Risk Factors for Venous Ulcer Following ACUTE Venous Thromboembolism: Results from the Riete Registry

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3548-3548
Author(s):  
Jean-Philippe Galanaud ◽  
Laurent Bertoletti ◽  
Paolo Prandoni ◽  
Pedro Gallego ◽  
Daniela Mastroiacovo ◽  
...  
Keyword(s):  
Risk Factors ◽  
Board Of Directors ◽  
Venous Ulcer ◽  
Advisory Committees ◽  
Venous Ulcers ◽  
Increased Risk ◽  
History Of ◽  
Male Sex ◽  
One Year

Abstract Background: Venous ulcer, the most serious consequence of chronic venous insufficiency (CVI), is associated with a high morbidity, impaired quality of life and high costs. To date, risk factors for venous ulcer after acute VTE have not been characterized. Objective: To identify independent predictors of venous ulcer development one year after an acute VTE event. Methods: Using data from the RIETE international registry, we analysed risk factors for venous ulcers in patients with an objectively confirmed symptomatic acute VTE (DVT and/or pulmonary embolism (PE)) and followed up for at least one year. During follow-up, signs and symptoms of CVI, occurrence of a venous ulcer in the leg ipsilateral to DVT or, in the absence of reported DVT, in any leg were reported by local investigators. Independent predictors of venous ulcers were assessed using a stepwise multivariable model. Results: Of the 34,144 patients included in the RIETE registry, 4,305 were recruited in centres participating in long-term (1 to 3 years) follow-up. Of these, 54% (n=2,337) underwent an assessment for CVI. After a mean (SD) follow-up of 383 (+/-575) days, 55% (n=1297) had signs or symptoms of CVI and 2.5% (n=59) had developed a venous ulcer. History of previous VTE (OR=4.4 [2.6 - 7.7], signs of venous insufficiency (i.e. leg varicosities) at time of VTE event (OR=2.3 [1.3 - 4.0]), diabetes (OR=2.0 [1.0 - 3.8]), obesity (OR=1.8 [1.1 - 3.2]) and male sex (OR=2.7 [1.5 - 4.9]) were independent predictors of an increased risk of venous ulcer. Conversely, older age, presence of an objectively confirmed DVT at study enrolment, anticoagulant duration (<1 vs. >1 year), anticoagulant type (extended low molecular weight heparin vs. vitamin K antagonist), or presence of vena cava filter had no significant impact on risk of venous ulcer. When restricting our analysis to the 1790 patients with objectively confirmed DVT only, results remained similar in magnitude. Proximal character of DVT was associated with a 30% non-significant increased risk of - unquestionable - post-thrombotic ulcer but the proportion of distal DVT was low in our population (11%). Conclusions: After an acute VTE event, history of VTE, pre-existing signs of CVI, male sex, diabetes and obesity independently influenced the risk of venous ulcer. VTE therapeutic management (neither duration nor drugs) did not appear to modify this risk. Our results suggest that clinicians should consider strategies aimed to prevent ulcers in high risk patients, such as preventing VTE recurrence, use of compression stockings in those with CVI and encouraging weight loss in obese patients. Disclosures Galanaud: bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding; Daichi: Membership on an entity's Board of Directors or advisory committees, Research Funding. Bertoletti:Daichi: Honoraria; bayer: Honoraria; BMS-Pfizer: Consultancy, Honoraria. Monreal:Bayer: Consultancy, Membership on an entity's Board of Directors or advisory committees; sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; boehringer: Consultancy, Membership on an entity's Board of Directors or advisory committees; daichii: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Prognostic Factors for Developing Thrombosis in Polycytemia Vera: A Retrospective Analysis of 331 Patients with Long-Term Follow-up Highlights the Importance of White Blood Cells Levels

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 48-49
Author(s):  
Samantha Ferrari ◽  
Chiara Pagani ◽  
Mariella D'Adda ◽  
Nicola Bianchetti ◽  
Annamaria Pelizzari ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multivariate Analysis ◽  
High Risk ◽  
Board Of Directors ◽  
Advisory Board ◽  
Advisory Committees ◽  
Risk Status ◽  
History Of ◽  
Wbc Count

