Evidence map›Paper›PMID 38049729›Full record

ArticleBMC infectious diseases2023

Comparative effectiveness of tocilizumab vs standard care in patients with severe COVID-19-related pneumonia: a retrospective cohort study utilizing registry data as a synthetic control.

Yukari Uemura, Ryoto Ozaki, Tomohiro Shinozaki, Hiroshi Ohtsu, Yousuke Shimizu, Kazuo Izumi, Sho Saito, Nobuaki Matsunaga, Norio Ohmagari

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC infectious diseases, 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
–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

2 citing papers in PubMed.

  1. Review
  2. Article
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.

Yukari UemuraBiostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjyuku-ku, Tokyo, 162-8655, Japan. yuemura@hosp.ncgm.go.jp.
Ryoto OzakiBiometrics Department, Clinical Development Division, Chugai Pharmaceutical CO., LTD, Tokyo, Japan.
Tomohiro ShinozakiDepartment of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.
Hiroshi OhtsuClinical Pharmacology and Regulatory Sciences, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Yousuke ShimizuBiostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjyuku-ku, Tokyo, 162-8655, Japan.
Kazuo IzumiCenter for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
Sho SaitoDisease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.
Nobuaki MatsunagaDisease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.
Norio OhmagariDisease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe severity of coronavirus disease 2019 (COVID-19) infections has led to the development of several therapeutic agents, with tocilizumab becoming increasingly used to treat patients with COVID-19-related pneumonia. This study compared the use of tocilizumab treatment with the standard of care (SOC) to determine its efficacy against severe COVID-19-related pneumonia in Japan.

methodsThis retrospective cohort study was designed to evaluate the efficacy of tocilizumab in two different databases: the JA42434 single-arm study and COVID-19 Registry Japan (COVIREGI-JP), with a synthetic control group from the COVIREGI-JP cohort as a benchmark for the tocilizumab group. The study's primary objective was to evaluate the efficacy of tocilizumab in treating severe COVID-19-related pneumonia compared to the SOC among patients included in the above two databases. The SOC group was extracted as the synthetic control group using exact matching and a propensity score matching in sequence per subject. As a secondary objective, the efficacy of tocilizumab compared to the SOC was evaluated exclusively among patients included in the COVIREGI-JP database. In each objective, the primary endpoint was defined as the time to discharge or the status of awaiting discharge.

resultsFor the primary endpoint, the hazard ratio (HR) of the tocilizumab group against the SOC group was 1.070 (95% confidence interval [CI]: 0.565-2.028). The median time from Study Day 1 to discharge or the state of awaiting discharge was 15 days in the tocilizumab group and 16 days in the SOC group. The HRs for the secondary endpoints, namely, time to improvement in the clinical state, time to clinical failure, and time to recovery, were 1.112 (95% CI: 0.596-2.075), 0.628 (95% CI: 0.202-1.953), and 1.019 (95% CI: 0.555-1.871), respectively. Similarly, the HR of the primary endpoint for the secondary objective was 0.846 (95% CI: 0.582-1.230).

conclusionsTocilizumab did not demonstrate a positive effect on time to discharge or the state of awaiting discharge. Furthermore, no statistically significant differences in other clinical outcomes, such as time to improvement in the clinical state, time to clinical failure, and time to recovery, were observed among the groups.

Indexed as

COVID-19Antibodies, Monoclonal, HumanizedCOVID-19 Drug TreatmentHumansRetrospective StudiesRoutinely Collected Health DataSARS-CoV-2Treatment OutcomeAntibodies, Monoclonal, HumanizedtocilizumabCOVID-19 Registry JapanCOVID-19-related pneumoniaSynthetic controlTocilizumab

Identifiers

PMID38049729
PMCPMC10694888

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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.