Case series of reports of pruritus and sipuleucel-T submitted to the Food and Drug Administration Adverse Event Reporting System.
|アブストラクト||Sipuleucel-T, an autologous active cellular immunotherapy, is indicated for the treatment of asymptomatic or minimally symptomatic castration-resistant prostate cancer. The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) received a report of pruritus without rash following the second dose of sipuleucel-T in a patient who had otherwise not started any new medications concurrent with the first and second doses of sipuleucel-T. No further sipuleucel-T was administered, but symptoms persisted for at least 6 weeks despite treatment with several medications aimed at symptomatic relief of pruritus. Rash is the only dermatologic adverse event included in the sipuleucel-T U.S. package insert. A search of the FAERS database yielded seven additional U.S. reports of pruritus and sipuleucel-T identified as the primary suspect medication; two of these occurred prior to the administration of sipuleucel-T (following leukapheresis). In data mining analyses, pruritus following sipuleucel-T was not reported more frequently than expected when compared to all other adverse event-drug/biologic combinations in FAERS. Thus, pruritus following sipuleucel-T administration was rarely, but not disproportionately, reported to FAERS. Although we cannot exclude the possibility that diabetes, malignancy, or other conditions may have contributed to pruritus in our index patient, in view of the timing of sipuleucel-T therapy and onset of symptoms, a drug/biologic-related reaction is plausible. In the appropriate clinical scenario, sipuleucel-T (or its components) should not be overlooked as a potential etiological agent in pruritus.|
|ジャーナル名||Journal of pharmaceutical health care and sciences|
|投稿者||Dores, Graca M; Perez-Vilar, Silvia; Niu, Manette T|
|組織名||1Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for;Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New;Hampshire Avenue, Silver Spring, MD 20993-0002 USA.0000 0001 2243;3366grid.417587.8;2Office of Surveillance and Epidemiology, Center for Drug Evaluation and;Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver;Spring, MD 20993-0002 USA.0000 0001 2154 2448grid.483500.a|