Safety of Ixekizumab in Patients With Psoriatic Arthritis: Results From a Pooled Analysis of Three Clinical Trials

Abstract

The PsA ixekizumab safety integrated dataset reached 1373.4 PY total exposure. Ixekizumab-treated patients had higher rates of overall TEAEs, serious infections, mucocutaneous Candida, hypersensitivities (non-anaphylactic), and ISRs than placebo. No unexpected safety outcomes were reported. This article is protected by copyright. All rights reserved.

Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis

“…The IR of CEC-confirmed MACE was 0.6/100 PY, with no trend for an increase with increasing IXE exposure. These findings are consistent with that reported in a pooled safety analysis of IXE from 3 clinical trials (0.7/100PY) [7].…”

“…Patients with latent TB were allowed into the clinical trials if treatment was completed per the standard guidelines or were ongoing at the time of study inception; 32 (1.8/100PY) had treatment-emergent latent TB infection. There were no cases of TB reactivation or active TB in the PsA clinical program [7]. Several analyses, primarily from the European registries for biologics, have reported the association between TNF-α inhibitor administration and risk of TB infections; this is particularly true for anti-TNF monoclonal antibodies such as infliximab and ADA when compared with etanercept [19][20][21].…”

“…* 95% CI was not evaluated for IBD. AE: adverse event; CEC: Clinical Events Committee; CI: confidence interval; IBD: inflammatory bowel disease; IR: incidence rate; IXE: ixekizumab; MACE: major adverse cardiovascular events; MedDRA: Medical Dictionary for Regulatory Activities; Ns: number of patients entered in each time interval; n: number in group; PBO: placebo; PY: patient-years; Q2W: every 2 weeks; Q4W: every 4 weeks; TEAEs: treatment-emergent adverse events frequent TEAEs [7]; the IR for these events decreased with an increase in the duration of IXE exposure. This is consistent with the pattern observed in the psoriasis clinical trials and with the findings associated with the use of secukinumab in PsA [9,10].…”

“…A previously published integrated analysis paper by Mease et al, from three clinical trials showed no unexpected safety signals with IXE treatment up to week 96 [7]. We report the results of integrated analysis that evaluated long-term safety and tolerability of up to 3 years of exposure to IXE using data from three clinical trials for 1822.2 patient-years (PY) in patients with active PsA.…”

Interleukin‐17 Inhibition in Spondyloarthritis Is Associated With Subclinical Gut Microbiome Perturbations and a Distinctive Interleukin‐25–Driven Intestinal Inflammation

“…Taken together, our results suggest that IL‐17i–induced CD is driven by divergent pathways compared to typical, “idiopathic” CD. It is, however, essential to note that while IBD exacerbation was frequently observed following IL‐17i in CD studies (up to 10%) , exacerbations of (or de novo) IBD occurred in <1% of SpA patients enrolled in randomized clinical trials . Nevertheless, several confirmed cases in routine clinical practice have since been reported .…”