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.
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| http://dx.doi.org/10.1007/s40744-020-00261-0 | DOI Listing |
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Improvement in spinal pain at night and its impact on long-term outcomes in radiographic axial spondyloarthritis: Results from Ixekizumab COAST-V randomised trial.
Semin Arthritis Rheum
December 2024
Institute of Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan; Department of Nursing, Chung Shan Medical University, Taichung, Taiwan; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan; Department of Allergy, Immunology, and Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan.
Introduction: Spinal pain at night is a major contributor to the patient burden of radiographic axial spondyloarthritis (r-axSpA), resulting in substantial functional limitations and impairment of health-related quality of life (QoL). Ixekizumab (IXE), an interleukin-17A inhibitor, has shown efficacy in patients with r-axSpA.
Objective: To assess spinal pain at night improvement up to week (W) 52 in COAST-V and to determine if clinically important improvement in spinal pain at night at W16 is associated with improvement in disease activity and other patient-reported outcomes (PROs) at W16 and W52.
Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Psoriasis and Special Body Area Involvement: Sub-analysis of a Randomized, Double-Blind, Multicenter Phase 3 Study.
Adv Ther
September 2024
Department of Dermatology, School of Medicine, Rui Jin Hospital, Shanghai Jiao Tong University, 197, Rui Jin Er Road, Shanghai, 200025, China.
Article Synopsis
- The study examined the effectiveness of ixekizumab (IXE) in treating moderate-to-severe psoriasis with special body area involvement (fingernails, scalp, palms) among Chinese patients.
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Ixekizumab Demonstrates Rapid and Consistent Efficacy for Patients with Psoriatic Arthritis, Regardless of Psoriasis Severity.
Dermatol Ther (Heidelb)
June 2024
Department of Rheumatology, University Hospitals Leuven, Louvain, Belgium.
Introduction: Skin involvement in patients with psoriatic arthritis (PsA) worsens the severity and burden of disease. Ixekizumab (IXE), a selective interleukin (IL)-17A antagonist, was compared to placebo (PBO) in the SPIRIT-P1 (NCT01695239) and SPIRIT-P2 (NCT02349295) studies in patients with PsA and evidence of plaque psoriasis. This post hoc analysis reports musculoskeletal, skin, and nail outcomes through week 24 in patients from SPIRIT-P1 and SPIRIT-P2, stratified by mild, moderate, or psoriasis at baseline.
View Article and Find Full Text PDFPharmacokinetics, Safety, and Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 1, Single- and Multiple-Dose Study.
Adv Ther
September 2023
Department of Dermatology, School of Medicine, Rui Jin Hospital, Shanghai Jiao Tong University, 197, Rui Jin Er Road, Shanghai, 200025, China.
Introduction: We evaluated the pharmacokinetics (PK), safety, and efficacy of ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, in Chinese patients with moderate-to-severe psoriasis.
Methods: In this phase 1, multicenter, open-label study, adults (≥ 18 years) diagnosed with moderate-to-severe plaque psoriasis for ≥ 6 months involving ≥ 10% of their body surface area received ixekizumab 80 mg by subcutaneous injection and were observed for 20 weeks (single-dose phase) and then an initial dose of 160 mg followed by randomization (1:1) to 80 mg ixekizumab every 2 weeks (IXE Q2W) or every 4 weeks (IXE Q4W) for an 8-week treatment period (multiple-dose phase).
Results: The median time to maximum observed ixekizumab concentrations occurred 2-4 days after dosing and the geometric mean half-life was 15-16 days, after single (n = 12) and multiple (n = 29) doses.
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