Effects of fostamatinib: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Key Research Findings

Fostamatinib, a spleen tyrosine kinase inhibitor, has shown promise in the treatment of immune thrombocytopenia (ITP). 16 , 25 , 2 In phase 3 clinical trials, fostamatinib demonstrated a significant increase in platelet counts in patients with ITP. 16 Moreover, fostamatinib has been shown to be effective in patients who have not responded to conventional treatments such as steroids or thrombopoietin receptor agonists. 25 In addition to ITP, fostamatinib may have potential for treating warm autoimmune hemolytic anemia (wAIHA). 13 Studies have shown that fostamatinib can inhibit TNF-α production, which is a key factor in the development of wAIHA. 13

Benefits and Risks

Benefit Summary

Fostamatinib can increase platelet counts and reduce the risk of bleeding in ITP patients. 16 It may also be effective in patients who have not responded to conventional ITP treatments. 25 Fostamatinib also has potential for treating warm autoimmune hemolytic anemia (wAIHA). 13

Risk Summary

Fostamatinib can cause side effects such as diarrhea, hypertension, nausea, epistaxis, and abnormal liver function tests. 16 Most side effects are mild or moderate and can be managed with dose reduction, interruption, or additional medication. 16 Fostamatinib has been shown to induce CYP2C8. 19 Therefore, caution is advised when co-administering fostamatinib with pioglitazone, a CYP2C8 substrate. 19

Comparison of Studies

Similarities

Multiple clinical trials have demonstrated the efficacy of fostamatinib in treating ITP. 16 , 25 , 2 These studies have shown that fostamatinib increases platelet counts and reduces the risk of bleeding. 16 , 25 Fostamatinib has also been found to be effective in patients who have not responded to conventional ITP treatments. 25

Differences

The clinical trials evaluating the efficacy and safety of fostamatinib have differed in design and patient populations. 16 , 25 , 2 For example, 16 evaluated the long-term safety and efficacy of fostamatinib, while 25 focused on the short-term effects of the drug. 2 compared the safety, effectiveness, and cost of fostamatinib to other ITP treatments. 3 investigated the potential of fostamatinib in treating experimental autoimmune glomerulonephritis (GN), a rodent model of antiglomerular basement membrane disease.

Consistency and Discrepancies

The results of multiple clinical trials consistently suggest that fostamatinib is effective in treating ITP. 16 , 25 , 2 However, due to variations in study design and patient populations, directly comparing the results of these studies is challenging. 16 , 25 , 2

Real-World Application Considerations

Fostamatinib holds potential as a valuable treatment for ITP, but it is not guaranteed to be effective in all patients. 16 , 25 , 2 As fostamatinib can cause side effects, it is crucial to follow your doctor's instructions carefully. 16 It is important to be aware that fostamatinib induces CYP2C8. 19 Therefore, close monitoring is required when co-administering fostamatinib with pioglitazone, a CYP2C8 substrate. 19

Limitations of Current Research

Research on fostamatinib is still in its early stages, and data on long-term safety and efficacy is limited. 16 , 25 , 2 Additionally, variations in study design and patient populations make direct comparisons between different clinical trials difficult. 16 , 25 , 2

Future Research Directions

Further research is necessary to assess the long-term safety and efficacy of fostamatinib. 16 Studies on combination therapy with other ITP treatments are also warranted. 2 Fostamatinib shows potential for treating wAIHA. 13 Further investigations into the effects of fostamatinib on wAIHA are crucial. Further research regarding the CYP2C8 induction by fostamatinib is required. 19

Conclusion

Fostamatinib has demonstrated the potential to increase platelet counts and reduce the risk of bleeding in ITP patients. 16 , 25 It may also be an effective option for patients who have not responded to conventional ITP treatments. 25 Fostamatinib may have potential for treating wAIHA. 13 However, it is important to note that fostamatinib can cause side effects and induces CYP2C8. 19 Therefore, it is essential to follow your doctor's instructions carefully. 19 Further research is needed to fully assess the long-term safety and efficacy of fostamatinib. 16 , 25 , 2

Literature analysis of 25 papers
Positive Content
23
Neutral Content
1
Negative Content
1
Article Type
5
2
0
1
24
1.

Fostamatinib, an oral spleen tyrosine kinase inhibitor, in the treatment of rheumatoid arthritis: a meta-analysis of randomized controlled trials.