Polycythemia Vera (PV) is a chronic myeloproliferative neoplasm characterized by erythrocytosis, constitutively active mutations in JAK2 and an increased susceptibility to thrombotic events (TEs). There is still controversy about the role of increased hematocrit and of other variables including elevated white blood cell count as risk factors for the occurrence of TEs. A better definition of the relative prognostic importance of hematologic parameters would help us to better tailor the therapeutic approach to PV patients (pts), which is currently mainly based on the use of acetilsalycilic acid (ASA), venesection and hydroxyurea . The aim of our study was to analyze if any clinical or laboratory variables were significantly associated to the occurrence of TEs both at PV diagnosis and during the course of the disease in a large series of PV pts uniformly followed at a single Center over a period of 29.5 years from January 1986 to June 2019. Clinical and laboratory data were obtained from the time of diagnosis until death, progression to acute leukemia or last follow-up. Hematocrit (Hct), hemoglobin (Hb), white blood cell (WBC) and platelet (PLT) levels were recorded for each patient at least every 6 months. Among a total of 331 pts, the median age was 65 years (range 30-92 years), and 56% were male. "High risk" features (age ≥ 60 years and/or history of prior thrombosis) were present in 221 pts (66.7%). The incidence of cardiovascular risk factors was: hypertension 64%, diabetes 15%, hyperlipidemia 28%, history of active or remote smoking 41%. Patients on ASA were 279 (84%), 19 (6%) were on oral anticoagulation, while 27 (8%) were on ASA+oral anticoagulant. At PV diagnosis 54 pts (16%) presented with thrombosis, arterial in 32 (59%) and venous in 22 (41%). A previous TE was recorded in 57 pts (17%): in 43 (75%) arterial, in 12 (22%) venous and in 2 (3%) mixed (arterial+venous). Previous thrombosis was the only variable significantly associated with the presence of a TE at PV diagnosis (P=0.02). After PV diagnosis, with a median follow-up of 81 months (range 1-374 months), 63 pts (19%) experienced a TE and 11 of them a further episode, for a total of 74 TEs. The incidence rate (pts/year) of TEs was 2.7%. Forty-two events were arterial (57%), 31 were venous (42%) and 1 (1%) was mixed. It was the first TE for 37 pts. Cerebrovascular accidents and deep-venous thrombosis were the most frequent arterial and venous TEs both at PV diagnosis and throughout the disease course, with a relative incidence of 50% and 32% respectively. The table compares the characteristics of patients who did or did not develop a TE after PV diagnosis. At univariate analysis, PV high risk status, a previous TE and hyperlipidemia at PV diagnosis were significantly associated with a subsequent TE. Among hematologic variables an elevated WBC count at the time of thrombosis, but not Hct or PLT levels, was highly significantly associated with the development of a TE. At multivariate analysis, WBC count ≥10.4 x 10^9/L and hyperlipidemia maintained their independent prognostic value, while high risk status and a previous TE lost their prognostic significance. Both at univariate and multivariate analysis, hyperlipidemia at diagnosis (P=0.009 and P=0.002) and high WBC count at thrombosis (P=0.001 and P=&lt;0.0001) predicted for arterial thromboses, while only a history of prior thrombosis (P=0.03) predicted for venous ones. In conclusion, our analysis confirms that elevated WBC count at the moment of the event more than increased hematocrit is associated to the development of thrombosis in PV pts. We also found that hyperlipidemia was an independent risk factor for arterial thrombosis, calling for an accurate management of increased lipid levels. Whether a reduction of the WBC count during the course of PV may reduce the frequency of TE remains to be demonstrated by prospective studies. Table Disclosures D'Adda: Novartis: Other: Advisory board; Incyte: Other: Advisory board; Pfizer: Other: Advisory board. Rossi:Daiichi Sankyo: Consultancy, Honoraria; Sanofi: Honoraria; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Novartis: Other: Advisory board; Alexion: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria; Celgene: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Jazz: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees.

Atrial Fibrillation in Patients with Chronic Lymphocytic Leukemia (CLL)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2950-2950 ◽  
Author(s):  
Tait D. Shanafelt ◽  
Kari G. Chaffee ◽  
Timothy G. Call ◽  
Sameer A. Parikh ◽  
Susan M. Schwager ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Heart Disease ◽  
Valvular Heart Disease ◽  
Research Funding ◽  
Newly Diagnosed ◽  
Advisory Committees ◽  
Increased Risk ◽  
History Of ◽  
Male Sex

Abstract BACKGROUND: Consistent with the advanced age at diagnosis (median age ~70 years), most patients with CLL have co-existent health problems. These co-morbidities influence the ability of many CLL patients to tolerate aggressive chemotherapy-based treatment and can also contribute to treatment-related side effects. The recent development of novel signaling inhibitors, particularly the Bruton's tyrosine kinase inhibitor ibrutinib, has been a major treatment advance for patients with CLL. While these agents generally have favorable toxicity profiles relative to standard chemotherapy-based treatments, they are chronic therapies which patients typically stay on for an extended period. Preliminary data suggests ibrutinib may be associated with an increased risk of atrial fibrillation (Afib). In one randomized trial comparing ibrutinib to ofatumumab in patient with relapsed CLL, incident grade 3+ Afib occurred in 3% of ibrutinib treated patients compared to 0% of ofatumumab treated patients (NEJM 371:213). Despite these observations, the baseline frequency of Afib in patients with CLL is not well described - particularly incident atrial fibrillation acquired during the course of the disease. METHODS: We used the Mayo Clinic CLL database to evaluate the prevalence of Afib at the time of CLL diagnosis as well as the incidence of Afib during follow-up. All patients with a new diagnosis of CLL after January 1995 who were seen at Mayo within 12 months of diagnosis were included in the analysis. Afib was identified by chart review and by billing search using ICD9 codes. Data on co-morbid conditions associated with risk of Afib was also abstracted (e.g. hypertension, coronary artery disease [CAD], valvular heart disease, cardiomyopathy, diabetes mellitus, pulmonary disease). RESULTS: A total of 2444 patients with newly diagnosed and previously untreated CLL were seen at Mayo Clinic within 12 months of diagnosis between 1/1995 and 4/2015.Median age at diagnosis was 65 years and 1626 (66.5%) patients were men. A history of Afib was present at the time of CLL diagnosis in 148 (6.1%) patients. Four additional patients had Afib documented in the record but the precise date of onset (e.g. prior to or after CLL diagnosis date) could not be determined. Age, male sex and history of CAD, valvular heart disease, cardiomyopathy, hypertension, and diabetes were associated with a greater likelihood of having a history of Afib at the time of CLL diagnosis (all p&lt;0.01). Among the 2292 patients without a history of Afib at CLL diagnosis, 139 (6.1%) had incident Afib during the course of follow-up for their CLL. The incidence of Afib among patients without a history of Afib at diagnosis was approximately 1%/year (Figure 1A). Considering both Afib present at the time of CLL diagnosis or acquired during the course of the disease, 291 (11.9%) of the 2444 patients in this cohort experienced Afib (median follow-up: 59 months). Among patients without Afib at the time of CLL diagnosis, the following characteristics at the time of CLL diagnosis were associated with an increased risk of incident Afib on multivariate analysis: older age (age 65-74 HR=2.4, p&lt;0.001; age ≥75 HR=3.6, p&lt;0.001), male sex (HR=1.8, p=0.004); valvular heart disease (HR=2.4, p=0.007), and hypertension (HR=1.5; p=0.02). A predictive model for acquired Afib was subsequently constructed based on the independent factors in the Cox regression model. An individual weighted risk score was assigned to each independent factor based on the regression coefficients of the HRs. The Afib risk score (range 0-7) was defined as the sum of the scores of these independent factors. The risk of incident Afib among patients with risk scores of 0-1, 2-3, 4, and 5+ is shown in Figure 1B. Rates for these 4 groups were significantly different (p&lt;0.001), with the 10-year Afib rates (95% C.I.) for those with a score of 0-1, 2-3, 4, and 5+: 4% (2-6%), 9% (6-13%), 17% (11-23%), and 33% (20-43%), respectively. CONCLUSIONS: A history of Afib is present in approximately 1 out of every 16 patients with newly diagnosed CLL. Among patients without Afib at diagnosis, the incidence rate of Afib is ~1%/year. The risk of incident Afib in newly diagnosed CLL patients can be predicted based on age, sex, and co-morbid health conditions present at diagnosis. These data provide context to help interpret data on the frequency of Afib in CLL patients treated with ibrutinib and other novel agents. Disclosures Shanafelt: Janssen: Research Funding; Polyphenon E Int'l: Research Funding; Glaxo-Smith_Kline: Research Funding; Cephalon: Research Funding; Genentech: Research Funding; Hospira: Research Funding; Celgene: Research Funding; Pharmactckucs: Research Funding. Ding:Merek: Research Funding. Kay:Tolero Pharm: Research Funding; Hospira: Research Funding; Genentech: Research Funding; Pharmacyclics: Research Funding; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding.

