Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y).

Bibliographic Details
Title:	Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y).
Authors:	Landewé, Robert B. M., Gensler, Lianne S., Poddubnyy, Denis, Rahman, Proton, Hojnik, Maja, Xiaoqi Li, Soyi Liu Leage, Adams, David, Carlier, Hilde, Van den Bosch, Filip, Landewé, Robert Bm, Li, Xiaoqi, Liu Leage, Soyi, COAST-Y study group
Source:	Annals of the Rheumatic Diseases; Aug2021, Vol. 80 Issue 8, p1022-1030, 9p
Abstract:	Objectives: The objective of COAST-Y was to evaluate the effect of continuing versus withdrawing ixekizumab (IXE) in patients with axial spondyloarthritis (axSpA) who had achieved remission.Methods: COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP). Patients who completed the originating 52-week COAST-V, COAST-W or COAST-X studies entered a 24-week lead-in period and continued either 80 mg IXE every 2 (Q2W) or 4 weeks (Q4W). Patients who achieved remission (an Ankylosing Spondylitis Disease Activity Score (ASDAS)<1.3 at least once at week 16 or week 20, and <2.1 at both visits) were randomly assigned equally at week 24 to continue IXE Q4W, IXE Q2W or withdraw to PBO in a blinded fashion. The primary endpoint was the proportion of flare-free patients (flare: ASDAS≥2.1 at two consecutive visits or ASDAS>3.5 at any visit) after the 40-week RWRP, with time-to-flare as a major secondary endpoint.Results: Of 773 enrolled patients, 741 completed the 24-week lead-in period and 155 entered the RWRP. Forty weeks after randomised withdrawal, 83.3% of patients in the combined IXE (85/102, p<0.001), IXE Q4W (40/48, p=0.003) and IXE Q2W (45/54, p=0.001) groups remained flare-free versus 54.7% in the PBO group (29/53). Continuing IXE significantly delayed time-to-flare versus PBO, with most patients remaining flare-free for up to 20 weeks after IXE withdrawal.Conclusions: Patients with axSpA who continued treatment with IXE were significantly less likely to flare and had significantly delayed time-to-flare compared with patients who withdrew to PBO. [ABSTRACT FROM AUTHOR]
	Copyright of Annals of the Rheumatic Diseases is the property of BMJ Publishing Group 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. (Copyright applies to all Abstracts.)
Database:	Complementary Index

FullText	Text: Availability: 0 CustomLinks: – Url: https://www.doi.org/10.1136/annrheumdis-2020-219717? Name: ScienceDirect (all content)-s8985755 Category: fullText Text: View record from ScienceDirect MouseOverText: View record from ScienceDirect – Url: https://resolver.ebsco.com/c/xy5jbn/result?sid=EBSCO:edb&genre=article&issn=00034967&ISBN=&volume=80&issue=8&date=20210801&spage=1022&pages=1022-1030&title=Annals of the Rheumatic Diseases&atitle=Continuing%20versus%20withdrawing%20ixekizumab%20treatment%20in%20patients%20with%20axial%20spondyloarthritis%20who%20achieved%20remission%3A%20efficacy%20and%20safety%20results%20from%20a%20placebo-controlled%2C%20randomised%20withdrawal%20study%20%28COAST-Y%29.&aulast=Landew%C3%A9%2C%20Robert%20B.%20M.&id=DOI:10.1136/annrheumdis-2020-219717 Name: Full Text Finder (for New FTF UI) (s8985755) Category: fullText Text: Find It @ SCU Libraries MouseOverText: Find It @ SCU Libraries
Header	DbId: edb DbLabel: Complementary Index An: 151392566 RelevancyScore: 925 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 925.488830566406
IllustrationInfo
Items	– Name: Title Label: Title Group: Ti Data: Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Landewé%2C+Robert+B%2E+M%2E%22">Landewé, Robert B. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Gensler%2C+Lianne+S%2E%22">Gensler, Lianne S.