Pegloticase
Treatment for Gout
Typical Dosage: 8 mg IV every two weeks
Effectiveness
90%
Safety Score
45%
Clinical Trials
18
Participants
2K
Comparative Safety Scale(Higher is safer)
Cyanideā ļø
Methš
Cigarettesš¬
Chemoā¢ļø
Alcoholšŗ
Morphineš
Antibioticsš
Tylenolš
Exerciseš
Waterš§
45
DangerousModerateSafe
Treatment Details
Dosage Range
8 mg IV every two weeks
Time to Effect
24 hours (sUA reduction), weeks-months (clinical benefits)
Treatment Duration
6-12 months
Evidence Quality
MODERATENumber Needed to Treat (NNT)
2(Treat 2 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
4(Treat 4 patients to see 1 additional serious adverse event)
Confidence Score
80%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$234,000
Monitoring:$15,000
Side Effect Mgmt:$7,000
Total Annual:$256,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$350,000/QALY
QALYs Gained
1
Outcome-Based Costs
Cost per Responder
$568,889
Cost per Remission
$731,429
Comparison vs Conventional management (refractory gout)
Cost Difference
+$250,000/year
More expensive
QALY Difference
+0.80 QALYs
Better outcomes
Dominance
No dominance
Pegloticase Outcomes
for Gout
Efficacy Outcomes
Overall Effectiveness
+90%
Response Rate
+45%
Remission Rate
+35%
Common Side Effects
Infusion reactions
+40%
Gout flares (initiation)
+25%
Nausea
+15%
Antibody formation (loss of efficacy)
+30%
Active Clinical Trials
2 active trials recruiting for Pegloticase in Gout
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
NCT06229145ACTIVE NOT RECRUITINGPHASE4
262 participants
INTERVENTIONAL
Birmingham, United States +73 more
Started: Mar 18, 2024
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
NCT07116746RECRUITINGPHASE2
25 participants
INTERVENTIONAL
Margate, United States +3 more
Started: Dec 3, 2025
Completed Clinical Trials
16 completed trials for Pegloticase in Gout
Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
NCT00111657COMPLETEDPHASE2
30 participants
INTERVENTIONAL
Durham, United States
Started: Dec 1, 2004
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
NCT01356498COMPLETEDPHASE3
151 participants
INTERVENTIONAL
San Francisco, United States +21 more
Started: Dec 1, 2006
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
NCT02598596COMPLETEDPHASE2
132 participants
INTERVENTIONAL
Birmingham, United States +10 more
Started: Dec 1, 2015
Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
NCT00325195COMPLETEDPHASE3
225 participants
INTERVENTIONAL
Birmingham, United States +55 more
Started: May 1, 2006
Observational Study of the Use of Pegloticase (KRYSTEXXAĀ®) in Refractory Chronic Gout
NCT01466166COMPLETED
188 participants
OBSERVATIONAL
Birmingham, United States +66 more
Started: Nov 15, 2011
A Phase 4, Open-label Study of KRYSTEXXAĀ® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
NCT04762498COMPLETEDPHASE4
50 participants
INTERVENTIONAL
Anchorage, United States +11 more
Started: Jan 26, 2021
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
NCT00080210COMPLETEDPHASE2
40 participants
INTERVENTIONAL
Birmingham, United States +8 more
Started: Mar 1, 2004
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXAĀ® in Gout Participants Refractory to Conventional Therapy
NCT03905512COMPLETEDPHASE2
170 participants
INTERVENTIONAL
Anniston, United States +42 more
Started: May 7, 2019
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
NCT04511702COMPLETEDPHASE4
191 participants
INTERVENTIONAL
Birmingham, United States +38 more
Started: Oct 2, 2020
Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
NCT04087720COMPLETEDPHASE4
20 participants
INTERVENTIONAL
Birmingham, United States +7 more
Started: Sep 9, 2019
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
NCT04772313COMPLETEDPHASE4
11 participants
INTERVENTIONAL
Birmingham, United States +14 more
Started: Mar 8, 2021
REduCing Immunogenicity to PegloticasE (RECIPE) Study
NCT03303989COMPLETEDPHASE2
35 participants
INTERVENTIONAL
Birmingham, United States
Started: Jun 14, 2018
Study of KRYSTEXXAĀ® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
NCT03994731COMPLETEDPHASE4
152 participants
INTERVENTIONAL
Birmingham, United States +59 more
Started: Jun 13, 2019
Study of Pegloticase (KRYSTEXXAĀ®) Plus Methotrexate in Patients With Uncontrolled Gout
NCT03635957COMPLETEDPHASE4
14 participants
INTERVENTIONAL
Anchorage, United States +5 more
Started: Sep 26, 2018
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
NCT00675103COMPLETEDPHASE3
7 participants
INTERVENTIONAL
Chicago, United States +3 more
Started: May 1, 2008
Recapturing Immune Tolerance to Pegloticase for the Management of Tophaceous Gout
NCT06186219COMPLETEDPHASE1
2 participants
INTERVENTIONAL
Los Angeles, United States
Started: Apr 10, 2024