PMID- 30858896
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 1759-720X (Print)
IS  - 1759-7218 (Electronic)
IS  - 1759-720X (Linking)
VI  - 11
DP  - 2019
TI  - Effectiveness and safety of certolizumab pegol in rheumatoid arthritis patients 
      in Canadian practice: 2-year results from the observational FalphasT-CAN study.
PG  - 1759720X19831151
LID - 10.1177/1759720X19831151 [doi]
LID - 1759720X19831151
AB  - BACKGROUND: The aim of this study was to assess the real-world effectiveness and 
      safety of certolizumab pegol (CZP) in rheumatoid arthritis (RA) patients, and the 
      impact on patients' productivity, pain, and fatigue, in Canadian practice. 
      METHODS: FalphasT-CAN, a 2-year prospective, observational study, evaluated CZP use 
      in Canadian adults with moderate to severe, active RA. The primary objective was 
      to assess the proportion of patients achieving 28-joint Disease Activity Scores 
      (DAS28) <2.6 at Week 104. Secondary and additional endpoints assessed the 
      improvements in Patients' Assessment of Arthritis Pain (PtAAP), fatigue, Health 
      Assessment Questionnaire-Disability Index (HAQ-DI), and the proportion of 
      patients achieving minimal clinically important differences (MCID) in HAQ-DI. 
      Validated arthritis-specific Work Productivity Surveys (WPS-RA) assessed the 
      RA-associated impact on productivity. Incidence of CZP-related treatment-emergent 
      adverse events (TEAEs) was reported for patients receiving ⩾1 dose of CZP (safety 
      set). RESULTS: The full analysis set (baseline DAS28 ⩾ 2.6, ⩾1 dose of CZP and ⩾1 
      valid post-baseline DAS28 measurement) included 451 of the 546 patients recruited 
      into the study; a total of 229/451 (50.8%) patients completed Week 104. At Week 
      104, 90/451 (20.0%) patients achieved DAS28 < 2.6. Rapid improvements in disease 
      activity, pain, and fatigue were observed. At Week 104, 66.2% of patients 
      achieved HAQ-DI MCID. Patients employed at Week 104, reported reduced 
      absenteeism, and improved productivity. CZP-related TEAEs were consistent with 
      the known CZP safety profile. CONCLUSIONS: CZP was an effective RA treatment in 
      Canadian practice, and no new CZP-related safety signals were identified. The 
      improvements in household and workplace productivity are the first observations 
      in a real-world Canadian setting.
FAU - Bessette, Louis
AU  - Bessette L
AUID- ORCID: 0000-0002-6834-2731
AD  - Department of Medicine, Laval University, 2705, Laurier Boulevard, Quebec City, 
      Quebec, Canada.
FAU - Haraoui, Boulos
AU  - Haraoui B
AD  - Department of Medicine, Centre Hospitalier de l'Universite de Montreal, Montreal, 
      Quebec, Canada.
FAU - Chow, Andrew
AU  - Chow A
AD  - Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
FAU - Fortin, Isabelle
AU  - Fortin I
AD  - Centre de Rhumatologie de l'Est du Quebec a Rimouski, Rimouski, Quebec, Canada.
FAU - Dixit, Sanjay
AU  - Dixit S
AD  - Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
FAU - Khraishi, Majed
AU  - Khraishi M
AD  - Department of Medicine, Memorial University of Newfoundland, St John's, 
      Newfoundland and Labrador, Canada.
FAU - Haaland, Derek
AU  - Haaland D
AD  - Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
FAU - Elmoufti, Sami
AU  - Elmoufti S
AD  - UCB Pharma, Oakville, Ontario, Canada.
FAU - Staelens, Fabienne
AU  - Staelens F
AD  - UCB Pharma, Braine-l'Alleud, Belgium.
FAU - Bogatyreva, Irina
AU  - Bogatyreva I
AD  - UCB Pharma, Brussels, Belgium.
FAU - Syrotuik, Jerry
AU  - Syrotuik J
AD  - UCB Pharma, Oakville, Ontario, Canada.
FAU - Shaikh, Saeed
AU  - Shaikh S
AD  - Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
LA  - eng
PT  - Journal Article
DEP - 20190305
PL  - England
TA  - Ther Adv Musculoskelet Dis
JT  - Therapeutic advances in musculoskeletal disease
JID - 101517322
PMC - PMC6402066
OTO - NOTNLM
OT  - biologic
OT  - certolizumab pegol
OT  - effectiveness
OT  - rheumatoid arthritis
OT  - safety
COIS- Conflict of interest statement: The author(s) declared the following potential 
      conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: LB: Advisory boards/consulting, and/or received 
      research grants: Amgen, BMS, Janssen, Roche, UCB Pharma, AbbVie, Pfizer, Merck, 
      Celgene, Sanofi, Eli Lilly and Novartis; BH: Advisory boards/consulting, and/or 
      received research grants: AbbVie, Amgen, BMS, Celgene, Janssen, Eli Lilly, Merck, 
      Novartis, UCB Pharma and Pfizer; AC: Advisory boards/consulting, and/or received 
      research grants: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Eli Lilly, Genzyme, 
      GSK, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi Aventis, UCB Pharma; IF, SD: 
      None declared; MK: Received research grants: Abbott, Amgen and Pfizer; DH: 
      Advisory boards/consulting, conducted research, and/or received grants: AbbVie, 
      Amgen, AstraZeneca, Adiga Life Sciences, Abbott, BMS, Celgene, Circassia, GSK, 
      Janssen, Eli Lilly, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, and UCB 
      Pharma; SE, JS: Employees of UCB Pharma; SS: Consulting: Roche, Eli Lilly, 
      Sanofi, and Amgen.
EDAT- 2019/03/13 06:00
MHDA- 2019/03/13 06:01
PMCR- 2019/03/05
CRDT- 2019/03/13 06:00
PHST- 2018/08/03 00:00 [received]
PHST- 2018/11/15 00:00 [accepted]
PHST- 2019/03/13 06:00 [entrez]
PHST- 2019/03/13 06:00 [pubmed]
PHST- 2019/03/13 06:01 [medline]
PHST- 2019/03/05 00:00 [pmc-release]
AID - 10.1177_1759720X19831151 [pii]
AID - 10.1177/1759720X19831151 [doi]
PST - epublish
SO  - Ther Adv Musculoskelet Dis. 2019 Mar 5;11:1759720X19831151. doi: 
      10.1177/1759720X19831151. eCollection 2019.