Systemic sclerosis & Raynaud's
Safety and efficacy of blinatumomab in the treatment of refractory systemic sclerosis: a case series
Authors' conclusion
CD19-directed T-cell engagement with blinatumomab induces rapid B-cell depletion and short-term clinical improvement in refractory SSc but lacks durability after a single treatment cycle.
Study context
- Population
- Patients with severe, treatment-refractory antitopoisomerase I-positive systemic sclerosis (SSc)median follow-up 8 months (range: 6–12)
- Participants
- 5 patients
- Outcome
- Safety: CRS, neurotoxicity, infections, serum immunoglobulin levels
Methodological detailsexploratory, 2 tertiary hospitals
- Exploratory
- 2 tertiary hospitals
Main finding
As reported in the abstract
Low-grade cytokine release syndrome (CRS) (grade 1, n = 2; grade 2, n = 1), managed conservatively
3
Neurotoxicity or severe infections
0
Observational data: associations, not effects.
Further findings
Modified Rodnan skin score (mRSS) change from baseline · 3 months
- Median mRSS change (range: +1 to −8) from a baseline of 16 (range: 0-25)
- −4 points
- Exploratory
Lung function and patient-reported outcomes · 3 months
- Transient improvement
- Exploratory
Clinical relapse · between months 3 and 6
- All patients experienced clinical relapse, leading to resumption of immunosuppressive therapy in most cases
B-cell repopulation · 1 month
- Occurred by 1 month in all but 1 patient, dominated by naïve and transitional subsets
Safety
Low-grade CRS
- Patients with low-grade CRS, managed conservatively
- 3
- Grade 1 CRS
- 2
- Grade 2 CRS
- 1
Neurotoxicity and severe infections
- None occurred
- 0
Original publication
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