Lupus & antiphospholipid syndrome
Mezagitamab in systemic lupus erythematosus: clinical and mechanistic findings of CD38 inhibition in an autoimmune disease
Authors' conclusion
Mezagitamab had a favourable safety profile in patients with moderate to severe SLE and elicited a pharmacodynamic effect consistent with CD38+ cell depletion.
Study context
- Population
- Adults with moderate to severe systemic lupus erythematosus (SLE) (2012 SLICC or ACR criteria, SLEDAI-2K ≥6, anti-dsDNA and/or anti-ENA positive) on standard background therapy17 exposed to mezagitamab
- Participants
- 22 adults
- Comparison
- Mezagitamab 45 mg, 90 mg or 135 mg vs placebo every 3 weeks over 12 weeks, with standard background therapy
- Primary endpoint
- Safety and tolerability
Methodological detailsphase 1b, double-blind, placebo-controlled, multicentre
- Phase 1b
- Double-blind
- Placebo-controlled
- Multicentre
Primary result
As reported in the abstract
- No treatment-emergent AEs exceeding grade
- 2
Secondary outcomes
CD38 receptor occupancy on CD38+ NK cells and NK-cell depletion (pharmacodynamics)
- Median CD38 receptor occupancy on CD38+ NK cells, up to
- 88.4%
- Concurrent depletion of these cells in 135 mg, up to
- 90%
IgG and autoantibodies
- Mean reductions in all dose groups less than
- 20%
CLASI and SLEDAI-2K responder analyses (exploratory)
- No observable differences across treatment groups
- Trend for more profound skin responses with baseline CLASI >10
Safety
Adverse events
- AEs balanced across treatment groups; no treatment-emergent AEs exceeding grade
- 2
Original publication
Mezagitamab in systemic lupus erythematosus: clinical and mechanistic findings of CD38 inhibition in an autoimmune disease. Lupus Sci Med. Published 7 March 2024. doi:10.
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