C5i-naive 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 2 (Phase 3 Trial)

PiaSky® demonstrated noninferiority vs eculizumab for both hemolysis control and transfusion avoidance in treatment-naïve patients from baseline through week 251,3

COMMODORE 2 Co-Primary Endpoints1,3

*Hemolysis control calculated as mean central LDH≤1.5×ULN from Week 5–25.

PiaSky® PNH trial: proven C5 inhibitor efficacy for hemolysis control and transfusion avoidance.

Similar hemolysis control with Q4W SC PiaSky® compared to Q2W IV SoC1,3

Noninferiority of PiaSky® compared to eculizumab was also demonstrated for both secondary efficacy endpoints of breakthrough hemolysis and stabilized hemoglobin from baseline through week 251,3

PiaSky® shows equivalent hemolysis control to eculizumab in PNH patients, with dosing every 4 weeks.
COMMODORE 2 Secondary Endpoints1,3
PiaSky® improves hemoglobin stability and reduces breakthrough hemolysis in PNH patients.

PiaSky® may help people with PNH achieve normalized fatigue levels1

People treated with PiaSky® saw greater improvements in FACIT-Fatigue scores, bringing them to within ‘normal’ population levels1

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® PNH therapy improves fatigue scores and quality of life compared with eculizumab."
PiaSky® has a comparable safety profile to other C5 inhibitors1,4,5
AE rates across the PiaSky® population were similar to the eculizumab population1,4,5

COMMODORE 2 C5i-naïve patients

PiaSky® (n=135)

Eculizumab (n=69)


Total number of patients with:


≥1 AE, n (%)


105 (78)


55 (80)


Grade 3-5 AE


24 (18)


17 (25)


Serious AE


14 (10)


9 (13)


Treatment-related serious AE


4 (3)


1 (1)


Adverse Event

leading to discontinuation of study treatment


1 (1)


1 (1)


Adverse Event

leading to dose modification of study treatment


5 (4)


3 (4)

What is your impression on efficacy and safety data findings from the COMMODORE studies?
Pooled safety data from across the COMMODORE programme 
(includes both C5i-naïve and C5i-experienced patients)
"Bar chart comparing adverse event rates for SC PiaSky® and IV eculizumab in the COMMODORE programme. Rates per 100 patient-years were similar across most events, with infusion-related reactions higher for eculizumab."

COMMODORE 2 assessed efficacy and safety of PiaSky® vs eculizumab in treatment-naïve patients with PNH1

Phase III COMMODORE 2: Evaluating the noninferiority of PiaSky® vs eculizumab in C5i-naïve patients with PNH1

§Hemolysis control was defined as LDH ≤1.5x ULN.
Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline, in the absence of transfusion.
BTH = breakthrough hemolysis; Hb = hemoglobin; IV = intravenous; SC = subcutaneous.

Flowchart of Phase III COMMODORE 2 trial comparing SC PiaSky® and IV eculizumab in 204 C5i-naïve patients with PNH, showing randomization, 24-week treatment, and study endpoints including hemolysis control, transfusion avoidance, and safety.

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.