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

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COMMODORE 1 (Phase 3 Trial)

No compromise in efficacy when switching to PiaSky®1

COMMODORE 1 Exploratory Endpoints2

*Central LDH ≤1.5x ULN.

†Thirty-nine patients were evaluable for efficacy.

‡Thirty-seven patients were evaluable for efficacy.

PiaSky® PNH trial shows strong efficacy, maintaining hemolysis control, avoiding transfusions, stabilizing hemoglobin, and reducing breakthrough hemolysis.
Improvements in fatigue are maintained in people who switch to PiaSky®2,5*
COMMODORE 1: FACIT-Fatigue†

*Adjusted mean change in FACIT-Fatigue score calculated as Week 25 vs baseline.

†FACIT-Fatigue is a 13-item patient-reported outcome instrument used to assess fatigue-related symptoms and impact on daily functioning.

‡A mean change of ≥5 is considered to be clinically meaningful.

PiaSky® improves fatigue in PNH patients, maintaining FACIT-Fatigue scores close to normal population levels.

What are your impressions on the efficacy and safety data findings from the COMMODORE program?

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

*Six patients reported 8 events (infections [n=3], neutropenia [n=1], pyrexia [n=1], hyperbilirubinemia [n=1], skin laceration [n=1], and cervical dysplasia [n=1].

†One patient reported 3 events (infections [n=2] and transient ischemic attack [n=1]).

‡Pneumonia; not related to treatment.

§Other AEs are a broad set of other preferred terms.

PiaSky® is well-tolerated in PNH treatment, showing a safety profile similar to other C5 inhibitors in clinical trials.

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

Immune complex formation occurs when switching between C5is6

*Some clinical symptoms were ongoing at clinical cutoff.
†Patients in COMMODORE 2 were able to switch to PiaSky following the primary treatment period.

PiaSky® demonstrates a low and manageable TICR risk when switching from other C5 inhibitors in PNH treatment.

TICRs in PNH Treatment: Addressing Patient Switching Concerns

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

PiaSky® is the latest addition to the established C5 inhibitor category. In addition to proven efficacy and safety, it offers patients at-home administration every 4 weeks after training from their healthcare provider.¹**

**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.

Additional Resources

Access other helpful resources to get your patients started on PiaSky®.

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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.