Author: KunwarSumit, DevkotaAshok Raj, GhimireDipesh K C

Effective in achieving ACR20
ACR50 and ACR70 responses
ALT ≥3 times ULN
Diarrhea
Hypertension
Infection
Neutropenia

A meta-analysis of five studies concluded that fostamatinib is moderately effective in treating rheumatoid arthritis (RA) but can increase the risk of infection, diarrhea, hypertension, and neutropenia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

2.

Fostamatinib or Thrombopoietic Receptor Agonists for the Treatment of Chronic Immune Thrombocytopenia in Adult Patients: A Real-World Assessment of Safety, Effectiveness and Cost.

Author: DranitsarisGeorge, PeevyhouseAaron, WoodTiffany, KreychmanYuliya, NeuhalfenHeather, MoeziMehdi

ITP treatment

This real-world study compared the safety, effectiveness, and cost of fostamatinib with thrombopoietic agents (TPOs) for the treatment of chronic immune thrombocytopenia purpura (ITP) in adults.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

3.

Spleen tyrosine kinase inhibition attenuates autoantibody production and reverses experimental autoimmune GN.

Author: McAdooStephen P, ReynoldsJohn, BhangalGurjeet, SmithJennifer, McDaidJohn P, TannaAnisha, JacksonWilliam D, MasudaEsteban S, CookH Terence, PuseyCharles D, TamFrederick W K

Autoimmune GN treatment

This study investigated the effect of SYK inhibition on autoantibody production and renal injury in experimental autoimmune glomerulonephritis. Fostamatinib, a SYK inhibitor, completely prevented the induction of the disease and reversed existing renal injury.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

A potential therapeutic strategy for chronic lymphocytic leukemia by combining Idelalisib and GS-9973, a novel spleen tyrosine kinase (Syk) inhibitor.

Author: BurkeRussell T, MeadowsSarah, LoriauxMarc M, CurrieKevin S, MitchellScott A, MaciejewskiPatricia, ClarkeAstrid S, DipaoloJulie A, DrukerBrian J, LannuttiBrian J, SpurgeonStephen E

CLL growth inhibition

Idelalisib, a PI3Kd inhibitor, and GS-9973, a Syk inhibitor, both show clinical activity against lymphoid malignancies. This study suggests that combining these two drugs could lead to synergistic growth inhibition and disruption of chemokine signaling in chronic lymphocytic leukemia (CLL).

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

5.

Fostamatinib, an oral spleen tyrosine kinase inhibitor, in the treatment of rheumatoid arthritis: a meta-analysis of randomized controlled trials.

Author: KunwarSumit, DevkotaAshok Raj, GhimireDipesh K C

Effective in achieving ACR20
ACR50 and ACR70 responses
ALT ≥3 times ULN
Diarrhea
Hypertension
Infection
Neutropenia

A meta-analysis of five studies concluded that fostamatinib is moderately effective in treating rheumatoid arthritis (RA) but can increase the risk of infection, diarrhea, hypertension, and neutropenia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

6.

Orally bioavailable Syk inhibitors with activity in a rat PK/PD model.

Author: ThomaGebhard, VeenstraSiem, StrangRoss, BlanzJoachim, VangrevelingheEric, BerghausenJörg, LeeChristian C, ZerwesHans-Günter

Potent Syk inhibitor
Aurora kinase inhibition

A potent, orally bioavailable Syk inhibitor was discovered, but it also inhibited Aurora kinase, leading to findings in the micronucleus assay and preventing further development.

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

7.

A phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 2 dosing regimens of fostamatinib in patients with rheumatoid arthritis with an inadequate response to a tumor necrosis factor-α antagonist.

Author: GenoveseMark C, van der HeijdeDésirée M, KeystoneEdward C, SpindlerAlberto J, BenhamouClaude, KavanaughArthur, FudmanEdward, LamplKathy, O'BrienChris, DuffieldEmma L, PoileyJeffrey, WeinblattMichael E

Improved ACR20 response
Diarrhea
Headache
Hypertension

In a 24-week study comparing fostamatinib to placebo in patients with rheumatoid arthritis (RA), fostamatinib 100 mg bid achieved statistical improvements in ACR20 response at 24 weeks versus placebo. Fostamatinib 100 mg bid for 4 weeks then 150 mg qd did not show this improvement. The most common adverse events were diarrhea, hypertension, and headache.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Effects of fostamatinib, an oral spleen tyrosine kinase inhibitor, in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

Author: WeinblattMichael E, GenoveseMark C, HoMeilien, HollisSally, Rosiak-JedrychowiczKrystyna, KavanaughArthur, MillsonDavid S, LeonGustavo, WangMillie, van der HeijdeDésirée

Improved ACR20 response
Diarrhea
Hypertension

Fostamatinib was found to be statistically significant, but not clinically significant, in improving the ACR20 response in patients with rheumatoid arthritis compared to placebo. However, there was no significant difference in the SHS score.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

The kinase inhibitors R406 and GS-9973 impair T cell functions and macrophage-mediated anti-tumor activity of rituximab in chronic lymphocytic leukemia patients.

