Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2)

Autor: Lisa Macpherson, Stephen Hall, Anthony M. Turkiewicz, Julie Birt, Amanda M. Gellett, Jordi Gratacós, Eva Dokoupilova, Bernard Combe, Arnaud Constantin, Gaia Gallo, Peter Nash, Aubrey Trevelin Sprabery, Clinton C. Bertram, Vladimir Geneus, Ana Maria Orbai
Přispěvatelé: Johns Hopkins University School of Medicine [Baltimore], Hospital Parc Taulí, Universitat Autònoma de Barcelona (UAB), Monash University [Melbourne], Masaryk University [Brno] (MUNI), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Griffith University [Brisbane], Eli Lilly and Company [Indianapolis], Hôpital Pierre-Paul Riquet [Toulouse], CHU Toulouse [Toulouse], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Rheumatology and Therapy
Rheumatology and Therapy, Springer, 2021, 8 (1), pp.199-217. ⟨10.1007/s40744-020-00261-0⟩
ISSN: 2198-6576
2198-6584
DOI: 10.1007/s40744-020-00261-0⟩
Popis: Purpose 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. Electronic supplementary material The online version of this article (10.1007/s40744-020-00261-0) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
Externí odkaz: