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Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis

OBJECTIVES: To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world. SETTING: 46 primary care rheumatology practices across Canada. PARTICIPANTS: 303 biological-naïve...

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Autores principales: Rahman, Proton, Choquette, Denis, Bensen, William G, Khraishi, Majed, Chow, Andrew, Zummer, Michel, Shaikh, Saeed, Sheriff, Maqbool, Dixit, Sanjay, Sholter, Dalton, Psaradellis, Eliofotisti, Sampalis, John S, Letourneau, Vincent, Lehman, Allen J, Nantel, François, Rampakakis, Emmanouil, Otawa, Susan, Shawi, May
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4823435/
https://www.ncbi.nlm.nih.gov/pubmed/27048632
http://dx.doi.org/10.1136/bmjopen-2015-009661
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author Rahman, Proton
Choquette, Denis
Bensen, William G
Khraishi, Majed
Chow, Andrew
Zummer, Michel
Shaikh, Saeed
Sheriff, Maqbool
Dixit, Sanjay
Sholter, Dalton
Psaradellis, Eliofotisti
Sampalis, John S
Letourneau, Vincent
Lehman, Allen J
Nantel, François
Rampakakis, Emmanouil
Otawa, Susan
Shawi, May
author_facet Rahman, Proton
Choquette, Denis
Bensen, William G
Khraishi, Majed
Chow, Andrew
Zummer, Michel
Shaikh, Saeed
Sheriff, Maqbool
Dixit, Sanjay
Sholter, Dalton
Psaradellis, Eliofotisti
Sampalis, John S
Letourneau, Vincent
Lehman, Allen J
Nantel, François
Rampakakis, Emmanouil
Otawa, Susan
Shawi, May
author_sort Rahman, Proton
collection PubMed
description OBJECTIVES: To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world. SETTING: 46 primary care rheumatology practices across Canada. PARTICIPANTS: 303 biological-naïve patients with AS or patients previously treated with a biological for <6 months and who were eligible for infliximab treatment as per routine care within the Biologic Treatment Registry Across Canada (BioTRAC). INTERVENTION: Not applicable (non-interventional study). PRIMARY AND SECONDARY OUTCOMES: Effectiveness was assessed with changes in disease parameters (AS Disease Activity Score (ASDAS), Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Health Assessment Questionnaire Disease Index (HAQ-DI), physician global assessment of disease activity (MDGA), patient global disease activity (PtGA), back pain, C-reactive protein, erythrocyte sedimentation rate (ESR), morning stiffness). Safety was assessed with the incidence of adverse events (AEs). RESULTS: Of the 303 patients included, 44.6% were enrolled in 2005–2007 and 55.4% in 2008–2013. Patients enrolled in 2005–2007 had significantly higher MDGA and ESR at baseline while all other disease parameters examined were numerically higher with the exception of PtGA. Treatment with infliximab significantly (p<0.001) improved all disease parameters over time in both groups. At 6 months, 56% and 31% of patients achieved clinically important (change≥1.1) and major (change≥2.0) improvement in ASDAS, respectively; at 48 months, these proportions increased to 75% and 50%, respectively. Among patients unemployed due to disability at baseline, 12.1% returned to work (mean Kaplan-Meier (KM)-based time=38.8 months). The estimated retention rate at 12 and 24 months was 78.3% and 60.1%, respectively. The profile and incidence of AEs were comparable to data previously reported for tumour necrosis factor-α inhibitors. CONCLUSIONS: Characteristics of patients with AS at infliximab initiation changed over time towards lower disease activity and shorter disease duration. Infliximab treatment significantly reduced disease activity independent of treatment initiation year, although patients enrolled in recent years achieved lower disease activity over 48 months. TRIAL REGISTRATION NUMBER: NCT00741793.
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spelling pubmed-48234352016-04-19 Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis Rahman, Proton Choquette, Denis Bensen, William G Khraishi, Majed Chow, Andrew Zummer, Michel Shaikh, Saeed Sheriff, Maqbool Dixit, Sanjay Sholter, Dalton Psaradellis, Eliofotisti Sampalis, John S Letourneau, Vincent Lehman, Allen J Nantel, François Rampakakis, Emmanouil Otawa, Susan Shawi, May BMJ Open Rheumatology OBJECTIVES: To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world. SETTING: 46 primary care rheumatology practices across Canada. PARTICIPANTS: 303 biological-naïve patients with AS or patients previously treated with a biological for <6 months and who were eligible for infliximab treatment as per routine care within the Biologic Treatment Registry Across Canada (BioTRAC). INTERVENTION: Not applicable (non-interventional study). PRIMARY AND SECONDARY OUTCOMES: Effectiveness was assessed with changes in disease parameters (AS Disease Activity Score (ASDAS), Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Health Assessment Questionnaire Disease Index (HAQ-DI), physician global assessment of disease activity (MDGA), patient global disease activity (PtGA), back pain, C-reactive protein, erythrocyte sedimentation rate (ESR), morning stiffness). Safety was assessed with the incidence of adverse events (AEs). RESULTS: Of the 303 patients included, 44.6% were enrolled in 2005–2007 and 55.4% in 2008–2013. Patients enrolled in 2005–2007 had significantly higher MDGA and ESR at baseline while all other disease parameters examined were numerically higher with the exception of PtGA. Treatment with infliximab significantly (p<0.001) improved all disease parameters over time in both groups. At 6 months, 56% and 31% of patients achieved clinically important (change≥1.1) and major (change≥2.0) improvement in ASDAS, respectively; at 48 months, these proportions increased to 75% and 50%, respectively. Among patients unemployed due to disability at baseline, 12.1% returned to work (mean Kaplan-Meier (KM)-based time=38.8 months). The estimated retention rate at 12 and 24 months was 78.3% and 60.1%, respectively. The profile and incidence of AEs were comparable to data previously reported for tumour necrosis factor-α inhibitors. CONCLUSIONS: Characteristics of patients with AS at infliximab initiation changed over time towards lower disease activity and shorter disease duration. Infliximab treatment significantly reduced disease activity independent of treatment initiation year, although patients enrolled in recent years achieved lower disease activity over 48 months. TRIAL REGISTRATION NUMBER: NCT00741793. BMJ Publishing Group 2016-04-05 /pmc/articles/PMC4823435/ /pubmed/27048632 http://dx.doi.org/10.1136/bmjopen-2015-009661 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Rheumatology
Rahman, Proton
Choquette, Denis
Bensen, William G
Khraishi, Majed
Chow, Andrew
Zummer, Michel
Shaikh, Saeed
Sheriff, Maqbool
Dixit, Sanjay
Sholter, Dalton
Psaradellis, Eliofotisti
Sampalis, John S
Letourneau, Vincent
Lehman, Allen J
Nantel, François
Rampakakis, Emmanouil
Otawa, Susan
Shawi, May
Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis
title Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis
title_full Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis
title_fullStr Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis
title_full_unstemmed Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis
title_short Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis
title_sort biologic treatment registry across canada (biotrac): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis
topic Rheumatology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4823435/
https://www.ncbi.nlm.nih.gov/pubmed/27048632
http://dx.doi.org/10.1136/bmjopen-2015-009661
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