Belimumab treatment of adult idiopathic inflammatory myopathy
Authors' conclusion
The study did not meet the primary endpoint and no statistically significant differences were observed in clinical responses between arms.
Study context
- Population
- Adults with refractory idiopathic inflammatory myopathy (IIM)15 in ITT analysis
- Participants
- 17 adults
- Comparison
- IV belimumab 10 mg/kg added to standard of care vs placebo
Methodological detailsmulticentre, double-blind, placebo-controlled, 24-week open-label extension
- Multicentre
- Double-blind
- Placebo-controlled
- 24-week open-label extension
Primary result
As reported in the abstract
TIS ≥40 · weeks 40 and 64
P = non-significant (NS)
Further findings
DOI achieved · weeks 40 and 64
P = NS
Events
| Outcome | Belimumab | Placebo |
|---|---|---|
| Major responses (TIS = 72.5) after week 40 | 2 | 0 |
Mean total improvement score (TIS)
- The mean TIS was similar among groups
Placebo after switch to open-label
- No improvement observed
Steroid-sparing effect
- There was no steroid-sparing effect
B cell phenotype
- Total B cells not reduced; belimumab depleted naïve B cells and increased number and frequency of memory B cells
Original publication
Belimumab treatment of adult idiopathic inflammatory myopathy. Rheumatology (Oxford). Published 16 June 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →