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Patient Demographics and Baseline Characteristics At 31 August 2013: 140 patients enrolled at 24 sites in 7 countries. Data analysis performed on n=137(3.

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Presentation on theme: "Patient Demographics and Baseline Characteristics At 31 August 2013: 140 patients enrolled at 24 sites in 7 countries. Data analysis performed on n=137(3."— Presentation transcript:

1 Patient Demographics and Baseline Characteristics At 31 August 2013: 140 patients enrolled at 24 sites in 7 countries. Data analysis performed on n=137(3 excluded) 61 of 137 patients present with bleeding of WHO grade 1 – 3 at baseline. The mean PLT count at baseline is 24 x 10 9 /L The median PLT count at baseline is 10 x 10 9 /L Primary Immune Thrombocytopenia (ITP) is an autoimmune disorder characterized by platelet counts < 100 x 10 9 /L. There is limited available robust epidemiological and clinical data for ITP outside the United States and Europe. Current treatment protocols lack uniformity. Many existing guidelines are based on evidence from the USA and Europe - not necessarily reflecting best practice for populations in the Asia-Pacific, Middle-East and Latin America. The International ITP-Registry is a prospective cohort study which seeks to collect epidemiological and clinical data of adult ITP predominantly in the Asia-Pacific Region. This will be achieved through the compilation of an anonymous centralized database of demographic, ITP-specific clinical and co-morbid disease information. Study Design and Analysis Prospective follow-up from date of primary ITP diagnosis for a minimum of 24 months. Data for the registry are collected at a minimum of: Initial/baseline visit,1 visit within 6 months of baseline, 1 visit 7 - 12 months from baseline, at least 1 visit annually after month 12, any hospitalisations required for management of ITP. Descriptive statistics are used to report on patient distributions and demographics, disease characteristics and disease progression, co-morbidities, drug treatments and platelet response and refractoriness analysis. Treatment Used Episodes of use Patients treated (% all registry patients) Platelet Response† (% of patients treated) CRPRRNR Corticosteroids *59696 (78)48%23%8%16% Prednisolone40078 (63)46%26%7%14% Methlyprednisolone15334 (28)65%14%8%12% Dexamethasone2914 (11)10%21%14%52% Immunotherapies *2415 (12)42%21%8%29% Anti-D22 (2)50%… … Danazol11 (1)…100%…… Azathiroprine96 (5)56%22%… Cyclophosphamide43 (2)…50%25% Cyclosporine63 (2)…33%…67% TPO-receptor agonists82 (2)75%25%…… Romiplostim11 (1)100%……… Eltrombopag71 (1)75%25%…… Blood Products/IVIg13462 (50)………… IVIg6530 (24)20% 9%49% Fresh Frozen Plasma11 (1)………… Pooled Platelets5532 (26)………… PRBC138 (7)………… First-line treatments 123 patients included in post baseline analysis (14 drop-outs). Corticosteroids are used in 96 of 123 (78%) patients, of whom 48% showed a complete platelet response IVIg are used in 30 of 123 (24%) patients, of whom 20% showed a complete platelet response. Second-line treatments Immunotherapies were used in 15 of 123 (12%) patients TPO-receptor agonists are used in 2 of 123 (2%) patients. ACKNOWLEDGEMENTS Funding for this Registry (NCT 01970189) is provided by GlaxoSmithKline (GSK). All listed authors meet the criteria for authorship set forth by the International Committee of Medical Journal Editors. Thanks to Ms Kiara McIntyre for her contributions to this poster. BACKGROUND Table 1: Demographics and patient baseline characteristics. Figure 1: Key data collected by registry Figure 2: Participating countries and proportional patient contribution International ITP-Registry with Focus on the Asia-Pacific Region: Preliminary Findings of the Epidemiological and Clinical Data Beng H. Chong 1, Jong-Wook Lee 2, Tzeon-Jye Chiou 3, Rajaa Marouf 4, Jun Ho Jang 5, Soo Chin Ng 6, Ai-Sim Goh 7, Shinichiro Okamoto 8, Pantep Angchaisuksiri 9, Osman Ilhan 10, Lai Heng Lee 11, Dimitri Bennett 12, Sarah Davidson 13, Ronny Odegbami 14, Teresa Brears 14 1 Department of Haematology, St George Hospital, Sydney, Australia, 2 Seoul St Mary's Hospital, Seoul, Korea, Republic Of, 3 Taipei Veterans General Hospital, Taipei, Taiwan, Province of China, 4 Mubarak Alkabeer Hospital, Jabriya, Kuwait, 5 Samsung Medical Centre, Seoul, Korea, Republic Of, 6 Sime Darby Medical Centre, Subang-Jaya, 7 Penang Hospital, Penang, Malaysia, 8 Keio University, Tokyo, Japan, 9 Ramathibodi Hospital, Bangkok, Thailand, 10 Ankara University, Ankara, Turkey, 11 Singapore General Hospital, Singapore, Singapore, 12 GlaxoSmithKline, Pennsylvania, United States, 13 Centre for Thrombotic and Bleeding Disorder Research, St George Hospital, Sydney, Australia, 14 GlaxoSmithKline, London, United Kingdom REFERENCES # Miller AB, et al. Reporting results of cancer treatment. Cancer. 1981;47(1):207-214. † Rodeghiero F, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood 2009; 113(11):2386-2393 * “Others” not shown Patients, n (%) Mean Age, years (range)47.7 (18 - 96) Gender FemaleMale 82 (59.9)55 (40.1) Ethnicity AsianMiddle EasternCaucasianOther 111 (81.0)14 (10.2)11 (8.0)1 (0.8) Platelet Count at diagnosis ≤ 10 x 10 9 /L57 (44.9) > 10 x 10 9 /L - < 30 x 10 9 /L35 (27.6) > 30 x 10 9 /L - < 50 x 10 9 /L13 (10.2) ≥ 50 x 10 9 /L22 (17.3) Bleeding events by severity at diagnosis (WHO Classification) # Grade 1 (petechial bleeding) Grade 2 (Mild bleeding, clinically significant) Grade 3 (Gross bleeding requiring blood transfusion) Grade 4 (Debilitating blood loss associated with fatality) 30 (49.2)27 (44.3)4 (6.5)0 (0.0) Referral from GP51 (37.2) Routine lab testing19 (13.9) Presentation to emergency department 29 (21.2) Other37 (27.0) Unknown1 (0.7) OBJECTIVES RESULTS (CONT.) METHODS DATA COLLECTED RESULTS Table 2: Treatments used in ITP management and Platelet Response. CONCLUSIONS WHO grade 1-3 bleeding occurs in 50% of patients at baseline. Corticosteroids are the most frequently used first line treatment (59% of patients treated overall) with 48% of patients treated having a complete platelet response. Immunosuppressive therapies are the most often used second line therapy. Use of novel TPO-receptor agonists as second-line treatment is increasing. Data collection and analysis for this study is ongoing.


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