Phase 3
Completed N=80
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
Source: ClinicalTrials.gov NCT02119156 ↗Enrolled (actual)
80
Serious AEs
7.7%
Results posted
Jan 2020
Primary outcomePrimary: Median Time to First SLE Flare Index (SFI) — 183.0; NA; NA; NA Days
◆ Published Evidence
Emerging
11citations · ~3 / year
The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomised 52-week study.
Summary
This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.
Linked Publications
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The effect of 24-week belimumab treatment withdrawal followed by treatment restart in patients with SLE: an open-label, non-randomised 52-week study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to First SLE Flare Index (SFI) |
183.0; NA; NA; NA | — |
| SECONDARY Rate of SLE Index Flare Per Subject Year |
2.1; 0.6; 1.0; 0.3 | — |
| SECONDARY Median Time to First Severe SFI Flare |
NA; NA; NA; NA | — |
| SECONDARY Number of Participants With Evidence of Rebound |
2; 2; 0 | — |
| SECONDARY Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA) |
39; 29; 12; 11; 0; 0 | — |
| SECONDARY Percentage Change From Baseline in Immunoglobulin |
-19.205; -25.909; -22.193; -21.028; -31.455; -24.242 | — |
| SECONDARY Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA) |
-82.8; -69.4; -81.3; -82.8; -65.9; -83.2 | — |
| SECONDARY Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA) |
-15.044; -24.938; -32.336; 5.723; -27.434; -29.771 | — |
| SECONDARY Percentage Change From Baseline in Complement Levels |
10.3; 7.2; 32.1; 15.4; 16.0; 14.8 | — |
| SECONDARY Percentage Change From Baseline in B Cell Subsets |
-69.0; -76.1; -43.2; -73.7; -78.9; -50.0 | — |
| SECONDARY Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase) |
100.0; 83.3; 66.7; -19.0; -12.5; -35.6 | — |
| SECONDARY SELENA SLEDAI Scores Change From Baseline |
-6.2; -6.9; -6.3; -5.9; -6.6; -6.1 | — |
| SECONDARY Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study |
143.0; 170.0; 168.0; 278.0; 364.0; 364.0 | — |
| SECONDARY Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study |
168.0; 168.0; 166.0; 362.0; 364.0; 364.0 | — |
Eligibility Criteria
Inclusion Criteria
- Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study.
- Be 18 years of age at the Day 0 visit.
- Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol.
- Able to provide written informed consent to participate.
- Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0.
- Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies.
Exclusion Criteria
- Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk.
- Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.
Data sourced from ClinicalTrials.gov (NCT02119156) 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.