Evidence map›Paper›PMID 37721661›Full record

ArticleInvestigational new drugs2023

Safety and blood levels of daratumumab after switching from intravenous to subcutaneous administration in patients with multiple myeloma.

Kenta Yamaoka, Kei Irie, Nobuhiro Hiramoto, Masaki Hirabatake, Hiroaki Ikesue, Tohru Hashida, Tadashi Shimizu, Takayuki Ishikawa, Nobuyuki Muroi

Open access · hybridAbstract read
In one paragraph

Article in Investigational new drugs, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.5field-weighted citation impact, top 16% 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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. 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

9 authors at 3 institutions in 1 country.

Kenta YamaokaDepartment of Pharmacy, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan. kenta_yamaoka@kcho.jp.
Kei IrieDepartment of Pharmacy, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan.ORCID 0000-0002-0820-1208
Nobuhiro HiramotoDepartment of Hematology, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minami- machi, Chuo-ku, Kobe, 650-0047, Japan.
Masaki HirabatakeDepartment of Pharmacy, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan.
Hiroaki IkesueDepartment of Pharmacy, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan.ORCID 0000-0002-8499-131X
Tohru HashidaDepartment of Pharmacy, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan.ORCID 0000-0002-5702-5124
Tadashi ShimizuSchool of Pharmacy, Hyogo Medical University, 1-3-6 Minatojima, Chuo-ku, Kobe, 650-8530, Japan.ORCID 0000-0002-5563-6730
Takayuki IshikawaDepartment of Hematology, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minami- machi, Chuo-ku, Kobe, 650-0047, Japan.ORCID 0000-0002-2098-9616
Nobuyuki MuroiDepartment of Pharmacy, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan.
Kobe City Medical Center General Hospital · JPKobe Gakuin University · JPHyogo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The intravenous administration (IV) of daratumumab sometimes causes an infusion reaction and needs a long infusion time. Recently, a subcutaneous formulation (SC) of daratumumab, which has fewer infusion reactions and shorter administration time, was approved. However, because SC has a fixed dose, overdosing is a concern for patients with low body weights. In this study, we investigated the safety and blood levels of daratumumab after switching from IV to SC in patients with multiple myeloma (MM). Patients who switched from IV to SC of daratumumab between June 2021 and May 2022 at Kobe City Medical Center General Hospital were included in the study. Blood daratumumab levels were measured using liquid chromatography-tandem mass spectrometry. Safety after switching from IV to SC was evaluated for six months and graded according to the Common Terminology Criteria for Adverse Events, version 5.0. The median body weight of ten patients included in the analysis was 57.4 kg (range: 45.0-74.4). Blood daratumumab levels were significantly increased after switching to SC (p = 0.002); median through concentration at the last IV dose was 403.6 μg/mL (range: 96.3-776.3) and that at the third SC dose was 557.1 μg/mL (range: 288.3-997.2). Grade 1-2 injection site reactions were observed in six patients (60.0%) after switching to SC. A new grade 3 adverse event was observed in only one patient (neutropenia). The blood levels of daratumumab were significantly increased after switching from IV to SC in patients with MM; however, the dosage was tolerable.

Indexed as

Antibodies, MonoclonalAntineoplastic AgentsMultiple MyelomaAdministration, IntravenousAgedAged, 80 and overFemaleHumansInjections, SubcutaneousMaleMiddle AgedAntibodies, MonoclonalAntineoplastic AgentsdaratumumabDaratumumabIntravenousMultiple myelomaPharmacokineticsSubcutaneous

Identifiers

PMID37721661
PMCPMC10560139
OpenAlexW4386818137

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.