Appropriateness of Thrombophilia Testing in Tertiary Care Centers in Edmonton

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4470-4470
Author(s):  
Alabdurubalnabi Zainab ◽  
Salma Shivji ◽  
Cynthia Wu
Keyword(s):  
Family History ◽  
Board Of Directors ◽  
Protein C ◽  
Protein S ◽  
Test Results ◽  
Advisory Committees ◽  
Increased Risk ◽  
History Of ◽  
Thrombophilia Testing

Abstract INTRODUCTION Thrombophilia is associated with an increased risk of venous thromboembolism (VTE). Despite this link, determining the presence or absence of such conditions has no role in VTE management including determining the choice or duration of anticoagulant therapy. Testing can be potentially harmful when results are misinterpreted or impact patient anxiety and insurance eligibility. METHODS We performed a retrospective chart review of adult patients presenting to the emergency department (ED) or were admitted to the University of Alberta Hospital (UAH), Royal Alexandra Hospital (RAH) and Grey Nuns Hospital (GNH) and underwent any number of thrombophilia tests (including factor V Leiden [FVL], prothrombin gene mutation [PT20210], protein C [PC], protein S [PS], antithrombin [AT] and antiphospholipid antibody testing). To assess for appropriateness of testing, categories of data were collected including presence of other strong risk factors obviating the need to look for other causes, indicators for higher yield (age of patient, presence of family history of VTE, idiopathic nature of VTE), presence of factors that confound testing (such as therapeutic anticoagulation) and relevant follow up (appropriate repeat testing when necessary). We also collected basic patient demographics, VTE details and ordering physician/service details to evaluate under what circumstances testing may be ordered more frequently. RESULTS 134 charts of patients tested for thrombophilia were reviewed between 2007-2013 at UAH and RAH Hospitals. A total of 965 thrombophilia tests were done (see analysis table). 13.4% of the testing was ordered by hematologists, 23.1% by neurologists, 52.2% by other internists. Overall, all patients had tests performed inappropriately, lacked appropriate follow up or had uninterpretable results and none had documented counseling prior to thrombophilia testing. CONCLUSIONS Thrombophilia testing is frequently ordered inappropriately and not adequately followed up. Strategies to educate physicians on indications and limitations of testing are warranted. These strategies can help decrease over/under/misinterpretation of thrombophilia testing as well as result in significant savings to the health care system if testing can be reduced. Table 1. Demographics Sample Size Males Females Total 74 (55.22%) 60 (44.78%) 134 (100%) Age at time of testing (Yrs) Range 19-88 Average 48.7 Patients' Test Results Test Times Performed Abnormal Results APCR 134 (100%) 32 (23.8%) FVL genetic test 58 (43%) 21 (39%) PT20210 105 (77%) 4 (3.8%) Protein C 100 (74.1%) 8 (8%) Protein S 99 (73.3%) 16 (16.2%) AT levels 99 (73.3%) 19 (19.2%) Anticardiolipin Ab 117 (86.7%) 4 (3.4%) Lupus Anticoagulant 109 (81.3%) 10 (10.2%) Provoking Factors Patients with One or More Provoking Factors Major 10 7.4% Moderate 74 56% Minor 29 21.8% No Provoking Factors 49 36.8% Family History of VTE 12 8.9% Protein C and Protein S Testing Done During Acute VTE 64 64% Patient was on Warfarin 25 25% Number of Abnormal Test Results 24 16% Number of Repeated Abnormal Tests 0 0% AT Testing Total Tests Performed 99 73.3% Done During Acute VTE 62 63% Patient was on Therap. Heparin or LMWH 62 62.6% Number of Abnormal Test Results 19 19.2% Abnormal Tests Repeated? 7 37% Repeat Tests Showing Normal Results 3 57% APA Testing Tests were Repeated After 12 Weeks for Confirmation 11% Disclosures Wu: Leo Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.

