Last updated: 09/19/2024 05:50:18
Efficacy of Belimumab versus Anifrolumab in SLE
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Efficacy of Belimumab vs. Anifrolumab in the Treatment of Systemic Lupus Erythematosus (SLE): A Multi-level Meta-regression and Network Meta-analysis
Trial description: This is a systematic literature review (SLR) study to identify and synthesize the evidence examining Belimumab and anifrolumab as treatment for participants with SLE and to determine the comparative efficacy of these drugs using a multi-level network meta-regression (ML-NMR) and network meta-analysis (NMA) of randomized controlled trial (RCT) data.Alternative analysis scenarios and methodologies (Simulated Treatment Comparison [STC] and Matching Adjusted Indirect Treatment Comparison [MAIC]) were additionally explored to inform recently published indirect comparison results.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage (%) of participants achieving SLE Responder Index-4 (SRI-4) response
Timeframe: At Week 52
Secondary outcomes:
Mean change from Baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score
Timeframe: Baseline and up to Week 52
Number of participants achieving greater than or equal to (>=) 4 points reduction in SLEDAI-2K score
Timeframe: At Week 52
Number of participants with organ domain response in SLEDAI-2K
Timeframe: At Week 52
Mean change from Baseline in Physician Global Assessment (PGA) total score
Timeframe: Baseline and up to Week 52
Time to first flare using British Isles Lupus Assessment Group (BILAG) definition
Timeframe: Up to Week 52
Number of participants experiencing flare
Timeframe: Up to Week 52
Annualized flare rates
Timeframe: Up to Week 52
Mean change from Baseline in Anti-double stranded deoxyribonucleic acid (anti-dsDNA) total score
Timeframe: Baseline and up to Week 52
Number of participants with prednisone dose reduction from baseline
Timeframe: Baseline and up to Week 52
Percentage of participants switching from anti-dsDNA positive to negative
Timeframe: At Week 52
Number of participants experiencing treatment emergent adverse events (TEAE), serious adverse events, or infections
Timeframe: Up to Week 52
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-03-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Binod Neupane, Pragya Shukla, Mahmoud Slim, Amber Martin, Michelle Petri, George K Bertsias, Alfred H J Kim, Antonis Fanouriakis, Roger A Levy, Deven Chauhan, Nick Ballew. Belimumab versus anifrolumab in adults with systemic lupus erythematosus: an indirect comparison of clinical response at 52 weeks.. Lupus science & medicine. 2023-May;10(1): e000907.
DOI: 10.1136/lupus-2023-000907
PMID: 37147022
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
January 2022 to October 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Adults with age greater than or equal to (>=) 18 years diagnosed with SLE.
- Participant receiving Belimumab or Anifrolumab as intervention for SLE.
- Participants without SLE; Participants with only active lupus nephritis; included if just kidney involvement in SLE >=15% of participants have lupus nephritis; pediatric participants with less than (<) 18 years; and participants with comorbid SLE and rheumatoid arthritis (rhupus).
- Study evaluates treatment other than those listed as interventions of interest in the inclusion criteria.
Inclusion and exclusion criteria
Inclusion criteria:
- Adults with age greater than or equal to (>=) 18 years diagnosed with SLE.
- Participant receiving Belimumab or Anifrolumab as intervention for SLE.
- Participant receiving Placebo and/or Best standard of care as comparators.
- Participants with following outcomes: Efficacy: Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score: change in score, % with response; SLEDAI-2K score: change in score, % with response; BILAG score: change in score, % with response; Composite Lupus Assessment (BICLA): % with response; PGA scale: change in score; Systemic Lupus International Collaborating Clinics (SLICC)/ Systemic Lupus International Collaborating Clinics Damage Index (SDI) score: change in score; SRI-4: % with response; Cutaneous Lupus erythematosus activity and severity Index (CLASI): change in score, % with response; Flare: Annualized flare rate; Time to first flare; Proportion of participants with flares; >=50% reduction in both swollen and tender joints; Reduction in steroid use. Patient-reported outcome (PROs): 36-item Short Form health survey (SF-36); Functional Assessment of Chronic Illness Therapy (FACIT). Safety: Incidence and severity (grade) of all AEs reported; Incidence of serious adverse events (SAEs); Mortality (and cause, if available); Any discontinuations; Discontinuations due to AEs.
- Studies with following study design: Randomized, clinical trials; Single-arm clinical trials; Pooled studies.
- Studies published between time period 01-January-1946 through April-2022.
- Studies with English Language.
Exclusion criteria:
- Participants without SLE; Participants with only active lupus nephritis; included if just kidney involvement in SLE >=15% of participants have lupus nephritis; pediatric participants with less than (<) 18 years; and participants with comorbid SLE and rheumatoid arthritis (rhupus).
- Study evaluates treatment other than those listed as interventions of interest in the inclusion criteria.
- Studies that did not report at least one of the outcomes of interest listed in the inclusion criteria.
- Crossover designs that did not include adequate washout period (at least 7 days) and did not have statistical analysis taking paired design into account; Letters, case reports, editorials, reviews; Observational designs: prospective and retrospective cohorts, cross-sectional, and case-control studies.
- Studies published after April-2022.
- Languages other than English.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-03-10
Actual study completion date
2022-03-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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