Author: ColadoAna, AlmejúnMaría Belén, PodazaEnrique, RisnikDenise, StanganelliCarmen, ElíasEsteban Enrique, Dos SantosPatricia, SlavutskyIrma, Fernández GreccoHoracio, CabrejoMaría, BezaresRaimundo Fernando, GiordanoMirta, GamberaleRomina, BorgeMercedes

CLL treatment
T cell impairment

This study examined the effect of clinically relevant doses of fostamatinib (R406) and entospletinib (GS-9973) on the activation and proliferation of T cells from chronic lymphocytic leukemia (CLL) patients. The study found that both inhibitors impaired the activation and proliferation of T cells from CLL patients and reduced macrophage-mediated phagocytosis of rituximab-coated CLL cells.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Spleen tyrosine kinase (Syk) inhibitor fostamatinib limits tissue damage and fibrosis in a bleomycin-induced scleroderma mouse model.

Author: PamukOmer Nuri, CanGuray, AyvazSuleyman, KaracaTuran, PamukGulsum Emel, DemirtasSelim, TsokosGeorge C

SSc protection

Fostamatinib is a Syk inhibitor. This study investigated the ability of fostamatinib to protect mice from bleomycin-induced scleroderma.

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

12.

Real-World Use of Fostamatinib in Patients with Immune Thrombocytopenia and Thrombotic Risk.

Author: MehtaAmit R, KefelaAron, TosteCharina, SweetDonald

ITP treatment
Thrombosis reduction

Fostamatinib, a spleen tyrosine kinase inhibitor, may be a suitable treatment option for patients with immune thrombocytopenia (ITP) who have significant cardiovascular history and are at increased risk for thrombosis.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

13.

Regulatory T-cell dysfunctions are associated with increase in tumor necrosis factor α in autoimmune hemolytic anemia and participate in Th17 polarization.

Author: CiudadMarion, OuandjiSethi, LamarthéeBaptiste, CladièreClaudie, GhesquièreThibault, NivetMartin, ThébaultMarine, BoidotRomain, Soudry-FaureAgnès, ChevrierSandy, RichardCorentin, MailletThibault, MaurierFrançois, GreigertHélène, GenetCoraline, RamonAndré, TradMalika, PredanValérie, SaasPhilippe, SamsonMaxime, BonnotteBernard, AudiaSylvain

Dampened TNF-α production
Inhibition of erythrocyte phagocytosis
Th17 polarization
Treg deficiency

A study investigated the involvement of T helper (Th) cells in warm autoimmune hemolytic anemia (wAIHA). It found a shift toward a Th17 polarization and a decrease in regulatory T cells (Treg) with functional deficiency. The study suggested that TNF-α inhibition, such as with fostamatinib, could be a promising multitargeting therapy for wAIHA.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Translational Biomarkers and Ex Vivo Models of Joint Tissues as a Tool for Drug Development in Rheumatoid Arthritis.

Author: Kjelgaard-PetersenCecilie F, PlattAdam, BraddockMartin, JenkinsMartin A, MusaKishwar, GrahamEmma, GantzelThorbjørn, SlynnGillian, WeinblattMichael E, KarsdalMorten A, ThudiumChristian S, Bay-JensenAnne-C

RA treatment

Rheumatoid arthritis (RA) is a chronic disease that causes joint pain and inflammation. This study investigated whether a medication called fostamatinib could be effective in treating RA.

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

15.

Effects of Fostamatinib on the Pharmacokinetics of Digoxin (a P-Glycoprotein Substrate): Results From in Vitro and Phase I Clinical Studies.

Author: MartinPaul, GillenMichael, MillsonDavid, OliverStuart, BrealeyClive, ElsbyRobert, BaluomMuhammad, LauDavid, MantTim

anti-inflammatory treatment
drug-drug interaction potential

This study investigates the potential for drug-drug interactions between fostamatinib, a spleen tyrosine kinase inhibitor, and digoxin, a drug used for congestive cardiac failure and certain supraventricular dysrhythmias. The study found that fostamatinib and its active metabolite R406 are inhibitors of P-glycoprotein (P-gp) in vitro, and that fostamatinib can affect the pharmacokinetic parameters of digoxin.

