Show simple item record

dc.contributor.authorMease, Philip
dc.contributor.authorRoussou, Euthalia
dc.contributor.authorBurmester, Gerd-Ruediger
dc.contributor.authorGoupille, Philippe
dc.contributor.authorGottlieb, Alice
dc.contributor.authorMoriarty, Susan R
dc.contributor.authorBenichou, Olivier
dc.contributor.authorAdams, David H
dc.contributor.authorXu, Wen
dc.contributor.authorNash, Peter
dc.date.accessioned2020-08-24T01:36:37Z
dc.date.available2020-08-24T01:36:37Z
dc.date.issued2019
dc.identifier.issn2151-464X
dc.identifier.doi10.1002/acr.23738
dc.identifier.urihttp://hdl.handle.net/10072/396671
dc.description.abstractObjective: To evaluate ixekizumab safety in adults with psoriatic arthritis (PsA). Methods: Safety data from 2 integrated data sets are presented: 1) 24-week, double-blind, placebo-controlled period of SPIRIT-P1 and SPIRIT-P2; and 2) all ixekizumab-treated patients of SPIRIT-P1 and SPIRIT-P2 plus SPIRIT-P3 open-label period. We report adverse event (AE) frequency and exposure-adjusted incidence rates per 100 patient-years at 12-week intervals to week 96. Results: The placebo-controlled period had 678 patients (safety population): 224 placebo, 229 ixekizumab every 4 weeks, and 225 ixekizumab every 2 weeks. Overall, 1,118 patients received ixekizumab (total exposure 1,373.4 patient-years). In the placebo-controlled period, the frequencies of ixekizumab-treated patients experiencing ≥1 treatment-emergent AE (TEAE) and those experiencing serious AEs were 68.1% (56.7% placebo) and 4.4% (2.7% placebo), respectively. Injection site reactions (ISRs) were very common (21.4% ixekizumab [4.5% placebo]), with ISR discontinuation rates of 1.1% (ixekizumab) and 0.4% (placebo). Through week 96, the incidence rates of ISRs decreased with increasing ixekizumab exposure. The frequencies of AEs of special interest were 32.8% (ixekizumab) and 27.7% (placebo); for serious infections, the frequencies were 1.3% and 0%, respectively; Candida infections, 2.6% and 0.4%; confirmed major adverse cardiac events, 0% and 0%; malignancy, 0.4% and 0%; hypersensitivities, 5.3% and 1.8%; and depression-related, 1.8% and 1.3%. The frequency of Crohn's disease and ulcerative colitis (investigator-reported) was 0% in both groups, and the frequencies of sponsor-determined inflammatory bowel disease were 0.2% in the ixekizumab group and 0% in the placebo group. Overall, no active tuberculosis, invasive Candida infections, anaphylaxis, or suicide/self-injury behaviors were reported. Conclusion: The PsA ixekizumab safety integrated data set reached 1,373.4 patient-years total exposure. Ixekizumab-treated patients had higher rates of overall TEAEs, serious infections, mucocutaneous Candida, hypersensitivities (non-anaphylactic), and ISRs than placebo-treated patients. No unexpected safety outcomes were reported.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherWiley
dc.relation.ispartofpagefrom367
dc.relation.ispartofpageto378
dc.relation.ispartofissue3
dc.relation.ispartofjournalArthritis Care and Research
dc.relation.ispartofvolume71
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchHealth services and systems
dc.subject.fieldofresearchPublic health
dc.subject.fieldofresearchPsychology
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode4203
dc.subject.fieldofresearchcode4206
dc.subject.fieldofresearchcode52
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsRheumatology
dc.subject.keywordsCARDIOVASCULAR EVENTS
dc.subject.keywordsMONOCLONAL-ANTIBODY
dc.titleSafety of Ixekizumab in Patients With Psoriatic Arthritis: Results From a Pooled Analysis of Three Clinical Trials
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationMease, P; Roussou, E; Burmester, G-R; Goupille, P; Gottlieb, A; Moriarty, SR; Benichou, O; Adams, DH; Xu, W; Nash, P, Safety of Ixekizumab in Patients With Psoriatic Arthritis: Results From a Pooled Analysis of Three Clinical Trials, Arthritis Care and Research, 2019, 71 (3), pp. 367-378
dcterms.dateAccepted2018-08-21
dcterms.licensehttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.date.updated2020-08-24T01:34:30Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© 2018, The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
gro.hasfulltextFull Text
gro.griffith.authorNash, Peter


Files in this item

This item appears in the following Collection(s)

  • Journal articles
    Contains articles published by Griffith authors in scholarly journals.

Show simple item record