Systemic Lupus Erythematosus
Conditions
Keywords
Belimumab, BENLYSTA, Systemic Lupus Erythematosus, Autoimmune Disease, Autoantibodies
Brief summary
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Interventions
BIOLOGICALBenlysta
As prescribed. Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus.
OTHERStandard of Care (SoC) Therapy
As prescribed. At baseline, SoC therapy must have included an immunosuppressant. During the registry, SoC therapy could include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females age 18 years or older. * Have a clinical diagnosis of active SLE. * Current or history of autoantibody-positive SLE. * Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics). * Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.
Exclusion criteria
* Treatment with an investigational drug within one year of enrollment. Investigational drug applies to any drug not approved for sale in the country it is being used. * Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent. * Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA. * Participants only receiving an anti-malarial for SLE. * Participants only receiving steroids for SLE.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy | Up to 63 Months | An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs included mortality, malignancies (excluding non-melanoma skin cancers \[NMSC\]), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events. Initial exposure ITT strategy assigned exposure status of participants based on SLE medication (Benlysta or Non-Benlysta) at enrollment (Day 0). This exposure strategy analyzed all accrued AESI data during the whole follow-up period irrespective of treatment switching from Benlysta to Non-Benlysta or vice-versa. |
| Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy | Up to 12 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events divided by (/) Total participant-years at risk of event expressed per 100 participant-years. |
| Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy | Up to 24 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
| Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy | Up to 36 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
| Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy | Up to 48 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
| Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy | Up to 63 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
| Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy | Up to 12 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
| Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy | Up to 24 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
| Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy | Up to 36 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
| Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy | Up to 48 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
| Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy | Up to 63 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
Countries
Argentina, Austria, Belgium, Canada, France, Germany, Israel, Italy, Portugal, Slovakia, Spain, Sweden, United States
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Participant flow
Recruitment details
As a non-interventional study, no treatments were given in this study. Data were collected during participants' routine clinical visits. A total of 3138 participants were enrolled in the study (Enrolled Population: All participants who were enrolled irrespective of whether they met the inclusion or exclusion criteria). Of these, 2967 participants were included in Eligible Population. Eligible Population included participants from the Enrolled Population who met inclusion or exclusion criteria.
Pre-assignment details
A total of 171 participants from Enrolled Population (87 participants due to an inclusion or exclusion violation identified after study enrollment, and additional 74 participants who were on combination of medications that include both anti-malarials and corticosteroids \[without immunosuppressant\] at enrollment, 5 participants due to the lack of baseline treatment information, and 5 participants due to loss of informed consent form) were not included in Eligible Population.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.3 YEARS STANDARD_DEVIATION 13.54 |
| Race/Ethnicity, Customized Alaska Native or American Indian from North/Central/South America | 42 Participants |
| Race/Ethnicity, Customized Asian | 63 Participants |
| Race/Ethnicity, Customized Black-African American or African Heritage | 532 Participants |
| Race/Ethnicity, Customized Multiracial | 39 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Unknown | 11 Participants |
| Race/Ethnicity, Customized White | 1543 Participants |
| Sex: Female, Male Female | 841 Participants |
| Sex: Female, Male Male | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 48 / 1,924 | 29 / 881 |
| other Total, other adverse events | 81 / 1,924 | 32 / 881 |
| serious Total, serious adverse events | 248 / 1,924 | 108 / 881 |
Outcome results
None listed