Masarova Lucia, Verstovsek Srdan, Palandri Francesca, Mesa Ruben, Harrison Claire, Sajeev Gautam, Gorsh Boris, Simpson Ryan, Cho Sang, Wang Zhaohui, Ellis Catherine, Conlon Seán, Signorovitch James
The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Future Oncol. 2025 Jul;21(16):2077-2087. doi: 10.1080/14796694.2025.2511564. Epub 2025 Jun 6.
To perform an indirect treatment comparison of safety outcomes between the Janus kinase (JAK) inhibitors momelotinib and fedratinib in patients with myelofibrosis.
Adverse events (AEs) for JAK inhibitor - naive and - experienced populations occurring in ≥ 10% of patients treated with momelotinib (SIMPLIFY-1/SIMPLIFY-2/MOMENTUM) or fedratinib (JAKARTA/JAKARTA-2) in phase 2/3 trials were evaluated using matching-adjusted indirect comparisons.
Risk of any-grade or grade 3/4 anemia, diarrhea, nausea, and treatment-emergent AEs leading to dose reductions was lower with momelotinib in both populations; any-grade thrombocytopenia was also significantly less likely in JAK inhibitor - naive patients.
Momelotinib showed a favorable safety profile vs fedratinib, including significantly lower risks of key hematologic and gastrointestinal AEs - such as anemia, diarrhea, and nausea - over 24 weeks.
对骨髓纤维化患者中,Janus激酶(JAK)抑制剂莫洛替尼和非达替尼的安全性结果进行间接治疗比较。
使用匹配调整间接比较,评估在2/3期试验中,接受莫洛替尼(SIMPLIFY-1/SIMPLIFY-2/MOMENTUM)或非达替尼(JAKARTA/JAKARTA-2)治疗且≥10%的初治及经治患者中发生的不良事件(AE)。
在这两类人群中,莫洛替尼导致的任何级别或3/4级贫血、腹泻、恶心以及导致剂量减少的治疗中出现的AE的风险均较低;在初治JAK抑制剂患者中,任何级别血小板减少症的发生可能性也显著更低。
与非达替尼相比,莫洛替尼显示出良好的安全性,在24周内,关键血液学和胃肠道AE(如贫血、腹泻和恶心)的风险显著更低。