PMID- 29355435
OWN - NLM
STAT- MEDLINE
DCOM- 20181121
LR  - 20221207
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Print)
IS  - 1520-9156 (Linking)
VI  - 20
IP  - 2
DP  - 2018 Feb
TI  - Anti-Insulin Antibodies and Adverse Events with Biosimilar Insulin Lispro 
      Compared with Humalog Insulin Lispro in People with Diabetes.
PG  - 160-170
LID - 10.1089/dia.2017.0373 [doi]
AB  - BACKGROUND: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro 
      (Humalog((R)); Ly-Lis). Two randomized, controlled, open-label, parallel-group, 
      phase 3 studies were conducted to compare the efficacy and safety of SAR-Lis and 
      Ly-Lis, both in combination with insulin glargine (Lantus((R))). SORELLA 1 was a 
      12-month study in 507 people with type 1 diabetes mellitus (T1DM); SORELLA 2 was 
      a 6-month study in 505 people with type 2 diabetes mellitus (T2DM). In this 
      study, the impact of anti-insulin antibodies (AIA) to SAR-Lis and Ly-Lis on 
      safety and glycemic control is reported. METHODS: AIA were measured regularly 
      throughout both studies at a centralized laboratory blinded to treatment groups 
      using a drug-specific AIA assay. The AIA status (positive or negative), AIA 
      titers, and cross-reactivity to human insulin, insulin glargine, and insulin 
      glargine metabolite M1 were analyzed. The potential effect of AIA on safety, 
      particularly as related to hypersensitivity reactions, hypoglycemia, and 
      treatment-emergent adverse events, as well as on glycemic control (HbA(1c), 
      insulin dose), was evaluated. RESULTS: AIA positive status at baseline was 
      similar for the two insulins, but higher in T1DM than in T2DM. In both studies, 
      the percentage of people newly developing AIA in the two treatment groups, or 
      having a >/=4-fold increase in AIA titers, did not differ. No relationship was 
      observed between maximum individual AIA titers and change in HbA(1c) or insulin 
      dose, hypoglycemia, or hypersensitivity reactions or between efficacy/safety 
      measures and subgroups by presence or absence of treatment-emergent AIA. 
      Hypersensitivity events and events adjudicated as allergic reactions were few and 
      did not differ between the two groups. CONCLUSION: Insulin lispro SAR342434 and 
      the originator insulin lispro had a similar immunogenicity profile in people with 
      T1DM or T2DM.
FAU - Home, Philip
AU  - Home P
AD  - 1 Institute for Cellular Medicine, Newcastle University , Newcastle upon Tyne, 
      United Kingdom .
FAU - Derwahl, Karl-Michael
AU  - Derwahl KM
AD  - 2 Institut fur Klinische Forschung und Entwicklung (IKFE) , Berlin, Germany .
FAU - Ziemen, Monika
AU  - Ziemen M
AD  - 3 Sanofi-Aventis Deutschland, Frankfurt, Germany .
FAU - Wernicke-Panten, Karin
AU  - Wernicke-Panten K
AD  - 3 Sanofi-Aventis Deutschland, Frankfurt, Germany .
FAU - Pierre, Suzanne
AU  - Pierre S
AD  - 4 Sanofi, Paris, France .
FAU - Kirchhein, Yvonne
AU  - Kirchhein Y
AD  - 3 Sanofi-Aventis Deutschland, Frankfurt, Germany .
FAU - Garg, Satish K
AU  - Garg SK
AD  - 5 Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, 
      Colorado.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Insulin Antibodies)
RN  - 0 (Insulin Lispro)
RN  - 0 (SAR342434)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Biosimilar Pharmaceuticals/*therapeutic use
MH  - Blood Glucose
MH  - Diabetes Mellitus, Type 1/blood/*drug therapy/immunology
MH  - Female
MH  - Glycated Hemoglobin
MH  - Humans
MH  - Insulin Antibodies/*blood
MH  - Insulin Lispro/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5771536
OTO - NOTNLM
OT  - Anti-insulin antibodies
OT  - Biosimilar
OT  - Immunogenicity
OT  - Insulin lispro
OT  - SAR342434
COIS- P.H. or institutions with which he is associated has received funding for 
      research, advisory, and lecturing activities from Antriabio, AstraZeneca, Biocon, 
      GlaxoSmithKline, Janssen, Hanmi, Merck (MSD), Novo Nordisk, Roche Diagnostics, 
      and Sanofi; K.-M.D. or institutions with which he is associated has received 
      funding for clinical research, advisory, and lecturing activities from Astra 
      Zeneca, Bayer, Lilly, Novo Nordisk, Merck (MSD), Pfizer, and Sanofi. M.Z., 
      K.W.-P., and Y.K. are employees and stockholders of Sanofi-Aventis Deutschland 
      GmbH, Frankfurt, Germany. S.P. is an employee and stockholder of Sanofi, Paris, 
      France. S.K.G. or institutions with which he is associated has received funding 
      for research, advisory, and travel activities from Dario, Eli Lilly, JDRF, 
      Johnson & Johnson, Lexicon, Mannkind, Medtronic, Merck, NCI, NIDDK, Novo Nordisk, 
      Roche, Sanofi, and T1D Exchange.
EDAT- 2018/01/23 06:00
MHDA- 2018/11/22 06:00
PMCR- 2018/02/01
CRDT- 2018/01/23 06:00
PHST- 2018/01/23 06:00 [entrez]
PHST- 2018/01/23 06:00 [pubmed]
PHST- 2018/11/22 06:00 [medline]
PHST- 2018/02/01 00:00 [pmc-release]
AID - 10.1089/dia.2017.0373 [pii]
AID - 10.1089/dia.2017.0373 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2018 Feb;20(2):160-170. doi: 10.1089/dia.2017.0373.