PMID- 35428697
OWN - NLM
STAT- MEDLINE
DCOM- 20220419
LR  - 20220716
IS  - 2056-5933 (Electronic)
IS  - 2056-5933 (Linking)
VI  - 8
IP  - 1
DP  - 2022 Apr
TI  - Phase 3, long-term, open-label extension period of safety and efficacy of 
      belimumab in patients with systemic lupus erythematosus in China, for up to 6 
      years.
LID - 10.1136/rmdopen-2021-001669 [doi]
LID - e001669
AB  - OBJECTIVES: To evaluate the long-term safety and efficacy of belimumab in 
      patients with systemic lupus erythematosus (SLE) in China. METHODS: In this phase 
      3, open-label extension period, eligible completers of study BEL113750 
      (NCT01345253) received intravenous belimumab 10 mg/kg monthly for </=6 years. The 
      primary endpoint was safety. Secondary endpoints included the SLE Responder Index 
      (SRI)-4 response rate, severe SLE flares and changes in prednisone use. Analyses 
      were based on observed data from the first dose of belimumab through to study 
      end. RESULTS: Of the 424 patients who received belimumab, 215 (50.7%) completed 
      the study, 208 (49.1%) withdrew and 1 patient died. Overall, 359/424 (84.7%) 
      patients had adverse events (AEs), and 96/424 (22.6%) had serious AEs. 26/424 
      (6.1%) patients discontinued study treatment/withdrew from the study due to AEs. 
      Postinfusion systemic reaction rate was 1.5 events/100 patient-years. Herpes 
      zoster infection rate was 3.0 events/100 patient-years, of which 0.4 events/100 
      patient-years were serious events. One papillary thyroid cancer and one vaginal 
      cancer were reported in year 0-1 and year 3-4, respectively. There were no 
      completed suicides/suicide attempts and no reports of serious depression. The 
      proportion of SRI-4 responders increased progressively (year 1, week 24: 190/346 
      (54.9%); year 5, week 48: 66/82 (80.5%)). Severe flares were experienced by 
      55/396 (13.9%) patients. For 335 patients with baseline prednisone-equivalent 
      dose >7.5 mg/day, the number of patients with a dose reduction to </=7.5 mg/day 
      increased over time (year 1, week 24: 30/333 (9.0%); year 5, week 48: 36/67 
      (53.7%)). CONCLUSIONS: Favourable safety profile and disease control appeared to 
      be maintained in patients with SLE in China for </=6 years, consistent with 
      previous belimumab studies.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Zhang, Fengchun
AU  - Zhang F
AUID- ORCID: 0000-0003-3484-4319
AD  - Department of Rheumatology and Clinical Immunology, Peking Union Medical College 
      Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 
      Beijing, China.
FAU - Zheng, Jie
AU  - Zheng J
AUID- ORCID: 0000-0002-7961-6427
AD  - Department of Dermatology, Ruijin Hospital, School of Medicine, Shanghai Jiao 
      Tong University, Shanghai, China.
FAU - Li, Yang
AU  - Li Y
AD  - Department of Rheumatology, The Second Affiliated Hospital, Harbin Medical 
      University, Nangang District, Harbin, China.
FAU - Wang, Guochun
AU  - Wang G
AD  - Department of Rheumatology, China-Japan Friendship Hospital, Beijing, China.
FAU - Wang, Mingjun
AU  - Wang M
AD  - Department of Rheumatology, The First Affiliated Hospital of Soochow University, 
      Suzhou, China.
FAU - Su, Yin
AU  - Su Y
AD  - Department of Rheumatology and Immunology, Peking University People's Hospital, 
      Beijing, China.
FAU - Gu, Jieruo
AU  - Gu J
AD  - Department of Rheumatology and Immunology, The Third Affiliated Hospital of Sun 
      Yat-Sen University, Guangzhou, Guangdong, China.
FAU - Li, Xingfu
AU  - Li X
AD  - Department of Rheumatology, Qilu Hospital of Shandong University, Jinan, China.
FAU - Bass, Damon
AU  - Bass D
AUID- ORCID: 0000-0003-2480-5674
AD  - Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
FAU - Chu, Myron
AU  - Chu M
AUID- ORCID: 0000-0001-5763-5603
AD  - Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
FAU - Curtis, Paula
AU  - Curtis P
AD  - Biostatistics, GlaxoSmithKline, Brentford, Middlesex, UK.
FAU - DeRose, Kathleen
AU  - DeRose K
AUID- ORCID: 0000-0002-1056-3400
AD  - Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA 
      kathleen.2.derose@gsk.com.
FAU - Kurrasch, Regina
AU  - Kurrasch R
AUID- ORCID: 0000-0002-2820-8423
AD  - Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
FAU - Lowe, Jenny
AU  - Lowe J
AUID- ORCID: 0000-0002-8565-2723
AD  - Immunoinflammation and Fibrosis, GlaxoSmithKline, Brentford, Middlesex, UK.
FAU - Meizlik, Paige
AU  - Meizlik P
AUID- ORCID: 0000-0002-2237-8552
AD  - Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
FAU - Roth, David A
AU  - Roth DA
AUID- ORCID: 0000-0001-8356-0457
AD  - Immunoinflammation, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01345253
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - RMD Open
JT  - RMD open
JID - 101662038
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunosuppressive Agents)
RN  - 73B0K5S26A (belimumab)
RN  - VB0R961HZT (Prednisone)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - *Immunosuppressive Agents/adverse effects
MH  - *Lupus Erythematosus, Systemic/drug therapy
MH  - Prednisone/adverse effects
MH  - Treatment Outcome
PMC - PMC9014060
OTO - NOTNLM
OT  - B-lymphocytes
OT  - biological therapy
OT  - cytokines
OT  - lupus erythematosus
OT  - systemic
COIS- Competing interests: FZ is a Principal Investigator at GSK. JZ, YL, GW, MW, YS, 
      JG and XL have no conflict of interest to declare. DB, PC, KD, JL, PM and DAR are 
      employees of GSK and hold stocks and shares in the company. MC and RK were 
      employees of GSK and held stocks and shares in the company at the time of study.
EDAT- 2022/04/17 06:00
MHDA- 2022/04/20 06:00
PMCR- 2022/04/14
CRDT- 2022/04/16 05:20
PHST- 2021/03/16 00:00 [received]
PHST- 2021/12/14 00:00 [accepted]
PHST- 2022/04/16 05:20 [entrez]
PHST- 2022/04/17 06:00 [pubmed]
PHST- 2022/04/20 06:00 [medline]
PHST- 2022/04/14 00:00 [pmc-release]
AID - rmdopen-2021-001669 [pii]
AID - 10.1136/rmdopen-2021-001669 [doi]
PST - ppublish
SO  - RMD Open. 2022 Apr;8(1):e001669. doi: 10.1136/rmdopen-2021-001669.