9d096860909ad7969a2dc94c7c629c22 319547.pdf 2ecc66268510c0230f9948854a3f1ac6b66f93c8 319547.pdf 2ddc6e4c1de017a8cd29933bb252e81ac5f228fbe3ea4441c1115f9e5f878df8 319547.pdf Title: Free-IgE as a Predictor of Responsiveness to Omalizumab in Oral Corticosteroid-Dependent Asthma Patients Subject: To date, no biomarkers have been found that are able to predict the clinical response to omalizumab. The aim of this study was to assess whether blood concentration of free Immunoglobulin E (IgE) can predict response to treatment with this monoclonal antibody. In a group of patients who were candidates for omalizumab treatment, forced spirometry and blood IgE were measured at entry and at each six-month visit, and free-IgE blood concentrations were measured at month 6. At month 18, the OMADORE protocol was applied. The complete follow-up lasted 30 months. Patients were considered responders if they met at least one of the following criteria: increase in forced expiratory volume in one second (FEV1) at the follow-up visit compared to baseline; reduction in corticosteroid dose at the last visit compared to baseline; reduction in omalizumab dose at the follow-up visit; a positive score on the composite index combining all three criteria. The biomarker used to predict treatment response was the free IgE value and the percentage of free IgE to total IgE measured at visit 1, after six months of omalizumab treatment. The percentage of responders varied according to the parameter used (FEV1, omalizumab, corticosteroid dose, and the composite index; 45.2%, 64.5%, 48.4%, and 77.4%, respectively). IgE blockade was around 97% both for the group as a whole and for the subgroups. There were no differences in free IgE values nor in the ratio of free IgE to total IgE between responders and non-responders. These results confirm that there is a group of patients who may benefit from the reduction/withdrawal of omalizumab. Determination of free IgE six months after initiation of omalizumab treatment does not discriminate between responders and non-responders. Keywords: blood IgE; free IgE; severe asthma; biomarker; predictor capacity; omalizumab; clinical response Author: Christian Domingo, Daniel-Ross Monserrate, Markus Ollert, Xavier Pomares, Carles Forné, Jorge del Estal and María José Amengual Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Fri Mar 21 14:08:37 2025 CET ModDate: Fri Mar 21 14:12:29 2025 CET Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 11 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1340843 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- MIKRSI+VnURWPalladioL Type 1 Custom yes yes yes 10 0 VIQUVI+URWPalladioL-Roma Type 1 Custom yes yes yes 16 0 HYVLCZ+URWPalladioL-Bold Type 1 Custom yes yes yes 22 0 TNXYBP+URWPalladioL-Ital Type 1 Custom yes yes yes 27 0 MIAMEI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 61 0 MIAMEJ+PalatinoLinotype CID TrueType Identity-H yes yes yes 64 0 MIAMEK+PalatinoLinotype TrueType WinAnsi yes yes no 70 0 MIAMFM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 73 0 MIAMMK+PalatinoLinotype TrueType MacRoman yes yes no 76 0 MIANKH+PalatinoLinotype,BoldItalic TrueType WinAnsi yes yes no 79 0 MIAMEI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 89 0 MIAMEJ+PalatinoLinotype CID TrueType Identity-H yes yes yes 92 0 MIAMEK+PalatinoLinotype TrueType WinAnsi yes yes no 98 0 MIAMFM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 101 0 MIAMMK+PalatinoLinotype TrueType MacRoman yes yes no 104 0 MIAMEI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 115 0 MIAMEJ+PalatinoLinotype CID TrueType Identity-H yes yes yes 118 0 MIAMEK+PalatinoLinotype TrueType WinAnsi yes yes no 124 0 MIAMFL+PalatinoLinotype,Italic CID TrueType Identity-H yes yes yes 127 0 MIAMFM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 133 0 MIAMMK+PalatinoLinotype TrueType MacRoman yes yes no 136 0 TMLEUV+EURM10 Type 1 Builtin yes yes yes 143 0 PXTEMV+CMSY10 Type 1 Builtin yes yes yes 151 0 MIAMEI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 166 0 MIAMEJ+PalatinoLinotype CID TrueType Identity-H yes yes yes 169 0 MIAMEK+PalatinoLinotype TrueType WinAnsi yes yes no 175 0 MIAMFL+PalatinoLinotype,Italic CID TrueType Identity-H yes yes yes 178 0 MIAMFM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 184 0 MIAMMK+PalatinoLinotype TrueType MacRoman yes yes no 187 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2025-11-19 04:10:20 CET RepresentationInformation: 319547.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-11-18 08:34:49 CET Size: 1340843 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 310 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Results Destination: section.2 Children: Item: Title: Analysis of Ability of IgE to Predict Treatment Response Destination: subsection.2.1 Item: Title: Side Effects Destination: subsection.2.2 Item: Title: Discussion Destination: section.3 Item: Title: Methods and Materials Destination: section.4 Children: Item: Title: Hypothesis Destination: subsection.4.1 Item: Title: Purpose Destination: subsection.4.2 Item: Title: Setting Destination: subsection.4.3 Item: Title: Design Destination: subsection.4.4 Item: Title: Population Destination: subsection.4.5 Item: Title: Inclusion Criteria Destination: subsection.4.6 Item: Title: Exclusion Criteria Destination: subsection.4.7 Item: Title: Treatment Response Definitions Destination: subsection.4.8 Item: Title: Methods Destination: subsection.4.9 Item: Title: Study Protocol (See Figure 4) Destination: subsection.4.10 Item: Title: Informed Consent Destination: subsection.4.11 Item: Title: Side Effects Destination: subsection.4.12 Item: Title: Sample Size Destination: subsection.4.13 Item: Title: Statistical Analysis Destination: subsection.4.14 Item: Title: Study Restrictions Destination: subsection.4.15 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: appendix.A. Info: Title: Free-IgE as a Predictor of Responsiveness to Omalizumab in Oral Corticosteroid-Dependent Asthma Patients Author: Christian Domingo, Daniel-Ross Monserrate, Markus Ollert, Xavier Pomares, Carles Forné, Jorge del Estal and María José Amengual Subject: To date, no biomarkers have been found that are able to predict the clinical response to omalizumab. The aim of this study was to assess whether blood concentration of free Immunoglobulin E (IgE) can predict response to treatment with this monoclonal antibody. In a group of patients who were candidates for omalizumab treatment, forced spirometry and blood IgE were measured at entry and at each six-month visit, and free-IgE blood concentrations were measured at month 6. At month 18, the OMADORE protocol was applied. The complete follow-up lasted 30 months. Patients were considered responders if they met at least one of the following criteria: increase in forced expiratory volume in one second (FEV1) at the follow-up visit compared to baseline; reduction in corticosteroid dose at the last visit compared to baseline; reduction in omalizumab dose at the follow-up visit; a positive score on the composite index combining all three criteria. The biomarker used to predict treatment response was the free IgE value and the percentage of free IgE to total IgE measured at visit 1, after six months of omalizumab treatment. The percentage of responders varied according to the parameter used (FEV1, omalizumab, corticosteroid dose, and the composite index; 45.2%, 64.5%, 48.4%, and 77.4%, respectively). IgE blockade was around 97% both for the group as a whole and for the subgroups. There were no differences in free IgE values nor in the ratio of free IgE to total IgE between responders and non-responders. These results confirm that there is a group of patients who may benefit from the reduction/withdrawal of omalizumab. Determination of free IgE six months after initiation of omalizumab treatment does not discriminate between responders and non-responders. 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