Predictors of treatment response and drug continuation in 842 patients with ankylosing spondylitis treated with anti-tumour necrosis factor: results from 8 years' surveillance in the Danish nationwide DANBIO registry
Objectives To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response, treatment duration and predictors of drug survival (ie, number of days individual patients maintained treatment) and clinical response among p...
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Published in | Annals of the rheumatic diseases Vol. 69; no. 11; pp. 2002 - 2008 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
London
BMJ Publishing Group Ltd and European League Against Rheumatism
01.11.2010
BMJ Publishing Group BMJ Publishing Group LTD |
Subjects | |
Online Access | Get full text |
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Abstract | Objectives To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response, treatment duration and predictors of drug survival (ie, number of days individual patients maintained treatment) and clinical response among patients with ankylosing spondylitis (AS) receiving their first treatment series with a tumour necrosis factor α (TNFα) inhibitor. Methods 842 TNFα inhibitor naive patients with AS were identified in DANBIO. Clinical response, drug survival and predictors thereof were investigated. ‘Clinical response’ was defined as a 50% or 20 mm reduction in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) within 6 months compared with baseline. Achievement of a BASDAI <40 mm within 6 months was used as a second response parameter. Results 603 patients (72%) were men, disease duration 5 (1–13) years (median (IQR), age 41 (32–50) years. 445 (53%) received infliximab, 247 (29%) adalimumab and 150 (18%) etanercept. Parameters at baseline/1-year follow-up were: C-reactive protein (CRP): 14 (7–27)/5 (2–10) mg/l, BASDAI 59 (44–72)/21 (8–39) mm, Bath Ankylosing Spondylitis Functional Index (BASFI) 50 (34–67)/24 (9–45) mm, Bath Ankylosing Spondylitis Metrology Index 40 (20–50)/20 (10–40) mm. Within 6 months, 407/644 patients (63%) achieved a clinical response. Median drug survival was 4.3 years. One- and 2-year survival rates were 74% and 63%, respectively. Baseline characteristics associated with longer drug survival were male gender, CRP >14 mg/l and low visual analogue scale fatigue (Cox regression analysis). Age, TNFα inhibitor and methotrexate use were insignificant. CRP >14 mg/l, lower BASFI and younger age at baseline was associated with clinical response and achievement of a BASDAI <40 mm (logistic regression analysis). Conclusion TNFα inhibitors provide a rapid and sustained decrease of disease activity among patients with AS in clinical practice. Factors associated with continued treatment, clinical response and achievement of a BASDAI <40 mm were identified. |
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AbstractList | OBJECTIVESTo use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response, treatment duration and predictors of drug survival (ie, number of days individual patients maintained treatment) and clinical response among patients with ankylosing spondylitis (AS) receiving their first treatment series with a tumour necrosis factor α (TNFα) inhibitor.METHODS842 TNFα inhibitor naive patients with AS were identified in DANBIO. Clinical response, drug survival and predictors thereof were investigated. 'Clinical response' was defined as a 50% or 20 mm reduction in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) within 6 months compared with baseline. Achievement of a BASDAI <40 mm within 6 months was used as a second response parameter.RESULTS603 patients (72%) were men, disease duration 5 (1-13) years (median (IQR), age 41 (32-50) years. 445 (53%) received infliximab, 247 (29%) adalimumab and 150 (18%) etanercept. Parameters at baseline/1-year follow-up were: C-reactive protein (CRP): 14 (7-27)/5 (2-10) mg/l, BASDAI 59 (44-72)/21 (8-39) mm, Bath Ankylosing Spondylitis Functional Index (BASFI) 50 (34-67)/24 (9-45) mm, Bath Ankylosing Spondylitis Metrology Index 40 (20-50)/20 (10-40) mm. Within 6 months, 407/644 patients (63%) achieved a clinical response. Median drug survival was 4.3 years. One- and 2-year survival rates were 74% and 63%, respectively. Baseline characteristics associated with longer drug survival were male gender, CRP >14 mg/l and low visual analogue scale fatigue (Cox regression analysis). Age, TNFα inhibitor and methotrexate use were insignificant. CRP >14 mg/l, lower BASFI and younger age at baseline was associated with clinical response and achievement of a BASDAI <40 mm (logistic regression analysis).CONCLUSIONTNFα inhibitors provide a rapid and sustained