 [30%]; OR 2·17; 95 CI% 1·16-6·13; p=0·032). During the median follow-up of 8 months (IQR 5-14), two of 90 patients discontinued treatment due to serious adverse events (grade 3); one (2%) patient with general oedema in the dexamethasone plus oseltamivir group and one (2%) patient with fever in the dexamethasone group. The most frequently observed adverse events of any grade were fatigue (five [12%] of 43 in the dexamethasone plus oseltamivir group vs eight [17%] of 47 in the dexamethasone group), gastrointestinal reactions (eight [19%] vs three [6%]), insomnia (seven [16%] vs four [9%]), and anxiety (five [12%] vs three [6%]). There were no grade 4 or 5 adverse events and no treatment-related deaths. INTERPRETATION: Dexamethasone plus oseltamivir offers a readily available combination therapy in the management of newly diagnosed primary immune thrombocytopenia. The preliminary activity of this combination warrants further investigation. Multiple cycles of oseltamivir, as a modification of current first-line treatment, might be more effective in maintaining the platelet response. FUNDING: National Natural Science Foundation of China.


Assuntos
Dexametasona/uso terapêutico , Inibidores Enzimáticos/uso terapêutico , Glucocorticoides/uso terapêutico , Oseltamivir/uso terapêutico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Administração Oral , Adulto , China/epidemiologia , Dexametasona/administração & dosagem , Dexametasona/efeitos adversos , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Inibidores Enzimáticos/administração & dosagem , Inibidores Enzimáticos/efeitos adversos , Feminino , Seguimentos , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Hemorragia/epidemiologia , Humanos , Análise de Intenção de Tratamento/métodos , Masculino , Pessoa de Meia-Idade , Oseltamivir/administração & dosagem , Oseltamivir/efeitos adversos , Contagem de Plaquetas/estatística & dados numéricos , Contagem de Plaquetas/tendências , Púrpura Trombocitopênica Idiopática/imunologia , Segurança , Resultado do Tratamento
3.
Rinsho Ketsueki ; 62(1): 58-60, 2021.
Artigo em Japonês | MEDLINE | ID: mdl-33551428

RESUMO

Immune thrombocytopenia (ITP) may occur following a viral infection. We report the case of a 30-year-old woman with thrombocytopenia who was subsequently diagnosed with ITP. Although she was asymptomatic, chest computed tomography (CT) showed ground-glass opacities in the lower lung regions. The patient had a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) real-time polymerase chain reaction (RT-PCR) test. She responded well to 400 mg/kg of intravenous immunoglobulin therapy. Coronavirus disease of 2019 or COVID-19 should be considered as a cause of ITP during the pandemic, and chest CT scans and RT-PCR tests should be performed in patients suspected of ITP.


Assuntos
Púrpura Trombocitopênica Idiopática , Adulto , Feminino , Humanos , Púrpura Trombocitopênica Idiopática/diagnóstico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Púrpura Trombocitopênica Idiopática/etiologia
4.
J Stroke Cerebrovasc Dis ; 30(4): 105637, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33508727

RESUMO

Immune thrombocytopenic purpura (ITP) can increase the risk of not only hemorrhagic incidents but also thrombotic events. Although several patients with ITP who developed cerebral infarction have been reported, concurrence of spinal cord infarction and ITP has not been reported. We report the case of a female patient who developed spinal cord infarction during the exacerbation of her ITP. This case suggests a possible association between spinal cord infarction and ITP, which can cause paradoxical thrombosis.


Assuntos
Infarto/etiologia , Púrpura Trombocitopênica Idiopática/complicações , Medula Espinal/irrigação sanguínea , Trombose/etiologia , Idoso , Progressão da Doença , Feminino , Glucocorticoides/uso terapêutico , Fármacos Hematológicos/uso terapêutico , Humanos , Imunossupressores/uso terapêutico , Infarto/diagnóstico por imagem , Infarto/reabilitação , Púrpura Trombocitopênica Idiopática/diagnóstico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Trombose/diagnóstico por imagem , Resultado do Tratamento
5.
Ann Hematol ; 100(3): 653-659, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33495923