Incidence and Prognostic Impact of Secondary Neoplasia after High Dose Therapy Supported By Autologous Stem Cell Transplantation in Follicular Lymphoma. a Long Term Follow-up Analysis from the Geltamo Registry

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3451-3451
Author(s):  
ANA Jimenez Ubieto ◽  
Carlos Grande ◽  
Dolores Caballero ◽  
Lucrecia Yañez ◽  
Silvana Novelli ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Solid Tumors ◽  
Myeloid Leukemia ◽  
Conditioning Regimen ◽  
Second Malignancies ◽  
Advisory Committees ◽  
Secondary Neoplasia ◽  
Increased Risk ◽  
Male Sex

Abstract Background:High dose therapy supported by autologous stem cell transplantation (HDT/ASCT) has been a treatment frequently indicated in follicular lymphoma (FL) patients and has contributed to modify the natural history of the disease. Secondary neoplasia is one of the concerns after HDT/ASCT, although its incidence after transplant-free treatments is considerable (RummelM et al. Lancet Oncol 2016; Sacchi S et al. Haematologica 2008). The high incidence of secondary neoplasia in some of the studies, together with the lack of OS advantage in transplanted patients compared to those treated with conventional Chemo/R, has led to abandon HDT/ASCT by many groups. However, its incidence is very variable among studies due in part to cohort different in terms of age, pre-ASCT treatments, used of TBI-based or TBI-free conditioning regimen or length of follow-up. Methods:The Incidence of secondary neoplasia, the factors associated with its development and the survival of 655 FL patients reported to the Spanish GELTAMO registry and intensified with HDT/ASCT between 1989 and 2007 with a median follow-up of 12.3 years from HDT/ASCT and 14.5 years from diagnosis were analyzed. Baseline characteristics and therapeutic-related data are listed in the table. Standardized Incidence Ratios (SIR) were calculated to assess the risk of a second malignancy by dividing the number of observed second malignancies with the number of expected sex matched incidence using the 2008 crudes rates in the Spanish population (J Farley et al. EJC 2013). Data were updated with a cut-off date of 31 June 2016. Results:Median OS were 21.3 years from HDT/ASCT and 22.6 years from the time of FL diagnosis. A total of 83 patients (12.75%) developed 85 second malignancies. There were 45 cases of solid tumors (51%), including 8 skin cancers; 34 cases of Acute Myeloid Leukemia or Myelodysplastic Syndromes (AML/MDS) (40%); 2 Acute Lymphoblastic Leukemia (ALL), 1 chronic myeloid leukemia (CML), 1 Hodgkin lymphoma (HL) and 2 cases of other cancers. The accumulated incidence at 5, 10 and 15 years were 6.7%, 12% and 17.8%, respectively. The incidence for solid tumors and AML/SMD were 2.1%, 4.1%, 9.5% and 3.1%,6.4% and 8,1% at 5, 10 and 15 years, respectively. Median time from HDT/AST to the diagnosis of the second malignancy was 5.5 years (IQR 3.2-9.6). Solid tumors and AML/SMD were documented with a median time of occurrence since HDT/ASCT 7.7 years (IQR 3.2-9.9) and 4.2 years (IQR 1.7-7.3), respectively. The SIR for second neoplasia was 2.8 (CI 95%: 2.6-2.9) and only 1.4 (CI 95% 1.3-16) in the case of solid tumors. Only male sex (P=.006) and the use of anthracycline at first line therapy in the case of solid tumors (P=.02) were associated with an increased number of second neoplasia. Older age and a status of disease before HDT/ASCT different to complete response showed a tendency. There were no differences according to the use of fludarabine or rituximab previously to HDT/ASCT, number of therapy lines before HDT/ASCT, time from diagnosis to HDT/ASCT or conditioning regimen. Median OS for patients with second neoplasia is 12 years from the time of FL diagnosis, 9.4 years from ASCT (fig 2)[14.5 y. for solid tumors and 8 y. for sMDS/sAML (P=.01)] and 1.5 years from the time of diagnosis of second neoplasia [2.3 y. for solid tumors and 1.25 y. for sMDS/sAML (P=.01)], respectively Conclusion: This very long follow-up study, that includes patients from the rituximab era, indicates that FL patients undergoing an ASCT are at an increased risk of developing a 2nd malignancy, especially AML-MDS. However, the incidence is not higher than the reported in other series without transplantation. Only male sex and the use of anthracyclines were associated with an increased risk of 2nd neoplasia. Given the favorable survival obtained by ASCT in FL, the risk of secondary neoplasia shouldn't preclude its application. However, once a neoplasia is diagnosed the prognosis is dismal. Thus, a carefully selection of patients candidates to HDT/ASCT is necessary. Table Table. Figure Figure. Disclosures Lopez-Jimenez: Abbvie: Membership on an entity's Board of Directors or advisory committees; Velgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; MundiPharma: Honoraria, Membership on an entity's Board of Directors or advisory committees. Martín:Sevier: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria.

scholarly journals Risk Factors for Thrombotic Events in Patients with PNH: A Nested Case-Control Study in the International PNH Registry

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 6-8
Author(s):  
Britta Hoechsmann ◽  
Regis Peffault De Latour ◽  
Anita Hill ◽  
Alexander Röth ◽  
Timothy Devos ◽  
...  
Keyword(s):  
Risk Factors ◽  
Board Of Directors ◽  
Research Funding ◽  
Index Date ◽  
Case Control Study ◽  
Advisory Committees ◽  
Clone Size ◽  
Increased Risk ◽  
History Of ◽  
Control Study