decrease of disease activity among patients with AS in clinical practice. Factors associated with continued treatment, clinical response and achievement of a BASDAI <40 mm were identified. Objectives To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response, treatment duration and predictors of drug survival (ie, number of days individual patients maintained treatment) and clinical response among patients with ankylosing spondylitis (AS) receiving their first treatment series with a tumour necrosis factor α (TNFα) inhibitor. Methods 842 TNFα inhibitor naive patients with AS were identified in DANBIO. Clinical response, drug survival and predictors thereof were investigated. ‘Clinical response’ was defined as a 50% or 20 mm reduction in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) within 6 months compared with baseline. Achievement of a BASDAI <40 mm within 6 months was used as a second response parameter. Results 603 patients (72%) were men, disease duration 5 (1–13) years (median (IQR), age 41 (32–50) years. 445 (53%) received infliximab, 247 (29%) adalimumab and 150 (18%) etanercept. Parameters at baseline/1-year follow-up were: C-reactive protein (CRP): 14 (7–27)/5 (2–10) mg/l, BASDAI 59 (44–72)/21 (8–39) mm, Bath Ankylosing Spondylitis Functional Index (BASFI) 50 (34–67)/24 (9–45) mm, Bath Ankylosing Spondylitis Metrology Index 40 (20–50)/20 (10–40) mm. Within 6 months, 407/644 patients (63%) achieved a clinical response. Median drug survival was 4.3 years. One- and 2-year survival rates were 74% and 63%, respectively. Baseline characteristics associated with longer drug survival were male gender, CRP >14 mg/l and low visual analogue scale fatigue (Cox regression analysis). Age, TNFα inhibitor and methotrexate use were insignificant. CRP >14 mg/l, lower BASFI and younger age at baseline was associated with clinical response and achievement of a BASDAI <40 mm (logistic regression analysis). Conclusion TNFα inhibitors provide a rapid and sustained decrease of disease activity among patients with AS in clinical practice. Factors associated with continued treatment, clinical response and achievement of a BASDAI <40 mm were identified. To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response, treatment duration and predictors of drug survival (ie, number of days individual patients maintained treatment) and clinical response among patients with ankylosing spondylitis (AS) receiving their first treatment series with a tumour necrosis factor α (TNFα) inhibitor. 842 TNFα inhibitor naive patients with AS were identified in DANBIO. Clinical response, drug survival and predictors thereof were investigated. 'Clinical response' was defined as a 50% or 20 mm reduction in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) within 6 months compared with baseline. Achievement of a BASDAI <40 mm within 6 months was used as a second response parameter. 603 patients (72%) were men, disease duration 5 (1-13) years (median (IQR), age 41 (32-50) years. 445 (53%) received infliximab, 247 (29%) adalimumab and 150 (18%) etanercept. Parameters at baseline/1-year follow-up were: C-reactive protein (CRP): 14 (7-27)/5 (2-10) mg/l, BASDAI 59 (44-72)/21 (8-39) mm, Bath Ankylosing Spondylitis Functional Index (BASFI) 50 (34-67)/24 (9-45) mm, Bath Ankylosing Spondylitis Metrology Index 40 (20-50)/20 (10-40) mm. Within 6 months, 407/644 patients (63%) achieved a clinical response. Median drug survival was 4.3 years. One- and 2-year survival rates were 74% and 63%, respectively. Baseline characteristics associated with longer drug survival were male gender, CRP >14 mg/l and low visual analogue scale fatigue (Cox regression analysis). Age, TNFα inhibitor and methotrexate use were insignificant. CRP >14 mg/l, lower BASFI and younger age at baseline was associated with clinical response and achievement of a BASDAI <40 mm (logistic regression analysis). TNFα inhibitors provide a rapid and sustained decrease of disease activity among patients with AS in clinical practice. Factors associated with continued treatment, clinical response and achievement of a BASDAI <40 mm were identified. Objectives To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response, treatment duration and predictors of drug survival (ie, number of days individual patients maintained treatment) and clinical response among patients with ankylosing spondylitis (AS) receiving their first treatment series with a tumour necrosis factor α (TNFα) inhibitor. Methods 842 TNFα inhibitor naive patients with AS were identified in DANBIO. Clinical response, drug survival and predictors thereof were investigated. 