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A single 1 g/kg dose of intravenous immunoglobulin is a safe and effective treatment for immune thrombocytopenia; results of the first HaemSTAR ‘Flash‐Mob’ retrospective study incorporating 961 patients
138 auth. Phillip L R Nicolson, R. Perry, R. Buka, Amelia Fisher, Gemma Scott, L. Magill, K. Okoth, D. Chan-Lam, A. Thorpe, M. Macheta, Luke Carter‐Brzezinski, S. Ackroyd, Alvin Katumba, C. Bradbury, Sheila Jen, ...
Immune thrombocytopenia (ITP) is an autoimmune condition characterised by an isolated thrombocytopenia. Intravenous immunoglobulin (IVIg) is a commonly used rescue treatment, alone or alongside other treatments such as corticosteroids, when a rapid …
Immune thrombocytopenia (ITP) is an autoimmune condition characterised by an isolated thrombocytopenia. Intravenous immunoglobulin (IVIg) is a commonly used rescue treatment, alone or alongside other treatments such as corticosteroids, when a rapid increase in platelet count is required. Most patients (80%) respond to IVIg, some within 24 h and the majority by 2–4 days. IVIg is expensive and can have significant side-effects, as well as the associated infective risks of being a pooled plasma product. Studies in the 1990s suggested optimal dosing using 1 g/kg/day for 1–2 days but supply constraints have resulted in increasingly restrictive dosing recommendations. NHS England (NHSE) Specialised Commissioning Circulars (SCC1676 25 11 16 and SCC1804 1 11 17) recommend 1 g/kg on a single day, with a second dose at 7 days only if there is failure to achieve a haemostatically adequate platelet count (≥309 10/l). We aimed to audit UK haematologists’ IVIg prescribing as well as examine response rates and time to response (TTR). Here we report the results of this project, the first to be entirely conceived and performed by HaemSTAR and the world’s largest study of IVIg treatments for ITP to date. Details of the audit standards, study population, procedures, statistical analyses, and study protocol are included in the Supplementary Material. Data was obtained from 961 patients receiving a total of 961 initial and 416 subsequent IVIg treatments (see Supplementary Figure S1). Basic demographics, type of ITP, baseline clinical characteristics, details of IVIg treatments and previous and concomitant therapies can be found in the Supplementary Material. Of note, 52 6% of IVIg treatments were given alongside concurrent ITP-directed therapy. In all, 35 8% of treatment episodes were dosed according to NHSE guidelines. The most common dosing strategies were 1 g/kg on a single day (32 7%) or 1 g/kg on 2 consecutive days (31 2%) (Table I and Supplementary Results). The platelet count was <309 10/l at the time of IVIg infusion for 75 5% of treatments (Table I). In all, 92 9% of treatments were given for indications consistent with a requirement for a rapid increase in platelet count (Table I and Supplementary Table SI). Following IVIg, 915 (88%) of the 1040 treatments where the baseline platelet count was <309 10/l achieved a platelet count above this threshold. The median (interquartile range (IQR)) TTR was 4 (2–10) days and the response duration was 15 (7–25) days. In all, 810 (60%) of the 1349 treatments where baseline platelet count was <1009 10/l achieved a platelet count of ≥1009 10/l. The median (IQR) TTR was 9 (4–22) days and the response duration was 11 (5–20) days. To examine how response rates varied by type of ITP see Supplementary Results and Supplementary Table SII. Multivariate analysis was used to explore if any patient-, diseaseor treatment-related variables had an effect on the platelet response. For full description of these results see Supplementary Material. Of particular note, whether patients were dosed with 1 g/kg on 1 or 2 consecutive days, did not affect the attainment of platelet counts of ≥309 10/l or ≥1009 10/l or duration of time for which the platelet count was above these thresholds (Fig 1). These outcomes were also not influenced by concurrent or prior treatment with any other disease modifying agent. We also found evidence of dose capping in those patients ≥100 kg (see Supplementary Discussion and Supplementary Figure S2). There was no significant difference in the speed or duration of platelet response whether IVIg was given as a single dose of 1 g/kg or as two 1 g/kg infusions on consecutive days. Despite NHSE (SCC1676 25 11 16) advocating a single 1 g/kg infusion, adherence to this dosing strategy was poor. The reluctance of clinicians to change practice may reflect alternate guidelines permissive for the use of 1–2 g/kg IVIg and the paucity of data upon which NHSE recommendations were made. The two randomised studies that consider IVIg dose in adults are of 55 patients in total and do not directly compare 1 g/kg on 1 vs 2 days. We hope our data will reassure clinicians that the single 1 g/kg dosing regimen is effective, less expensive, rations a scarce resource and reduces correspondence
Published in
British Journal of Haematology
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4
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2 | 2021 |
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