Belimumab Assessment of Safety in SLE

Browse trials for

• Lupus Erythematosus, Systemic 1,222
• Autoimmune Diseases 672

Keywords

• Antibodies
• Lupus
• SLE
• Systemic Lupus Erythematosus
• Autoimmune Disease
• Belimumab

Lupus Erythematosus, Systemic

1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 4,019 is above the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Eligibility criteria

Study arms

• Placebo comparator
  Placebo plus standard therapy

  Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.

  Biological: Placebo plus standard therapy · Other: Standard therapy

• Experimental
  Belimumab 10 mg/kg plus standard therapy

  Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.

  Biological: Belimumab 10 mg/kg plus standard therapy · Other: Standard therapy

Interventions

• BiologicalPlacebo plus standard therapy

  Placebo plus standard therapy

• BiologicalBelimumab 10 mg/kg plus standard therapy

  Drug page: Belimumab

  Belimumab 10 mg/kg plus standard therapy

  Also known as: BENLYSTA™

• OtherStandard therapy

  Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.

Primary outcomes

1. Number of Deaths - On Treatment Period (Week 52)

   Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than \[\>\]50 percent \[%\]) of the time. The on-treatment period was the primary analysis period for safety analyses.

   Time frame: Up to Week 52 (On-treatment period)

2. Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)

   A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale \[C-SSRS\]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.

   Time frame: Up to Week 52 (On-treatment period)

3. Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)

   An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.

   Time frame: Up to Week 52 (On-treatment period)

Secondary outcomes

1. Number of Deaths Reported - On-study Period (Week 52)

   Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.

   Time frame: Up to Week 52 (On-study period)

2. Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)

   A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.

   Time frame: Up to Week 52 (On-study period)

3. Number of Participants With SAEs Reported During On-study Period (Week 52)

   A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.

   Time frame: Up to Week 52 (On-study period)

4. 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

   The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by \>=25% from Baseline to \<=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (\<=9 versus \>=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).

   Time frame: Week 40 to Week 52

5. Number of Participants With All-cause Mortality During Years 2 to 5

   Number of participants with all-cause mortality during years 2 to 5 has been presented.

   Time frame: From 2 years to 5 years

6. Number of Participants With New Primary Malignancies During Years 2 to 5

   Number of participants with new primary malignancies during years 2 to 5 has been presented.

   Time frame: From 2 years to 5 years

Baseline characteristics

Publications

• Sheikh S, Scheinberg MA, Wei CC, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello M, Maksimowicz-McKinnon K, Abud Mendoza C, Navarra S, Garcia M, Garcia de la Torre I, Ordi Ros J, Nami A, Levy R, Bass D, Ross J, Punwaney R, Harris J, Pierce A, Thorneloe K, Ji B, Roth D. Mortality and adverse events of special interest in adult patients with active, auto-antibody-positive systemic lupus erythematosus receiving intravenous belimumab (BASE): a global, randomised, double-blind, placebo-controlled, multicentre Phase 4 trial. Lancet Rheumatol. 2020; DOI: 10.1016/S2665-9913(20)30355-6
• Sheikh SZ, Scheinberg MA, Wei JC, Tegzova D, Stohl W, de Toledo RA, Mucenic T, Banfi MRA, Maksimowicz-McKinnon K, Abud-Mendoza C, Navarra S, Garcia M, Garcia-De La Torre I, Ros JO, Levy RA, Bass DL, Terres JR, Punwaney R, Harris J, Nami A, Pierce A, Thorneloe KS, Ji B, Roth DA. 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. Lancet Rheumatol. 2021 Feb;3(2):e122-e130. doi: 10.1016/S2665-9913(20)30355-6. Epub 2020 Dec 15. PubMed 38279368 ↗

Study documents

• Study protocol · Nov 25, 2020
• Statistical analysis plan · Sep 22, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · clinicalstudydatarequest.com