PMID- 28326189
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191120
IS  - 2056-5933 (Print)
IS  - 2056-5933 (Electronic)
IS  - 2056-5933 (Linking)
VI  - 3
IP  - 1
DP  - 2017
TI  - Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients 
      with inadequate response/intolerance to tumour necrosis factor inhibitors.
PG  - e000416
LID - 10.1136/rmdopen-2016-000416 [doi]
LID - e000416
AB  - OBJECTIVE: To evaluate effects of the anti-interleukin-6 receptor monoclonal 
      antibody sarilumab administered with conventional synthetic disease-modifying 
      antirheumatic drugs (csDMARDs) on patient-reported outcomes (PROs) in the TARGET 
      trial in patients with rheumatoid arthritis (RA) with inadequate response or 
      intolerance to tumour necrosis factor inhibitors (TNF-IR). METHODS: 546 patients 
      (81.9% female, mean age 52.9 years) were randomised to placebo, sarilumab 150 or 
      200 mg subcutaneously every 2 weeks + csDMARDs. PROs included patient global 
      assessment (PtGA); pain and morning stiffness visual analogue scales; Health 
      Assessment Questionnaire Disability Index (HAQ-DI); Short Form-36 Health Survey 
      (SF-36); FACIT-Fatigue (FACIT-F); Work Productivity Survey-Rheumatoid Arthritis 
      (WPS-RA) and Rheumatoid Arthritis Impact of Disease (RAID). Changes from baseline 
      at weeks 12 and 24 were analysed using a mixed model for repeated measures; post 
      hoc analyses included percentages of patients reporting improvements >/= minimum 
      clinically important differences (MCID) and scores >/= normative values. RESULTS: 
      Sarilumab + csDMARDs doses resulted in improvements from baseline at week 12 vs 
      placebo + csDMARDs in PtGA, pain, HAQ-DI, SF-36 and FACIT-F that were maintained 
      at week 24. Sarilumab improved morning stiffness and reduced the impact of RA on 
      work, family, social/leisure activities participation (WPS-RA) and on patients' 
      lives (RAID). Percentages of patients reporting improvements >/=MCID and >/= 
      normative scores were greater with sarilumab than placebo. CONCLUSIONS: In 
      patients with TNF-IR RA, 150 and 200 mg sarilumab + csDMARDs resulted in 
      clinically meaningful patient-reported benefits on pain, fatigue, function, 
      participation and health status at 12 and 24 weeks that exceeded placebo + 
      csDMARDs, and were consistent with the clinical profile previously reported. 
      TRIAL REGISTRATION NUMBER: NCT01709578; Results.
FAU - Strand, Vibeke
AU  - Strand V
AD  - Stanford University School of Medicine , Palo Alto, California , USA.
FAU - Reaney, Matthew
AU  - Reaney M
AD  - Sanofi , Guildford , UK.
FAU - Chen, Chieh-I
AU  - Chen CI
AD  - Regeneron Pharmaceuticals, Inc , Tarrytown, New York , USA.
FAU - Proudfoot, Clare W J
AU  - Proudfoot CW
AD  - Sanofi , Guildford , UK.
FAU - Guillonneau, Sophie
AU  - Guillonneau S
AD  - Sanofi , Chilly-Mazarin , France.
FAU - Bauer, Deborah
AU  - Bauer D
AD  - Sanofi Genzyme , Bridgewater, New Jersey , USA.
FAU - Mangan, Erin
AU  - Mangan E
AD  - Regeneron Pharmaceuticals, Inc , Tarrytown, New York , USA.
FAU - Graham, Neil M H
AU  - Graham NM
AD  - Regeneron Pharmaceuticals, Inc , Tarrytown, New York , USA.
FAU - van Hoogstraten, Hubert
AU  - van Hoogstraten H
AD  - Sanofi Genzyme , Bridgewater, New Jersey , USA.
FAU - Lin, Yong
AU  - Lin Y
AD  - Sanofi Genzyme , Bridgewater, New Jersey , USA.
FAU - Pacheco-Tena, Cesar
AU  - Pacheco-Tena C
AD  - Universidad Autonoma de Chihuahua , Chihuahua , Mexico.
FAU - Fleischmann, Roy
AU  - Fleischmann R
AD  - Metroplex Clinical Research Center and University of Texas Southwestern Medical 
      Center , Dallas, Texas , USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01709578
PT  - Journal Article
DEP - 20170307
PL  - England
TA  - RMD Open
JT  - RMD open
JID - 101662038
PMC - PMC5353328
OTO - NOTNLM
OT  - Anti-TNF
OT  - DMARDs (biologic)
OT  - Outcomes research
OT  - Patient perspective
OT  - Rheumatoid Arthritis
COIS- Competing interests: VS has received consulting fees from AbbVie, Amgen, Biogen, 
      Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), 
      Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, 
      Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi and UCB. MR, 
      CWJP, SG, HvH, DB and YL are employees of Sanofi Genzyme and may hold stock 
      and/or stock options in the company. CIC, EM and NMHG are employees of Regeneron 
      Pharmaceuticals, and may hold stock and/or stock options in the company. CP-T has 
      been principal investigator for Roche, Bristol-Myers Squibb, MS, Vertex, Sanofi, 
      AstraZeneca, Johnson & Johnson, Novo Nordisk and AbbVie and has received speaker 
      fees from Roche, Bristol-Myers Squibb, AbbVie, UCB, Janssen and MSD. RF has 
      received research grants from AbbVie, Amgen, Ardea, AstraZeneca, Bristol-Myers 
      Squibb, Celgene, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Pfizer, Roche, 
      Sanofi Aventis and UCB; and has received consulting fees from AbbVie, Akros, 
      Amgen, AstraZeneca, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, Roche and 
      UCB.
EDAT- 2017/03/23 06:00
MHDA- 2017/03/23 06:01
PMCR- 2017/03/07
CRDT- 2017/03/23 06:00
PHST- 2016/11/30 00:00 [received]
PHST- 2017/02/13 00:00 [revised]
PHST- 2017/02/14 00:00 [accepted]
PHST- 2017/03/23 06:00 [entrez]
PHST- 2017/03/23 06:00 [pubmed]
PHST- 2017/03/23 06:01 [medline]
PHST- 2017/03/07 00:00 [pmc-release]
AID - rmdopen-2016-000416 [pii]
AID - 10.1136/rmdopen-2016-000416 [doi]
PST - epublish
SO  - RMD Open. 2017 Mar 7;3(1):e000416. doi: 10.1136/rmdopen-2016-000416. eCollection 
      2017.