PMID- 33292797
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240330
IS  - 2520-1026 (Electronic)
IS  - 2520-1026 (Linking)
VI  - 4
IP  - 1
DP  - 2020 Nov 15
TI  - Long-term effectiveness and safety of infliximab and golimumab in ankylosing 
      spondylitis patients from a Canadian prospective observational registry.
PG  - 56
LID - 10.1186/s41927-020-00158-z [doi]
LID - 56
AB  - BACKGROUND: The objectives of this study were to describe the profile of 
      ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or 
      subcutaneous golimumab (GLM) treatment in Canadian routine care setting along 
      with assessing long-term effectiveness and safety. METHODS: AS patients who were 
      eligible for treatment with IFX or subcutaneous GLM as per their respective 
      Canadian product monographs were enrolled into the BioTRAC registry from 2005 to 
      2017. The study visits occurred at baseline and every 6 months thereafter. 
      Effectiveness was assessed by changes in clinical outcomes and acute phase 
      reactants. Safety was evaluated by assessing the incidence of adverse events 
      (AEs) and drug survival rates. RESULTS: A total of 389 IFX- and 421 GLM-treated 
      patients were enrolled. A significant decrease in disease duration at baseline 
      was observed in the IFX cohort, from a median of 8.0 in 2005-2008 to 1.0 years in 
      2009-2015 (p < 0.001). A reduction in baseline BASFI score (p = 0.011) and 
      proportion of patients in ASDAS very high disease activity (p = 0.004) was also 
      observed over time. Meanwhile, in the GLM cohort, most disease parameters 
      remained similar from 2010 to 2017. Treatment with both agents significantly 
      improved all disease parameters over time with similar efficacy between the two 
      agents. The incidence of AEs and SAEs were 136 and 131 events/100 PYs and 10.5 
      and 8.45 events/100 PYs for IFX- and GLM-treated patients, respectively. 
      CONCLUSION: Both IFX and GLM treatment in AS significantly reduced disease 
      activity in most outcome measures in a similar fashion and were well tolerated in 
      Canadian routine care. TRIAL REGISTRATION: NCT00741793 .
FAU - Rahman, Proton
AU  - Rahman P
AD  - Memorial University, St. John's, NL, Canada.
FAU - Starr, Michael
AU  - Starr M
AD  - McGill University, Montreal, QC, Canada.
FAU - Haaland, Derek
AU  - Haaland D
AD  - , Barrie, ON, Canada.
FAU - Bessette, Louis
AU  - Bessette L
AD  - Universite Laval, Quebec, QC, Canada.
FAU - Teo, Michelle
AU  - Teo M
AD  - , Penticton, 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. 
      fnantel@its.jnj.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT00741793
PT  - Journal Article
DEP - 20201115
PL  - England
TA  - BMC Rheumatol
JT  - BMC rheumatology
JID - 101738571
PMC - PMC7666769
OTO - NOTNLM
OT  - Ankylosing spondylitis
OT  - Axial spondyloarthritis
OT  - Effectiveness
OT  - Golimumab
OT  - Infliximab
OT  - Registry
OT  - Safety
COIS- Proton Rahman has received consulting fees for Abbott, AbbVie, Amgen, BMS, 
      Celgene, Janssen, Novartis, Pfizer and Roche; and received research grant from 
      Janssen. Michael Starr received consultant fees from Janssen, AbbVie, Novartis, 
      Sanofi, Pfizer, BMS and Lilly. Derek Haaland received grant/research support, 
      sponsored study funding and speaker fees from Janssen. Louis Bessette received 
      speaker fees from Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, 
      Celgene, Lilly and Novartis; consultant fees from Amgen, BMS, Janssen, Roche, 
      UCB, AbbVie, Pfizer, Celgene, Lilly and Novartis and research grants from Amgen, 
      BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly and 
      Novartis. Michelle Teo received research support and consulting fees from 
      Janssen. Allen Lehman and Francois Nantel are employees of Janssen Inc. and are 
      JNJ stockholders.
EDAT- 2020/12/10 06:00
MHDA- 2020/12/10 06:01
PMCR- 2020/11/15
CRDT- 2020/12/09 05:47
PHST- 2020/06/01 00:00 [received]
PHST- 2020/08/12 00:00 [accepted]
PHST- 2020/12/09 05:47 [entrez]
PHST- 2020/12/10 06:00 [pubmed]
PHST- 2020/12/10 06:01 [medline]
PHST- 2020/11/15 00:00 [pmc-release]
AID - 10.1186/s41927-020-00158-z [pii]
AID - 158 [pii]
AID - 10.1186/s41927-020-00158-z [doi]
PST - epublish
SO  - BMC Rheumatol. 2020 Nov 15;4(1):56. doi: 10.1186/s41927-020-00158-z.