Effectiveness and safety of empegfilgrastim (Extimia®, BIOCAD) in patients with lymphoproliferative diseases who receive cytotoxic therapy: results of LEGERITY, the second interim analysis of multicenter retrospective-and-prospective observational post-marketing study

• DOI: 10.26442/18151434.2022.1.201493
• Publication Date: 2022-04-30T12:21:31Z
• Authors: Ekaterina S. Nest...; Aleksandra F. Say...; Dmitry G. Sherstnev; Tatiana V. Shelek...; Tatiana Y. Klitoc...; Gulnara N. Khusai...; Irina B. Lysenko; Irina S. Lyalina; Marina V. Demchen...; Svetlana A. Orlova; Andrei V. Proydakov; Madina V. Betrozova; Natalia V. Fadeeva; Alina A. Gofman; Yana M. Marchenko; Sergey V. Voloshin; Elena A. Pashneva; Vladislav O. Sarz...; Damir G. Ishchanov; Irina V. Poddubnaya
• Keywords: Interim analysis; Tolerability

Aim. To assess effectiveness and safety of Extimia BIOCAD (INN: empegfilgrastim) used to decrease the rate duration neutropenia, febrile neutropenia infections that manifest in patients with lymphoproliferative diseases who receive myelosuppressive therapy.
 Materials methods. The paper presents results second interim analysis multicenter retrospective-and-prospective observational post-marketing study cytotoxic therapy. stage describes patient characteristics, therapy 221 morphologically confirmed lymphoma received one or more cycles chemotherapy as part LEGERITY study. endpoints interest included Grade 3/4 patients, after first cycle any line; neutropenia; infectious complications; antibacterial prescriptions; assessment relative dose-intensity chemotherapy. Additionally, incidence all adverse drug reactions (ADRs) was assessed at least dose drug; serious ADRs Common Terminology Criteria for Adverse Events (CTCAE) 5.0 discontinuations due also assessed.
 Results. As analysis, various indolent aggressive lymphomas. Median age 53 years (1982). A group older (over 60 age) accounted 34% population. Patients 1 injection per cycle. registered 6.7% (n=14) patients. Overall, all-grade reported 21.4% (n=44) Febrile 2.9% cases. Severe use antimicrobials were no throughout CT period each Most commonly mild-to-moderate ossalgias (6.8%) myalgias, back pain, arthralgias (3.2%), did not require pharmaceutical One (0.5%) had a severe reaction CTCAE 4 hypotension episode.
 Conclusion. Interim support high Russian original pegylated granulocyte colony-stimulating factor empegfilgrastim (Extimia) both Real world evidence demonstrates favourable tolerability profile groups, including aging moment publication, is ongoing. Final conclusions on are be drawn upon completion.