</searchLink><br /><searchLink fieldCode="AR" term="%22Poddubnyy%2C+Denis%22">Poddubnyy, Denis</searchLink><br /><searchLink fieldCode="AR" term="%22Rahman%2C+Proton%22">Rahman, Proton</searchLink><br /><searchLink fieldCode="AR" term="%22Hojnik%2C+Maja%22">Hojnik, Maja</searchLink><br /><searchLink fieldCode="AR" term="%22Xiaoqi+Li%22">Xiaoqi Li</searchLink><br /><searchLink fieldCode="AR" term="%22Soyi+Liu+Leage%22">Soyi Liu Leage</searchLink><br /><searchLink fieldCode="AR" term="%22Adams%2C+David%22">Adams, David</searchLink><br /><searchLink fieldCode="AR" term="%22Carlier%2C+Hilde%22">Carlier, Hilde</searchLink><br /><searchLink fieldCode="AR" term="%22Van+den+Bosch%2C+Filip%22">Van den Bosch, Filip</searchLink><br /><searchLink fieldCode="AR" term="%22Landewé%2C+Robert+Bm%22">Landewé, Robert Bm</searchLink><br /><searchLink fieldCode="AR" term="%22Li%2C+Xiaoqi%22">Li, Xiaoqi</searchLink><br /><searchLink fieldCode="AR" term="%22Liu+Leage%2C+Soyi%22">Liu Leage, Soyi</searchLink><br /><searchLink fieldCode="AR" term="%22COAST-Y+study+group%22">COAST-Y study group</searchLink> – Name: TitleSource Label: Source Group: Src Data: Annals of the Rheumatic Diseases; Aug2021, Vol. 80 Issue 8, p1022-1030, 9p – Name: Abstract Label: Abstract Group: Ab Data: <bold>Objectives: </bold>The objective of COAST-Y was to evaluate the effect of continuing versus withdrawing ixekizumab (IXE) in patients with axial spondyloarthritis (axSpA) who had achieved remission.<bold>Methods: </bold>COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP). Patients who completed the originating 52-week COAST-V, COAST-W or COAST-X studies entered a 24-week lead-in period and continued either 80 mg IXE every 2 (Q2W) or 4 weeks (Q4W). Patients who achieved remission (an Ankylosing Spondylitis Disease Activity Score (ASDAS)<1.3 at least once at week 16 or week 20, and <2.1 at both visits) were randomly assigned equally at week 24 to continue IXE Q4W, IXE Q2W or withdraw to PBO in a blinded fashion. The primary endpoint was the proportion of flare-free patients (flare: ASDAS≥2.1 at two consecutive visits or ASDAS>3.5 at any visit) after the 40-week RWRP, with time-to-flare as a major secondary endpoint.<bold>Results: </bold>Of 773 enrolled patients, 741 completed the 24-week lead-in period and 155 entered the RWRP. Forty weeks after randomised withdrawal, 83.3% of patients in the combined IXE (85/102, p<0.001), IXE Q4W (40/48, p=0.003) and IXE Q2W (45/54, p=0.001) groups remained flare-free versus 54.7% in the PBO group (29/53). Continuing IXE significantly delayed time-to-flare versus PBO, with most patients remaining flare-free for up to 20 weeks after IXE withdrawal.<bold>Conclusions: </bold>Patients with axSpA who continued treatment with IXE were significantly less likely to flare and had significantly delayed time-to-flare compared with patients who withdrew to PBO. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Group: Ab Data: <i>Copyright of Annals of the Rheumatic Diseases is the property of BMJ Publishing Group 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.)
PLink	https://login.libproxy.scu.edu/login?url=https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&scope=site&db=edb&AN=151392566
RecordInfo	BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1136/annrheumdis-2020-219717 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 9 StartPage: 1022 Titles: – TitleFull: Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Landewé, Robert B. M. – PersonEntity: Name: NameFull: Gensler, Lianne S. – PersonEntity: Name: NameFull: Poddubnyy, Denis – PersonEntity: Name: NameFull: Rahman, Proton – PersonEntity: Name: NameFull: Hojnik, Maja – PersonEntity: Name: NameFull: Xiaoqi Li – PersonEntity: Name: NameFull: Soyi Liu Leage – PersonEntity: Name: NameFull: Adams, David – PersonEntity: Name: NameFull: Carlier, Hilde – PersonEntity: Name: NameFull: Van den Bosch, Filip – PersonEntity: Name: NameFull: Landewé, Robert Bm – PersonEntity: Name: NameFull: Li, Xiaoqi – PersonEntity: Name: NameFull: Liu Leage, Soyi – PersonEntity: Name: NameFull: COAST-Y study group IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 08 Text: Aug2021 Type: published Y: 2021 Identifiers: – Type: issn-print Value: 00034967 Numbering: – Type: volume Value: 80 – Type: issue Value: 8 Titles: – TitleFull: Annals of the Rheumatic Diseases Type: main
ResultId	1