Abstract
BackgroundThe efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA).MethodsPatients with active PsA who were biologic-naive (SPIRIT-P1) or had prior inadequate response to tumor necrosis factor inhibitors (SPIRIT-P2) were randomized to 80 mg IXE every 4 (IXE Q4W) or 2 weeks (IXE Q2W), after a 160-mg initial dose. In this post hoc analysis, efficacy and safety were assessed up to week 52 in the subgroups of patients who received (i) IXE as monotherapy and (ii) IXE along with a stable dose of MTX (no dose tapering or increase). Efficacy outcomes included, but were not limited to, the percentage of patients achieving the American College of Rheumatology (ACR) responses.ResultsOut of 455 patients initially randomized to IXE, 177 (38.9%) received monotherapy, 230 (50.5%) had concomitant MTX use, and 48 (10.5%) had other concomitant medication. Overall, 183 (40.2%) received IXE with a stable dose of concomitant MTX for 1 year. At week 52, the percentage of patients achieving ACR20/50/70 responses in IXE Q4W monotherapy versus concomitant MTX groups were 66.3% versus 55.3%, 48.4% versus 38.8%, and 35.8% versus 27.1%, respectively; these responses were generally similar with IXE Q2W. The safety profiles were similar between patients receiving IXE with or without concomitant MTX.ConclusionsIn this post hoc analysis, treatment with IXE demonstrated sustained efficacy in patients with PsA up to 1 year of treatment, with or without concomitant MTX therapy.Trial registrationClinicalTrials.gov NCT01695239 and NCT02349295.
Highlights
The efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA)
The current treatment guidelines from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis suggests tumor necrosis factor inhibitors (TNFi) along with disease-modifying antirheumatic drugs (DMARDs, such as methotrexate [MTX]) as firstline treatment for PsA, whereas the European League Against Rheumatism (EULAR) 2019 recommends using conventional synthetic DMARDs followed by TNFi for the treatment of PsA [3, 4]
Safety outcomes included the proportion of patients experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and prespecified Adverse event (AE) of special interest. Statistical methods This post hoc, integrated subgroup analysis included all patients initially randomized to IXE at week 0 from the Results A total of 455 patients were included in this analysis, of whom 177 (38.9%) patients received IXE monotherapy for up to a year of treatment
Summary
The efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA). Psoriatic arthritis (PsA) is a chronic inflammatory condition that predominantly affects peripheral joints and is associated with peri-articular and extra-articular manifestations. Treatment of this disease can be challenging because of its known complex nature and heterogeneous presentation [1, 2]. Methotrexate is approved for the treatment of psoriasis [5] It is used as a first-line treatment for rheumatoid arthritis and is widely used off-label for the treatment of PsA either as monotherapy or in combination with biologics such as TNFi. there are limited data to establish its efficacy in the treatment of PsA by itself [6]. In the methotrexate in psoriatic arthritis (MIPA) trial, no statistically significant difference was found between MTX-treated patients and placebo-treated patients [7]
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