Evidence map›Paper›PMID 27832516›Full record

ArticleInternational journal of hematology2017

Assessing the safety and efficacy of ruxolitinib in a multicenter, open-label study in Japanese patients with myelofibrosis.

Norio Komatsu, Keita Kirito, Kazuya Shimoda, Takayuki Ishikawa, Kohshi Ohishi, Kazuma Ohyashiki, Naoto Takahashi, Hikaru Okada, Taro Amagasaki, Toshio Yonezu and 1 more

Erratum issuedAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in International journal of hematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.4field-weighted citation impact, top 18% 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

12 citing papers in PubMed, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 1 country.

Norio KomatsuDepartment of Hematology, Juntendo University School of Medicine, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. komatsun@juntendo.ac.jp.
Keita KiritoDepartment of Hematology and Oncology, University of Yamanashi, Yamanashi, 409-3898, Japan.
Kazuya ShimodaDepartment of Gastroenterology and Hematology, University of Miyazaki, Miyazaki, 889-1692, Japan.
Takayuki IshikawaDepartment of Hematology, Kobe City Medical Center General Hospital, Kobe, 650-0047, Japan.
Kohshi OhishiBlood Transfusion Service, Mie University, Tsu, Mie, 514-8507, Japan.
Kazuma OhyashikiDepartment of Hematology, Tokyo Medical University, Tokyo, 160-8402, Japan.
Naoto TakahashiDepartment of Hematology, Nephrology, and Rheumatology, Akita University Graduate School of Medicine, Akita, 010-8502, Japan.
Hikaru OkadaNovartis Pharma KK, Tokyo, 105-6333, Japan.
Taro AmagasakiNovartis Pharma KK, Tokyo, 105-6333, Japan.
Toshio YonezuNovartis Pharma KK, Tokyo, 105-6333, Japan.
Koichi AkashiDepartment of Medicine and Biosystemic Science, Kyushu University, Fukuoka, 812-8582, Japan.
Novartis (Japan) · JPAkita University · JPJuntendo University · JPKobe City Medical Center General Hospital · JPKyushu University · JPMie University · JPTokyo Medical University · JPUniversity of Miyazaki · JPUniversity of Yamanashi · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ruxolitinib is a potent JAK1/JAK2 inhibitor that has demonstrated durable improvements in splenomegaly, symptoms, and overall survival in controlled clinical trials in patients with myelofibrosis. The single-arm study reported here was initiated to collect further safety and efficacy data in Japanese patients with myelofibrosis and is the largest study of ruxolitinib in this population. The primary objective was to assess safety. Secondary endpoints included changes in spleen size and patient-reported outcomes. The primary analysis occurred when all patients (N = 51) completed 24 weeks or discontinued. Overall, 86.3% of patients completed treatment; 9.8% discontinued due to adverse events (AEs). Consistent with previous studies, the most common AEs were anemia (62.7%) and thrombocytopenia (29.4%). Furthermore, levels of select immunologic biomarkers remained stable, and no deaths occurred. At week 24, 30.0% of evaluable patients experienced ≥50% reductions from baseline in palpable spleen length; 26.0% had ≥35% reductions in spleen volume. Additionally, ruxolitinib led to clinically significant improvements in symptoms and quality of life. Overall, findings from this study indicate that ruxolitinib is safe and effective in Japanese patients with myelofibrosis, with these benefits extending to patients with intermediate-1-risk myelofibrosis and to those with low platelet counts.

Indexed as

AdultAgedAged, 80 and overAnemiaFemaleHumansMaleMiddle AgedNitrilesPrimary MyelofibrosisPyrazolesPyrimidinesQuality of LifeSpleenSplenomegalyThrombocytopeniaNitrilesPyrazolesPyrimidinesruxolitinibJapanese patientsMyelofibrosisRuxolitinib

Identifiers

PMID27832516
OpenAlexW2556678968

What OpenQuestion holds

Textmetadata
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.