PMID- 32968710
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240329
IS  - 2520-1026 (Electronic)
IS  - 2520-1026 (Linking)
VI  - 4
DP  - 2020
TI  - Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in 
      rheumatoid arthritis patients from a Canadian prospective observational registry.
PG  - 46
LID - 10.1186/s41927-020-00145-4 [doi]
LID - 46
AB  - BACKGROUND: Long-term clinical registries are essential tools to evaluate new 
      therapies in a patient population that differs from those in randomized clinical 
      trials. The objectives are to describe the profile of rheumatoid arthritis (RA) 
      patients treated with anti-TNF agents in Canadian routine care. METHODS: RA 
      patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or 
      intravenous golimumab (GLM-IV) as per their respective Canadian product 
      monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study 
      visits occurred at baseline and every 6 months thereafter. Effectiveness was 
      assessed by changes in disease activity. Safety was evaluated by the incidence of 
      adverse events (AEs) and drug survival. RESULTS: Of the 890 IFX-, 530 GLM- and 
      157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, 
      the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A 
      significant decrease in baseline disease duration and disease activity parameters 
      (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. 
      Treatment with IFX, GLM- and GLM-IV significantly improved all disease parameters 
      over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence 
      of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM- and GLM-IV-treated 
      patients, respectively. CONCLUSION: Differences in baseline characteristics 
      between patients treated with an anti-TNFs over time shows the evolution of 
      treatment modalities over time. All treatments significantly reduced disease 
      activity and improved functionality in a similar fashion. The incidence of 
      adverse events was consistent with the safety profiles of IFX and GLM. TRIAL 
      REGISTRATION: ClinicalTrials.gov Identifier: NCT00741793 (Retrospectively 
      registered on August 26, 2008).
CI  - (c) The Author(s) 2020.
FAU - Rahman, Proton
AU  - Rahman P
AD  - Memorial University, St. John's, NL Canada. GRID: grid.25055.37. ISNI: 0000 0000 
      9130 6822
FAU - Baer, Philip
AU  - Baer P
AD  - Scarborough, Canada.
FAU - Keystone, Ed
AU  - Keystone E
AD  - University of Toronto, Toronto, ON Canada. GRID: grid.17063.33. ISNI: 0000 0001 
      2157 2938
FAU - Choquette, Denis
AU  - Choquette D
AD  - Institut de Rhumatologie de Montreal, Montreal, QC Canada.
FAU - Thorne, Carter
AU  - Thorne C
AD  - Newmarket, Canada.
FAU - Haraoui, Boulos
AU  - Haraoui B
AD  - Institut de Rhumatologie de Montreal, Montreal, QC Canada.
FAU - Chow, Andrew
AU  - Chow A
AD  - Mississauga, ON Canada.
FAU - Faraawi, Rafat
AU  - Faraawi R
AD  - McMaster University, Hamilton, ON Canada. GRID: grid.25073.33. ISNI: 0000 0004 
      1936 8227
FAU - Olszynski, Wojciech
AU  - Olszynski W
AD  - University of Saskatchewan, Saskatoon, SK Canada. GRID: grid.25152.31. ISNI: 0000 
      0001 2154 235X
FAU - Kelsall, John
AU  - Kelsall J
AD  - Providence Health, Vancouver, BC Canada.
FAU - Rampakakis, Emmanouil
AU  - Rampakakis E
AD  - JSS Medical Research, Montreal, QC Canada.
FAU - Lehman, Allen J
AU  - Lehman AJ
AD  - Janssen Inc., 19 Green Belt Dr., Toronto, ON M3C 1N9 Canada.
FAU - Nantel, Francois
AU  - Nantel F
AUID- ORCID: 0000-0002-7970-3328
AD  - Janssen Inc., 19 Green Belt Dr., Toronto, ON M3C 1N9 Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT00741793
PT  - Journal Article
DEP - 20200919
PL  - England
TA  - BMC Rheumatol
JT  - BMC rheumatology
JID - 101738571
PMC - PMC7501619
OTO - NOTNLM
OT  - Effectiveness
OT  - Golimumab
OT  - Infliximab
OT  - Registry
OT  - Rheumatoid arthritis
OT  - Safety
COIS- Competing interestsProton Rahman has received consulting fees for Abbott, AbbVie, 
      Amgen, BMS, Celgene, Janssen, Novartis, Pfizer and Roche; and received research 
      grant from Janssen. Philip Baer has received consultant fees from AbbVie, Amgen, 
      Janssen, Lilly, Novartis, Boehringer Ingelheim, Pfizer Inc., Sanofi-Genzyme and 
      Merck and speaker's fees from Amgen, Janssen, Abbvie, Pfizer Inc. and Lilly. Ed 
      Keystone received funding for research from AbbVie, Amgen, Gilead Sciences, Lilly 
      Pharmaceuticals, Merck, Pfizer Pharmaceuticals, PuraPharm, Sanofi; consulting 
      agreements/advisory board membership from AbbVie, Amgen, AstraZeneca Pharma, 
      Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche 
      Inc., Genentech Inc., Gilead, Janssen Inc., Lilly Pharmaceuticals, Merck, Pfizer 
      Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis; speaker honoraria from 
      Amgen, AbbVie, Bristol-Myers Squibb, Hoffmann-La Roche Inc., Janssen Inc., Merck, 
      Pfizer Pharmaceuticals, Sanofi Genzyme and UCB. Denis Choquette has received 
      consulting and speaking fees from Bristol-Myers Squibb, Abbvie, Amgen, Celgene, 
      Genentech, Amgen, Pfzer, Roche and Novartis. Boulos Haraoui received advisory 
      boards/consulting, and/or received research grants from AbbVie, Amgen, BMS, 
      Celgene, Janssen, Eli Lilly, Merck, Novartis, UCB Pharma and Pfizer. Andrew Chow 
      received advisory boards/consulting, and/or received research grants: AbbVie, 
      Amgen, AstraZeneca, BMS, Celgene, Eli Lilly, Genzyme, GSK, Janssen, Merck, 
      Novartis, Pfizer, Roche, Sanofi Aventis and UCB Pharma. Rafat Faraawi received 
      consultant and speaker fees from Janssen Inc. Wojciech Olszynski received 
      speaker/consultant fees for Amgen, Merck, Novartis, and Warner Chilcott. JPB: 
      research grants, consulting fees, or speakers' bureau fees from Abbott, Amgen, 
      Bristol Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, 
      Servier, Takeda, and Warner Chilcott. John Kelsall reports personal fees from 
      Abbott, AstraZeneca, BMS, Merck-Schering, Lilly, Pfizer, Wyeth, Roche, Takeda and 
      UCB. Allen Lehman and Francois Nantel are employees of Janssen Inc. and are JNJ 
      stockholders.
EDAT- 2020/09/25 06:00
MHDA- 2020/09/25 06:01
PMCR- 2020/09/19
CRDT- 2020/09/24 05:35
PHST- 2020/01/30 00:00 [received]
PHST- 2020/06/03 00:00 [accepted]
PHST- 2020/09/24 05:35 [entrez]
PHST- 2020/09/25 06:00 [pubmed]
PHST- 2020/09/25 06:01 [medline]
PHST- 2020/09/19 00:00 [pmc-release]
AID - 145 [pii]
AID - 10.1186/s41927-020-00145-4 [doi]
PST - epublish
SO  - BMC Rheumatol. 2020 Sep 19;4:46. doi: 10.1186/s41927-020-00145-4. eCollection 
      2020.