Responses to ixekizumab in male and female patients with psoriatic arthritis : results from two randomized, phase 3 clinical trials

2022
journal article
article
11
dc.abstract.enIntroduction: Differences in psoriatic arthritis (PsA) treatment response between sexes for ixekizumab, an interleukin-17A antagonist, are largely unexplored. This analysis used data from randomized clinical trials (RCTs) evaluating ixekizumab to study differences in treatment response between male and female patients with PsA. Methods: We used pooled data from patients enrolled in SPIRIT-P1 and SPIRIT-P2 (NCT01695239 and NCT02349295, respectively), phase 3 RCTs evaluating ixekizumab every 4 and 2 weeks in patients with active PsA. Subgroups of patients were defined by sex (male, female). Efficacy was measured by the proportion of male and female patients achieving American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70), minimal disease activity or very low disease activity (MDA/VLDA), and Disease Activity Index for Psoriatic Arthritis (DAPSA) scores representing low disease activity (LDA) or remission through week 156. Changes from baseline in components of the above measures were also assessed through week 156. Results: Compared to male patients at baseline, female patients were older, had higher body mass index and lower C-reactive protein levels, and had worse tender joint count, Health Assessment Questionnaire Disability Index, and Leeds Enthesitis Index scores. Through week 156, female patients in all treatment arms had lower response rates than male patients in all analyzed composite measures (ACR20/50/70; MDA/VLDA; DAPSA LDA/remission), with significant differences observed at multiple timepoints in both ixekizumab treatment arms. Female patients also had smaller numeric changes from baseline in the composite measures’ individual components. Conclusion: Compared to female patients, male patients had greater response rates in ACR20/50/70, MDA/VLDA, and DAPSA LDA/remission and numerically larger improvements in these measures’ individual components, although clinical significance is unclear. Continued efforts to understand sex differences in treatment response may provide insights that can help optimize clinical decision making.
dc.affiliationWydział Lekarski : Klinika Reumatologii i Immunologiipl
dc.cm.date2022-06-06T03:12:16Z
dc.cm.id108253pl
dc.cm.idOmegaUJCM46fb5d6bd8044617b8a6a452b3560cb2pl
dc.contributor.authorEder, Lihipl
dc.contributor.authorTony, Hans-Peterpl
dc.contributor.authorOdhav, Satishpl
dc.contributor.authorAgirregoiko, Eva Galindezpl
dc.contributor.authorKorkosz, Mariusz - 130283 pl
dc.contributor.authorSchwartzman, Sergiopl
dc.contributor.authorSprabery, Aubrey Trevelinpl
dc.contributor.authorGellett, Amanda M.pl
dc.contributor.authorPark, So Youngpl
dc.contributor.authorBertram, Clinton C.pl
dc.contributor.authorOgdie, Alexispl
dc.date.accession2022-06-03pl
dc.date.accessioned2022-06-06T03:12:16Z
dc.date.available2022-06-06T03:12:16Z
dc.date.issued2022pl
dc.date.openaccess0
dc.description.accesstimew momencie opublikowania
dc.description.number3pl
dc.description.physical919-933pl
dc.description.versionostateczna wersja wydawcy
dc.description.volume9pl
dc.identifier.doi10.1007/s40744-022-00445-wpl
dc.identifier.eissn2198-6584pl
dc.identifier.issn2198-6576pl
dc.identifier.urihttps://ruj.uj.edu.pl/xmlui/handle/item/292676
dc.identifier.weblinkhttps://link.springer.com/article/10.1007/s40744-022-00445-wpl
dc.languageengpl
dc.language.containerengpl
dc.pbn.affiliationDziedzina nauk medycznych i nauk o zdrowiu : nauki medyczne
dc.rightsUdzielam licencji. Uznanie autorstwa - Użycie niekomercyjne 4.0 Międzynarodowa
dc.rights.licenceCC-BY-NC
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/legalcode.pl
dc.share.typeOtwarte czasopismo
dc.subject.enixekizumab
dc.subject.enpsoriatic arthritis
dc.subject.ensex differences
dc.subject.enwomen’s health
dc.subject.enoutcome measures
dc.subtypeArticlepl
dc.titleResponses to ixekizumab in male and female patients with psoriatic arthritis : results from two randomized, phase 3 clinical trialspl
dc.title.journalRheumatology and Therapypl
dc.typeJournalArticlepl
