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Pegloticase with MTX
Pegloticase is a pegylated uricase enzyme that breaks down uric acid into allantoin, while methotrexate (MTX) is added to reduce anti-drug antibody formation and improve tolerability.
Pegloticase is a pegylated uricase enzyme that breaks down uric acid into allantoin, while methotrexate (MTX) is added to reduce anti-drug antibody formation and improve tolerability. Used for Chronic gout refractory to conventional urate-lowering therapy.
At a glance
| Generic name | Pegloticase with MTX |
|---|---|
| Also known as | Methotrexate |
| Sponsor | Amgen |
| Drug class | Recombinant uricase (pegylated enzyme) |
| Target | Uric acid (substrate); reduces anti-pegloticase antibodies via MTX immunosuppression |
| Modality | Biologic |
| Therapeutic area | Rheumatology / Gout |
| Phase | FDA-approved |
Mechanism of action
Pegloticase catalyzes the oxidation of uric acid to allantoin, a more soluble compound that is readily excreted. The addition of methotrexate as an immunosuppressant helps prevent the development of antibodies against the pegylated enzyme, which can reduce drug efficacy and increase infusion reactions. This combination approach allows for sustained uric acid lowering in patients with severe, refractory gout.
Approved indications
- Chronic gout refractory to conventional urate-lowering therapy
Common side effects
- Infusion reactions
- Gout flares
- Nausea
- Chest pain
- Anaphylaxis
Key clinical trials
- 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 (PHASE3)
- 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 (PHASE4)
- Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate (PHASE4)
- A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL) (PHASE4)
- Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy (PHASE4)
- Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout (PHASE4)
- Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pegloticase with MTX CI brief — competitive landscape report
- Pegloticase with MTX updates RSS · CI watch RSS
- Amgen portfolio CI