Evidence map›Paper›PMID 28956263›Full record

Trial reportInternational journal of hematology2018

Ruxolitinib is effective and safe in Japanese patients with hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera with splenomegaly.

Keita Kirito, Kenshi Suzuki, Koichi Miyamura, Masahiro Takeuchi, Hiroshi Handa, Shinichiro Okamoto, Brian Gadbaw, Kyosuke Yamauchi, Taro Amagasaki, Kazuo Ito and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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

10 citing papers in PubMed.

  1. Observational
  2. Review
  3. Review
  4. Review
  5. [Systemic pruritus: what is new in diagnosis and treatment?]Dermatologie (Heidelberg, Germany) · 2022
    Review
  6. Volumetric Splenomegaly in Patients With Polycythemia Vera.Journal of Korean medical science · 2022
    Article
  7. Real-World Outcomes of Ruxolitinib Treatment for Polycythemia Vera.Clinical lymphoma, myeloma & leukemia · 2020
    Article
  8. [Clinical shortcuts in the differential diagnosis of pruritus].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2020
    Review
  9. Non-dermatological Challenges of Chronic Itch.Acta dermato-venereologica · 2020
    Review
  10. Review
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

11 authors.

Keita KiritoDepartment of Hematology and Oncology, University of Yamanashi, 1110 Simokawakita, Chuou-shi, Yamanashi, 409-3898, Japan. kirito@yamanashi.ac.jp.
Kenshi SuzukiDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Koichi MiyamuraDepartment of Hematology, Nagoya Daiichi Hospital, Nagoya, Japan.
Masahiro TakeuchiDepartment of Hematology, Chiba University Hospital, Chiba, Japan.
Hiroshi HandaDepartment of Medicine, Gunma University Hospital, Gunma, Japan.
Shinichiro OkamotoHematology Division, Department of Medicine, Keio University Hospital, Tokyo, Japan.
Brian GadbawNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Kyosuke YamauchiNovartis Pharma KK, Tokyo, Japan.
Taro AmagasakiNovartis Pharma KK, Tokyo, Japan.
Kazuo ItoNovartis Pharma KK, Tokyo, Japan.
Masayuki HinoDepartment of Hematology, Osaka City University Hospital, Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ruxolitinib, a potent JAK1/JAK2 inhibitor, was found to be superior to the best available therapy (BAT) in controlling hematocrit, reducing splenomegaly, and improving symptoms in the phase 3 RESPONSE study of patients with polycythemia vera with splenomegaly who experienced an inadequate response to or adverse effects from hydroxyurea. We report findings from a subgroup analysis of Japanese patients in RESPONSE (n = 18). The composite response rate (hematocrit control and spleen response) was higher in patients receiving ruxolitinib (50.0%) than in those receiving BAT (8.3%). A total of 50.0% of patients randomized to ruxolitinib achieved a spleen response vs 8.3% of those receiving BAT; 100 and 33.3% of patients in the respective groups achieved hematocrit control, with mean hematocrit in ruxolitinib-treated patients remaining stable at < 45% throughout the study. Similarly, a higher proportion of ruxolitinib-treated patients achieved complete hematologic remission (33.3 vs 16.7%). Ruxolitinib also led to rapid improvements in pruritus. All responses with ruxolitinib were durable to week 80, and its safety profile was consistent with that in the overall study. These findings suggest that ruxolitinib is an effective and well-tolerated treatment option for Japanese patients with polycythemia vera with an inadequate response to or adverse effects from hydroxyurea.

Indexed as

AdultAgedAged, 80 and overAsian PeopleFemaleHematocritHumansHydroxyureaJanus Kinase InhibitorsMaleMiddle AgedNitrilesPolycythemia VeraPyrazolesPyrimidinesSplenomegalyHydroxyureaJanus Kinase InhibitorsNitrilesPyrazolesPyrimidinesruxolitinibHematocritJAK inhibitorJapanPolycythemia veraRuxolitinib

Identifiers

PMID28956263

What OpenQuestion holds

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Registered trials

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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.