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dc.contributor.authorOrbai, Ana-Maria
dc.contributor.authorGratacós, Jordi
dc.contributor.authorTurkiewicz, Anthony
dc.contributor.authorHall, Stephen
dc.contributor.authorDokoupilova, Eva
dc.contributor.authorCombe, Bernard
dc.contributor.authorNash, Peter
dc.contributor.authorGallo, Gaia
dc.contributor.authorBertram, Clinton C
dc.contributor.authorGellett, Amanda M
dc.contributor.authorSprabery, Aubrey Trevelin
dc.contributor.authorBirt, Julie
dc.contributor.authorMacpherson, Lisa
dc.contributor.authorGeneus, Vladimir J
dc.contributor.authorConstantin, Arnaud
dc.date.accessioned2020-12-08T04:55:34Z
dc.date.available2020-12-08T04:55:34Z
dc.date.issued2020
dc.identifier.issn2198-6576
dc.identifier.doi10.1007/s40744-020-00261-0
dc.identifier.urihttp://hdl.handle.net/10072/400066
dc.description.abstractPurpose: Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A. The objective of this study was to assess the long-term efficacy and safety (to week 156) of ixekizumab in patients with active psoriatic arthritis and inadequate response or intolerance to one or two tumor necrosis factor inhibitors. Methods: In the SPIRIT-P2 study (ClinicalTrials.gov ID: NCT02349295), patients were randomized to placebo or ixekizumab 80 mg every 4 weeks (IXE Q4W) or every 2 weeks (IXE Q2W) following a 160-mg starting dose. During the extension period (weeks 24-156), patients maintained their original ixekizumab dose, and placebo patients received IXE Q4W or IXE Q2W (1:1). Exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) are presented. Results: Of 363 patients enrolled in the study, 310 entered the extension period. In all patients treated with IXE Q4W and IXE Q2W at week 0, responses persisted to week 156. At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA. Placebo patients re-randomized to ixekizumab also demonstrated sustained efficacy, as measured by ACR and MDA responses. In the All Ixekizumab Exposure Safety Population (n = 337), with 644 PY of ixekizumab exposure, treatment-emergent adverse events (TEAEs) were reported by 286 patients (44.4 IR). The most common TEAEs were upper respiratory tract infection (9.80 IR), nasopharyngitis (8.2 IR), sinusitis (6.2 IR), and bronchitis (4.5 IR). Serious adverse events were reported by 42 (6.5 IR) patients (included 3 deaths and 10 infections). Conclusion: In this 156-week study of ixekizumab, improvements in signs and symptoms of psoriatic arthritis and the safety profile remained consistent with those in previous reports. Trial registration: ClinicalTrials.gov identifier: NCT02349295.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherSpringer Science and Business Media LLC
dc.relation.ispartofjournalRheumatology and Therapy
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchcode3202
dc.subject.keywordsEfficacy
dc.subject.keywordsInterleukin-17A
dc.subject.keywordsIxekizumab
dc.subject.keywordsPsoriatic arthritis
dc.subject.keywordsSafety
dc.titleEfficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationOrbai, A-M; Gratacós, J; Turkiewicz, A; Hall, S; Dokoupilova, E; Combe, B; Nash, P; Gallo, G; Bertram, CC; Gellett, AM; Sprabery, AT; Birt, J; Macpherson, L; Geneus, VJ; Constantin, A, Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)., Rheumatology and Therapy, 2020
dcterms.dateAccepted2020-11-16
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2020-12-08T03:51:48Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© The Author(s), 2020. This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
gro.hasfulltextFull Text
gro.griffith.authorNash, Peter


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