Concomitant Immunomodulatory Therapy Improves Pegloticase Persistence in Gout

Concomitant use of immunomodulatory drugs improves pegloticase persistence in patients with gout, according to study results presented at the American College of Rheumatology (ACR) Convergence 2021, held virtually from November 3 to 10, 2021. Concurrent treatment with immunomodulatory drugs and pegloticase did not appear to increase toxicity or have new safety risks.

Resistance to oral urate-lowering therapy (ULT) is a significant barrier in gout management. Previous clinical trials have suggested that concomitant treatment with immunomodulatory drugs may reduce the risk for pegloticase resistance.

Researchers conducted a retrospective study using data from the ACR’s Rheumatology Informatics System for Effectiveness (RISE) registry between 2016 and 2020. Cohort entry date was defined by first use of pegloticase. Two exposure groups were defined, namely, immunomodulatory users (≥1 prescription within ±60 days of index date) and non-immunomodulatory users.

The primary outcome was pegloticase discontinuation, modeled using Cox regression. Models were adjusted for age, sex, race, body mass index, national area deprivation index, concurrent medication use, and comorbidities.

The study cohort included 700 pegloticase users, among whom 124 received immunomodulatory drugs and 576 did not. Median follow-up duration was 14 months. A total of 90% of patients achieved the serum urate treatment target of 6 mg/dL or lesser during follow-up. Among immunomodulatory users, the most common drugs were methotrexate (79%) and azathioprine (12.1%). The median number of pegloticase infusions was 7 in the immunomodulatory group vs 5 in the non-immunomodulatory group.

Compared with nonusers, patients who received immunomodulatory drugs were less likely to discontinue pegloticase during follow-up (P =.00012). The hazard ratio of discontinuation with concomitant immunomodulatory therapy was 0.57 (95% CI, 0.43-0.78).

Laboratory abnormalities were uncommon (<5%) among pegloticase users and not more common among patients receiving concomitant immunomodulatory therapy.

Researchers concluded, “Consistent with small trials, results from this large observational registry suggest that concomitant immunomodulatory drug use improves pegloticase persistence. Rare lab abnormalities suggest no disproportionate toxicity resulting from this strategy.”

Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures. 

Reference

Yun H, LaMoreaux B, Chen L, et al. Effectiveness and safety of pegloticase with concomitant immunomodulatory therapy. Presented at: ACR Convergence 2021; November 3-10, 2021. Abstract 1529.