Phase 4
Completed N=4,019
Belimumab Assessment of Safety in SLE
Source: ClinicalTrials.gov NCT01705977 ↗Enrolled (actual)
4,019
Serious AEs
11.8%
Results posted
Nov 2019
Primary outcomePrimary: Number of Deaths - On Treatment Period (Week 52) — 8; 10 Participants
◆ Published Evidence
Established
46citations · ~9 / year
Mortality and adverse events of special interest with intravenous belimumab for adults with active, autoantibody-positive systemic lupus erythematosus (BASE): a multicentre, double-blind, randomised, placebo-controlled, phase 4 trial.
Summary
The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.
Linked Publications
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Mortality and adverse events of special interest with intravenous belimumab for adults with active, autoantibody-positive systemic lupus erythematosus (BASE): a multicentre, double-blind, randomised, placebo-controlled, phase 4 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Deaths - On Treatment Period (Week 52) |
8; 10 | — |
| PRIMARY Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) |
82; 75; 50; 36; 5; 5 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52) |
222; 220 | — |
| SECONDARY Number of Deaths Reported - On-study Period (Week 52) |
22; 13 | — |
| SECONDARY Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52) |
95; 80; 59; 39; 7; 5 | — |
| SECONDARY Number of Participants With SAEs Reported During On-study Period (Week 52) |
241; 233 | — |
| SECONDARY Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 |
16.2; 19.9 | 0.0284 sig |
| SECONDARY Number of Participants With All-cause Mortality During Years 2 to 5 |
58; 38 | — |
| SECONDARY Number of Participants With New Primary Malignancies During Years 2 to 5 |
22; 24 | — |
Eligibility Criteria
Key Inclusion Criteria
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).
Key Exclusion Criteria
- Pregnant or nursing.
- Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
- Have received a live vaccine within the past 30 days.
- Have severe active lupus kidney disease.
- Have severe active central nervous system (CNS) lupus.
- Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Data sourced from ClinicalTrials.gov (NCT01705977) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.