Evidence map›Paper›PMID 29737044›Full record

Trial reportImmunity, inflammation and disease2018

A clinical follow-up of omalizumab in routine treatment of allergic asthma monitored by CD-sens.

S Gunnar O Johansson, Gunnar Lilja, Jenny Hallberg, Anna Nopp

Abstract readClinical Trial
In one paragraph

Trial report in Immunity, inflammation and disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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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

4 authors.

S Gunnar O JohanssonDepartment of Clinical Science and Education, Södersjukhuset and Karolinska Institutet, Stockholm, Sweden.
Gunnar LiljaDepartment of Clinical Science and Education, Södersjukhuset and Karolinska Institutet, Stockholm, Sweden.
Jenny HallbergDepartment of Clinical Science and Education, Södersjukhuset and Karolinska Institutet, Stockholm, Sweden.
Anna NoppDepartment of Clinical Science and Education, Södersjukhuset and Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0003-1389-8676

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOmalizumab has been available for treatment of allergic asthma for more than a decade and thus, its efficacy in routine treatment was of interest to evaluate. Basophil allergen threshold sensitivity (CD-sens) has been shown to correlate with the bronchial allergen threshold sensitivity and can be used to objectively measure omalizumab treatment efficacy. We aimed to evaluate the effect of omalizumab treatment of allergic asthma by CD-sens, as an objective marker of the IgE-mediated inflammation, and related to SPT, spirometry, FeNO, Asthma Control Questionnaire (ACQ), and Global Evaluation of Treatment Effectiveness (GETE).

methodsThirty-two patients were treated with omalizumab for 16 weeks. CD-sens was used to define the response and related to clinical parameters. If CD-sens was negative (<0.1) (CD-sens low Group) the patient continued with the standard dose. If CD-sens was ≥0.1 (CD-sens high Group) a second 16 weeks period with 25-50% dosage increase was started and evaluated after a total of 32 weeks.

resultsNine of 32 patients became CD-sens negative after treatment (CD-sens start: 8.0; 16 weeks: <0.01) and regarded as successful. 15/23 were unsuccessful (CD-sens start: 13; 16 weeks: 1.65) and the omalizumab dose was increased. CD-sens decreased significantly (p < 0.05) and further 3/15 patients became CD-sens negative (CD-sens at 32 weeks: 0.5). There was a significantly smaller IgE-ab fraction (IgE-ab/IgE) in the CD-sens low versus the CD-sens high Group (p < 0.0001). A significant decrease in ACQ was seen in both groups after 16 weeks treatment (p = 0.05 and 0.01, respectively). No significant changes could be detected for the other clinical parameters.

conclusionBy the use of the objective laboratory method CD-sens, which effectively measure the direct effect of omalizumab, that is, the IgE-mediated part of the allergic asthma, in combination with clinical parameters it might be possible to more effectively monitor and treat IgE-mediated allergic asthma.

Indexed as

AdolescentAdultAllergensAnti-Asthmatic AgentsAsthmaBasophilsChildFemaleForced Expiratory VolumeHumansImmunoglobulin EMaleMiddle AgedNitric OxideOmalizumabSkin TestsAllergensAnti-Asthmatic AgentsImmunoglobulin ENitric OxideOmalizumabBasophilsIgE-antibodyomalizumab

Identifiers

PMID29737044
PMCPMC6113766

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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.