'Clinical response' was defined as a 50% or 20 mm reduction in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) within 6 months compared with baseline. Achievement of a BASDAI <40 mm within 6 months was used as a second response parameter. Results 603 patients (72%) were men, disease duration 5 (1â[euro]"13) years (median (IQR), age 41 (32â[euro]"50) years. 445 (53%) received infliximab, 247 (29%) adalimumab and 150 (18%) etanercept. Parameters at baseline/1-year follow-up were: C-reactive protein (CRP): 14 (7â[euro]"27)/5 (2â[euro]"10) mg/l, BASDAI 59 (44â[euro]"72)/21 (8â[euro]"39) mm, Bath Ankylosing Spondylitis Functional Index (BASFI) 50 (34â[euro]"67)/24 (9â[euro]"45) mm, Bath Ankylosing Spondylitis Metrology Index 40 (20â[euro]"50)/20 (10â[euro]"40) mm. Within 6 months, 407/644 patients (63%) achieved a clinical response. Median drug survival was 4.3 years. One- and 2-year survival rates were 74% and 63%, respectively. Baseline characteristics associated with longer drug survival were male gender, CRP >14 mg/l and low visual analogue scale fatigue (Cox regression analysis). Age, TNFα inhibitor and methotrexate use were insignificant. CRP >14 mg/l, lower BASFI and younger age at baseline was associated with clinical response and achievement of a BASDAI <40 mm (logistic regression analysis). Conclusion TNFα inhibitors provide a rapid and sustained decrease of disease activity among patients with AS in clinical practice. Factors associated with continued treatment, clinical response and achievement of a BASDAI <40 mm were identified. Objectives To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response, treatment duration and predictors of drug survival (ie, number of days individual patients maintained treatment) and clinical response among patients with ankylosing spondylitis (AS) receiving their first treatment series with a tumour necrosis factor α (TNFα) inhibitor. Methods 842 TNFα inhibitor naive patients with AS were identified in DANBIO. Clinical response, drug survival and predictors thereof were investigated. ‘Clinical response’ was defined as a 50% or 20 mm reduction in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) within 6 months compared with baseline. Achievement of a BASDAI <40 mm within 6 months was used as a second response parameter. Results 603 patients (72%) were men, disease duration 5 (1–13) years (median (IQR), age 41 (32–50) years. 445 (53%) received infliximab, 247 (29%) adalimumab and 150 (18%) etanercept. Parameters at baseline/1-year follow-up were: C-reactive protein (CRP): 14 (7–27)/5 (2–10) mg/l, BASDAI 59 (44–72)/21 (8–39) mm, Bath Ankylosing Spondylitis Functional Index (BASFI) 50 (34–67)/24 (9–45) mm, Bath Ankylosing Spondylitis Metrology Index 40 (20–50)/20 (10–40) mm. Within 6 months, 407/644 patients (63%) achieved a clinical response. Median drug survival was 4.3 years. One- and 2-year survival rates were 74% and 63%, respectively. Baseline characteristics associated with longer drug survival were male gender, CRP >14 mg/l and low visual analogue scale fatigue (Cox regression analysis). Age, TNFα inhibitor and methotrexate use were insignificant. CRP >14 mg/l, lower BASFI and younger age at baseline was associated with clinical response and achievement of a BASDAI <40 mm (logistic regression analysis). Conclusion TNFα inhibitors provide a rapid and sustained decrease of disease activity among patients with AS in clinical practice. Factors associated with continued treatment, clinical response and achievement of a BASDAI <40 mm were identified. |
Author | Østergaard, Mikkel Dreyer, Lene Krogh, Niels Steen Glintborg, Bente Kristensen, Hanne Lene Hetland, Merete Lund |
Author_xml | – sequence: 1 givenname: Bente surname: Glintborg fullname: Glintborg, Bente email: glintborg@dadlnet.dk organization: Department of Rheumatology, Gentofte University Hospital, Hellerup, Denmark – sequence: 2 givenname: Mikkel surname: Østergaard fullname: Østergaard, Mikkel email: glintborg@dadlnet.dk organization: Department of Rheumatology, Copenhagen University Hospitals at Hvidovre and Glostrup, Denmark – sequence: 3 givenname: Niels Steen surname: Krogh fullname: Krogh, Niels Steen email: glintborg@dadlnet.dk organization: Zitelab Aps, Copenhagen, Denmark – sequence: 4 givenname: Lene surname: Dreyer fullname: Dreyer, Lene email: glintborg@dadlnet.dk organization: Department of Rheumatology, Rigshospitalet, Copenhagen, Denmark – sequence: 5 givenname: Hanne Lene surname: Kristensen fullname: Kristensen, Hanne Lene email: glintborg@dadlnet.dk organization: Department of Rheumatology, Slagelse Hospital, Slagelse, Denmark – sequence: 6 givenname: Merete Lund surname: Hetland fullname: Hetland, Merete Lund email: glintborg@dadlnet.dk organization: The Danish Rheumatological Database (DANBIO), Hvidovre, Denmark |