INTRODUCTION Although thrombotic events (TEs) are the leading cause of paroxysmal nocturnal hemoglobinuria (PNH)-related mortality, the risk factors predictive of TEs are not well established. Several small or previous studies reported that the proportion of PNH cells, elevated lactate dehydrogenase (LDH), age, thrombosis at diagnosis, and treatment may impact TE risk.1-5 The International PNH Registry (NCT01374360) is an observational cohort study containing the largest database of safety, quality-of-life, and outcome data from patients with PNH. Here, we analyzed patient data from the Registry to identify risk factors for TEs. METHODS Data from Registry patients who were untreated at enrollment, had an incident TE after enrollment, non-zero follow-up time, and with documented birthdate, sex, enrollment date, treatment status, and country, were included in this analysis. The first TEs experienced by eligible patients after enrollment were identified as TE cases; the date of the index TE event was defined as the Index Date. Up to five controls were selected from the risk set for each TE case matched on age (±5 years at Index Date), gender, country, and history of bone marrow disease (BMD). Cases that could not be matched with at least one control were excluded from the study. For covariates included in the analysis, conflicting or absent values were marked as "missing." Univariate conditional logistic regression was used to estimate odds ratios (ORs) with 95% Wald confidence intervals (CIs) of TE associated with candidate risk factors: glycophosphatidylinositol (GPI)-deficient granulocytes, GPI-deficient erythrocytes, LDH ratio, recent high-disease activity (HDA; defined as within six months prior to the Index Date, LDH ratio ≥1.5xULN, and hemoglobin &lt;10 g/dL or at least one of the following symptoms: abdominal pain, dyspnea, dysphagia, fatigue, hemoglobinuria, and/or male erectile dysfunction), LDH ratio and number of HDA symptoms, history of TE, history of major adverse vascular event (MAVE), and recent prophylactic anticoagulant (PA) use. RESULTS Due to the strict eligibility criteria, 57 TE cases and 189 non-TE controls met the conditions and were matched for the case-control study. The mean age at Index Date was 46.8 years for TE cases and 47.1 years for non-TE control (Table A). Cases were more likely to have a clone size of ≥ 50% GPI-deficient granulocytes, an LDH ratio ≥ 1.5xULN, recent HDA, and a history of TE or MAVE, compared with controls. From univariate analyses, the following factors were found to be associated with statistically significantly increased risk of TE: recent HDA (OR, 2.65; 95% CI, 1.10-6.61), LDH ≥1.5xULN and 2-3 HDA symptoms (OR, 8.61; 95% CI, 1.46-96.96), LDH ≥1.5xULN and ≥4 HDA symptoms (OR, 14.50; 95% CI, 1.70-209.25), and a history of TE (OR, 3.60; 95% CI, 1.41-9.24) or MAVE (OR, 2.17; 95% CI, 0.96-4.80), and recent PA use (OR, 4.35; 95% CI, 1.57-13.13) (Figure A). The strengths of this analysis include a robust study design for evaluation of a rare outcome and multiple risk factors, increased generalizability with an international patient population, and the ability to evaluate both medical history and recent clinical characteristics relevant to PNH and TE; however, not all patients had available data for each parameter assessed and the number of TE cases identified were relatively small. Despite these limitations, factors that were statistically significantly associated with increased TE risk were identified from the analysis. CONCLUSIONS Based on this observational PNH Registry analysis, we identified several clinical features of PNH that were associated with an elevated risk of TE, including ≥50% GPI-deficient granulocyte clone size, LDH ratios ≥1.5xULN, recent HDA, LDH ≥1.5xULN plus HDA symptoms, a history of TE or MAVE, and recent PA use compared with non-TE controls; for recent PA use, these patients were most likely at increased risk of TE, which may explain why they received treatment. Our data add to the findings of previously published studies1,4 by expanding the results to a broader patient population. These results highlight the importance and urgency of identifying and monitoring risk factors for TE in patients with PNH to inform treatment decisions. Disclosures Hoechsmann: Roche: Consultancy, Honoraria; Apellis: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Alexion: Consultancy, Honoraria, Research Funding. Peffault De Latour:Apellis: Membership on an entity's Board of Directors or advisory committees; Amgen: Research Funding; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Alexion Pharmaceuticals Inc.: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Hill:Alexion Pharmaceuticals, Inc.: Current Employment. Röth:Roche: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria; Apellis: Consultancy, Honoraria; Alexion Pharmaceuticals Inc.: Consultancy, Honoraria, Research Funding; Biocryst: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Devos:Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees. Patriquin:Octapharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Apellis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Alexion Pharmaceuticals, Inc.: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Jain:Alexion Pharmaceuticals, Inc.: Current Employment, Current equity holder in publicly-traded company. Zu:Alexion Pharmaceuticals, Inc.: Ended employment in the past 24 months; Merck & Co.: Current Employment. Lee:Alexion Pharmaceuticals Inc.: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

scholarly journals A Scoring System to Predict the Risk of Atrial Fibrillation in Chronic Lymphocytic Leukemia and Its Validation in a Cohort of Ibrutinib-Treated Patients

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3118-3118 ◽  
Author(s):  
Andrea Visentin ◽  
Marina Deodato ◽  
Francesca Romana Mauro ◽  
Francesco Autore ◽  
Gianluigi Reda ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Board Member ◽  
Prognostic Markers ◽  
Advisory Board ◽  
Lymphocytic Leukemia ◽  
Advisory Committees ◽  
Increased Risk ◽  
History Of

