PMID- 32690797
OWN - NLM
STAT- MEDLINE
DCOM- 20201106
LR  - 20201106
IS  - 1526-632X (Electronic)
IS  - 0028-3878 (Linking)
VI  - 95
IP  - 14
DP  - 2020 Oct 6
TI  - Long-term safety and tolerability of bimagrumab (BYM338) in sporadic inclusion 
      body myositis.
PG  - e1971-e1978
LID - 10.1212/WNL.0000000000010417 [doi]
AB  - OBJECTIVE: To assess the long-term safety and tolerability and to monitor 
      benefits of extended use of bimagrumab in individuals with sporadic inclusion 
      body myositis (sIBM) who completed a single-dose core study. METHODS: In this 
      multicenter, open-label extension study, 10 adults received bimagrumab 10 mg/kg 
      IV every 4 weeks up to 2 years (104 weeks). Safety (primary endpoint) was 
      assessed by recording adverse events (AEs). Clinical benefits were assessed by 
      changes from baseline in thigh muscle volume (TMV), lean body mass (LBM), 
      6-minute walk distance (6MWD), handgrip, and quadriceps strength. RESULTS: 
      Participants had a mean age of 70.1 (SD 10.4) years. All participants (n = 10) 
      discontinued the treatment due to early termination of the study (n = 7) or AEs 
      (n = 3; myocardial infarction, esophageal carcinoma, and dementia, none of which 
      were treatment related). The most common AEs were muscle spasms and falls (both 9 
      of 10, 90%), followed by diarrhea (6 of 10, 60%) and acne and skin eruption (both 
      5 of 10, 50%). At weeks 8 and 16, mean TMV increased from baseline by 4.1% (SD 
      4.3%) and 4.5% (SD 6.3%). Mean LBM increased from baseline and was sustained at 
      6.9% (SD 3.9%) at week 76. Means of 6MWD showed a progressive decline from 
      baseline to week 76, during which there was a modest numerical increase in 
      handgrip strength and no significant changes in quadriceps strength. CONCLUSIONS: 
      Long-term treatment up to 2 years with bimagrumab had a good safety profile and 
      was well tolerated in individuals with sIBM. An increase in muscle mass was noted 
      on a group level; however, there was no evidence of clinical improvement. 
      CLINICALTRIALSGOV IDENTIFIER: NCT02250443. CLASSIFICATION OF EVIDENCE: This study 
      provides Class IV evidence that for patients with sIBM, long-term bimagrumab 
      treatment was safe and well tolerated and did not lead to functional improvement.
CI  - (c) 2020 American Academy of Neurology.
FAU - Sivakumar, Kumaraswamy
AU  - Sivakumar K
AD  - From the Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of 
      Neurology (T.I.C., A.A.A), Brigham and Women's Hospital and Harvard Medical 
      School, Boston, MA; Novartis Institutes for BioMedical Research (B.S., D.L.), 
      Basel, Switzerland; Novartis Healthcare Pvt Ltd (H.A.), Hyderabad, India; 
      Novartis Pharma AG (L.B.T), Basel, Switzerland. Dr. Cochrane is now at Biogen 
      Inc, Cambridge, MA. Dr. Sloth is now at Novo Nordisk, Copenhagen, Denmark. 
      ksiva@nrcaz.com.
FAU - Cochrane, Thomas I
AU  - Cochrane TI
AD  - From the Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of 
      Neurology (T.I.C., A.A.A), Brigham and Women's Hospital and Harvard Medical 
      School, Boston, MA; Novartis Institutes for BioMedical Research (B.S., D.L.), 
      Basel, Switzerland; Novartis Healthcare Pvt Ltd (H.A.), Hyderabad, India; 
      Novartis Pharma AG (L.B.T), Basel, Switzerland. Dr. Cochrane is now at Biogen 
      Inc, Cambridge, MA. Dr. Sloth is now at Novo Nordisk, Copenhagen, Denmark.
