Effects of fedratinib: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Major Research Findings

Fedratinib is a selective JAK2 inhibitor that has been approved for the treatment of myelofibrosis (MF), a type of blood cancer characterized by the overproduction of certain blood cells. 20 8 Fedratinib works by blocking the activity of JAK2, a protein that plays a role in the growth and development of blood cells. This helps to reduce the number of abnormal blood cells and improve symptoms of MF, such as fatigue, shortness of breath, and an enlarged spleen. 20 8 In a clinical trial called JAKARTA, fedratinib was shown to significantly reduce splenomegaly and symptom burden compared to placebo, including some patients previously treated with ruxolitinib, another JAK inhibitor. 20 Fedratinib is a potential treatment option for patients with MF who have not responded to or cannot tolerate other JAK inhibitors. 20 14 The research suggests that fedratinib may also have potential applications in treating other cancers, such as colorectal cancer, gastric cancer, and hepatoblastoma. 9 2 5 Additionally, it is suggested that fedratinib, while primarily targeting JAK2, may affect other pathways involved in cancer progression, highlighting its potential as a multi-target therapeutic agent. 6 9

Benefits and Risks

Benefits Summary

Fedratinib has been shown to be effective in treating MF, reducing splenomegaly, and improving symptoms. 20 8 Fedratinib is a more selective JAK inhibitor than other JAK inhibitors, such as ruxolitinib, which might lead to fewer side effects. 20 16 14 It is an effective treatment option for patients who have not responded to or cannot tolerate other JAK inhibitors. 20 14

Risks Summary

The most common side effects of fedratinib include anemia, gastrointestinal problems, and elevated liver enzymes. 20 There is also a rare risk of encephalopathy, which affects about 1% of patients. 20 Monitoring thiamine levels and supplementation are recommended, especially in patients at higher risk for encephalopathy. 20

Comparison Across Studies

Commonalities

Multiple studies consistently show that fedratinib is an effective treatment for MF, resulting in the reduction of spleen size and improvement in symptoms. 20 8 14 6

Differences

There are variations in the reported effects and side effects of fedratinib across different studies. 20 16 14 6 For example, the incidence of encephalopathy as a side effect varies between studies. 20 Additionally, the effectiveness of fedratinib may differ from patient to patient. 14

Consistency and Discrepancies

While multiple studies demonstrate the efficacy of fedratinib in treating MF, there are variations in reported outcomes and side effects across different research. 20 16 14 6 Therefore, more research is needed to definitively assess the effectiveness and safety of fedratinib and to explore potential individual patient variations in response. 14

Considerations for Real-World Application

While fedratinib shows promise in treating MF, it’s important to remember that it has potential side effects. 20 16 14 If considering fedratinib, consulting with a doctor to understand the risks and benefits is crucial. 20 14

Limitations of Current Research

The long-term effects and safety of fedratinib are still being investigated and require further research. 20 8 14 Additionally, the effectiveness of fedratinib can vary from patient to patient. 14

Future Research Directions

Further research is necessary to understand the long-term effects and safety of fedratinib, including potential individual patient differences in response. 20 8 14 Studying the combined effects of fedratinib with other treatment options is also essential. 14 6

Conclusion

Fedratinib is a promising treatment for MF, offering a potentially effective option for patients with the disease, particularly those who have not responded to other treatments. 20 8 14 6 However, more research is needed to understand its long-term effects and safety, and to explore potential individual variations in response. 20 8 14 Always consult with a doctor to understand the potential risks and benefits of fedratinib before starting treatment. 20 14

Literature analysis of 24 papers
Positive Content
22
Neutral Content
1
Negative Content
1
Article Type
1
0
0
7
24
3.

Matching-adjusted indirect comparison of the pelabresib-ruxolitinib combination vs JAKi monotherapy in myelofibrosis.

Author: GuptaVikas, MascarenhasJohn, KremyanskayaMarina, RampalRaajit K, TalpazMoshe, KiladjianJean-Jacques, VannucchiAlessandro M, VerstovsekSrdan, ColakGozde, DeyDebarshi, HarrisonClaire

Myelofibrosis treatment

Pelabresib, a BET inhibitor, in combination with ruxolitinib, may have higher efficacy than JAKi monotherapy in JAKi treatment-naive patients with myelofibrosis (MF) based on an indirect comparison analysis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Comprehensive profiling of clinical JAK inhibitors in myeloproliferative neoplasms.

Author: KongTim, YuLaYow, LaranjeiraAngelo B A, FisherDaniel A C, HeFan, CoxMaggie J, OhStephen T

Anti-proliferative effect
JAK2 inhibition
Leukemic engraftment reduction
MPN treatment
Survival extension

JAK2 inhibitors are medications used to treat myeloproliferative neoplasm (MPN). This study compared the effects of four JAK2 inhibitors (ruxolitinib, fedratinib, pacritinib, and momelotinib) on MPN cells in the laboratory. The study found that all four inhibitors effectively suppressed JAK-STAT signaling, but they also had different effects on other pathways, which may explain their different clinical profiles.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

7.

Zhike Pingchuan Granule suppresses interleukin (IL)-6 or the medium of M2 macrophages induced apoptosis in human bronchial epithelial cells.