RESUMO

The primary aim of this study was to describe the use of primary anti-infective prophylaxis (AP) in common clinical practice in patients affected by immune thrombocytopenia (ITP) and treated with RTX. Population studied consisted of patients affected by ITP (age ≥ 18 years) who had received at least one dose of RTX from January 2008 to June 2018. Five Italian haematology centres participated in the current study. Data were retrospectively collected: demographic data (age, gender), concomitant comorbidities and previous therapies for ITP, characteristics of AP, the occurrence of infections and their management. The ITP cohort consisted of 67 patients sub-grouped into two categories according to the administration of AP: (1) treated with AP (N= 34; 51%) and (2) not treated with AP (N=33, 49%). AP consisted of combined trimethoprim/sulfamethoxazole (TMP/SMX) and acyclovir (AC) in half of patients. TPM/SMX as a single agent was adopted in 32% patients and one patient received only AC. Overall, infections were experienced in 15% of patients during follow-up with a similar proportion in the 2 groups (treated and not treated) of patients (14.7% vs 15%). Clinical course of infections was however, less severe in patients treated with AP, where all infections were grade 2 and did not require hospitalization. In neither group of patients was reported Pneumocystis pneumonia. In conclusion, despite the absence of clear evidence, our analysis shows that AP in patients with ITP receiving RTX is frequently adopted, even if in the absence of well-defined criteria. Prophylaxis administration is quite consistent within the same haematological Center; thus, it seems related to clinicians' experience.


Assuntos
Antibioticoprofilaxia , Infecções Oportunistas/tratamento farmacológico , Padrões de Prática Médica/estatística & dados numéricos , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Rituximab/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibioticoprofilaxia/métodos , Antibioticoprofilaxia/estatística & dados numéricos , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Infecções Oportunistas/epidemiologia , Infecções Oportunistas/etiologia , Púrpura Trombocitopênica Idiopática/complicações , Púrpura Trombocitopênica Idiopática/epidemiologia , Estudos Retrospectivos , Adulto Jovem
7.
Gan To Kagaku Ryoho ; 47(12): 1723-1725, 2020 Dec.
Artigo em Japonês | MEDLINE | ID: mdl-33342992

RESUMO

A 68-year-old woman presenting with anorexia and epigastric pain was diagnosed with metastatic pancreatic cancer and idiopathic thrombocytopenic purpura(ITP). Chemotherapy was initiated with S-1. Subsequently, gemcitabine was administered in combination with prednisolone. Her platelets returned to normal after the treatment with steroids and chemotherapy, but the treatment could not be withdrawn completely. Pancreatic cancer presenting as idiopathic thrombocytopenic purpura has rarely been reported in the literature. Here, we present our experience and discuss a case of pancreatic cancer complicated with ITP.


Assuntos
Neoplasias Pancreáticas , Púrpura Trombocitopênica Idiopática , Idoso , Feminino , Humanos , Neoplasias Pancreáticas/complicações , Neoplasias Pancreáticas/tratamento farmacológico , Prednisolona , Púrpura Trombocitopênica Idiopática/complicações , Púrpura Trombocitopênica Idiopática/tratamento farmacológico
9.
Am J Hematol ; 95(12): 1542-1552, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32871029

RESUMO

We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO), vs HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. So, HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs 66.7%, P < .001) and complete response (CR, 75.0% vs 42.7%, P < .001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs 36.5%, P = .02; sustained CR: 46.0% vs 32.3%, P = .043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = .04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as clinicaltrials.gov identifier: NCT01734044.


Assuntos
Dexametasona/administração & dosagem , Púrpura Trombocitopênica Idiopática , Trombopoetina/administração & dosagem , Adulto , Idoso , Dexametasona/efeitos adversos , Intervalo Livre de Doença , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Púrpura Trombocitopênica Idiopática/mortalidade , Taxa de Sobrevida , Trombopoetina/efeitos adversos
10.
Int J Hematol ; 112(6): 764-772, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32856231

RESUMO

Immune thrombotic thrombocytopenic purpura (iTTP) is caused by ADAMTS13 deficiency due to anti-ADAMTS13 autoantibodies. Rituximab, an anti-CD20 monoclonal antibody, is often used to suppress these autoantibodies. This retrospective study, conducted in an iTTP cohort in Japan, evaluated the long-term efficacy of rituximab as off-label treatment for refractory or relapsed cases. A total of 252 iTTP patients with severe ADAMTS13 deficiency (< 10%) and its inhibitor were enrolled, and 169 episodes in 156 patients were analyzed. Sixty-five episodes with relapse or resistance to conventional treatment were treated with rituximab, while 104 episodes received conventional treatment only. The rituximab group had a significantly higher inhibitor titer than the rituximab-untreated group. During the median follow-up period of 3.9 years, there were 8 relapses in the rituximab group and 17 relapses in the rituximab-untreated group. The median time to relapse in the rituximab group (2.9 years) was significantly longer than that in the rituximab-untreated group (1.2 years). Relapse-free survival at 2 years was significantly higher in the rituximab group than in the rituximab-untreated group. The incidence of relapse at 5 years did not differ between the 2 groups. Rituximab reduced the risk of relapse in refractory or relapsed iTTP patients for 2 years.


