Injection Site Reactions with Long-Term Pegcetacoplan Use in Patients with Paroxysmal Nocturnal Hemoglobinuria: A Brief Report.

ABSTRACT:

Introduction

Pegcetacoplan is a targeted complement component 3 (C3) therapy approved for adults with paroxysmal nocturnal hemoglobinuria (PNH; US) or PNH plus anemia despite C5-targeted therapy for ≥ 3 months (EU). Patients with PNH receiving pegcetacoplan in the phase 3 PEGASUS trial who experienced injection site reactions (ISRs) mostly experienced mild events. We evaluated ISR incidence and severity with longer-term treatment in the PEGASUS cohort of the Study 307 open-label extension (307 OLE).

Methods

Patients from PEGASUS enrolled in the 307 OLE continued pegcetacoplan subcutaneous self-administration twice or three times weekly or every 3 days for an additional 48 weeks. ISRs were coded as adverse events (AEs) or treatment-emergent AEs (TEAEs) and summarized by MedDR

SUBMITTER: Sharma V 

PROVIDER: S-EPMC10567944 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature