Friday, 17 Nov 2017

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 - 17 November 2017

Dr. Jack Cush reviews the news and highlights from the past week on RheumNow.com. This week he covers FDA warnings on gout drugs, steroid use in Australia, biosimilars lost savings and methotrexate hepatotoxicity in psoriatic arthritis (PsA).

Podcast of ACR17 - Day 4

Care to learn what you missed at last weeks ACR 2017 meeting in San Diego?  Here are 4 one hour audio podcasts - each with a compliation of 2-4 minute reports from Drs. Cush, Kavanaugh, the RheumNow Faculty and other rheumatology thought leaders and researchers.  Another good way to learn from RheumNow.

The ACR17 RheumNow Week in Review - 10 November 2017

This special edition of the RheumNow Week in Review covers highlights of selected sessions from the 2017 ACR annual meeting in San Diego. Dr. Jack Cush reviews lupus and the microbiome, daily podcasts, pregnancy and lactation, osteoporosis drug holidays and screening for pulmonary hypertension.

Many thanks to the RheumNow Faculty for their work and expertise!

Podcast of ACR 17 - Day 3

Check out this compilation of our ACR17 Day 3 broadcasts, merged into a single one hour podcast !

ACR 2017 - Day 3 and 4 Highlights

Day 3 at the annual meeting was rich with information. Yet the most anticipated and best attended session was the Late Breaking Abstracts and the session revealing the new ACR/NPF Guidelines for Psoriatic Arthritis (more on the latter in another report).  Day 4 was full of review sessions and a modicum of original content and for me, the 7:30AM Rheumatology Roundup.