Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)

Immune thrombocytopenia (ITP) Warm autoimmune hemolytic anemia (wAIHA)

ITP participants: Treatment failure free (yes, no) by 12 m after start of second course of ianalumab is defined as any of: • platelet count <30G/L later than 8 weeks from start of second course • use of rescue treatment later than 8 weeks from second course • start of new ITP treatment • death • inability to taper TPO-RA by week 24, For wAIHA participants Durable response (Hb ≥10 g/dL and ≥2 g/dL increase from baseline) for a period of at least 8 consecutive weeks, between W9 and W25 in the absence of rescue or prohibited treatment prior to that durable response achievement.

Primary ITP participants only: • Response rate and complete response rate, Primary ITP participants only: • Number and proportion of participants receiving rescue treatment and/or new ITP therapy, wAIHA participants only: • Response rate and complete response rate, wAIHA participants only: • Number and proportion of participants who received rescue treatment and/or new wAIHA therapy, for all participants: Frequency of adverse events and other safety parameters, for all participants: Number of severe infections and proportion of participants with severe infection, for all participants: Ianalumab concentration in serum, for all participants: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time

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