Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors : 3-Year Follow-Up (SPIRIT-P2)
Orbai, Ana-Maria (Johns Hopkins University School of Medicine)
Gratacós, Jordi (Universitat Autònoma de Barcelona. Departament de Medicina)
Turkiewicz, Anthony (Rheumatology Associates Clinical Research Unit (Birmingham, Estats Units))
Hall, Stephen (Monash University)
Dokoupilova, Eva (Masaryk University. Department of Pharmaceutical Technology, Faculty of Pharmacy)
Combe, Bernard (CHU Montpellier and Montpellier University)
Nash, Peter (Griffith University. School of Medicine)
Gallo, Gaia (Eli Lilly and Company)
Bertram, Clinton C. (Eli Lilly and Company)
Gellett, Amanda M. (Eli Lilly and Company)
Sprabery, Aubrey Trevelin (Eli Lilly and Company)
Birt, Julie (Eli Lilly and Company)
Macpherson, Lisa (Eli Lilly and Company)
Geneus, Vladimir J. (Eli Lilly and Company)
Constantin, Arnaud (Université Toulouse III)

Data:	2020
Resum:	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. 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. 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). 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. ClinicalTrials. gov identifier: NCT02349295. The online version of this article (10. 1007/s40744-020-00261-0) contains supplementary material, which is available to authorized users.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Estudi clínic ; recerca ; Versió publicada
Matèria:	Efficacy ; Interleukin-17A ; Ixekizumab ; Psoriatic arthritis ; Safety
Publicat a:	Rheumatology and Therapy, Vol. 8 (march 2021) , p. 199-217, ISSN 2198-6584

DOI: 10.1007/s40744-020-00261-0
PMID: 33278016

19 p, 1.8 MB

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