PMID- 29209946
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 5
IP  - 1
DP  - 2018 Jun
TI  - Usability and Patient Preference Phase 3 Study of the Sarilumab Pen in Patients 
      with Active Moderate-to-Severe Rheumatoid Arthritis.
PG  - 231-242
LID - 10.1007/s40744-017-0090-2 [doi]
AB  - INTRODUCTION: Sarilumab is a human monoclonal antibody that blocks the 
      interleukin-6 receptor alpha (IL-6Ralpha). The phase 3 SARIL-RA-EASY study (EASY) 
      assessed the robustness of an autoinjector (pen) for administering sarilumab when 
      used by adults with active moderate-to-severe rheumatoid arthritis (RA) who are 
      candidates for anti-IL-6R therapy in an unsupervised real-world setting. METHODS: 
      EASY was a 12-week, multicenter, randomized, open-label, parallel-group usability 
      study of the sarilumab pen and prefilled syringe. Patients were randomized 
      1:1:1:1 to sarilumab 150 or 200 mg every 2 weeks (q2w) administered via pen or 
      syringe, plus background disease-modifying antirheumatic drugs. Patients reported 
      their ability to remove the pen cap and initiate and complete injections; 
      negative responses were defined as product technical complaints (PTCs). The 
      primary endpoint was the number of validated product technical failures (PTFs; 
      PTC with a validated technical cause). This study was not powered to demonstrate 
      bioequivalence or differences in efficacy among groups. RESULTS: A total of 217 
      patients were randomized. There were 600 successful injections with the sarilumab 
      pen in 108 patients and no pen-associated PTFs. One PTC was observed (the pen was 
      mistakenly activated before injection). At week 12, 88% of patients indicated the 
      pen was "easy" to use, and 98% reported they were "satisfied" with the pen. 
      Proportions of patients achieving an American College of Rheumatology 20/50/70 
      response and a 28-joint disease activity score by C-reactive protein < 2.6 were 
      similar at each dose between the pen and syringe groups, as were the 
      pharmacokinetics. There were no clinically meaningful differences in adverse 
      events (AEs), serious AEs, and AEs leading to discontinuation in the pen and 
      syringe groups. The most common treatment-emergent AEs were infections and 
      neutropenia. CONCLUSION: This study demonstrated the ease of use and robustness 
      of the sarilumab pen when used by patients with RA in an unsupervised setting. 
      Pharmacokinetics, safety, and efficacy were generally similar for the pen and 
      syringe groups (NCT02057250). FUNDING: Sanofi Genzyme and Regeneron 
      Pharmaceuticals, Inc. TRIAL REGISTRATION: Clinicaltrials.gov identifier, 
      NCT02057250.
FAU - Kivitz, Alan
AU  - Kivitz A
AD  - Altoona Center for Clinical Research, Duncansville, PA, USA. ajkivitz@yahoo.com.
FAU - Baret-Cormel, Lydie
AU  - Baret-Cormel L
AD  - Sanofi, Paris, France.
FAU - van Hoogstraten, Hubert
AU  - van Hoogstraten H
AD  - Sanofi Genzyme, Bridgewater, NJ, USA.
FAU - Wang, Sheldon
AU  - Wang S
AD  - Sanofi Genzyme, Bridgewater, NJ, USA.
FAU - Parrino, Janie
AU  - Parrino J
AD  - Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.
FAU - Xu, Christine
AU  - Xu C
AD  - Sanofi Genzyme, Bridgewater, NJ, USA.
FAU - Stanislav, Marina
AU  - Stanislav M
AD  - V.A. Nassonova Research Rheumatology Institute, Moscow, Russia.
LA  - eng
SI  - ClinicalTrials.gov/NCT02057250
PT  - Journal Article
DEP - 20171205
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC5935610
OTO - NOTNLM
OT  - Autoinjector
OT  - IL-6
OT  - IL-6Ralpha
OT  - Patient preference
OT  - Pen
OT  - Prefilled syringe
OT  - Rheumatoid arthritis
OT  - Sarilumab
EDAT- 2017/12/07 06:00
MHDA- 2017/12/07 06:01
PMCR- 2017/12/05
CRDT- 2017/12/07 06:00
PHST- 2017/10/25 00:00 [received]
PHST- 2017/12/07 06:00 [pubmed]
PHST- 2017/12/07 06:01 [medline]
PHST- 2017/12/07 06:00 [entrez]
PHST- 2017/12/05 00:00 [pmc-release]
AID - 10.1007/s40744-017-0090-2 [pii]
AID - 90 [pii]
AID - 10.1007/s40744-017-0090-2 [doi]
PST - ppublish
SO  - Rheumatol Ther. 2018 Jun;5(1):231-242. doi: 10.1007/s40744-017-0090-2. Epub 2017 
      Dec 5.