Evidence map›Paper›PMID 26261238›Full record

Trial reportBlood2015

Ropeginterferon alfa-2b, a novel IFNα-2b, induces high response rates with low toxicity in patients with polycythemia vera.

Heinz Gisslinger, Oleh Zagrijtschuk, Veronika Buxhofer-Ausch, Josef Thaler, Ernst Schloegl, Guenther A Gastl, Dominik Wolf, Robert Kralovics, Bettina Gisslinger, Karin Strecker and 9 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01193699 (An Open-label, Prospective, Multicentre, Phase I/II Dose Escalation Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Efficacy of P1101, PEG-Proline-Interferon Alpha-2b in Patients With Polycythaemia Vera), which is not on this map. Cited by 115 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 8 pooled it
7.6field-weighted citation impact, top 2% 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.

NCT01193699 phase1 / phase2completednot on this map

An Open-label, Prospective, Multicentre, Phase I/II Dose Escalation Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Efficacy of P1101, PEG-Proline-Interferon Alpha-2b in Patients With Polycythaemia Vera

TypeinterventionalSponsorAOP Orphan Pharmaceuticals AGRan2010 to 2018Enrolled24ConditionsPolycythemia VeraArmsPEG-P-INF alpha-2b (P1101)
3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 8 syntheses or guidelines pooled it, 178 citations in OpenAlex.

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55 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

19 authors at 9 institutions in 2 countries.

Heinz GisslingerDepartment of Internal Medicine I, Division of Hematology and Blood Coagulation, Medical University of Vienna, Vienna, Austria;
Oleh ZagrijtschukAOP Orphan Pharmaceuticals AG, Vienna, Austria;
Veronika Buxhofer-AuschSozialmedizinisches Zentrum Ost - Donauspital, Vienna, Austria; Krankenhaus der Elisabethinen Linz, Linz, Austria;
Josef ThalerDepartment of Internal Medicine IV, Wels-Grieskirchen Hospital, Wels, Austria;
Ernst SchloeglThird Medical Department, Hanusch Hospital, Vienna, Austria;
Guenther A GastlDepartment of Internal Medicine V, Hematology & Oncology, Innsbruck Medical University, Innsbruck, Austria;
Dominik WolfDepartment of Internal Medicine V, Hematology & Oncology, Innsbruck Medical University, Innsbruck, Austria; Medical Clinic 3, Oncology, Hematology and Rheumatology, University Hospital of Bonn, Bonn, Germany;
Robert KralovicsDepartment of Internal Medicine I, Division of Hematology and Blood Coagulation, Medical University of Vienna, Vienna, Austria; Center for Molecular Medicine of the Austrian Academy of Sciences, Vienna, Austria;
Bettina GisslingerDepartment of Internal Medicine I, Division of Hematology and Blood Coagulation, Medical University of Vienna, Vienna, Austria;
Karin StreckerSozialmedizinisches Zentrum Ost - Donauspital, Vienna, Austria;
Alexander EgleLaboratory for Immunological and Molecular Cancer Research, Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Center, Paracelsus Medical University, Salzburg, Austria; and.
Thomas MelchardtLaboratory for Immunological and Molecular Cancer Research, Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Center, Paracelsus Medical University, Salzburg, Austria; and.
Sonja BurgstallerDepartment of Internal Medicine IV, Wels-Grieskirchen Hospital, Wels, Austria;
Ella WillenbacherDepartment of Internal Medicine V, Hematology & Oncology, Innsbruck Medical University, Innsbruck, Austria;
Martin SchallingDepartment of Internal Medicine I, Division of Hematology and Blood Coagulation, Medical University of Vienna, Vienna, Austria;
Nicole C ThemCenter for Molecular Medicine of the Austrian Academy of Sciences, Vienna, Austria;
Pavla KadlecovaAdvanced Drug and Device Services SAS, Brno, Czech Republic.
Christoph KladeAOP Orphan Pharmaceuticals AG, Vienna, Austria;
Richard GreilLaboratory for Immunological and Molecular Cancer Research, Department of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Diseases, Rheumatology, Oncologic Center, Paracelsus Medical University, Salzburg, Austria; and.
Medical University of Vienna · ATParacelsus Medical University · ATAOP Orphan (Austria) · ATAustrian Academy of Sciences · ATDonauspital · ATInnsbruck Medical University · ATKlinikum Wels-Grieskirchen · ATHanusch Hospital · ATUniversity Hospital Bonn · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this prospective, open-label, multicenter phase 1/2 dose escalation study, we used a next-generation, mono-pegylated interferon (IFN) α-2b isoform, ropeginterferon alfa-2b. The unique feature of ropeginterferon alfa-2b is a longer elimination half-life, which allows administration every 2 weeks. We present data from 51 polycythemia vera patients. The main goal was to define the maximum tolerated dose and to assess safety and efficacy. A dose range of 50 to 540 µg was tested without the appearance of dose-limiting toxicities. All drug-related adverse events were known toxicities associated with IFN-α. The cumulative overall response rate was 90%, comprising complete response in 47% and partial response in 43% of patients; the best individual molecular response level was a complete response in 21% of patients and partial response in 47%. Notably, we did not observe any correlation between the dose level and the response rate or response duration, suggesting that already low levels of ropeginterferon alfa-2b are sufficient to induce significant hematologic and molecular responses. These data suggest promising efficacy and safety of ropeginterferon alfa-2b and support the development of the drug in a randomized phase 3 clinical trial. The study was disclosed at www.clinicaltrials.gov as #NCT01193699 before including the first patient.

Indexed as

AdultAgedAged, 80 and overFemaleFollow-Up StudiesHalf-LifeHumansInterferon-alphaInterferon alpha-2MaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingPolycythemia VeraPolyethylene GlycolsPrognosisInterferon-alphaInterferon alpha-2Polyethylene GlycolsRecombinant Proteins

Identifiers

PMID26261238
PMCPMC4608390
OpenAlexW2292715199

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.