PMID- 28653345
OWN - NLM
STAT- MEDLINE
DCOM- 20170926
LR  - 20220317
IS  - 1532-5415 (Electronic)
IS  - 0002-8614 (Linking)
VI  - 65
IP  - 9
DP  - 2017 Sep
TI  - Treatment of Sarcopenia with Bimagrumab: Results from a Phase II, Randomized, 
      Controlled, Proof-of-Concept Study.
PG  - 1988-1995
LID - 10.1111/jgs.14927 [doi]
AB  - OBJECTIVES: To assess the effects of bimagrumab on skeletal muscle mass and 
      function in older adults with sarcopenia and mobility limitations. DESIGN: A 
      24-week, randomized, double-blind, placebo-controlled, parallel-arm, 
      proof-of-concept study. SETTING: Five centers in the United States. PARTICIPANTS: 
      Community-dwelling adults (N = 40) aged 65 and older with gait speed between 0.4 
      and 1.0 m/s over 4 m and an appendicular skeletal muscle index of 7.25 kg/m(2) or 
      less for men and 5.67 kg/m(2) or less for women. INTERVENTION: Intravenous 
      bimagrumab 30 mg/kg (n = 19) or placebo (n = 21). MEASUREMENTS: Change from 
      baseline in thigh muscle volume (TMV), subcutaneous and intermuscular fat, 
      appendicular and total lean body mass, grip strength, gait speed, and 6-minute 
      walk distance (6MWD). RESULTS: Thirty-two (80%) participants completed the study. 
      TMV increased by Week 2, was sustained throughout the treatment period, and 
      remained above baseline at the end of study in bimagrumab-treated participants, 
      whereas there was no change with placebo treatment (Week 2: 5.15 +/- 2.19% vs 
      -0.34 +/- 2.59%, P < .001; Week 4: 6.12 +/- 2.56% vs 0.16 +/- 3.42%, P < .001; Week 8: 
      8.01 +/- 3.70% vs 0.35 +/- 3.32%, P < .001; Week 16: 7.72 +/- 5.31% vs 0.42 +/- 5.14%, 
      P < .001; Week 24: 4.80 +/- 5.81% vs -1.01 +/- 4.43%, P = .002). Participants with 
      slower walking speed at baseline receiving bimagrumab had clinically meaningful 
      and statistically significantly greater improvements in gait speed (mean 
      0.15 m/s, P = .009) and 6MWD (mean 82 m, P = .022) than those receiving placebo 
      at Week 16. Adverse events in the bimagrumab group included muscle-related 
      symptoms, acne, and diarrhea, most of which were mild in severity and resolved by 
      the end of study. CONCLUSION: Treatment with bimagrumab over 16 weeks increased 
      muscle mass and strength in older adults with sarcopenia and improved mobility in 
      those with slow walking speed.
CI  - (c) 2017, Copyright the Authors Journal compilation (c) 2017, The American Geriatrics 
      Society.
FAU - Rooks, Daniel
AU  - Rooks D
AD  - Novartis Institutes for Biomedical Research, Cambridge, Massachusetts.
FAU - Praestgaard, Jens
AU  - Praestgaard J
AD  - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
FAU - Hariry, Sam
AU  - Hariry S
AD  - Novartis Institutes for Biomedical Research, Basel, Switzerland.
FAU - Laurent, Didier
AU  - Laurent D
AD  - Novartis Institutes for Biomedical Research, Basel, Switzerland.
FAU - Petricoul, Olivier
AU  - Petricoul O
AD  - Novartis Institutes for Biomedical Research, Basel, Switzerland.
FAU - Perry, Robert G
AU  - Perry RG
AD  - Elite Research Institute, Miami Lakes, Florida.
FAU - Lach-Trifilieff, Estelle
AU  - Lach-Trifilieff E
AD  - Novartis Institutes for Biomedical Research, Basel, Switzerland.
FAU - Roubenoff, Ronenn
AU  - Roubenoff R
AD  - Novartis Institutes for Biomedical Research, Basel, Switzerland.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170627
PL  - United States
TA  - J Am Geriatr Soc
JT  - Journal of the American Geriatrics Society
JID - 7503062
RN  - 0 (Antibodies, Blocking)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - N15SW1DIV8 (bimagrumab)
SB  - IM
CIN - J Am Geriatr Soc. 2018 Jan;66(1):207-208. PMID: 29148043
CIN - J Am Geriatr Soc. 2018 Jan;66(1):208-209. PMID: 29148045
MH  - Absorptiometry, Photon
MH  - Administration, Intravenous
MH  - Aged
MH  - Antibodies, Blocking/*therapeutic use
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Double-Blind Method
MH  - Female
MH  - Gait
MH  - Humans
MH  - Male
MH  - Mobility Limitation
MH  - Muscle, Skeletal/*physiopathology
MH  - Sarcopenia/*drug therapy
MH  - United States
OTO - NOTNLM
OT  - 6-minute walk test
OT  - bimagrumab
OT  - gait speed
OT  - lean body mass
OT  - muscle
OT  - randomized controlled trial
OT  - sarcopenia
EDAT- 2017/06/28 06:00
MHDA- 2017/09/28 06:00
CRDT- 2017/06/28 06:00
PHST- 2017/06/28 06:00 [pubmed]
PHST- 2017/09/28 06:00 [medline]
PHST- 2017/06/28 06:00 [entrez]
AID - 10.1111/jgs.14927 [doi]
PST - ppublish
SO  - J Am Geriatr Soc. 2017 Sep;65(9):1988-1995. doi: 10.1111/jgs.14927. Epub 2017 Jun 
      27.