Assuntos
Uso Off-Label , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Rituximab/uso terapêutico , Proteína ADAMTS13/deficiência , Proteína ADAMTS13/imunologia , Adulto , Idoso , Autoanticorpos , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Púrpura Trombocitopênica Idiopática/genética , Púrpura Trombocitopênica Idiopática/mortalidade , Recidiva , Estudos Retrospectivos , Prevenção Secundária , Fatores de Tempo , Resultado do Tratamento
11.
Ann Hematol ; 99(10): 2315-2322, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32728937

RESUMO

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by lower platelet count resulting from immune cells-mediated platelet clearance. Tacrolimus is an immunosuppressive agent which selectively inhibits T cell activation. Whether tacrolimus plays a role in ITP remains unclear. This study aimed to investigate the effect of tacrolimus on ITP in mice. An ITP mouse model was established by injection of rat anti-mouse integrin GPIIb/CD41 immunoglobulin and treated with tacrolimus followed by isolation of peripheral blood mononuclear cells and plasma. The mRNA expression of T-bet, GATA3, and Foxp3 was measured by RT-PCR, and level of IFN-γ, IL-12p70, IL-4, IL-13, and TGF-ß in plasma was measured by ELISA. Tacrolimus inhibited antiplatelet antibody-mediated platelet clearance in ITP mouse model. Meanwhile, tacrolimus-treated ITP mice displayed a significant decrease in the mRNA expression of T-bet and plasma level of IFN-γ and IL-12p70 compared with ITP mice but without differences when compared with normal mice. Furthermore, the expression of GATA3, Foxp3, and plasma level of IL-4 and TGF-ß were upregulated in tacrolimus-treated ITP mice without significant differences to normal mice (except TGF-ß). Tacrolimus prevents antiplatelet antibody-mediated thrombocytopenia in ITP mice possibly through regulating T cell differentiations, suggesting it might be a novel approach for preventing ITP.


Assuntos
Imunossupressores/uso terapêutico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Tacrolimo/uso terapêutico , Animais , Plaquetas/imunologia , Citocinas/biossíntese , Citocinas/genética , Modelos Animais de Doenças , Regulação da Expressão Gênica/efeitos dos fármacos , Humanos , Isoanticorpos/sangue , Camundongos , Camundongos Endogâmicos C57BL , Púrpura Trombocitopênica Idiopática/genética , Púrpura Trombocitopênica Idiopática/metabolismo , RNA Mensageiro/biossíntese , RNA Mensageiro/genética , Organismos Livres de Patógenos Específicos , Subpopulações de Linfócitos T/efeitos dos fármacos , Subpopulações de Linfócitos T/imunologia , Fatores de Transcrição/biossíntese , Fatores de Transcrição/genética
12.
Int J Hematol ; 112(5): 746-750, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32613314

RESUMO

COVID-19 is a new disease with many undescribed clinical manifestations. We report herein a case of severe immune thrombocytopenic purpura (ITP) in a critical COVID-19 patient. A patient presented a severe episode of immune thrombocytopenia (< 10 × 109/L) 20 days after admission for a critical COVID-19. This thrombocytopenia was associated with a life-threatening bleeding. Response to first-line therapies was delayed as it took up to 13 days after initiation of intravenous immunoglobulin and high-dose dexamethasone to observe an increase in platelet count. COVID-19 may be associated with late presenting severe ITP. Such ITP may also be relatively resistant to first-line agents. Hematological manifestations of COVID-19, such as the ones associated with life-threatening bleeding, must be recognized.


Assuntos
Infecções por Coronavirus/complicações , Pandemias , Pneumonia Viral/complicações , Púrpura Trombocitopênica Idiopática/etiologia , Betacoronavirus , Terapia Combinada , Infecções por Coronavirus/tratamento farmacológico , Dexametasona/uso terapêutico , Hemorragia/etiologia , Humanos , Imunoglobulinas Intravenosas , Hemorragias Intracranianas/etiologia , Masculino , Pessoa de Meia-Idade , Pneumonia Estafilocócica/etiologia , Pneumonia Associada à Ventilação Mecânica/etiologia , Atelectasia Pulmonar/etiologia , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Púrpura Trombocitopênica Idiopática/terapia , /terapia
14.
Int J Hematol ; 112(2): 159-168, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32476083

