Treatment Approaches in Uncontrolled Gout
There are strong recommendations in the guidelines, but urate-lowering therapies (ULTs) are still underutilized or are underdosed to achieve target serum uric acid (sUA) levels. The progressive nature of uncontrolled gout may benefit from proactive treatment rather than managing flares as they occur.1-3
ACR Guidelines Recommendations
2020 ACR Guidelines for the management of gout recommend a treat-to-target approach of serum uric acid (sUA) <6 mg/dL1,3-5:
- Strongly recommend initiating with an oral urate-lowering therapy (ULT) for patients with ≥1 subcutaneous tophi, evidence of radiographic damage from gout, or ≥2 gout flares per year
- Strongly recommend uricase-based therapy for patients whom xanthine oxidase inhibitor (XOI) treatment, uricosurics, and other interventions have failed to achieve sUA target, and who continue to have frequent gout flares (≥2/year) or who have non-resolving subcutaneous tophi*
Failure to achieve or maintain sUA levels <6 mg/dL may be due to gout severity, insufficient lifestyle or diet modifications, non-adherence or intolerance to ULT, delayed ULT prescribing, and/or inadequate dosage.1,2,6
Treat-to-Target Approach
ACR Guidelines recommend a treat-to-target approach and ULT titration.
Management milestones after ULT initiation1
- Monitor sUA every 2–5 weeks during titration phase
- Titrate dose until sUA <6 mg/dL is achieved
- Continuing ULT indefinitely once stable is conditionally recommended, unless not tolerated or burdensome
- Maintain concurrent anti-inflammatory prophylaxis for 3–6 months during titration
Get Your Patients in the Target Zone
- When sUA levels are lower, MSU crystals dissolve at a faster rate.7,8
- Rapidly decreasing a patient’s sUA level to <6.0 mg/dL may reduce the risk of long-term impacts (eg, bone erosion, joint deformity).3,5,7,9
*There is moderate certainty of evidence about the efficacy of the benefits, harms, and high certainty about the costs of uricase-based therapy. For patients with high disease activity, the magnitude of potential benefits outweighs the harms and costs of the drug.
Considerations for Urate-Lowering Therapy Options
When treating a patient with gout, it can often take time—sometimes years—to reach target sUA levels and dissolve tophi. Patients with uncontrolled gout can present differently, but persistent elevated sUA is the common thread. Treating uncontrolled gout is not a one-size-fits-all approach.7,10-12
Uncontrolled gout patients may not have an adequate or timely response to oral ULTs
Oral ULTs are often underutilized and underdosed which could be due to concerns around side effects, comorbidities, and patient compliance in addition2,6-8,11:
- With standard oral ULTs, dissolution of tophi may take 2 years or more, although the time to resolution may be faster with a target sUA that is lower than the guideline recommendation of 6 mg/dL, highlighting the need for additional treatment options in patients with uncontrolled gout
- Some patients with uncontrolled gout do not achieve or maintain sUA levels below the target 6 mg/dL while being treated with oral ULTs
- Patients with late stage CKD are often limited in the use of oral ULTs due to poor excretion6,13,14
Uricase-based therapy can be highly effective at rapidly reducing sUA levels, yet is underused16
5%
Of the ~170,000 people who meet the clinical definition of uncontrolled gout, only 5% of them are on uricase therapy each year.16-20†‡
†The number of uncontrolled gout patients was estimated by applying the rate of uncontrolled gout patients to the total gout population in 2024. Total gout population derived from the 2015-2016 National Health and Nutrition Examination Survey (NHANES) patient-reported gout prevalence survey adjusted for over-reporting and population growth. Rate of uncontrolled gout patients derived from Intercontinental Medical Statistics (IMS) Health and Quintiles (IQVIA) Longitudinal Access and Adjudication Data (LAAD) Claims.16-19
‡Patients receiving uricase estimated based on number of patients with claims for existing uricase therapy or procedure code "J2705" in 2024 in IQVIA LAAD claims, assuming 40% coverage of this dataset.20
New Treatment Options Are Needed for Uncontrolled Gout
Patients with uncontrolled gout can present differently, but persistently elevated sUA is the common thread.7
Finding the right treatment for your patients may help address the systemic progression of monosodium urate (MSU) crystals throughout the body. For patients with persistently high sUA levels not controlled by their current treatment regimen, consider discussing alternate options.1,3-5
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The information provided on this website is intended for healthcare professionals (HCPs) for informational and educational purposes only. It is not intended to replace the independent clinical judgment of HCPs in diagnosing or treating individual patients.
References
1. FitzGerald JD, et al. Arthritis Care Res (Hoboken). 2020;72(6):744-760. 2. Schlesinger N, et al. Nat Rev Rheumatol. 2023;19(10):640-649. 3. Dalbeth N, et al. Lancet. 2021;397(10287):1843-1855. 4. Richette P, et al. Ann Rheum Dis. 2017;76(1):29-42. 5. Yang X, et al. Drug Dev Res. 2012;73(2):66-72. 6. Fels E, et al. Curr Opin Rheumatol. 2008;20(2):198-202. 7. Francis-Sedlak M, et al. Rheumatol Ther. 2021;8(1):183-197. 8. Perez-Ruiz F, et al. Adv Ther. 2015;32(1):31-41. 9. Morlock RJ, et al. Rheumatol Ther. 2025;12(1):37-51. 10. Perez-Ruiz F, et al. Arthritis Rheum. 2002;47(4):356-360. 11. Dalbeth N, et al. Nat Rev Dis Primers. 2019;5(1):69. 12. Laurent V, et al. RMD Open. 2023;9(4):e003725. 13. Becker MA, et al. J Rheumatol. 2009;36(5):1041-1048. 14. Kannuthurai V, et al. Kidney360. 2023;4(9):e1332-e1340. 15. Edwards NL. Arthritis Rheum. 2008;58(9):2587-2590. 16. Chen-Xu M, et al. Arthritis Rheumatol. 2019;71(6):991-999. 17. GBD 2024 Gout Collaborators. Lancet Rheumatol. 2024;6(8):e507-e517. 18. McAdams MA, et al. J Rheumatol. 2011;38(1):135-141. 19. Data on file. US CRG Patient Estimates. August 2025. Sobi internal analysis based on claims data and literature review. 20. Data on File. Sobi, Inc. 2023.