FAU - Sloth, Birgitte
AU  - Sloth B
AD  - From the Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of 
      Neurology (T.I.C., A.A.A), Brigham and Women's Hospital and Harvard Medical 
      School, Boston, MA; Novartis Institutes for BioMedical Research (B.S., D.L.), 
      Basel, Switzerland; Novartis Healthcare Pvt Ltd (H.A.), Hyderabad, India; 
      Novartis Pharma AG (L.B.T), Basel, Switzerland. Dr. Cochrane is now at Biogen 
      Inc, Cambridge, MA. Dr. Sloth is now at Novo Nordisk, Copenhagen, Denmark.
FAU - Ashar, Hardik
AU  - Ashar H
AD  - From the Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of 
      Neurology (T.I.C., A.A.A), Brigham and Women's Hospital and Harvard Medical 
      School, Boston, MA; Novartis Institutes for BioMedical Research (B.S., D.L.), 
      Basel, Switzerland; Novartis Healthcare Pvt Ltd (H.A.), Hyderabad, India; 
      Novartis Pharma AG (L.B.T), Basel, Switzerland. Dr. Cochrane is now at Biogen 
      Inc, Cambridge, MA. Dr. Sloth is now at Novo Nordisk, Copenhagen, Denmark.
FAU - Laurent, Didier
AU  - Laurent D
AD  - From the Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of 
      Neurology (T.I.C., A.A.A), Brigham and Women's Hospital and Harvard Medical 
      School, Boston, MA; Novartis Institutes for BioMedical Research (B.S., D.L.), 
      Basel, Switzerland; Novartis Healthcare Pvt Ltd (H.A.), Hyderabad, India; 
      Novartis Pharma AG (L.B.T), Basel, Switzerland. Dr. Cochrane is now at Biogen 
      Inc, Cambridge, MA. Dr. Sloth is now at Novo Nordisk, Copenhagen, Denmark.
FAU - Tanko, Laszlo B
AU  - Tanko LB
AD  - From the Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of 
      Neurology (T.I.C., A.A.A), Brigham and Women's Hospital and Harvard Medical 
      School, Boston, MA; Novartis Institutes for BioMedical Research (B.S., D.L.), 
      Basel, Switzerland; Novartis Healthcare Pvt Ltd (H.A.), Hyderabad, India; 
      Novartis Pharma AG (L.B.T), Basel, Switzerland. Dr. Cochrane is now at Biogen 
      Inc, Cambridge, MA. Dr. Sloth is now at Novo Nordisk, Copenhagen, Denmark.
FAU - Amato, Anthony A
AU  - Amato AA
AD  - From the Neuromuscular Research Center (K.S.), Phoenix, AZ; Department of 
      Neurology (T.I.C., A.A.A), Brigham and Women's Hospital and Harvard Medical 
      School, Boston, MA; Novartis Institutes for BioMedical Research (B.S., D.L.), 
      Basel, Switzerland; Novartis Healthcare Pvt Ltd (H.A.), Hyderabad, India; 
      Novartis Pharma AG (L.B.T), Basel, Switzerland. Dr. Cochrane is now at Biogen 
      Inc, Cambridge, MA. Dr. Sloth is now at Novo Nordisk, Copenhagen, Denmark.
LA  - eng
SI  - ClinicalTrials.gov/NCT02250443
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200720
PL  - United States
TA  - Neurology
JT  - Neurology
JID - 0401060
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - N15SW1DIV8 (bimagrumab)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscle Strength/drug effects
MH  - Myositis, Inclusion Body/*drug therapy
MH  - Time
MH  - Treatment Outcome
EDAT- 2020/07/22 06:00
MHDA- 2020/11/11 06:00
CRDT- 2020/07/22 06:00
PHST- 2019/10/22 00:00 [received]
PHST- 2020/04/10 00:00 [accepted]
PHST- 2020/07/22 06:00 [pubmed]
PHST- 2020/11/11 06:00 [medline]
PHST- 2020/07/22 06:00 [entrez]
AID - WNL.0000000000010417 [pii]
AID - 10.1212/WNL.0000000000010417 [doi]
PST - ppublish
SO  - Neurology. 2020 Oct 6;95(14):e1971-e1978. doi: 10.1212/WNL.0000000000010417. Epub 
      2020 Jul 20.