RESUMO

Thrombopoietin receptor agonists (TPO-RAs) are used for treatment of chronic immune thrombocytopenia (ITP). Several studies have shown that TPO-RAs induce remission and sustained response, despite long-term discontinuation of therapy. Furthermore, TPO-RAs are effective in patients with newly diagnosed ITP. Here, we retrospectively assessed all patients with ITP who received TPO-RAs in our hospital, focusing on newly diagnosed, non-splenectomized patients who had discontinued TPO-RAs due to sustained complete response (CR, platelet count ≥ 100 × 109/L). Moreover, we explored predictive factors related to sustained treatment-free remission (TFR) without additional ITP treatment. Seventy-seven consecutive patients with ITP received TPO-RAs from 2011 to 2018. Twenty-seven newly diagnosed patients achieved CR and discontinued TPO-RAs. The overall response and discontinuation rates in all patients with ITP were 79.2% and 41.6%, respectively. In newly diagnosed patients who discontinued TPO-RAs, the 2-year TFR rate, cumulative incidence of loss of CR, and response (R) rate (platelet count ≥ 30 × 109/L) were 66.4%, 46.7%, and 34.0%, respectively. Patients who achieved R within 14 days from the start of TPO-RA administration exhibited a higher 2-year TFR rate, compared with patients who did not (87.5% vs. 48.5%, p = 0.0106). In conclusion, patients with newly diagnosed ITP who achieve sustained response should consider discontinuation of TPO-RAs.


Assuntos
Benzoatos/administração & dosagem , Hidrazinas/administração & dosagem , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Pirazóis/administração & dosagem , Receptores Fc/administração & dosagem , Receptores de Trombopoetina/agonistas , Proteínas Recombinantes de Fusão/administração & dosagem , Trombopoetina/administração & dosagem , Suspensão de Tratamento , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
16.
Zhonghua Xue Ye Xue Za Zhi ; 41(4): 292-296, 2020 Apr 14.
Artigo em Chinês | MEDLINE | ID: mdl-32447932

RESUMO

Objective: To explore the effect and mechanism of low-dose chidamide on the treatment of primary immune thrombocytopenia (ITP) . Methods: Passive ITP animal model and active ITP animal model were established by C57BL/6J mice. Different doses of chidamide (0, 0.01, 0.1, 0.5, and 5 mg/kg) were orally administrated twice a week for 120 hours in passive ITP mice. Secondly, low-dose chidamine (0.1 mg/kg) was given intragastrically administrated twice a week in active ITP mice. The platelet counts in the peripheral blood before and after treatment were detected. Four weeks later, mice were executed to prepare splenocyte suspension; natural regulatory T cells (CD4(+)CD25(+)Foxp3(+) nTreg cells) in splenocyte suspension were detected by flow cytometry. Serum IL-6 was measured by ELISA. Peripheral blood mononuclear cells from ITP patients were co-cultured with low-dose chidamide in vitro. After incubation for 72 hours, CD4(+)CD25(+)Foxp3(+) Treg cells of mononuclear cells was detected. CD4(+)CD25(+) Treg cells and CD4(+)CD25(-) effector T cells were separated by immunomagnetic beads. The Treg cells and effector T cells were co cultured in a ratio of 1∶4, and treated with low-dose chidamide. The proliferation of effector T cells was detected. Results: Chidamide with low dose (0.1 mg/kg) significantly improved platelet counts in passive ITP mouse model, as well as in the ITP active mouse model and reduced the mortality related to bleeding. Low-dose chidamide significantly increased the number and proportion of nTreg cells in mouse splenocytes, and decreased serum IL-6 level in active ITP mice. In ITP patients, low-dose chidamide also significantly expanded Treg cells in the PBMC culture system. Besides, the proliferation of effector T cells was suppressed. Conclusion: Low-dose chidamide enhances the proliferation of CD4(+)CD25(+)Foxp3(+) regulatory T cells to mediate immunosuppressive function. Serum IL-6 is inhibited for further immune tolerance. In vivo animal study suggestes that low-dose chidamide has a novel therapeutic effect on ITP.


Assuntos
Aminopiridinas/uso terapêutico , Benzamidas/uso terapêutico , Púrpura Trombocitopênica Idiopática , Animais , Fatores de Transcrição Forkhead , Humanos , Leucócitos Mononucleares , Camundongos , Camundongos Endogâmicos C57BL , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Linfócitos T Reguladores
17.
Am J Hematol ; 95(6): 643-651, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32129511