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

16.

Long-term fostamatinib treatment of adults with immune thrombocytopenia during the phase 3 clinical trial program.

Author: BusselJames B, ArnoldDonald M, BoxerMichael A, CooperNichola, MayerJiri, ZayedHany, TongSandra, DuliegeAnne-Marie

Fostamatinib benefits
ITP treatment
Fostamatinib side effects
Side effects

Fostamatinib, a drug used to treat immune thrombocytopenia, has been shown to be effective and safe for long-term use.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Effects of CYP3A4 Inhibitors Ketoconazole and Verapamil and the CYP3A4 Inducer Rifampicin on the Pharmacokinetic Parameters of Fostamatinib: Results from In Vitro and Phase I Clinical Studies.

Author: MartinPaul, GillenMichael, MillsonDavid, OliverStuart, BrealeyClive, GrossbardElliott B, BaluomMuhammad, LauDavid, SweenyDavid, MantTim, CravenKelli

Fostamatinib's active metabolite, R406, is primarily metabolized by CYP3A4. Co-administration of CYP3A4 inhibitors increased R406 exposure, while inducers decreased it.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Effects of Fostamatinib on the Pharmacokinetics of the CYP2C8 Substrate Pioglitazone: Results From In Vitro and Phase 1 Clinical Studies.

Author: MartinPaul, GillenMichael, MillsonDavid, OliverStuart, BrealeyClive, SurryDominic, SweenyDavid, LauDavid, LeesePhilip

CYP2C8 induction

Fostamatinib is a prodrug that induces CYP2C8, an enzyme responsible for metabolizing various drugs, including pioglitazone. This study investigated the effect of fostamatinib on the pharmacokinetics of pioglitazone. Coadministration of fostamatinib and pioglitazone was associated with lower pioglitazone and hydroxy pioglitazone levels, suggesting that fostamatinib may decrease the efficacy of pioglitazone. However, no significant safety concerns were observed.

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.

Language : English

21.

Fostamatinib Inhibits Neutrophils Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential Therapeutic.

Author: StrichJeffrey R, Ramos-BenitezMarcos J, RandazzoDavide, SteinSydney R, BabyakAshley, DaveyRichard T, SuffrediniAnthony F, ChildsRichard W, ChertowDaniel S

COVID-19 treatment
Immunothrombosis prevention

This study shows that fostamatinib, a drug that inhibits spleen tyrosine kinase (Syk), can prevent the release of neutrophil extracellular traps (NETs) stimulated by plasma from COVID-19 patients. NETs contribute to immunothrombosis and have been associated with COVID-19 mortality.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

23.

Changing Paradigms in ITP Management: Newer Tools for an Old Disease.

Author: JiangDebbie, Al-SamkariHanny, PanchSandhya R

HRQoL improvement
ITP treatment

This review discusses the evolution of immune thrombocytopenia (ITP) treatment, highlighting the impact of thrombopoietin receptor agonists. While these agents have revolutionized chronic ITP management, new therapies targeting various mechanisms of action are under investigation.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Blockade of Syk ameliorates the development of murine sclerodermatous chronic graft-versus-host disease.

Author: Le HuuDoanh, KimuraHiroshi, DateMutsumi, HamaguchiYasuhito, HasegawaMinoru, HauKhang Tran, FujimotoManabu, TakeharaKazuhiko, MatsushitaTakashi

Scl-cGVHD treatment

Sclerodermatous chronic graft-versus-host disease (Scl-cGVHD) is a serious condition that can affect the skin and internal organs. Syk is a protein that plays a role in immune signaling. This study explored the potential role of Syk in the development of Scl-cGVHD in a mouse model.

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

25.

Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo-controlled trials.

Author: BusselJames, ArnoldDonald M, GrossbardElliot, MayerJiří, TrelińskiJacek, HomendaWojciech, HellmannAndrzej, WindygaJerzy, SivchevaLiliya, KhalafallahAlhossain A, ZajaFrancesco, CooperNichola, MarkovtsovVadim, ZayedHany, DuliegeAnne-Marie

Sustained ITP responses
ALT increase
Diarrhea
Dizziness
Hypertension
Nausea

Fostamatinib produced clinically meaningful responses in patients with ITP, including those who failed other treatments.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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