To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (r-axSpA) and prior inadequate response or intolerance to 1 or 2 TNF inhibitors (TNFi).

Objective: To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (SpA) and prior inadequate response to or intolerance of 1 or 2 tumor necrosis factor inhibitors (TNFi). Methods: In this phase III randomized, double-blind, placebo-controlled trial, adult patients with an inadequate response to or intolerance of 1 or 2 TNFi and an established diagnosis of axial SpA (according to the Assessment of SpondyloArthritis international Society [ASAS] criteria for radiographic axial SpA, with radiographic sacroiliitis defined according to the modified New York criteria and ≥1 feature of SpA) were recruited and randomized 1:1:1 to receive placebo or 80-mg subcutaneous ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W), with an 80-mg or 160-mg starting dose. The primary end point was 40% improvement in disease activity according to the ASAS criteria (ASAS40) at week 16. Secondary outcomes and safety were also assessed. Results: A total of 316 patients were randomized to receive placebo (n = 104), IXEQ2W (n = 98), or IXEQ4W (n = 114). At week 16, significantly higher proportions of IXEQ2W patients (n = 30 [30.6%]; P = 0.003) or IXEQ4W patients (n = 29 [25.4%]; P = 0.017) had achieved an ASAS40 response versus the placebo group (n = 13 [12.5%]), with statistically significant differences reported as early as week 1 with ixekizumab treatment. Statistically significant improvements in disease activity, function, quality of life, and spinal magnetic resonance imaging–evident inflammation were observed after 16 weeks of ixekizumab treatment versus placebo. Treatment-emergent adverse events (AEs) with ixekizumab treatment were more frequent than with placebo. Serious AEs were similar across treatment arms. One death was reported (IXEQ2W group). Conclusion: Ixekizumab treatment for 16 weeks in patients with active radiographic axial SpA and previous inadequate response to or intolerance of 1 or 2 TNFi yields rapid and significant improvements in the signs and symptoms of radiographic axial SpA versus placebo.

Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors / Deodhar, Atul; Poddubnyy, Denis; Pacheco-Tena, Cesar; Salvarani, Carlo; Lespessailles, Eric; Rahman, Proton; Järvinen, Pentti; Sanchez-Burson, Juan; Gaffney, Karl; Lee, Eun Bong; Krishnan, Eswar; Santisteban, Silvia; Li, Xiaoqi; Zhao, Fangyi; Carlier, Hilde; Reveille, John D. - In: ARTHRITIS & RHEUMATOLOGY. - ISSN 2326-5205. - 71:4(2019), pp. 599-611.

Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors

Salvarani, Carlo;
2019

Abstract

To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (r-axSpA) and prior inadequate response or intolerance to 1 or 2 TNF inhibitors (TNFi).
8-mar-2019
71
4
599
611
Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors / Deodhar, Atul; Poddubnyy, Denis; Pacheco-Tena, Cesar; Salvarani, Carlo; Lespessailles, Eric; Rahman, Proton; Järvinen, Pentti; Sanchez-Burson, Juan; Gaffney, Karl; Lee, Eun Bong; Krishnan, Eswar; Santisteban, Silvia; Li, Xiaoqi; Zhao, Fangyi; Carlier, Hilde; Reveille, John D. - In: ARTHRITIS & RHEUMATOLOGY. - ISSN 2326-5205. - 71:4(2019), pp. 599-611.
Deodhar, Atul; Poddubnyy, Denis; Pacheco-Tena, Cesar; Salvarani, Carlo; Lespessailles, Eric; Rahman, Proton; Järvinen, Pentti; Sanchez-Burson, Juan; Gaffney, Karl; Lee, Eun Bong; Krishnan, Eswar; Santisteban, Silvia; Li, Xiaoqi; Zhao, Fangyi; Carlier, Hilde; Reveille, John D
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11380/1167256
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