Autoinflammatory & rare systemic diseases
Inebilizumab for Treatment of IgG4-Related Disease
Primary result · At least one flareResult — go to the resultHazard ratio 0.13 95% CI 0.06–0.28Authors' conclusion
Inebilizumab reduced the risk of flares of IgG4-related disease and increased the likelihood of flare-free complete remission at 1 year, confirming the role of CD19-targeted B-cell depletion as a potential treatment for IgG4-related disease.
Study context
- Population
- Adults with active IgG4-RD; background immunosuppressants not permitted
- Participants
- 135 adults
- Comparison
- Inebilizumab vs placebo for 52 weeks, with identical GC tapers
- Inebilizumabn = 68
- Placebon = 67reference
- Primary endpoint
- First treated, adjudicated disease flare during the treatment period (time-to-event analysis)
- Follow-up
- 52 weeks
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled, 1:1 randomisation
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- 1:1 randomisation
Primary result
At least one flare
Hazard ratio
0.13
95% CI 0.06–0.28
P < 0.001
Events by treatment group
Inebilizumabvs Placebo
HR 0.13 (95% CI 0.06–0.28); P < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | Estimate | P value | |
|---|---|---|---|
| Annualized flare rate · 52-week treatment period | rate ratio for flare 0.14 (95% CI 0.06–0.31) | P < 0.001 | |
| Flare-free, treatment-free complete remission · 52-week treatment period | OR for achieving flare-free, treatment-free complete remission 4.68 (95% CI 2.21–9.91) | P < 0.001 | |
| Flare-free, GC-free complete remission · 52-week treatment period | OR for achieving flare-free, GC-free complete remission 4.96 (95% CI 2.34–10.52) | P < 0.001 | |
| 0.050.21520Ratio (log scale) |
Safety
Serious adverse events during the treatment period
Original publication
Inebilizumab for Treatment of IgG4-Related Disease. N Engl J Med. Published 14 November 2024. doi:10.
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