Author: RenYumei, YanYongbin, ZhenLei, CaoCaihong, WangQuan, ZhangYingying, ZhuShan

Asthma control
JAK2/STAT3 signaling inhibition

Zhike Pingchuan Granule (ZKPC) is a traditional Chinese medicine that has been shown to have anti-inflammatory effects. This study investigated the effects of ZKPC on human bronchial epithelial cells induced by IL-6 and M2 cells.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Challenges and Perspectives for Therapeutic Targeting of Myeloproliferative Neoplasms.

Author: BrkicSime, MeyerSara C

Reduced splenomegaly
Symptom relief
Resistance development

JAK2 inhibitors, like ruxolitinib and fedratinib, have shown promise in treating myeloproliferative neoplasms (MPNs) by targeting the hyperactive JAK2 signaling pathway. However, resistance to JAK2 inhibition is a significant challenge, with compensatory signaling and other mechanisms contributing to intrinsic resistance.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Inhibition of Janus Kinase 1 synergizes docetaxel sensitivity in prostate cancer cells.

Author: NalairndranGeetha, ChungIvy, Abdul RazackAzad Hassan, ChungFelicia Fei-Lei, HiiLing-Wei, LimWei-Meng, LooiChin King, MaiChun-Wai, LeongChee-Onn

PCa treatment

JAK1 inhibition enhances docetaxel sensitivity in prostate cancer (PCa) cells. Depletion of endogenous JAK1 promoted docetaxel-induced apoptosis. Combining docetaxel with JAK1/2 inhibitors, baricitinib and ruxolitinib, synergistically increased docetaxel sensitivity in AR-negative PCa cells.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Effect of food on the bioavailability and tolerability of the JAK2-selective inhibitor fedratinib (SAR302503): Results from two phase I studies in healthy volunteers.

Author: ZhangMeng, XuChristine, MaLei, ShamiyehElias, YinJianyun, von MoltkeLisa L, SmithWilliam B

Myelofibrosis treatment
Gastrointestinal toxicities

This study investigated the effects of food intake on the pharmacokinetics and tolerability of fedratinib, a JAK2-selective inhibitor, in healthy subjects. Food intake had minimal impact on the pharmacokinetics of fedratinib, and tolerability was improved when taken following a high-fat breakfast.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

15.

The safety of JAK kinase inhibitors for the treatment of myelofibrosis.

Author: ColtroGiacomo, VannucchiAlessandro M

Symptom control
Dose-dependent toxicities

Janus kinase inhibitors (JAKi) have revolutionized the treatment of myelofibrosis but can have dose-dependent toxicities, making dose optimization and treatment discontinuation challenging.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

Anti-Inflammatory Properties of Drugs Used to Control COVID-19 and their Effects on the Renin-Angiotensin System and Angiotensin-Converting Enzyme-2.

Author: Gilzad-KohanHamed, JamaliFakhreddin

COVID-19 severity
Cytokine storm
Death

This review discusses the use of various anti-viral and anti-inflammatory drugs for treating COVID-19. It highlights the importance of managing inflammation in COVID-19 and emphasizes the need for well-designed clinical trials to assess the efficacy and safety of these treatments.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

A phase I study of the effect of repeated oral doses of pantoprazole on the pharmacokinetics of a single dose of fedratinib in healthy male subjects.

Author: OgasawaraKen, VinceBradley, XuChristine, ZhangMeng, PalmisanoMaria, KrishnaGopal

Janus kinase 2 inhibition

Repeated doses of pantoprazole did not significantly affect the pharmacokinetic properties of fedratinib, a Janus kinase 2 inhibitor, in healthy male subjects.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Beyond Ruxolitinib: Fedratinib and Other Emergent Treatment Options for Myelofibrosis.

Author: BewersdorfJan Philipp, JaszczurSara Mohamed, AfifiSalma, ZhaoJennifer C, ZeidanAmer M

Myelofibrosis Treatment
Encephalopathy Risk

This review discusses fedratinib, a selective JAK2 inhibitor approved for the treatment of myelofibrosis (MF). It summarizes clinical trial data on its efficacy and toxicity, including its black box warning for encephalopathy. It also explores ongoing trials and future treatment options for MF patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

Fedratinib: a pharmacotherapeutic option for JAK-inhibitor naïve and exposed patients with myelofibrosis.

Author: EnglandJames T, GuptaVikas

Myelofibrosis treatment
Cytokine-mediated inflammation
JAKi side effects
Splenomegaly

Ruxolitinib is a commonly used drug for myelofibrosis (MF), but its effectiveness is limited by variable durability of response. Long-term data on other JAK inhibitors, fedratinib and pacritinib, are not yet available.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

23.

Assessment of effects of repeated oral doses of fedratinib on inhibition of cytochrome P450 activities in patients with solid tumors using a cocktail approach.

Author: OgasawaraKen, LoRussoPatricia M, OlszanskiAnthony J, RixeOlivier, XuChristine, YinJian, PalmisanoMaria, KrishnaGopal

Treatment of myelofibrosis
CYP enzyme inhibition

Fedratinib is a medication approved for treating myelofibrosis. This study aimed to assess the effects of fedratinib on certain enzymes that break down drugs in the body (CYP2D6, CYP2C19, and CYP3A4).

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

24.

Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors.

Author: OgasawaraKen, XuChristine, YinJian, DarpoBorje, CarayannopoulosLeon, XueHongqi, PalmisanoMaria, KrishnaGopal

Solid tumor treatment

This study assessed the impact of repeated daily 500-mg fedratinib on QTc and other electrocardiogram (ECG) parameters in 60 patients with advanced solid tumors. Fedratinib did not cause clinically relevant ECG effects or QTc prolongation.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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