Lupus & antiphospholipid syndrome
Two-year treatment experience with BI 655064, an antagonistic anti-CD40 antibody, in patients with active lupus nephritis: An exploratory, phase II maintenance trial
Authors' conclusion
This exploratory, phase II maintenance trial failed to demonstrate the benefits of BI 655064 on renal outcomes in the treatment of LN.
Study context
- Population
- Patients with lupus nephritis (LN) who completed 1 year of randomised treatment in the 1293.10 trial, responded at Year 1 (CRR, partial renal response or urinary protein/creatinine ratio ≤1) and consented to continue57.0% of 121 from 1293.10
- Participants
- 69 patients
- Comparison
- BI 655064 (120, 180 or 240 mg) vs placebo added to standard of care during maintenance treatment for LN
- Primary endpoint
- Proportion of patients with CRR without renal flares
- Follow-up
- Year 2
Methodological detailsextension of the 1293.10 randomised trial, exploratory, placebo-controlled, multiple doses
- Extension of the 1293.10 randomised trial
- Exploratory
- Placebo-controlled
- Multiple doses
Primary result
As reported in the abstract
Adjusted proportion with CRR
Placebo
57.5%
- BI 655064 doses: adjusted proportion with CRR at Year 2
- 48.2%-59.5%
Secondary outcomes
| Outcome | BI 655064 120 mg | BI 655064 180 mg | BI 655064 240 mg | Placebo |
|---|---|---|---|---|
| Adjusted proportion with CRR · Year 1 | — not stated in the abstract | — not stated in the abstract | — not stated in the abstract | 71.4% |
| Total SELENA-SLEDAI score, mean change from baseline · Year 2Points | −8.9 | −7.2 | −10.6 | −5.3 |
| SELENA-SLEDAI non-renal score, change · Year 1 | — not stated in the abstract | — not stated in the abstract | — not stated in the abstract | −1.8 |
| SELENA-SLEDAI non-renal score, change · Year 2Placebo returned to near-baseline scores | — not stated in the abstract | — not stated in the abstract | — not stated in the abstract | −0.4 |
— not stated in the abstract
- Adjusted proportion with CRR — BI 655064 doses
- 53.4%-72.7%
- SELENA-SLEDAI non-renal score, change — BI 655064 doses
- −3.0 to −3.4
- SELENA-SLEDAI non-renal score, change — BI 655064 doses
- −2.4 to −4.1
Safety
- Serious adverse event (AEs) · 2 years · mainly driven by serious infections — BI 655064 240 mg
- 42.9%
- Serious infections · 2 years — BI 655064 240 mg
- 23.8%
- Severe AEs · 2 years — BI 655064 240 mg
- 47.6%
- Serious AEs — Other groups
- 23.1%-33.3%
- Serious infections — Other groups
- 7.7%-14.3%
- Severe AEs — Other groups
- 13.3%-28.6%
≥1 AE over 2 years
- All patients
- 97.1%
Original publication
Two-year treatment experience with BI 655064, an antagonistic anti-CD40 antibody, in patients with active lupus nephritis: An exploratory, phase II maintenance trial. Lupus. Published 19 March 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →