C5i-experienced patients

PiaSky®: Efficacy and Safety

For PNH patients, PiaSky® combines the proven efficacy of a C5 inhibitor with the convenience of subcutaneous administration every 4 weeks1,2

Product image

COMMODORE 1 (Phase 3 Trial)

No compromise in efficacy when switching to PiaSky®1

COMMODORE 1 Exploratory Endpoints2
Improvements in fatigue are maintained in people who switch to PiaSky®2,5*
COMMODORE 1: FACIT-Fatigue†

PiaSky® was well-tolerated in patients switching from standard of care2

In the COMMODORE 1 trial (N=86), Q4W SC PiaSky® was well-tolerated with a safety profile that is consistent with those of other C5is, except for the anticipated risk of TICRs2

Switching between PiaSky® and other C5 inhibitors poses a limited risk of TICRs2

Immune complex formation occurs when switching between C5is6

TICRs in patients switching to PiaSky® are mostly mild to moderate in severity and manageable

**Patients starting PiaSky® will receive an initial weight-based loading dose through IV infusion, administered by their healthcare provider. Four subsequent loading doses are then given weekly by subcutaneous injection. Weight-based maintenance dosing is then administered once every 4 weeks subcutaneously. Patients may self-inject after receiving training from their healthcare provider.

C5 = complement protein 5; FACIT-Fatigue = Functional Assessment of Chronic Illness Therapy Fatigue; IVH = intravascular hemolysis; LDH = lactate dehydrogenase; NIM = noninferiority margin; PNH = paroxysmal nocturnal hemoglobinuria; TICR = transient immune complex reactions; ULN = upper limit of normal.
References
  1. Rӧth A, et al. Am J Hematol. 2024;99:1768–1777.
  2. Scheinberg P, et al. Am J Hematol. 2024;99:1757–1767.
  3. PiaSky® (crovalimab) 170mg/mL solution for injection Summary of Product Characteristics. F. Hoffmann-La Roche; 2024.
  4. Röth A, et al. Eur J Haematol. 2025;114:373–382.
  5. Panse J, et al. ASH 2023; poster presentation [poster 4090].
  6. Röth A, et al. Eur J Hematol. 2025;114:199–382.