Lupus & antiphospholipid syndrome
Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials
Pooled result · DORIS remissionResult — go to the resultRR for attaining DORIS remission 1.51 95% CI 1.15–1.99Authors' conclusion
In adults with active SLE, belimumab plus standard therapy yielded greater benefit than placebo plus standard therapy in attaining DORIS remission (for which low rates were attained in both groups) and LLDAS, with differences observed as early as week 28 for DORIS remission and week 8 for LLDAS.
Study context
- Population
- Patients with active, autoantibody-positive systemic lupus erythematosus (SLE) in BLISS-76, BLISS-52, BLISS-NEA, BLISS-SC and EMBRACE
- Participants
- 3,086 patients5 phase 3 trials
- Comparison
- Belimumab plus standard therapy vs placebo plus standard therapy
- Belimumabn = 1,869
- Placebon = 1,217reference
- Outcome
- DORIS remission and LLDAS, every 4 weeks from week 4 to week 52
- Follow-up
- Week 52
Methodological detailsintegrated post-hoc analysis, modified Poisson regression adjusted for trial variance
- Integrated post-hoc analysis
- Modified Poisson regression adjusted for trial variance
Pooled result
DORIS remission
RR for attaining Definitions of Remission in SLE (DORIS) remission
1.51
95% CI 1.15–1.99
P = 0.0055
Events by group
As reported in the abstract
Further pooled results
| Outcome | Belimumab | Placebo | RR (95% CI) | P value | |
|---|---|---|---|---|---|
| LLDAS · week 52Higher also at weeks 8, 24, 32-52 | 17% | 10% | 1.74 (1.44–2.12) | P < 0.0001 | |
| 0.512Relative risk (log scale) |
DORIS remission in baseline high disease activity subgroups · week 52
- Higher with belimumab in all high disease activity subgroups, except prednisone-equivalent >7.5 mg per day (no difference)
Lupus low disease activity state (LLDAS) in baseline high disease activity subgroups · week 52
- Significantly higher with belimumab from week 44 in all high disease activity subgroups (earlier in some), maintained at week 52
Original publication
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