Study Shows SEL-212 Treatment Improves Quality of Life for Gout Patients
About the Study
A recent study presented at the 2024 European Congress of Rheumatology (EULAR) has shown that patients with gout refractory to standard treatment who received SEL-212 in either low dose (LD; 0.1 mg/kg) or high dose (HD; 0.15 mg/kg) formulations experienced improvements in health-related quality of life (HRQoL) and a reduction in tender joint count.
The Impact of Urate
Gout is a painful form of arthritis caused by high levels of uric acid in the blood. Hyperuricemia, defined as serum uric acid (sUA) levels of ≥6.8 mg/dL, can lead to the accumulation of monosodium urate crystals in the cartilage, soft tissue, and joints, and may result in the formation of tophi, tender and swollen joints, gout flares, and diminished HRQoL.
Limitations of Current Treatments
Currently available urate-lowering therapies have limitations. Uricase-based therapies effectively lower sUA; however, they are limited by immunogenicity-related efficacy reductions and infusion reactions.
About SEL-212
SEL-212 is a novel, once-monthly, uricase-based infusion treatment that consists of an infusion of SEL-110 followed by a pegylated uricase (SEL-037). The combination allows for targeted immunomodulation that maintains sUA without requiring broader immunosuppression.
The Study Design
The placebo-controlled, double-blind, replicate-design, phase 3 clinical trials (DISSOLVE I and DISSOLVE II) assessed the safety and efficacy of both HD and LD in adults with sUA ≥7 mg/dL with inadequate symptom control despite receiving medically appropriate doses of traditional gout treatments.
Patient Characteristics
In total, 87 patients in the pooled intent-to-treat (ITT) cohort were placed in the HD group, 88 were placed in the LD group, and 90 received placebo. These patients were mostly White, male, and had ≥1 tophus coupled with an impaired HRQoL at baseline. The mean age ranged from 52.2 to 55.3 years, and the mean duration of gout ranged from 11.3 to 12.3 years. Patient characteristics were generally comparable across treatment groups.
The Primary Endpoint
In DISSOLVE 1, patients continued in a 6-month blinded extension phase, and the primary endpoint was the percentage of patients who achieved and maintained sUA <6 mg/dL for ≥80% of the treatment period. Tolerability and safety were determined using the monitoring of adverse events.
Key Results
Reductions in the mean number of tender joints from baseline to month 6 were greater among patients in the HD and LD cohorts (5.3 and 6.7, respectively) compared with placebo (2.7). The mean gout flare incidence was 0.3 for all treatment groups during the first treatment period and 0.1 (HD), 0.0 (LD), and 0.2 (placebo) during months 4 through 6.
Conclusion
The study shows that SEL-212 treatment may be a promising option for patients with gout refractory to standard treatment. With its novel approach to uric acid lowering, SEL-212 offers a potential solution to the limitations of current treatments.
Originally Post From https://www.hcplive.com/view/novel-sel-212-therapy-improves-quality-of-life-in-patients-with-gout