Abstract BACKGROUD. The B-cell receptor inhibitor ibrutinib has significantly improved treatment and overall management of chronic lymphocytic leukemia (CLL). Although several data derived from clinical trials suggest that ibrutinib increases the risk of atrial fibrillation (AF), the incidence of AF in a real-life cohort of CLL patients is unknown. Furthermore, it would be clinically relevant to identify patients at high risk of AF during ibrutinib. The aim of this study is to report the prevalence and risk factors of AF in ibrutinib-naive CLL, in order to define a predictive model for the development of AF and to test it in a cohort of subjects receiving ibrutinib. METHODS. We retrospectively analyzed data from 860 ibrutinib-naive CLL patients, referred to the Padua University hospital. Comorbidities, clinical and biological prognostic markers were analyzed using the Mann-Whiney, Fisher exact or Chi-square tests, when appropriated. Time to AF (TTAF) and overall survival (OS) were evaluated with Kaplan-Meier method. Univariate and multivariate Cox models were run to identify independent factors associated with AF. Then, risk values were obtained based on the hazard ratios. The score for AF was calculated as the sum of each risk values. Subsequently, the model was evaluated in a cohort of 354 ibrutinib-treated patients referred from 8 Italian hematological centers. RESULTS. Among the 860 patients from Padua hospital, 60% were male, 49% were older than 65 years, 73% were Binet A stage at diagnosis and 41% underwent at least one line of treatment. A prior history of AF was present in 21 patients (2.4%) at CLL diagnosis, while, among the remaining 839 patients without a previous history of AF, 47 (5.6%) developed it after a median follow-up of 9.4 years, resulting in an estimated incidence of almost 0.8% cases/year. Moreover, the median OS for patients with AF was significantly shorter than that patients without AF (12 vs 22 years, p<0.0001). Based on univariate and multivariate analysis, variables associated with the risk of AF were: age>65 years (p=0.001, 1 point), male gender (p=0.003, 1 point), valvular hearth diseases (p=0.001, 2 points), cardiopathy (p<0.001, 3 points), hyperthyroidism (p=0.001, 1 point), chronic lung diseases (p=0.001, 1 point), diabetes mellitus (p=0.023, 1 point), severe infections (p=0.019, 1 point). As expected, no clinical and biological prognostic markers (i.e. Binet stage, IGHV mutation, TP53 abnormalities) for CLL were associated with an increased risk of AF. A predictive model was designed based on these factors and it stratified patients into 4 different groups. The estimated TTAF after 15 years of follow-up were 0%, 10%, 19% and 61% for patients with score 0, 1-2, 3-4, and ≥5 respectively (p<0.001, Fig. 1A). Furthermore, it underwent internal validation using the bootstrap method. Subsequently, we applied our AF model to a cohort of 354 ibrutinib-treated patients, 64% were male, the median age was 69 years, 88 were treatment-naive, 70% U-IGHV and 39% harbored TP53 abnormalities. Forty-four subjects developed AF after a median observation of 25 months, with an estimated 2-year TTAF of 12%. Only 9 out of the 44 patients (20%) discontinued ibrutinib. Sixteen patients (4%) were classified as AF score 0, 218 (62%) score 1-2, 73 (21%) score 3-4 and 46 (13%) at least score 5. Our model was also able to identify patients at a higher risk AF during ibrutinib, in fact the 2-year risk of AF was 0%, 5%, 17% and 40% for patients with score 0, 1-2, 3-4, and ≥5 respectively (p<0.001, Fig. 1B). Patients with a score of 5 or higher have a risk 20 times higher to developed AF than the other subjects (HR 19.6, 95% interval 7-52, p<0.0001). So far, the OS of ibrutinib-treated patients with AF was not inferior to that of patients who did not developed AF (2-years OS 89% and 82%, respectively p=0.1252), but the median follow-up is only 2 years. CONCLUSIONS. In this study, variables associated with an increased risk of developing AF were identified and recapitulated into a scoring system. Our model proved to be a valid tool to identify patients at a higher risk of developing AF, including ibrutinib-treated patients. Taking these data into account, patients with a score ≥5 should be carefully monitored during ibrutinib treatment given the very high-risk of developing AF or should be considered for alternative therapies. Disclosures Visentin: janssen: Consultancy, Honoraria. Mauro:abbvie: Other: board member; janssen: Other: board member. Reda:Janssen and Cilag: Consultancy; ABBVIE: Consultancy; Gilead: Consultancy; Celgene: Consultancy. Molica:Jansen: Other: Advisory board; Gilead: Other: Advisory board; Roche: Other: Advisory board; AbbVie: Other: Advisory board. Rigolin:Gilead: Research Funding. Tedeschi:Gilead: Consultancy; Janssen: Consultancy, Speakers Bureau; AbbVie: Consultancy. Cortelezzi:novartis: Consultancy; abbvie: Consultancy; roche: Consultancy; janssen: Consultancy. Coscia:Abbvie, Gilead, Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen, Karyopharm: Research Funding. Cuneo:Abbvie: Other: advisory board, Speakers Bureau; Roche: Other: advisory board, Speakers Bureau; Gilead: Other: advisory board, Speakers Bureau; janssen: Other: advisory board, Speakers Bureau. Foà:CELGENE: Other: ADVISORY BOARD, Speakers Bureau; CELTRION: Other: ADVISORY BOARD; ABBVIE: Other: ADVISORY BOARD, Speakers Bureau; JANSSEN: Other: ADVISORY BOARD, Speakers Bureau; GILEAD: Speakers Bureau; NOVARTIS: Speakers Bureau; AMGEN: Other: ADVISORY BOARD; INCYTE: Other: ADVISORY BOARD; ROCHE: Other: ADVISORY BOARD, Speakers Bureau. Trentin:Roche: Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria; Gilead: Research Funding; Janssen: Research Funding.

scholarly journals Venous Thromboembolism Is Associated with Inferior Survival after Allogeneic Hematopoietic Cell Transplant

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4866-4866
Author(s):  
Lauren M. Granat ◽  
Lisa A. Rybicki ◽  
Mailey L. Wilks ◽  
Christina Ferraro ◽  
Matt Kalaycio ◽  
...  
Keyword(s):  
Risk Factors ◽  
Board Of Directors ◽  
Acute Gvhd ◽  
Cell Transplant ◽  
Hematopoietic Cell Transplant ◽  
Advisory Committees ◽  
Allogeneic Hct ◽  
Allogeneic Hematopoietic Cell Transplant ◽  
Increased Risk ◽  
History Of

