- Article
- Source: Campus Sanofi
- 1 Sept 2024
Safety Profile
In the 3-year follow-up to the 2021 ROCKstar study, no new safety signals were observed.1 |
In the ROCKstar and KD025-208 studies
REZUROCK was generally well tolerated in patients with cGVHD2
Safety was evaluated across 2 clinical studies (n=186)3,4
Consider the safety profile of REZUROCK in patients with cGVHD who often receive immunosuppressive therapy.
Please refer to the full Summary of Product Characteristics before prescribing.
The most common adverse reactions leading to discontinuation were nausea (2.4%) and headache (2.4%). Adverse reactions leading to dose interruption occurred in 9.6% of patients and were mainly investigations (3.6%), including ALT increased, GGT increased and blood creatine phosphokinase increased (1.2% each), and infections (2.4%)2
The most common adverse reactions (≥5%) were asthenia (21.0%), nausea (12.4%), liver function test abnormalities of elevation of AST (7.5%), elevation of ALT (7.0%) and elevation of GGT (4.8%), headache (8.6%), diarrhoea (7.0%) and musculoskeletal pain (5.9%)2
Serious adverse reactions were pneumonia (1.1%), cellulitis, infectious colitis, staphylococcal bacteraemia, diarrhoea, nausea, vomiting, microangiopathic haemolytic anaemia, multiple organ dysfunction syndrome and cGVHD (0.5% each)2
There were no reports of CMV infection in both the ROCKstar and the foundational, dose-finding KD025-208 studies, and only 1 report of CMV reactivation in total3,4
In the ROCKstar and KD025-208 clinical studies of REZUROCK, grade ≥3 cytopenias were reported in <4% and 4% of patients, respectively3,4
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1 - Lee SJ, Cutler C, Pavletic S, et al. Belumosudil for chronic-graft-versus-host disease after 2 or more lines of systemic therapy: 3-year follow-up to the ROCKstar study. Poster presented at: Tandem Meetings; February 21, 2024; San Antonio, TX.
2 - REZUROCK. Summary of Product Characteristics
3 - Jagasia M, Lazaryan A, Bachier CR, et al. ROCK2 inhibition with belumosudil (KD025) for the treatment of chronic graft-versus-host disease. J Clin Oncol. 2021;39(17):1888-1898. doi:10.1200/JCO.20.02754
4 - Cutler C, Lee SJ, Arai S, et al; on behalf of the ROCKstar Study Investigators. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study. Blood. 2021;138(22):2278-2289. doi:10.1182/blood.2021012021
cGVHD, chronic graft-versus-host disease; CMV, cytomegalovirus.
MAT-XU-2204907 (v10.0) Date of Preparation: February 2025