Randomized controlled trial of intravenous immunoglobulin for autoimmune postural orthostatic tachycardia syndrome (iSTAND).
| Title: | Randomized controlled trial of intravenous immunoglobulin for autoimmune postural orthostatic tachycardia syndrome (iSTAND). |
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| Authors: | Vernino, Steven1 (AUTHOR) Steven.Vernino@UTSouthwestern.edu, Hopkins, Steve1 (AUTHOR), Bryarly, Meredith1 (AUTHOR), Hernandez, Roberto S.1 (AUTHOR), Salter, Amber1 (AUTHOR) |
| Source: | Clinical Autonomic Research. Feb2024, Vol. 34 Issue 1, p153-163. 11p. |
| Subject Terms: | *POSTURAL orthostatic tachycardia syndrome, *ORTHOSTATIC intolerance, *RANDOMIZED controlled trials, *AUTOANTIBODY analysis, *INTRAVENOUS therapy, *INTRAVENOUS immunoglobulins |
| Abstract: | Objective: This study assesses response to intravenous immunoglobulin (IVIG) in presumed autoimmune postural orthostatic tachycardia syndrome (POTS). Background: POTS may be associated with autoimmune disorders, serum autoantibodies, or recent infection. Uncontrolled case studies suggest that IVIG is beneficial for treating autoimmune POTS. No previous randomized controlled trials have been conducted. Methods: This single-site randomized controlled trial compared IVIG with intravenous albumin infusions. Albumin comparator ensured blinding and control for effects of volume expansion. Eligible patients with POTS had COMPASS-31 total weighted score ≥ 40 and met predetermined criteria suggesting autoimmunity. Over 12 weeks, participants received eight infusions (0.4 gm/kg each). Four infusions were given weekly followed by four infusions every other week. Primary outcome measure was improvement in COMPASS-31 2 weeks after final infusion. Results: A total of 50 participants consented; 30 met inclusion criteria and received study drug (16 IVIG and 14 albumin; 29 female). Group baseline characteristics were well matched; 27 participants completed treatment protocol. Change in COMPASS-31 did not differ between groups (median change [IQR]; IVIG: −5.5 [−23.3, 2.5] versus albumin: −10.6 [−14.1, −4.7]; p-value = 0.629). The IVIG group had a higher response rate (46.7% versus 38.5%), but this was not statistically significant. Adverse events were common but usually mild and did not differ between treatment groups. Conclusions: This small randomized controlled trial of IVIG in POTS found no statistical difference in response compared with albumin infusion. Both groups showed improvement possibly related to volume expansion or other effects obscuring group differences. These findings inform development of future immunomodulatory clinical trials in POTS. [ABSTRACT FROM AUTHOR] |
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| Items | – Name: Title Label: Title Group: Ti Data: Randomized controlled trial of intravenous immunoglobulin for autoimmune postural orthostatic tachycardia syndrome (iSTAND). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Vernino%2C+Steven%22">Vernino, Steven</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> Steven.Vernino@UTSouthwestern.edu</i><br /><searchLink fieldCode="AR" term="%22Hopkins%2C+Steve%22">Hopkins, Steve</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bryarly%2C+Meredith%22">Bryarly, Meredith</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hernandez%2C+Roberto+S%2E%22">Hernandez, Roberto S.</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Salter%2C+Amber%22">Salter, Amber</searchLink><relatesTo>1</relatesTo> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Clinical+Autonomic+Research%22">Clinical Autonomic Research</searchLink>. Feb2024, Vol. 34 Issue 1, p153-163. 11p. – Name: Subject Label: Subject Terms Group: Su Data: *<searchLink fieldCode="DE" term="%22POSTURAL+orthostatic+tachycardia+syndrome%22">POSTURAL orthostatic tachycardia syndrome</searchLink><br />*<searchLink fieldCode="DE" term="%22ORTHOSTATIC+intolerance%22">ORTHOSTATIC intolerance</searchLink><br />*<searchLink fieldCode="DE" term="%22RANDOMIZED+controlled+trials%22">RANDOMIZED controlled trials</searchLink><br />*<searchLink fieldCode="DE" term="%22AUTOANTIBODY+analysis%22">AUTOANTIBODY analysis</searchLink><br />*<searchLink fieldCode="DE" term="%22INTRAVENOUS+therapy%22">INTRAVENOUS therapy</searchLink><br />*<searchLink fieldCode="DE" term="%22INTRAVENOUS+immunoglobulins%22">INTRAVENOUS immunoglobulins</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Objective: This study assesses response to intravenous immunoglobulin (IVIG) in presumed autoimmune postural orthostatic tachycardia syndrome (POTS). Background: POTS may be associated with autoimmune disorders, serum autoantibodies, or recent infection. Uncontrolled case studies suggest that IVIG is beneficial for treating autoimmune POTS. No previous randomized controlled trials have been conducted. Methods: This single-site randomized controlled trial compared IVIG with intravenous albumin infusions. Albumin comparator ensured blinding and control for effects of volume expansion. Eligible patients with POTS had COMPASS-31 total weighted score ≥ 40 and met predetermined criteria suggesting autoimmunity. Over 12 weeks, participants received eight infusions (0.4 gm/kg each). Four infusions were given weekly followed by four infusions every other week. Primary outcome measure was improvement in COMPASS-31 2 weeks after final infusion. Results: A total of 50 participants consented; 30 met inclusion criteria and received study drug (16 IVIG and 14 albumin; 29 female). Group baseline characteristics were well matched; 27 participants completed treatment protocol. Change in COMPASS-31 did not differ between groups (median change [IQR]; IVIG: −5.5 [−23.3, 2.5] versus albumin: −10.6 [−14.1, −4.7]; p-value = 0.629). The IVIG group had a higher response rate (46.7% versus 38.5%), but this was not statistically significant. Adverse events were common but usually mild and did not differ between treatment groups. Conclusions: This small randomized controlled trial of IVIG in POTS found no statistical difference in response compared with albumin infusion. Both groups showed improvement possibly related to volume expansion or other effects obscuring group differences. These findings inform development of future immunomodulatory clinical trials in POTS. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Clinical Autonomic Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s10286-024-01020-9 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 11 StartPage: 153 Subjects: – SubjectFull: POSTURAL orthostatic tachycardia syndrome Type: general – SubjectFull: ORTHOSTATIC intolerance Type: general – SubjectFull: RANDOMIZED controlled trials Type: general – SubjectFull: AUTOANTIBODY analysis Type: general – SubjectFull: INTRAVENOUS therapy Type: general – SubjectFull: INTRAVENOUS immunoglobulins Type: general Titles: – TitleFull: Randomized controlled trial of intravenous immunoglobulin for autoimmune postural orthostatic tachycardia syndrome (iSTAND). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Vernino, Steven – PersonEntity: Name: NameFull: Hopkins, Steve – PersonEntity: Name: NameFull: Bryarly, Meredith – PersonEntity: Name: NameFull: Hernandez, Roberto S. – PersonEntity: Name: NameFull: Salter, Amber IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 02 Text: Feb2024 Type: published Y: 2024 Identifiers: – Type: issn-print Value: 09599851 Numbering: – Type: volume Value: 34 – Type: issue Value: 1 Titles: – TitleFull: Clinical Autonomic Research Type: main |
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