Wednesday, 21 Nov 2018

You are here

IL-23 Inhibitor Fails in Ankylosing Spondylitis

A study of the IL-23 risankizumab in active ankylosing spondylitis (AS) patients failed to show efficacy and did not meet primary efficacy endpoints in a 6-month trial.

Risankizumab (RIZ) is a new, humanised anti-IL-23 monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23). It was studied in a 24-week trial involving 159 biologic-naïve, active AS patients. The primary outcome was a 40% improvement in Assessment in Spondylo Arthritis International Society (ASAS40) at week 12. 

In this placebo-controlled trial, the ASAS40 response rates were nearly the same for all groups 25.5%, 20.5%, 15.0%, and 17.5% (RIZ 18 mg, 90 mg, 180 mg and placebo groups). Adverse event rates were similar in all treatment groups.

While IL-23 inhibition (with this agent and another-guselkumab) has shown significant efficacy and benefits in cutaneous psoriasis and psoratic arthritis, the same has not been shown for patients with AS or axial spondyloarthritis. This in contrast to the efficacy of biologic inhibition of IL-17 (eg, secukinumab) and IL-12/23 (ustekinumab) that have shown efficay in SpA.

These data suggest that IL-23 alone may not be a primary driver of inflammation in AS.

The author has received compensation as an advisor or consultant on this subject

Add new comment

More Like This

First FDA Approved Drug for HLH

The first drug specifically for primary hemophagocytic lymphohistiocytosis (HLH) was approved today, the FDA announced.

Emapalumab (Gamifant), manufactured by Novimmune SA, may be used in all patients (including newborns and older children) "who have refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy," the FDA said.

Should Immunoglobulins be Monitored with Rituximab Use?

Boston researchers have found that in a large cohort study of patients receiving rituximab (RTX), most were not being monitored for hypogammaglobulinemia, despite the observed significant increase in severe infections and increased mortality in RTX treated patients.

IL-6 for Adult Still's: A New Option?

Some clinical benefits were seen among patients with adult-onset Still's disease treated with tocilizumab (Actemra) in a small clinical trial, but the study's primary endpoint was not met, Japanese researchers reported.

Unproven But Profitable Stem Cell Clinics

Stem cell clinics are popular and proliferating as they are largely a cash business and fall outside of FDA regulatory control. In lieu of scientific proof, most advocates use patient testimonials and the placebo effect to back up their claims.

Out of Pocket Costs for Biosimilars - No Savings So Far

JAMA has published an analysis showing that under Medicare Part D, RA biosimilar infliximab-dyyb was only moderately less expensive (18% less) than the biologic infliximab and, owing to differences in gap discounts, the out of pocket costs for the biosimilar was nearly $1700 more than infliximab in 2017.