Friday, 20 Apr 2018

You are here

New insights into the impact of pegloticase in chronic refractory gout

Pegloticase is indicated for treatment of patients with refractory gout. One major issue hampering the comfort levels of rheumatologists to use this agent is the boxed warning in the package insert regarding the documentation of anaphylaxis with the infusions. It is well known that treatment with pegloticase is associated with the development of anti-drug antibodies, which are believed to belie these reactions. 

Abstract THU0438 by Drs. Calabrese, Kavanaugh, Yeo, and Lipsky is a study taking a deep dive into all the infusion reactions encountered during the pegloticase trials where each reaction was adjudicated post hoc and the relationship to whether the patients continued to have their uric acid suppressed (a surrogate of lack of antidrug antibodies) or whether they were failing (a surrogate for the presence of anti-drug antibodies) was explored. The NIAID/FAAN criteria were used to classify infusion reactions. 

The bottom and surprising line is that in the cohort receiving pegloticase q 2 weeks (as recommended in the PI) and who maintained uric acid suppression (i.e., the way we do in clinical practice) the rate of infusion reactions of any kind was 0.5% or 1 in 200 infusions. Furthermore, in this group there were no cases of anaphylaxis.

Lastly, among the 6 cases of ‘anaphylaxis’ among the over 1600 infusions none were fatal or even serious (i.e., requiring advanced support) and 3 of the patients stayed in the trial. It appears that when pegloticase is used correctly it has an excellent safety profile and these data should be reassuring. 

 

L Calabrese, A. Kavanaugh, A Yeo, P Lipsky
Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

The RheumNow Week in Review – Vitamin D Snark Report (4.20.18)

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com.  A second life for Syk kinase, Vitamin D talk, VTE, regulatory hearings and the Lupus clinic edge.

RheumNow Week in Review - Do you Dig Shingrix? (4.6.2018)

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com. Highlights includes manpower shortfalls, comorbidities in AA Lupus, certolizumab pregnancy safety, which Shingles vaccine is best and the power of combination biologics in severe refractory  SLE.

"Breakthrough" Drug Designation by the FDA

The current issue of the NEJM reviews the Food and Drug Administration (FDA) “breakthrough therapy” designation that was introduced in 2012 to expedite testing and approval of medications that were intended to treat serious or life-threatening conditions.  This status is granted when preliminary evidence with a new drug suggests substantial benefits over existing therapies for these unfortunate conditions.

ACR Projects Significant Manpower Shortages for 2030

Arthritis & Rheumatology has published the results of the 2015 Workforce Study of Rheumatology Specialists, and estimates a current shortage (demand > supply) of 700 (12.9%) full-time rheumatologists and that this deficit will worsen (102%) to 4133 FTE by 2030.

RheumNow Week in Review -The Temporal Artery Biopsy Letdown (4.6.2018)

Dr. Jack Cush reviews the news and journal reports from the past week on RheumNow.com. News on the cost of RA care, infections on planes, CV events and Sacroiliitis in IBD, NXP-2 antibodies and calcinosis and rituximab in myositis ILD patients.