Real‐world safety and treatment patterns of subcutaneous IgPro20 for chronic inflammatory demyelinating polyneuropathy: Post‐marketing surveillance in Japan

• DOI: 10.1111/cen3.12816
• Publication Date: 2024-10-04T06:14:03Z
• Authors: Naoki Terasaka; Takanori Mizushima; Yuki Niwa; Tetsushi Akasaki; Hideo Usui
• Keywords: Postmarketing surveillance

Abstract Objectives IgPro20, a subcutaneous immunoglobulin replacement therapy, is approved in Japan for chronic inflammatory demyelinating polyneuropathy (CIDP). This post‐marketing surveillance study characterized real‐world treatment patterns and safety profile of injection site reactions associated with IgPro20 Japanese patients CIDP. Methods Patients CIDP initiating between October 2019 September 2022 at medical institutions were followed 6 months. The primary outcome was the incidence reactions. Other outcomes included patient clinicodemographic characteristics, status, CIDP‐related concomitant medications any concurrent therapies. Results analysis 108 from 38 sites. subtypes typical (61.1%), multifocal acquired sensory motor neuropathy (multifocal; 19.4%), others (14.8%) or unknown (4.6%). Approximately one‐fifth (21.3%) commenced dosage <200 mg/kg, 27.8% ≥200 to ≤300 37.0% >300 ≤400 mg/kg 11.1% >400 mg/kg. Most doses (82.7%) given home: 62.0% self‐administered, 11.7% caregiver 8.9% healthcare professional assistance. A total 55 used medications, including corticosteroids (35.2%), immunosuppressants (19.4%) intravenous G (7.4%). data also showed that various these combinations. 40 (37.0%) experienced reactions, most frequently erythema swelling (17.6%); one case ulcer occurred (0.9%). No significant relationship dosage/speed observed. Conclusions use consistent phase III trial data.