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ContentType | Journal Article |
Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2015 INIST-CNRS Copyright: 2010 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions |
Copyright_xml | – notice: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions – notice: 2015 INIST-CNRS – notice: Copyright: 2010 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions |
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DOI | 10.1136/ard.2009.124446 |
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Keywords | Human Diseases of the osteoarticular system Rheumatology Inflammatory joint disease Spine disease Spondylarthropathy Chronic Treatment Surveillance Tumor necrosis factor Danish Predictive factor Ankylosing spondylitis |
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References | Zink, Listing, Kary 2005; 64 Gérard, le Goff, Maugars 2008; 75 Heiberg, Koldingsnes, Mikkelsen 2008; 59 Braun, Brandt, Listing 2005; 64 Coates, Cawkwell, Ng 2008; 47 Katz, Criswell 1996; 9 Braun, Baraliakos, Listing 2008; 67 Hjardem, Hetland, Østergaard 2005; 64 Hetland, Unkerskov, Ravn 2005; 34 Schefte, Hetland 2010; 49 Hjardem, Østergaard, Pødenphant 2007; 66 van der Heijde, Kivitz, Schiff 2006; 54 Brocq, Roux, Albert 2007; 74 Konttinen, Tuompo, Uusitalo 2007; 26 Rudwaleit, Claudepierre, Wordsworth 2009; 36 van der Heijde, Dijkmans, Geusens 2005; 52 Hyrich, Watson, Silman 2006; 45 Hetland, Lindegaard, Hansen 2008; 67 Braun, Brandt, Listing 2002; 359 Kvien, Mikkelsen, Nordvåg 2003; 30 Hetland, Christensen, Tarp 2010; 62 Carmona, Gómez-Reino 2006; 8 Braun, Davis, Dougados 2006; 65 Davis, Van der Heijde, Dougados 2005; 32 Calin, Dijkmans, Emery 2004; 63 Anderson, Baron, van der Heijde 2001; 44 Zink, Listing, Klindworth 2001; 60 Zochling, van der Heijde, Burgos-Vargas 2006; 65 Davis, van der Heijde, Braun 2005; 64 Luc, Gossec, Ruyssen-Witrand 2007; 34 Braun, Sieper 2007; 369 Buchbinder, March, Lassere 2007; 37 Heiberg, Nordvåg, Mikkelsen 2005; 52 Sieper, Rudwaleit, Baraliakos 2009; 68 Rudwaleit, Listing, Brandt 2004; 63 Sokka, Toloza, Cutolo 2009; 11 Cutolo, Straub, Bijlsma 2007; 3 Duclos, Gossec, Ruyssen-Witrand 2006; 33 Geborek, Crnkic, Petersson 2002; 61 Zochling, van der Heijde, Dougados 2006; 65 Thompson, Pegley 1991; 30 Pincus, Yazici, van Vollenhoven 2006; 33 |
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Need for longterm observations in standard care to complement clinical trials publication-title: J Rheumatol contributor: fullname: van Vollenhoven – volume: 64 start-page: 1274 year: 2005 article-title: Treatment continuation in patients receiving biological agents or conventional DMARD therapy publication-title: Ann Rheum Dis contributor: fullname: Kary – volume: 68 start-page: ii1 year: 2009 article-title: The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis publication-title: Ann Rheum Dis contributor: fullname: Baraliakos – volume: 32 start-page: 1751 year: 2005 article-title: Baseline factors that influence ASAS 20 response in patients with ankylosing spondylitis treated with etanercept publication-title: J Rheumatol contributor: fullname: Dougados – volume: 49 start-page: 99 year: 2010 article-title: An open-source, self-explanatory touch screen in routine care. 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Snippet | Objectives To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response,... To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response, treatment... Objectives To use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response,... OBJECTIVESTo use prospectively registered data from the Danish nationwide rheumatological database (DANBIO) to describe disease activity, clinical response,... |
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SubjectTerms | Adult Age Antirheumatic Agents - therapeutic use Biological and medical sciences Biological products Clinical trials Denmark Diseases of the osteoarticular system Diseases of the spine Drug Administration Schedule Epidemiologic Methods Female Gangrene Humans Immunosuppressive Agents - therapeutic use Inflammatory joint diseases Male Medical sciences Middle Aged Patient Compliance - statistics & numerical data Prognosis Registration Rheumatic diseases Rheumatoid arthritis Spondylitis, Ankylosing - drug therapy Studies Treatment Outcome Tumor Necrosis Factor-alpha - antagonists & inhibitors Tumor necrosis factor-TNF Womens health |
Title | Predictors of treatment response and drug continuation in 842 patients with ankylosing spondylitis treated with anti-tumour necrosis factor: results from 8 years' surveillance in the Danish nationwide DANBIO registry |
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