RESUMEN
AIMS: Real-world evidence on the safety profile and costs associated with immune thrombocytopenic purpura (ITP) treatment in adults is lacking. This study quantifies and compares adverse event (AE) crude rates and costs associated with ITP treatments as found in claims data. MATERIALS AND METHODS: A retrospective claims-based analysis was conducted using IMS Pharmetrics Plus database. Included patients were ≥18 years old, with a diagnosis of ITP (2007-2012); an ITP-related claim for anti-D, intravenous immunoglobulin (IVIG), rituximab, romiplostim, or eltrombopag; and 1-year continuous enrollment (3-years for rituximab) during follow-up. AEs and event costs were identified during active treatment, defined from the first claim of each drug to a pre-defined treatment gap or end of study period. Descriptive statistics were reported with Wilcoxon rank-sum significance tests. RESULTS: A total of 2,518 patients were identified (mean age = 50.8 (±16.3 years); 55.8% male). Of all patients, 22.8% experienced any AE. Significantly fewer anti-D patients had any AE (13.8% vs IVIG: 21.1%, rituximab: 29.4%, romiplostim: 28.1%, eltrombopag: 22.4%). Nausea/vomiting and arthralgia/musculoskeletal pain were most common across treatments, and hemolytic events did not differ significantly across treatments. Most costly AEs were urinary tract infection, aseptic meningitis, and fever ($5000+/case); headache, nasal congestion, and hemolytic event were $4,000-5,000/case. Cost per AE did not differ by treatment. LIMITATIONS AND CONCLUSIONS: Although lower than trial-based AE rates, claims for ITP treatment-related AEs are common, with higher numbers for rituximab and lower numbers for anti-D. This disparity suggests a possible differential cost burden overall that future analysis should explore.
Asunto(s)
Factores Inmunológicos/efectos adversos , Factores Inmunológicos/economía , Púrpura Trombocitopénica Idiopática/tratamiento farmacológico , Adulto , Anciano , Benzoatos/efectos adversos , Benzoatos/economía , Femenino , Humanos , Hidrazinas/efectos adversos , Hidrazinas/economía , Inmunoglobulinas Intravenosas/efectos adversos , Inmunoglobulinas Intravenosas/economía , Factores Inmunológicos/uso terapéutico , Revisión de Utilización de Seguros , Masculino , Persona de Mediana Edad , Pirazoles/efectos adversos , Pirazoles/economía , Receptores Fc , Proteínas Recombinantes de Fusión/efectos adversos , Proteínas Recombinantes de Fusión/economía , Estudios Retrospectivos , Globulina Inmune rho(D)/efectos adversos , Globulina Inmune rho(D)/economía , Rituximab/efectos adversos , Rituximab/economía , Trombopoyetina/efectos adversos , Trombopoyetina/economíaRESUMEN
Before the availability of hepatitis B immunoglobulin (HBIG) in hepatitis B-positive transplant recipients, the acute mortality was very high, in many centers up to 50% within 60 days post-transplant. The overall reinfection rate was approximately 60% within the initial 6 months, increasing to 80-90% within the initial 12 months and, in many cases, leading to allograft loss and death or retransplantation. These recurrent infections were often more severe and more rapidly progressing than the initial infection, probably due to high-dose immunosuppressive regimens. The poor prognosis before introduction of HBIG made hepatitis B liver disease an absolute contraindication for liver transplantation, leaving these patients with very limited treatment options. This changed in the late 1980s with the introduction of HBIG, which reduced the incidence of hepatitis B in the transplanted liver to approximately 15-50%, with concomitant improvement in graft and overall survival. The prognosis was further improved by a combination of long-term HBIG and antiviral therapy, in particular lamivudine, which reduced the reinfection rate, in most cases to between 0 and 5%. Owing to the cost and relative inconvenience of HBIG, some transplant centers have experimented with early discontinuation of HBIG and replacement with antiviral monotherapy. A number of studies, however, have found significantly higher recurrence rates associated with lamivudine monotherapy (40-50%) compared with combination therapy and, hence, lamivudine monotherapy is not recommended.