Safety of Decade Plus Use of IgPro20 in the Real World: Post-marketing Pharmacovigilance Report
Ceri Sawyer1, Adriana Radu1, Alphonse Hubsch1, Vai Katkade1
1CSL Behring
Objective:
To investigate spontaneous reports of thromboembolic events (TEEs) and infections in patients having received IgPro20.
Background:
IgPro20 is a subcutaneous human immunoglobulin approved since 2010 for the treatment of immunodeficiency; and since 2018 for maintenance therapy in chronic inflammatory demyelinating polyneuropathy (CIDP) and carries a class-warning for risk of TEE and infections.
Design/Methods:
The CSL Behring safety database was used to retrieve all post-marketing cases (from 2010 until 31 May 2023), which registered adverse events from ‘Opportunistic infections' (broad) and 'Embolic and thrombotic events' Standardized MedDRA Queries. Reporting rates of adverse events are presented as cases per 100 patient years of exposure to IgPro20, calculated by dividing the total amount of IgPro20 sold by the estimated weekly CIDP (20g) or immunodeficiency (10g) dose. The indication for IgPro20 use was based on the reporter designation.
Results:
The reporting rate of TEEs was 0.36 (estimate based on CIDP dose) or 0.18 (estimate based on immunodeficiency dose) per 100 patient years. Rate of infections were 1.27 (CIDP dose estimate) or 0.63 (immunodeficiency dose estimate) per 100 patient years; the most frequent were COVID-19, Influenza and Herpes Zoster (respectively, 0.31, 0.27 and 0.09 per 100 patient years (CIDP dose estimate) or 0.15, 0.13 and 0.05 per 100 patient years (immunodeficiency dose estimate). For 36 TEE cases (6.9% of all reported TEE cases) and for 88 infection cases (4.8 % of all reported infection cases), the reported indication was CIDP. Patient exposure for IgPro20 was estimated to be between 144,000 patient years based on the CIDP and 287,000 patient years based on the immunodeficiency dose.
Conclusions:
Spontaneous reports of adverse events, collected over a period of more than a decade, show that adverse events of interest in patients having received IgPro20 (including TEEs and infections) were rare, including in patients with CIDP.
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