Patients with uncontrolled gout receiving pegloticase had characteristics similar to those in previous randomized phase 3 clinical trials; patients were found to be significantly affected by co-morbid systemic diseases and had stable or improved renal function, according to study data presented at the 2021 virtual congress of the European Alliance of Rheumatology Associations (EULAR), which s ‘is held from June 2 to 5, 2021.
The researchers used the TriNetX Diamond database, which includes anonymized data from 4.3 million US patients with gout. Patients who received one or more pegloticase infusions were included in the analysis. The number of infusions was determined for a subgroup of patients who were included in the database 3 months or more before and 2 years or more after the first infusion of pegloticase. Renal function and immunomodulation prescriptions were also examined for this subgroup of patients.
A total of 1,494 patients (63.1 ± 14.0 years; 82% male; 76% white) with uncontrolled gout were identified. Before pegloticase treatment, the mean serum uric acid level was 8.7 ± 2.4 mg / dL, indicating uncontrolled gout (n = 50). Chronic kidney disease (CRF; 48%), essential hypertension (71%), type 2 diabetes (39%) and cardiovascular disease (38%) were the most frequently reported comorbidities and were found to be similar to those of the pivotal phase of pegloticase. 3 test populations.
Pretreatment renal function measurements were available for 134 patients, 44% of whom had stage 3 to 5 CKD. The mean estimated pre-treatment glomerular filtration rate (eGFR) was 61.2 ± 25.7 ml / min / 1.73 m2. For 48 patients with complete capture of the course of therapy and measurements of eGFR before and after therapy, renal function remained stable; The stage of CRF remained the same or improved in 81% of patients.
A total of 791 patients underwent complete treatment capture and received 8.7 ± 13.8 infusions. Of these patients, 189 (24%) received only one infusion of pegloticase and 173 (22%) received 12 or more infusions. A total of 19 (2%) patients received immunomodulation co-therapy with pegloticase, but the current analysis predates its use.
One of the limitations of the study was the inclusion of only a small percentage of the total cohort receiving co-treatment with an immunomodulator.
According to the researchers, “Future studies using more recent data sets are needed to assess actual outcomes in patients treated with pegloticase / immunomodulator co-therapy and to assess the impact of co-morbid systemic diseases. “
Disclosure: Some study authors reported affiliations with biotechnology, pharmaceutical, and / or device companies. Please see the original reference for a full list of author disclosures.
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Vesel C, Morton A, Francis-Sedlak M, Lamoreaux B. Demography, co-morbidities and renal function of uncontrolled gout patients who received pegloticase: result from a large database of complaints in the United States. Presented at: EULAR Virtual Congress 2021; June 2-5, 2021. Poster # POS1121.