ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 1187

A Large-Scale, Multicenter, Prospective, Open-Label, 6-Month Study To Evaluate The Safety Of Allopurinol Monotherapy In Patients With Gout

Michael A. Becker1, David Fitz-Patrick2, Chris Storgard3, Matt Cravets4 and Scott Baumgartner5, 1Medicine, University of Chicago, Chicago, IL, 2East-West Medical Research Institute, Honolulu, HI, 34939 Directors Place, Ardea Bioscience, San Diego, CA, 4Ardea Biosciences, Inc., San Diego, CA, 5Ardea Biosciences, San Diego, CA

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: gout, rheumatologic practice, treatment and uric acid

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Title: Metabolic and Crystal Arthropathies I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Documentation of the safety profile of allopurinol at doses ≥300 mg/day is important for its ongoing use as first-line monotherapy or in combination with newer agents. Current data are limited. This study examined the safety profile of allopurinol titrated as described below (ClinicalTrials.gov Identifier: NCT01391325). 

Methods: Patients meeting ARA criteria for the Classification of Acute Arthritis of Primary Gout and at least 2 gout flares in the preceding year were enrolled; caregivers were encouraged but not required to titrate allopurinol doses to achieve serum urate levels (sUA) of <6.0 mg/dL. Patients receiving pretrial urate-lowering therapy other than allopurinol underwent a 7-day washout period before initiating (or re-initiating) allopurinol therapy. Regular safety assessments were made; AEs were monitored throughout the study.

Results: Of 1735 patients enrolled, 1732 received at least 1 dose of allopurinol and constituted the safety population (93% male; 75% white; mean age, 51 years; mean BMI, 34.4 kg/m2). Baseline characteristics and comorbidity rates were similar across dosage ranges, but a higher percentage (29.2%) of those receiving <300 mg as maximal dose had moderately impaired renal function (CrCL <60 mL/min) than those who received 300 mg (13.8%) or >300 mg (9.7%). Patients who received >300-mg maximal daily dose had more severe disease at baseline (longer gout duration, tophi, more gout flares in prior year). Maximum daily dose was <300 mg in 250 patients (14.4%), 300 mg in 1132 patients (65.4%), and >300 mg in 350 patients (20.2%). In the safety population, only 744 patients (43%) achieved sUA levels <6.0 mg/dL at their last dose.

Table. Summary of Treatment-Emergent AEs (TEAEs, Safety Population)

 

Maximum Allopurinol Daily Dose (mg)

Total

Category

<300

(N=250)
n (%)

300
(N=1132)
n (%)

>300
(N=350)
n (%)

 

(N=1732)
n (%)

Any TEAE

124 (49.6)

623 (55.0)

208 (59.4)

955 (55.1)

TEAE with Rheumatology Common Toxicity Criteria Grade 3 or 4

14 (5.6)

60 (5.3)

21 (6.0)

95 (5.5)

TEAE possibly related to allopurinol

38 (15.2)

107 (9.5)

40 (11.4)

185 (10.7)

TEAE possibly related to prophylaxis

32 (12.8)

110 (9.7)

41 (11.7)

183 (10.6)

Serious TEAE

8 (3.2)

35 (3.1)

9 (2.6)

52 (3.0)

TEAE with outcome of death

1 (0.4)

2 (0.2)

0

3 (0.2)

TEAE leading to allopurinol withdrawal or study discontinuation

27 (10.8)

41 (3.6)

6 (1.7)

74 (4.3)

TEAE leading to prophylaxis switch or withdrawal

27 (10.8)

56 (4.9)

11 (3.1)

94 (5.4)

No clinically meaningful changes in laboratory values, including liver function tests, occurred. Rash incidence was low overall (1.5%), and allopurinol hypersensitivity syndrome was not encountered. The discontinuation rate in patients with a maximal dose of <300 mg was 49.6% vs 19.4% in those who received >300 mg.

Conclusion: This study revealed no new safety signals with medically appropriate allopurinol doses (approximately 300 mg/day). Data inspection showed few differences in TEAEs possibly related to allopurinol. Fewer than 50% of patients achieved the target sUA of <6 mg/dL at 6 months.


Disclosure:

M. A. Becker,

Takeda, Savient, Ardea Biosciences, AstraZeneca, BioCryst, URL/Mutual, Metabolex, Regeneron,

5,

UpToDate Inc.,

7;

D. Fitz-Patrick,

Ardea Biosciences,

2;

C. Storgard,

AstraZeneca,

1,

Ardea Biosciences, a wholly owned subsidiary of AstraZeneca,

3;

M. Cravets,

Full time employee of Ardea Biosciences, a wholly-owned subsidiary of AstraZeneca PLC,

3;

S. Baumgartner,

Stock options AstraZeneca,

1,

Full time employment Ardea Biosciences, a wholly owned subsidiary of AstraZeneca,

3.

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2013 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-large-scale-multicenter-prospective-open-label-6-month-study-to-evaluate-the-safety-of-allopurinol-monotherapy-in-patients-with-gout/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology