Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis. (16th November 2012)

• Record Type: Journal Article
• Authors: Langley, R.G.; Papp, K.; Gottlieb, A.B.; Krueger, G.G.; Gordon, K. B.; Williams, D.; Valdes, J.; Setze, C.; Strober, B.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 27:Number 10(2013:Oct.)
• Page Start: 1252
• Page End: 1261
• Publication Date: 2012-11-16
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/j.1468-3083.2012.04705.x
• Languages: English
• ISSNs: 0926-9959

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <p> <bold>Background </bold> Anti‐interleukin‐12/23 treatment (anti‐IL‐12/23) has recently demonstrated significant efficacy for moderate to severe psoriasis, yet potential safety signals warrant further investigation.</p> <p> <bold>Objectives </bold> Expand safety findings for the anti‐IL‐12/23, briakinumab, beyond individual phase II and III clinical trials.</p> <p> <bold>Methods </bold> Safety data pooled from five phase II and III clinical trials (parent studies) and an open‐label extension study (OLE), through 22 October 2010; patients with ≥1 dose of briakinumab in a parent study or the OLE are included. All parent study briakinumab treatment groups were combined with the OLE population, which received 100‐mg briakinumab every 4 weeks. Adverse events (AEs) were collected from the first dose of briakinumab, whether in a parent study or the OLE, through 45 days post‐last dose.</p> <p> <bold>Results </bold> Two thousand five hundred and twenty patients (4704 patient‐years drug exposure) received ≥1 dose of briakinumab during the interim period: 5.6% withdrew due to AEs. Serious infections occurred in 1.3% and malignancies in 2.6% (including 1.0% basal cell carcinoma, 0.8% squamous cell carcinoma). Twenty‐seven major adverse cardiovascular events (MACE) occurred, seven in one parent study and 20 in the OLE (incidence = 0.57 events/100 PY). Four cardiovascular risk factors were retrospectively found to be significant predictors for MACE during briakinumab exposure: history of cardiovascular disease, diabetes, body mass index (≥30) and baseline blood pressure (systolic ≥140 or diastolic ≥90).</p> <p> <bold>Conclusions </bold> Pooled briakinumab safety results from five parent studies and an OLE suggest increased rates of infections, malignancies and MACE, and that patients receiving anti‐IL‐12/23 treatment for moderate to severe psoriasis should be monitored for these potential safety signals.</p> </abstract>