Abstract Introduction Venous thromboembolism (VTE) is a common complication of both solid and hematologic malignancies. Risk factors for VTE and standard recommendations for prevention and treatment primarily pertain to solid tumor patients. There are fewer data in patients who have undergone allogeneic hematopoietic cell transplant (HCT). Therefore, we studied the incidence, risk factors, and impact of VTE on post-HCT outcomes. Methods We retrospectively reviewed 431 patients who underwent allogeneic HCT between 1/2014 and 8/2019 to identify patients with VTE. VTE was estimated with cumulative incidence methods. Risk factors for VTE were identified with Fine and Gray regression and results are reported as hazard ratio (HR) with a 95% confidence interval (CI). An apriori list of potential risk factors for VTE included age, gender, race, performance status, co-morbidity index, number of prior chemotherapy regimens, history of VTE, disease risk, donor/graft source, transplant conditioning regimen, and acute or chronic graft vs. host disease (GVHD). VTE was analyzed as a time-dependent covariate relative to other post-HCT outcomes. Results Patient characteristics are shown in the Table. The median age at time of transplant was 59 years, (range 18-76); 55.5% were male, the majority (90.7%) were White. The most common indication for transplant was acute myelogenous leukemia and myelodysplastic syndrome (70.3%). Within our cohort, 64 patients (14.8%) developed VTE after allogeneic HCT. The cumulative incidence of VTE at 1 year was 9% (CI 7-12%). Median time to VTE was 9.8 months (range 0.7-74.0) (Figure). Thrombosis site breakdown included the following: lower deep vein thrombosis (DVT) n=47 (74%), catheter related DVT n=12 (19%), DVT and pulmonary embolism (PE) n=12 (19%), PE alone n=4 (6%). Patients were most commonly treated with a direct oral anticoagulant (n=27, 42%), followed by enoxaparin (n=15, 23.4%). The majority of patients (n=38, 58%) were treated with anticoagulation for more than 6 months. Six (9.4%) patients had recurrent thrombosis after completion of anticoagulation therapy from the time of transplant until last known follow-up. Only 9 (14%) had an inferior vena cava filter placed due to contraindications for anticoagulation. In patients treated with anticoagulation, there was a low overall incidence of clinically significant bleeding (n=3, 5%). In multivariable analysis, age (HR 1.36 per 10-year increase, CI 1.09-1.70, P=0.006), history of VTE (HR 1.95, CI 1.09-3.48, P=0.024), and grade 2-4 acute GVHD (HR 1.75, CI 1.05-2.94, P=0.033) were significantly associated with VTE. VTE was not associated with relapse mortality (HR 0.95, CI 0.44-2.04, P=0.89), however VTE was significantly associated with an increased risk of non VTE-associated non-relapse mortality (NRM) (HR 4.09, CI 2.47-6.74, P&lt;0.001) and decreased overall survival (OS) (HR 2.19, CI 1.48-3.24, P&lt;0.001). Discussion VTE is an important complication after allogeneic HCT and is associated with significantly increased NRM and inferior OS. Older patients, those with a prior history of VTE, and patients with acute GVHD are at increased risk for development of VTE after HCT. We found an overall low risk of bleeding with anticoagulation and further study to investigate the role of prophylaxis in this high-risk cohort is needed. Figure 1 Figure 1. Disclosures Sobecks: CareDX: Membership on an entity's Board of Directors or advisory committees. Majhail: Incyte Corporation: Consultancy; Anthem, Inc: Consultancy. Angelini: Sanofi: Membership on an entity's Board of Directors or advisory committees. Hamilton: Syndax: Membership on an entity's Board of Directors or advisory committees; Equilium: Membership on an entity's Board of Directors or advisory committees.

scholarly journals Impact of atrial fibrillation pattern on outcomes after left atrial appendage closure: lessons from the prospective LAARGE registry

2021 ◽  
Author(s):  
Shinwan Kany ◽  
Johannes Brachmann ◽  
Thorsten Lewalter ◽  
Ibrahim Akin ◽  
Horst Sievert ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrial Appendage ◽  
Systemic Embolism ◽  
Long Term Outcomes ◽  
Increased Risk ◽  
History Of ◽  
One Year ◽  
The One

Abstract Background Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death. Methods Comparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE). Results A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02–2.72, p = 0.041). Conclusion Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality. Graphic abstract

Incidence of Recurrent Venous Ulcer in Patients Treated at an Outpatient Clinic: Historical Cohort

2022 ◽  
pp. 153473462110659
Author(s):  
Michele Neves Brajão Rocha ◽  
Carol Viviana Serna Gonzalez ◽  
Eline Lima Borges ◽  
Vera Lúcia Conceição de Gouveia Santos ◽  
Soraia Assad Nasbine Rabeh ◽  
...  
Keyword(s):  
Risk Factors ◽  
Outpatient Clinic ◽  
Onset Time ◽  
Venous Ulcer ◽  
High Recurrence Rate ◽  
Ulcer Recurrence ◽  
Clinical Approach ◽  
Historical Cohort ◽  
Venous Ulcers

The recurrence of venous ulcers is the wound reopening after a period of completed epithelisation of a previous ulcer due to exposure to causal factors and lack of prevention. Venous ulcers have a high recurrence rate that may increase through the years. Epidemiological evidence on its incidence and risk factors is scarce due to the lack of patient follow-up in outpatient clinics and adherence to treatment after healing. The objective was to analyze the incidence of venous ulcers recurrency in outpatients and the risk factors for its occurrence. It is an observational historical cohort with retrospective data collection, performed through electronic medical records. Setting: private health insurance outpatient clinic. The participants were adult patients with healed venous ulcers. Incidence of venous ulcer recurrence was calculated within individuals with healed ulcers from 2014 and 2018 with a follow-up of at least one year. Bivariate analysis and logistic regression were used to explore risk factors considering demographic, clinical, and wound-related variables. As a result, sixty-five (65) of the 134 patients with healed venous ulcers had a recurrence, leading to an incidence of 48.5%, with a mean onset time of 230.1 (SD 267) days. Patients with recurrent venous ulcers were primarily women (39/48.1%), with a mean age of 64 (SD 15.5) years, 57 (50.8%) had some comorbidity, with systemic arterial hypertension as the most frequent (47/51%). Obesity (15/88.2%) increased the risk of venous ulcers recurrence by 8.7 (OR 95% CI 2.1-60.8; P = .009) times. In conclusion, venous ulcers recurrence incidence was 48.5%, with obesity as a risk factor. This study demonstrates that the clinical approach of people with venous ulcers should not finish when the wound is healed. For ulcer recurrence prevention interventions addressing systemic factors, besides topical management of the wound, are essential.

