Post-Marketing Analysis of Peripheral Neuropathy Burden with New-Generation Proteasome Inhibitors Using the FDA Adverse Event Reporting SystemSyeda A. Mina1, Ibrahim Muhsen2, Ethan Burns3, Humaira Sarfraz2, Sai Ravi Pingali3, Jiaqiong Xu4, Shahrukh K. Hashmi51Mayo Clinic, Department of Medicine, Rochester, USA
2Houston Methodist Hospital, Department of Medicine, Houston, USA
3Houston Methodist Cancer Center, Houston Methodist Hospital, Houston, USA
4Center for Outcomes Research, Houston Methodist Research Institute, Houston, USA
5Mayo Clinic, Department of Medicine, Rochester, USA; Sheikh Shakbout Medical City, Department of Medicine, Abu Dhabi, UAE
Proteasome inhibitors (PIs) are an integral component of multiple myeloma therapies. Peripheral neuropathy (PN) is a well-known consequence of PIs, most frequently reported with earlier generations such as Bortezomib (BTZ). There is a paucity of data highlighting the risk of developing PN in the newer generation PIs Carfilzomib (CFZ) and Ixazomib (IZB). This study queried reports of PN reported with all three PIs using the Food and Drug Administration (FDA) Adverse Event (AE) Reporting System (FAERS). Signal disproportionality analysis was reported using a reporting odds ratio (ROR) and 95% confidence interval (CI). PN was reported in a total of 2.1%, 5.0%, and 10.9% of AE with CFZ, IZB, and BTZ, respectively. The ROR (95% CI) for peripheral neuropathy secondary to BTZ, CFZ, and IZB was 34.10 (32.76-35.49), 6.37 (5.50- 7.37), and 14.97 (13.63-16.44) respectively. Compared to BTZ, CFZ and IZB have a lower rate of reported PN, with RORs of 0.19 (0.16-0.22) and 0.48 (0.43-0.54), respectively. Keywords: Multiple myeloma, Proteasome inhibitors, Peripheral neuropathy
Yeni Jenerasyon Proteozom İnhibitörleriyle Olan Çevresel Nöropati Yükünün FDA Yan Etki Raporlama Sistemi Kullanılarak Pazarlama Sonrası AnaliziSyeda A. Mina1, Ibrahim Muhsen2, Ethan Burns3, Humaira Sarfraz2, Sai Ravi Pingali3, Jiaqiong Xu4, Shahrukh K. Hashmi51Mayo Clinic, Department of Medicine, Rochester, USA
2Houston Methodist Hospital, Department of Medicine, Houston, USA
3Houston Methodist Cancer Center, Houston Methodist Hospital, Houston, USA
4Center for Outcomes Research, Houston Methodist Research Institute, Houston, USA
5Mayo Clinic, Department of Medicine, Rochester, USA; Sheikh Shakbout Medical City, Department of Medicine, Abu Dhabi, UAE
Proteozom inhibitörleri (Pİ) multipl myelom tedavilerinin integral parçalarındandır. Çevresel nöropatiler (ÇN) Pİ’nin iyi bilinen bir sonucudur, bortezomib (BTZ) gibi önceki jenerasyonlarla daha sık bildirilmiştir. Yeni jenerasyon PI olan karfilzomib (KFZ) ve iksazomib (IZB) ile gelişen ÇN riskini vurgulayan çalışmalar yetersizdir. Bu çalışmada, Gıda ve İlaç İdaresi Olumsuz Olay (OO) Raporlama Sistemini (FAERS) kullanarak her üç PI ile karşılaşılan ÇN raporları değerlendirildi. Sinyal orantısızlık analizi, raporlama olasılık oranı (ROO) %95 güven aralığı (GA) kullanılarak yapıldı. ÇN; KFZ, IZB, BTZ ile sırasıyla OO’nun toplamında %2,1, %5,0, ve %10,9’unda rapor edilmişti. BTZ, KFZ, ve IZB’ye ikincil ÇN için ROO (%95 GA) sırasıyla 34,10 (32,76-35,49), 6,37 (5,50-7,37), ve 14,97 (13,63-16,44) idi. KFZ ve IZB ile, BTZ ile karşılaştırıldığında daha az ÇN rapor edilmişti, ROO sırasıyla 0,19 (0,16-0,22) ve 0,48 (0,43-0,54) idi. Anahtar Kelimeler: Multipl myelom, Proteozom inhibitörleri, Periferik nöropati
Syeda A. Mina, Ibrahim Muhsen, Ethan Burns, Humaira Sarfraz, Sai Ravi Pingali, Jiaqiong Xu, Shahrukh K. Hashmi. Post-Marketing Analysis of Peripheral Neuropathy Burden with New-Generation Proteasome Inhibitors Using the FDA Adverse Event Reporting System. Turk J Hematol. 2021; 38(3): 218-221
Corresponding Author: Shahrukh K. Hashmi, United Arab Emirates |
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