PMID- 36206400
OWN - NLM
STAT- MEDLINE
DCOM- 20221122
LR  - 20221124
IS  - 1477-0962 (Electronic)
IS  - 0961-2033 (Print)
IS  - 0961-2033 (Linking)
VI  - 31
IP  - 13
DP  - 2022 Nov
TI  - Safety of belimumab in adult patients with systemic lupus erythematosus: Results 
      of a large integrated analysis of controlled clinical trial data.
PG  - 1649-1659
LID - 10.1177/09612033221131183 [doi]
AB  - OBJECTIVES: Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease 
      that affects multiple organ systems. Belimumab, a targeted human monoclonal 
      antibody, binds to and inhibits soluble B-lymphocyte stimulator. The safety and 
      efficacy of belimumab has consistently been demonstrated in multiple clinical 
      trials for the treatment of patients with active SLE. Integration of these data 
      provides an additional opportunity to explore the safety of belimumab in a larger 
      and more diverse population. This post hoc pooled analysis of clinical studies 
      evaluated the safety profile of belimumab versus placebo in adults with SLE. 
      METHODS: This was a pooled post hoc analysis of 52-week safety data from one 
      Phase 2 and five Phase 3 belimumab trials in adult patients with SLE. Patients 
      received >/=1 dose of placebo or belimumab (1, 4, or 10 mg/kg intravenous or 200 mg 
      subcutaneous), plus standard therapy. Outcomes included the incidence of adverse 
      events (AEs), serious AEs (SAEs), severe AEs, AEs of special interest (AESI), and 
      mortality. RESULTS: Across 4170 patients (placebo: N = 1355; belimumab: N = 
      2815), baseline demographics, disease characteristics, and treatment exposure 
      were similar for placebo and belimumab. Most patients (placebo: 76.6%; belimumab: 
      81.0%) completed the protocol Week 52 visit. Overall, incidence of AEs, SAEs, 
      severe AEs, AESI, and mortality were similar between groups. In both groups, the 
      most commonly reported SAEs by system organ class were infections and 
      infestations (placebo: 5.9%; belimumab: 5.4%) and renal and urinary disorders 
      (placebo: 2.2%; belimumab: 1.7%). Additionally, a greater proportion of patients 
      experienced AESI with belimumab versus placebo for post-infusion/injection 
      systemic reactions (placebo: 8.1%; belimumab: 10.2%). Mortality rates were 
      similar between groups (placebo: 0.4%; belimumab: 0.6%). CONCLUSIONS: These 
      results are consistent with those of the individual studies, BASE, BLISS-LN, and 
      long-term extension studies, making belimumab one of the most studied SLE 
      treatments for safety. Collectively, this evidence continues to support a 
      positive benefit-risk profile of belimumab in the treatment of adult patients 
      with SLE.
FAU - Wallace, Daniel J
AU  - Wallace DJ
AD  - Division of Rheumatology, Cedars-Sinai, Los Angeles, CA, USA.
FAU - Atsumi, Tatsuya
AU  - Atsumi T
AD  - 163693Department of Rheumatology, Hokkaido University Hospital, Sapporo, Japan.
FAU - Daniels, Mark
AU  - Daniels M
AD  - Global Medical Affairs, GSK, Brentford, Middlesex, UK.
FAU - Hammer, Anne
AU  - Hammer A
AD  - Biostatistics, GSK, Collegeville, PA, USA.
FAU - Meizlik, Paige
AU  - Meizlik P
AD  - Global Safety, GSK, Collegeville, PA, USA.
AD  - At the time of the study.
FAU - Quasny, Holly
AU  - Quasny H
AD  - Research and Development, GSK, Durham, NC, USA.
FAU - Schwarting, Andreas
AU  - Schwarting A
AD  - Division of Rheumatology and Clinical Immunology, 22461University Medical Center, 
      Mainz, Germany.
FAU - Zhang, Fengchun
AU  - Zhang F
AD  - Internal Medicine Department, 34732Peking Union Medical College Hospital, 
      Beijing, China.
FAU - Roth, David A
AU  - Roth DA
AD  - Research and Development, GSK, Collegeville, PA, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20221007
PL  - England
TA  - Lupus
JT  - Lupus
JID - 9204265
RN  - 73B0K5S26A (belimumab)
RN  - 0 (Immunosuppressive Agents)
SB  - IM
MH  - Humans
MH  - Adult
MH  - *Lupus Erythematosus, Systemic
MH  - Immunosuppressive Agents/adverse effects
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Double-Blind Method
PMC - PMC9679798
OTO - NOTNLM
OT  - autoimmune diseases
OT  - belimumab
OT  - biological products
OT  - safety
OT  - systemic lupus erythematosus
COIS- The author(s) declared the following potential conflicts of interest with respect 
      to the research, authorship, and/or publication of this article: DJW has worked 
      as a consultant and has been a paid speaker for GSK. TA has received financial 
      grants from GSK, and has been a consultant and a paid speaker for GSK. MD, AH, 
      HQ, and DAR are employees of GSK and hold stocks and shares in the company. PM 
      was an employee of GSK and held stocks and shares in the company at the time of 
      the study. AS has received financial grants from GSK, AbbVie, Actelion, Novartis, 
      and Pfizer, has been a paid consultant for GSK, and has been a paid speaker for 
      GSK, Amgen, Novartis, Pfizer, and Roche. FZ has been a paid speaker for GSK and 
      has taken part in a GSK advisory board.
EDAT- 2022/10/08 06:00
MHDA- 2022/11/23 06:00
PMCR- 2022/11/22
CRDT- 2022/10/07 14:52
PHST- 2022/10/08 06:00 [pubmed]
PHST- 2022/11/23 06:00 [medline]
PHST- 2022/10/07 14:52 [entrez]
PHST- 2022/11/22 00:00 [pmc-release]
AID - 10.1177_09612033221131183 [pii]
AID - 10.1177/09612033221131183 [doi]
PST - ppublish
SO  - Lupus. 2022 Nov;31(13):1649-1659. doi: 10.1177/09612033221131183. Epub 2022 Oct 
      7.