RESUMO

Romiplostim self-administration by patients or caregivers may offer time/cost savings to healthcare professionals (HCPs) and convenience for patients who avoid weekly clinic visits. We performed an integrated analysis of five clinical trials to evaluate the efficacy and safety of romiplostim self-administration. Data were analyzed from adults with immune thrombocytopenia (ITP) who received weekly romiplostim via self-administration or from an HCP. Patients who achieved a stable romiplostim dose for ≥3 weeks (HCP group ≥5 weeks to provide an appropriate index date to enable comparisons with the self-administration group) with platelet counts ≥50 × 109 /L were eligible. In the self-administration (n = 621) vs HCP (n = 133) groups, respectively, median age was 53 vs 58 years, median time since primary ITP diagnosis was 3.7 vs 2.5 years, and median baseline platelet count at ITP diagnosis was 19.0 vs 20.0 × 109 /L. In the self-administration and HCP-dosed groups, median romiplostim treatment duration was 89 vs 52 weeks and median total number of doses was 81 vs 50, respectively. In the self-administration and HCP groups, respectively: 95.0% and 100.0% of patients achieved ≥1 platelet response (defined as weekly platelet count ≥50 × 109 /L without rescue medication in previous 4 weeks); the median percentage of weeks with a response was 94.5% and 95.9%; and rescue medication was used in 36.7% and 39.8% of patients. Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration. Romiplostim self-administration appears effective and well tolerated in eligible patients with ITP.


Assuntos
Bases de Dados Factuais , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Receptores Fc/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Trombopoetina/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Contagem de Plaquetas , Púrpura Trombocitopênica Idiopática/sangue , Proteínas Recombinantes de Fusão/efeitos adversos , Autoadministração , Trombopoetina/efeitos adversos
18.
Hematology ; 25(1): 139-144, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32167032

RESUMO

Background: Antinuclear antibodies (ANAs) can be detected in about 30% of patients with primary immune thrombocytopenia (ITP), yet their relationship with treatment response to rituximab remains elusive.Methods: we retrospectively reviewed the clinical records of hospitalized adult ITP patients who were treated with rituximab from three medical centers across China. Rituximab was given intravenously at 100 mg weekly for 4 weeks, or at a single dose of 375 mg/m2. All included patients had their ANAs tested before rituximab treatment.Results: A total of 287 patients fulfilled the inclusion criteria and were eligible for analysis. ANAs were positive in 98 (34.1%) of the included patients. The incidence of overall response and complete response (CR) in ANA-positive patients was significantly higher than that in ANA-negative patients (overall response: 76.5% vs. 55.0%, P < 0.001; CR: 46.9% vs. 29.1%, P = 0.003). However, sustained response (SR) rates in ANA-positive patients at 6, 12 and 24 months were all lower compared with ANA-negative patients (all P < 0.05). The overall duration of response (DOR) estimated by Kaplan-Meier analysis in ANA-negative patients was greater than that in ANA-positive patients (P < 0.001).Conclusion: ITP patients with positive ANA test were likely to achieve a better initial response to rituximab treatment, while their long-term outcome was unfavorable. Therefore, ANA test could be useful for predicting rituximab response in ITP.


Assuntos
Antineoplásicos Imunológicos/uso terapêutico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Rituximab/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Imunológicos/farmacologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Rituximab/farmacologia , Adulto Jovem
19.
Int J Hematol ; 111(6): 771-778, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32162096

RESUMO

In the present study, we analyzed phenotypes of cells in the lymphocyte region of bone marrow in 68 patients with primary immune thrombocytopenia (ITP) to determine whether cellular phenotype predicts response to first-line therapy (corticosteroids or corticosteroids plus intravenous immunoglobulin). In 52 newly diagnosed ITP patients, an abnormal CD4:CD8 ratio (CD4/CD8 ratio < 0.4 and 2.3 < CD4/CD8 ratio) was noted in 22 patients in the responder group, whereas all non-responder and control individuals showed normal CD4:CD8 ratio (p < 0.001). The absolute number of CD19+ cells in patients with 0.4 ≤ CD4/CD8 ratio ≤ 2.3 or 2.3 < CD4/CD8 ratio was higher than that in other groups. (p = 0.016). In 16 chronic ITP patients, the absolute number of NK cells in the responder group was lower than those in the non-responder and control groups (p = 0.032). An abnormal CD4:CD8 ratio was noted in all patients in the responder group, whereas all patients in non-responder and control groups showed normal CD4:CD8 ratio (p < 0.001). The present results indicate that CD4:CD8 ratio, B cells, and NK cells contribute to the prediction of therapeutic outcomes of ITP patients.


Assuntos
Células da Medula Óssea/imunologia , Imunoglobulinas Intravenosas/administração & dosagem , Subpopulações de Linfócitos , Prednisona/administração & dosagem , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Antígenos CD19 , Linfócitos B , Relação CD4-CD8 , Citometria de Fluxo , Células Matadoras Naturais , Fenótipo , Valor Preditivo dos Testes , Resultado do Tratamento
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