scholarly journals Long-Term Survival Benefit of Eculizumab Treatment in Patients with Paroxysmal Nocturnal Hemoglobinuria: Data from the International PNH Registry

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2188-2188
Author(s):  
Louis Terriou ◽  
Christopher J. Patriquin ◽  
Morag Griffin ◽  
Jong Wook Lee ◽  
Philippe Gustovic ◽  
...  
Keyword(s):  
Rare Disease ◽  
Board Of Directors ◽  
Survival Probability ◽  
Advisory Committees ◽  
Term Survival ◽  
Treatment Status ◽  
History Of ◽  
Baseline Characteristics

Abstract Background Eculizumab, the first C5 inhibitor approved for paroxysmal nocturnal hemoglobinuria (PNH), transformed PNH treatment by improving survival to that of an age- and sex- matched general population. Previous analyses demonstrating the survival benefit of eculizumab in patients with PNH leveraged historical data and were limited by small patient numbers and short follow-up durations; few evaluated survival of patients receiving eculizumab compared with untreated patients. The objective of the current analysis was to describe the baseline characteristics and overall survival of a large international cohort of eculizumab-treated patients compared with a contemporaneous untreated cohort using data from the prospective, observational International PNH Registry (NCT01374360). Methods Data from patients enrolled in the Registry after March 16, 2007 with complete information for birth date, sex, enrollment date, and treatment status were included (database cut-off, April 12, 2021). Ever-treated patients were those who received eculizumab for a minimum treatment period of 35 days while enrolled in the Registry; never-treated patients did not receive eculizumab at any time before or during Registry participation. Univariate and multivariate analyses were performed using a Cox proportional hazards that incorporated the following parameters at baseline as covariates: treatment status, presence of high disease activity (HDA), age, sex, history of bone marrow failure (BMF), history of thrombotic events (TE), transfusion dependence, and estimated glomerular filtration rate ≤60 mL/min/1.73 m 2. HDA was defined as lactate dehydrogenase (LDH) ratio ≥1.5 × upper limit of normal (ULN) and ≥1 of the following: history of major adverse vascular events (including TE); anemia (hemoglobin &lt;10 g/dL), or physician-documented abdominal pain, dyspnea, dysphagia, fatigue, hemoglobinuria, or erectile dysfunction at any time before and including baseline. Baseline was defined as the date of eculizumab treatment initiation (ever-treated patients) or date of Registry enrollment (never-treated patients). Survival time was analyzed using a left-truncation approach that mapped time in patients' survival based on disease start date, defined as the earliest date of first-reported PNH diagnosis, PNH symptom, or first consistent flow cytometry result. Results Baseline characteristics of the 4627 patients included in the analysis (mean [SD] age at disease start, 40.2 [18.71] years; 53% female; 75% white) were comparable between the ever-treated and never-treated groups (n=1892 and n=2735, respectively). Compared with never-treated patients, more ever-treated patients had LDH ≥1.5 × ULN (90% vs 35%), and fewer had &lt;10% PNH granulocytes (3% vs 57%) or history of BMF (45% vs 76%). The univariate Cox proportional hazard ratio (HR) for mortality in ever-treated vs never-treated patients was 0.48 (95% CI, 0.39-0.60; P&lt;0.0001), indicating a 52% increase in survival in the treated group (Table). Among ever-treated patients, those with HDA at baseline experienced the largest reduction in mortality risk (HR [95% CI], 0.46 [0.33-0.64]; n=174); however, decreased mortality was also evident in ever-treated patients without HDA (HR, 0.65 [0.39-1.10]; n=212) or with unknown HDA status (HR, 0.50 [0.32-0.76; n=120) at baseline. Overall survival probability by treatment status was consistently greater in ever-treated vs never-treated patients through 20 years of follow-up; survival probability at 20 years was 82% (ever-treated) vs 69% (never-treated). Although long-term survival probability was greatest throughout follow-up in ever-treated patients with HDA at baseline, increased survival among ever-treated patients was evident in all 3 HDA status groups (Figure). Conclusion In this analysis of Registry data, treatment with the C5 inhibitor eculizumab improved patient survival compared with a never-treated cohort at a comparable time point in their disease course. Covariates were assessed at baseline only and competing risks and time on treatment were not controlled for, which are potential limitations. Survival benefits conferred by eculizumab treatment were observed regardless of HDA status at baseline, were more pronounced in treated patients with HDA vs those without HDA, and were maintained through 2 decades of real-world follow-up. Figure 1 Figure 1. Disclosures Terriou: Alexion, AstraZeneca Rare Disease: Consultancy, Membership on an entity's Board of Directors or advisory committees. Patriquin: Alexion, AstraZeneca Rare Disease: Consultancy, Honoraria, Speakers Bureau; Biocryst: Honoraria; Apellis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria. Griffin: Alexion, AstraZeneca Rare Disease: Honoraria, Membership on an entity's Board of Directors or advisory committees; BioCryst Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sobi Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Apellis: Other: Educational grant support. Lee: Alexion, AstraZeneca Rare Disease: Honoraria, Membership on an entity's Board of Directors or advisory committees. Gustovic: Alexion, AstraZeneca Rare Disease: Current Employment. Patel: Alexion, AstraZeneca Rare Disease: Current Employment. Szer: Alexion, AstraZeneca Rare Disease: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Apellis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Prevail Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

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