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Momelotinib vs fedratinib safety outcomes in patients with MF: An indirect treatment comparison
While Janus kinase inhibitors (JAKi) offer effective spleen volume reduction and symptom improvements in the majority of patients with myelofibrosis (MF), their safety profiles vary. Determining comparative safety outcomes between available JAKi will enable optimal treatment choices for patients with MF. Masarova et al. compared safety outcomes of JAKi momelotinib vs fedratinib in patients with MF using an indirect treatment comparison of a pooled population of JAKi-naïve patients treated with momelotinib or fedratinib in the phase III SIMPLIFY-1 (NCT01969838) and JAKARTA (NCT01437787) trials and JAKi-experienced patients in the phase II JAKARTA2 (NCT01523171) and phase III MOMENTUM (NCT04173494) and SIMPLIFY-2 (NCT02101268) trials. Treatment-emergent adverse events occurring in ≥10% of patients treated with 200 mg momelotinib or 400 mg fedratinib over 24 weeks were evaluated. Findings were published in Future Oncology.
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Key learnings |
In JAKi-naïve patients, momelotinib demonstrated statistically significantly lower RDs for Grade 3/4 anemia (RD, −37.1%; p < 0.001) and any-grade anemia (RD, −85.4%; p < 0.001), thrombocytopenia (RD, −42.8%; p < 0.001), diarrhea (RD, −48.3%; p < 0.001), and nausea (RD, −49.3%; p <0.001) vs fedratinib. |
JAKi-naïve patients receiving momelotinib had significantly lower rates of Grade 3/4 AEs (RD, −34.4%; p <0.001), serious AEs (RD, −14.0%; p < 0.05), and treatment-emergent AEs leading to dose reduction (RD, −30.4%; p < 0.001) vs fedratinib. |
In JAKi-experienced patients, momelotinib showed significantly lower RDs for Grade 3/4 anemia (RD, −33.6%; p < 0.001), any-grade anemia (RD, −40.7%; p < 0.001), diarrhea (RD, −32.7%; p < 0.001), nausea (RD, −41.1%; p < 0.001), and TEAEs leading to dose reduction (RD, −34.7%; p < 0.001) vs fedratinib. |
These findings demonstrate that momelotinib offers a favorable safety profile compared with fedratinib, with significantly lower risks of key hematologic and gastrointestinal adverse events in both JAKi-naïve and JAKi-experienced patients with MF. |
*p values stated are for ORs.
AE, adverse event; JAKi, Janus kinase inhibitor; MF, myelofibrosis; OR, odds ratio; RD, risk difference.
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