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dc.contributor.authorKivitz, Alan J
dc.contributor.authorNash, Peter
dc.contributor.authorTahir, Hasan
dc.contributor.authorEverding, Andrea
dc.contributor.authorMann, Herman
dc.contributor.authorKaszuba, Andrzej
dc.contributor.authorPellet, Pascale
dc.contributor.authorWidmer, Albert
dc.contributor.authorPricop, Luminita
dc.contributor.authorAbrams, Ken
dc.date.accessioned2020-08-24T00:20:55Z
dc.date.available2020-08-24T00:20:55Z
dc.date.issued2019
dc.identifier.issn2198-6576
dc.identifier.doi10.1007/s40744-019-0163-5
dc.identifier.urihttp://hdl.handle.net/10072/396664
dc.description.abstractIntroduction: To assess the efficacy and safety of the subcutaneous (s.c.) secukinumab 150 mg with loading (150 mg) or without loading (150 mg no-load) regimen through 104 weeks in patients with active psoriatic arthritis (PsA) in the FUTURE 4 (NCT02294227) study. Methods: Patients with PsA (N = 341) were randomized to s.c. secukinumab 150 mg, 150 mg no-load or placebo at baseline, weeks 1, 2, 3 and every 4 weeks thereafter. All placebo patients were reassigned to secukinumab 150 mg no-load at either week 16 (non-responders) or week 24 (responders). The primary end point was ACR20 at week 16. Patients could have their dose escalated from 150 to 300 mg based on their physician's decision starting at week 36. Pre- and post-escalation ACR and PASI responses were also assessed. Results: A total of 95.6% (326/341), 84.5% (288/341) and 79.8% (272/341) patients completed 16, 52 and 104 weeks of treatment, respectively. The primary end point was met; ACR20 response rate at week 16 was 41.2% and 39.8% with the 150 mg and 150 mg no-load groups, respectively, versus placebo (18.4%; adjusted P value = 0.0003 for both treatment arms). Efficacy responses observed at week 16 in both treatment regimens were sustained up to week 52 and 104, with many patients continuing to show improvements up to week 104. After dose escalation to 300 mg, the proportion of patients with non-/low-level ACR/PASI response decreased with increasing proportions of patients having higher ACR/PASI responses. No new or unexpected safety signals were reported. Conclusion: The secukinumab 150 mg or 150 mg no-load regimen demonstrated significant and sustained improvements in the signs and symptoms of psoriatic arthritis through 104 weeks; the loading regimen was associated with numerically higher and earlier responses for some high-hurdle end points. Improved efficacy was observed upon dose escalation from 150 to 300 mg. The safety profile was consistent with previous reports. Trial Registration: ClinicalTrials.gov identifier, NCT02294227. FUNDING: Novartis Pharma AG, Basel, Switzerland.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherSpringer
dc.relation.ispartofpagefrom393
dc.relation.ispartofpageto407
dc.relation.ispartofissue3
dc.relation.ispartofjournalRheumatology and Therapy
dc.relation.ispartofvolume6
dc.subject.fieldofresearchRheumatology and arthritis
dc.subject.fieldofresearchImmunology
dc.subject.fieldofresearchcode320223
dc.subject.fieldofresearchcode3204
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsRheumatology
dc.subject.keywordsBiologics
dc.subject.keywordsEfficacy
dc.titleEfficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationKivitz, AJ; Nash, P; Tahir, H; Everding, A; Mann, H; Kaszuba, A; Pellet, P; Widmer, A; Pricop, L; Abrams, K, Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study, Rheumatology and Therapy, 2019, 6 (3), pp. 393-407
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2020-08-24T00:17:56Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© The Author(s) 2019. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
gro.hasfulltextFull Text
gro.griffith.authorNash, Peter


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