PMID- 29955380
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220321
IS  - 2056-5933 (Print)
IS  - 2056-5933 (Electronic)
IS  - 2056-5933 (Linking)
VI  - 4
IP  - 1
DP  - 2018
TI  - Impact of tocilizumab administered intravenously or subcutaneously on 
      patient-reported quality-of-life outcomes in patients with rheumatoid arthritis.
PG  - e000602
LID - 10.1136/rmdopen-2017-000602 [doi]
LID - e000602
AB  - OBJECTIVE: Randomised controlled trials (RCTs) have shown tocilizumab (TCZ) 
      administered intravenously or subcutaneously with conventional synthetic 
      disease-modifying antirheumatic drugs (csDMARDs) to be superior to csDMARDs alone 
      for improving rheumatoid arthritis (RA) disease activity. This study evaluated 
      the effect of TCZ-intravenous and TCZ-subcutaneous on patient-reported outcomes 
      (PROs) in three RCT populations. METHODS: OPTION (NCT00106548), BREVACTA 
      (NCT01232569) and SUMMACTA (NCT01194414) were independent RCTs evaluating the 
      efficacy and safety of TCZ-intravenous and/or TCZ-subcutaneous with csDMARDs in 
      patients with RA. PROs included patient global assessment, pain, Health 
      Assessment Questionnaire-Disability Index, Functional Assessment of Chronic 
      Illness Therapy-Fatigue and Short Form-36. Study outcomes included the 
      proportions of patients reporting changes from baseline in PRO scores >/= 
      minimum clinically important differences (MCID) and scores >/= age and 
      gender-matched normative values. RESULTS: In OPTION, more patients who received 
      TCZ-intravenous reported improvements in PROs >/=MCID (50%-82% vs 31%-57%) and 
      scores >/= normative values (16%-44% vs 5%-28%) at week 16 compared with placebo. 
      Similarly, a greater proportion of patients in BREVACTA who received 
      TCZ-subcutaneous reported improvements >/= MCID (54%-73% vs 42%-55%) and scores >/= 
      normative values (8%-34% vs 4%-25%) at week 12 compared with placebo. In 
      SUMMACTA, 61%-84% of patients who received TCZ-subcutaneous and 64%-84% of those 
      who received TCZ-intravenous reported improvements >/= MCID and 14%-41% and 
      15%-24%, respectively, scores >/= normative values at week 24. CONCLUSIONS: 
      TCZ-intravenous or TCZ-subcutaneous with csDMARDs resulted in more patients 
      reporting clinically meaningful improvements and PRO scores >/= normative values 
      compared with placebo. These improvements were similar with TCZ-intravenous and 
      TCZ-subcutaneous.
FAU - Strand, Vibeke
AU  - Strand V
AD  - Division of Immunology and Rheumatology, Stanford University Medical School, Palo 
      Alto, California, USA.
FAU - Michalska, Margaret
AU  - Michalska M
AD  - US Medical Affairs, Genentech, South San Francisco, California, USA.
FAU - Birchwood, Christine
AU  - Birchwood C
AD  - US Medical Affairs, Genentech, South San Francisco, California, USA.
FAU - Pei, Jinglan
AU  - Pei J
AD  - US Medical Affairs, Genentech, South San Francisco, California, USA.
FAU - Tuckwell, Katie
AU  - Tuckwell K
AD  - US Medical Affairs, Genentech, South San Francisco, California, USA.
FAU - Finch, Rebecca
AU  - Finch R
AD  - PDBB-Biostatistics, Roche, Welwyn Garden City, UK.
FAU - Kivitz, Alan J
AU  - Kivitz AJ
AD  - Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.
FAU - Smolen, Josef S
AU  - Smolen JS
AD  - Division of Rheumatology and Department of Medicine, Medical University of 
      Vienna, Vienna, Austria.
FAU - Burmester, Gerd R
AU  - Burmester GR
AD  - Department of Rheumatology and Clinical Immunology, Charite-Universitatsmedizin 
      Berlin, Free University and Humboldt University of Berlin, Berlin, Germany.
LA  - eng
PT  - Journal Article
DEP - 20180617
PL  - England
TA  - RMD Open
JT  - RMD open
JID - 101662038
PMC - PMC6018870
OTO - NOTNLM
OT  - biologic therapy
OT  - patient-reported outcomes
OT  - rheumatoid arthritis
OT  - tocilizumab
COIS- Competing interests: VS has received consulting fees from AbbVie, Amgen, 
      AstraZeneca, Biogen, Boehringer Ingelheim, Celltrion, Crescendo Bioscience, F 
      Hoffmann-La Roche/Genentech, GSK, Janssen, Eli Lilly, Merck, Novartis, Pfizer, 
      Regeneron, Samsung, Sanofi and UCB. MM, CB, JP and KT are employees of Genentech. 
      RF is an employee and shareholder of F Hoffmann-La Roche. AJK has received 
      consulting fees from Genentech, Novartis, Pfizer, Sanofi-Regeneron and UCB; JSS 
      has received grants from AbbVie, Janssen, Lilly, MSD, Pfizer and Roche and has 
      provided expert advice to and/or had speaking engagements for AbbVie, Amgen, 
      AstraZeneca, Astro, Celgene, Celtrion, GlaxoSmithKline, ILTOO, Janssen, Lilly, 
      MedImmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi and UCB. GRB has 
      received grants and honoraria for consulting and lectures from Roche.
EDAT- 2018/06/30 06:00
MHDA- 2018/06/30 06:01
PMCR- 2018/06/17
CRDT- 2018/06/30 06:00
PHST- 2017/10/17 00:00 [received]
PHST- 2018/02/01 00:00 [revised]
PHST- 2018/03/20 00:00 [accepted]
PHST- 2018/06/30 06:00 [entrez]
PHST- 2018/06/30 06:00 [pubmed]
PHST- 2018/06/30 06:01 [medline]
PHST- 2018/06/17 00:00 [pmc-release]
AID - rmdopen-2017-000602 [pii]
AID - 10.1136/rmdopen-2017-000602 [doi]
PST - epublish
SO  - RMD Open. 2018 Jun 17;4(1):e000602. doi: 10.1136/rmdopen-2017-000602. eCollection 
      2018.