Objective: To characterize infusion site reactions (ISRs) reported as adverse events (AEs) in clinical studies of ND0612.

Background: ND0612 is an investigational, subcutaneous infusion of levodopa/carbidopa (max dose 720/90 mg/day), supplemented with oral therapies, delivered via 2 cannulas to reduce skin burden.

Method: Integrated analysis of ISRs reported as AEs in patients with Parkinson’s disease treated with a 24h regimen of ND0612 from two Phase 2 studies (NCT02577523 and NCT02726386) and one Phase 3 (NCT04006210) study. ‘Grouped preferred terms’ were defined for ISRs including nodules, hematoma, swelling, eschar, erythema, infection, and pain.

Results: This analysis included 419 patients with a mean ± SD exposure of 395 ± 471 days [max 6.2 years]. Overall, 369 (88.1%) patients reported at least one ISR-AE, including 15 (3.6%) patients with serious ISR-AEs; 49 (11.7%) patients discontinued due to an ISR. Of 2461 ISR-AEs, the most common were: nodules (1065 events, 43.3%), hematoma (815 events, 33.1%), pain (141 events, 5.7%), and infection (134 events, 5.4%). Most ISR-AEs were mild (2079 events, 84.5%); 347 (14.1%) and 34 (1.4%) were moderate or severe, respectively. Most (88.1%) cases of infusion site infection were mild-moderate in severity, with a median time to resolution of 15 days. Infusion site infection led to discontinuation in only 12 (2.9%) patients.

Conclusion: While ISRs were commonly reported as AEs, 99% of ISR-AEs were mild or moderate in severity and resolved with or without treatment. Despite the incidence of ISR events, most patients continued in the trials.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/characterization-of-infusion-site-reactions-with-24-hour-subcutaneous-infusion-of-nd0612/