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)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
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 Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
NCT07388498RECRUITINGPHASE3
270 participants
INTERVENTIONAL
Birmingham, United States +70 more
Started: Feb 9, 2026
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
NCT07116746ACTIVE NOT RECRUITINGPHASE2
15 participants
INTERVENTIONAL
Margate, United States +7 more
Started: Dec 3, 2025
Completed Clinical Trials
17 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
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
NCT06229145COMPLETEDPHASE4
306 participants
INTERVENTIONAL
Birmingham, United States +73 more
Started: Mar 18, 2024
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 (KRYSTEXXA®) in Refractory Chronic Gout
NCT01466166COMPLETED
188 participants
OBSERVATIONAL
Birmingham, United States +66 more
Started: Nov 15, 2011
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
NCT04762498COMPLETEDPHASE4
54 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 KRYSTEXXA® 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 KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
NCT03994731COMPLETEDPHASE4
152 participants
INTERVENTIONAL
Birmingham, United States +59 more
Started: Jun 13, 2019
Study of Pegloticase (KRYSTEXXA®) 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