Evidence map›Paper›PMID 29696684›Full record

Trial reportAmerican journal of hematology2018

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

James Bussel, Donald M Arnold, Elliot Grossbard, Jiří Mayer, Jacek Treliński, Wojciech Homenda, Andrzej Hellmann, Jerzy Windyga, Liliya Sivcheva, Alhossain A Khalafallah and 5 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in American journal of hematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 185 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
185citing papers in PubMed, 6 pooled it
22.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

185 citing papers in PubMed, 6 syntheses or guidelines pooled it, 336 citations in OpenAlex.

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  20. Mechanisms and therapeutic strategies of asthma: from bench to bedside.Signal transduction and targeted therapy · 2026
    Review

125 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 7 countries.

James BusselWeill Cornell Medicine, New York, New York.ORCID 0000-0002-2884-9247
Donald M ArnoldMcMaster University, Michael G. DeGroote School of Medicine, and Canadian Blood Services, Hamilton, Ontario, Canada.
Elliot GrossbardRigel Pharmaceuticals, South San Francisco, California.
Jiří MayerFakultni nemocnice Brno, Brno, Czech Republic.
Jacek TrelińskiWojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi, Lodz, Poland.
Wojciech HomendaWojewódzki Szpital Specjalistyczny im. J. Korczaka i Akademia Pomorska w Słupsku, Slupsk, Poland.
Andrzej HellmannUniversity Clinical Center, Medical University of Gdańsk, Gdańsk, Poland.
Jerzy WindygaInstytut Hematologii i Transfuzjologii, Warszawa, Poland.
Liliya SivchevaFirst Internal Department, MHAT Hristo Botev, AD, Vratsa, Vratsa, Bulgaria.
Alhossain A KhalafallahMenzies Institute for Medical Research, University of Tasmania, Launceston, Tasmania.
Francesco ZajaClinica Ematologica, DAME, University of Udine, Udine, Italy.
Nichola CooperHammersmith Hospital, London, United Kingdom.
Vadim MarkovtsovRigel Pharmaceuticals, South San Francisco, California.
Hany ZayedRigel Pharmaceuticals, South San Francisco, California.
Anne-Marie DuliegeRigel Pharmaceuticals, South San Francisco, California.
Rigel (United States) · USCanadian Blood Services · CACornell University · USGdańsk Medical University · PLHammersmith Hospital · GBInstytut Hematologii i Transfuzjologi · PLUniversity Hospital Brno · CZUniversity of Tasmania · AUUniversity of Udine · ITUniwersytet Pomorski w Słupsku · PLValley Tech Systems (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Spleen tyrosine kinase (Syk) signaling is central to phagocytosis-based, antibody-mediated platelet destruction in adults with immune thrombocytopenia (ITP). Fostamatinib, an oral Syk inhibitor, produced sustained on-treatment responses in a phase 2 ITP study. In two parallel, phase 3, multicenter, randomized, double-blind, placebo-controlled trials (FIT1 and FIT2), patients with persistent/chronic ITP were randomized 2:1 to fostamatinib (n = 101) or placebo (n = 49) at 100 mg BID for 24 weeks with a dose increase in nonresponders to 150 mg BID after 4 weeks. The primary endpoint was stable response (platelets ≥50 000/μL at ≥4 of 6 biweekly visits, weeks 14-24, without rescue therapy). Baseline median platelet count was 16 000/μL; median duration of ITP was 8.5 years. Stable responses occurred in 18% of patients on fostamatinib vs. 2% on placebo (P = .0003). Overall responses (defined retrospectively as ≥1 platelet count ≥50 000/μL within the first 12 weeks on treatment) occurred in 43% of patients on fostamatinib vs. 14% on placebo (P = .0006). Median time to response was 15 days (on 100 mg bid), and 83% responded within 8 weeks. The most common adverse events were diarrhea (31% on fostamatinib vs. 15% on placebo), hypertension (28% vs. 13%), nausea (19% vs. 8%), dizziness (11% vs. 8%), and ALT increase (11% vs. 0%). Most events were mild or moderate and resolved spontaneously or with medical management (antihypertensive, anti-motility agents). Fostamatinib produced clinically-meaningful responses in ITP patients including those who failed splenectomy, thrombopoietic agents, and/or rituximab. Fostamatinib is a novel ITP treatment option that targets an important mechanism of ITP pathogenesis.

Indexed as

AdultAminopyridinesBlood PlateletsChronic DiseaseHumansMorpholinesOxazinesPlatelet CountPurpura, Thrombocytopenic, IdiopathicPyridinesPyrimidinesSplenectomySyk KinaseTreatment OutcomeAminopyridinesfostamatinibMorpholinesOxazinesPyridinesPyrimidinesSyk Kinase

Identifiers

PMID29696684
PMCPMC6055608
OpenAlexW2799711263

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.