Lupus & antiphospholipid syndrome
Evaluation of RNase therapy in systemic lupus erythematosus: a randomised phase 2a clinical trial of RSLV-132
Authors' conclusion
Six months of RSLV-132 therapy consisting of a weekly loading dose of RSLV-132 for 1 month, followed by 5 months of biweekly administrations did not significantly improve the mean CLASI score relative to placebo in this cohort of patients with SLE.
Study context
- Population
- Patients with systemic lupus erythematosus (SLE) with baseline CLASI score of 10 or greater and positivity of at least one of five autoantibodies to RNA-binding proteins (SM/RNP, SSA/Ro, SSB/La, Sm, RNP)
- Participants
- 65 patients
- Comparison
- RSLV-132 10 mg/kg, 13 doses over 24 weeks, vs placebo
- Primary endpoint
- Mean CLASI score (change from baseline)
- Follow-up
- Days 85 and 169
Methodological detailsphase 2a, placebo-controlled
- Phase 2a
- Placebo-controlled
Primary result
As reported in the abstract
Mean CLASI score change from baseline · day 169
Placebo
−5.7
mean · ± 7.0
RSLV-132
−6.2
mean · ± 8.5
Secondary outcomes
BICLA response, high SLEDAI subgroup (≥9)
SRI-4 response, high SLEDAI subgroup (≥9)
BICLA response, high CLASI subgroup (≥21)
SRI-4 response, high CLASI subgroup (≥21)
Original publication
Evaluation of RNase therapy in systemic lupus erythematosus: a randomised phase 2a clinical trial of RSLV-132. Lupus Sci Med. Published 7 February 2024. doi:10.
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