dspace.entity.typePublication
dc.abstract.en
Introduction: Differences in psoriatic arthritis (PsA) treatment response between sexes for ixekizumab, an interleukin-17A antagonist, are largely unexplored. This analysis used data from randomized clinical trials (RCTs) evaluating ixekizumab to study differences in treatment response between male and female patients with PsA. Methods: We used pooled data from patients enrolled in SPIRIT-P1 and SPIRIT-P2 (NCT01695239 and NCT02349295, respectively), phase 3 RCTs evaluating ixekizumab every 4 and 2 weeks in patients with active PsA. Subgroups of patients were defined by sex (male, female). Efficacy was measured by the proportion of male and female patients achieving American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70), minimal disease activity or very low disease activity (MDA/VLDA), and Disease Activity Index for Psoriatic Arthritis (DAPSA) scores representing low disease activity (LDA) or remission through week 156. Changes from baseline in components of the above measures were also assessed through week 156. Results: Compared to male patients at baseline, female patients were older, had higher body mass index and lower C-reactive protein levels, and had worse tender joint count, Health Assessment Questionnaire Disability Index, and Leeds Enthesitis Index scores. Through week 156, female patients in all treatment arms had lower response rates than male patients in all analyzed composite measures (ACR20/50/70; MDA/VLDA; DAPSA LDA/remission), with significant differences observed at multiple timepoints in both ixekizumab treatment arms. Female patients also had smaller numeric changes from baseline in the composite measures’ individual components. Conclusion: Compared to female patients, male patients had greater response rates in ACR20/50/70, MDA/VLDA, and DAPSA LDA/remission and numerically larger improvements in these measures’ individual components, although clinical significance is unclear. Continued efforts to understand sex differences in treatment response may provide insights that can help optimize clinical decision making.
dc.affiliationpl
Wydział Lekarski : Klinika Reumatologii i Immunologii
dc.cm.date
2022-06-06T03:12:16Z
dc.cm.idpl
108253
dc.cm.idOmegapl
UJCM46fb5d6bd8044617b8a6a452b3560cb2
dc.contributor.authorpl
Eder, Lihi
dc.contributor.authorpl
Tony, Hans-Peter
dc.contributor.authorpl
Odhav, Satish
dc.contributor.authorpl
Agirregoiko, Eva Galindez
dc.contributor.authorpl
Korkosz, Mariusz - 130283
dc.contributor.authorpl
Schwartzman, Sergio
dc.contributor.authorpl
Sprabery, Aubrey Trevelin
dc.contributor.authorpl
Gellett, Amanda M.
dc.contributor.authorpl
Park, So Young
dc.contributor.authorpl
Bertram, Clinton C.
dc.contributor.authorpl
Ogdie, Alexis
dc.date.accessionpl
2022-06-03
dc.date.accessioned
2022-06-06T03:12:16Z
dc.date.available
2022-06-06T03:12:16Z
dc.date.issuedpl
2022
dc.date.openaccess
0
dc.description.accesstime
w momencie opublikowania
dc.description.numberpl
3
dc.description.physicalpl
919-933
dc.description.version
ostateczna wersja wydawcy
dc.description.volumepl
9
dc.identifier.doipl
10.1007/s40744-022-00445-w
dc.identifier.eissnpl
2198-6584
dc.identifier.issnpl
2198-6576
dc.identifier.uri
https://ruj.uj.edu.pl/xmlui/handle/item/292676
dc.identifier.weblinkpl
https://link.springer.com/article/10.1007/s40744-022-00445-w
dc.languagepl
eng
dc.language.containerpl
eng
dc.pbn.affiliation
Dziedzina nauk medycznych i nauk o zdrowiu : nauki medyczne
dc.rights
Udzielam licencji. Uznanie autorstwa - Użycie niekomercyjne 4.0 Międzynarodowa
dc.rights.licence
CC-BY-NC
dc.rights.uri
http://creativecommons.org/licenses/by-nc/4.0/legalcode.pl
dc.share.type
Otwarte czasopismo
dc.subject.en
ixekizumab
dc.subject.en
psoriatic arthritis
dc.subject.en
sex differences
dc.subject.en
women’s health
dc.subject.en
outcome measures
dc.subtypepl
Article
dc.titlepl
Responses to ixekizumab in male and female patients with psoriatic arthritis : results from two randomized, phase 3 clinical trials
dc.title.journalpl
Rheumatology and Therapy
dc.typepl
JournalArticle
dspace.entity.type
Publication
Affiliations

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