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Glintborg B.,Copenhagen University | Ostergaard M.,Glostrup Hospital | Ostergaard M.,Copenhagen University | Krogh N.S.,ZiteLab ApS | And 11 more authors.
Arthritis and Rheumatism | Year: 2013

Objective To describe the frequency of treatment switching and outcomes among patients with psoriatic arthritis (PsA) who switched tumor necrosis factor α inhibitor (TNFi) agents in routine care. Methods We conducted an observational cohort study based on the Danish nationwide DANBIO registry. Treatment outcomes were evaluated using the American College of Rheumatology criteria for 20% improvement (ACR20)/ACR50/ACR70, European League Against Rheumatism (EULAR) response criteria for good response, and the 28-joint count Disease Activity Score (DAS28) (remission). Kaplan-Meier and regression analyses were used for drug survival analyses and to identify predictors of outcome after treatment switching. Results Of 1,422 patients starting TNFi agents, 548 patients (39%) switched to a second biologic drug during up to 10 years of followup. Median followup was 2.3 years (interquartile range [IQR] 1.0-4.3 years). Switchers were more frequently women (56% versus 45%), had a shorter disease duration (3 versus 4 years), a higher median Health Assessment Questionnaire (HAQ) score (1.1 [IQR 0.6-1.6] versus 0.9 [IQR 0.5-1.4]), DAS28 (4.8 [4.0-5.7] versus 4.4 [3.6-5.2]), pain score on a visual analog scale (VAS) (65 mm [46-77] versus 62 mm [40-75]), and fatigue score on a VAS (69 mm [50-83] versus 64 mm [42-80] mm) (all P < 0.05 at start of first TNFi). During the first and second treatment, HAQ, DAS28, and VAS scores and C-reactive protein levels had decreased after 6 months (all P < 0.05), and median drug survival was 2.2 versus 1.3 years (P < 0.001). Lower fatigue score increased survival of the second TNFi. After switching, the proportions of patients achieving a sustained ACR20, ACR50, ACR70, EULAR good response, and DAS28 remission after 3-6 months were 22% (number needed to treat [NNT] 4.5), 13% (NNT 7.9), 5% (NNT 20), 19% (NNT 5.3), and 34% (NNT 2.9), respectively. Response rates were lower during the second treatment (all P < 0.01 versus first TNFi). At the 2-year visit, 47% of switchers had achieved an ACR20 response. No differences between drug-drug combinations were found. Conclusion Thirty-nine percent of the patients with PsA switched TNFi agents. Response rates and drug survival were lower after switching; however, half of the switchers had an ACR20 response 2 years after starting the first TNFi. Copyright © 2013 by the American College of Rheumatology.

Ornbjerg L.M.,Copenhagen University | Ostergaard M.,Copenhagen University | Boyesen P.,Diakonhjemmet Hospital | Krogh N.S.,Zitelab Aps | And 16 more authors.
Annals of the Rheumatic Diseases | Year: 2013

Objectives: To compare radiographic progression during treatment with disease-modifying antirheumatic drugs (DMARD) and subsequent treatment with tumour necrosis factor α inhibitors (TNF-I) in rheumatoid arthritis (RA) patients in clinical practice. Methods: Conventional radiographs (x-rays) of hands and wrists were obtained ∼2 years before start (prebaseline), at baseline and ∼2 years after start (follow-up) of TNF-I. Clinical data were obtained from the DANBIO registry and the patient files. x-Rays were scored blinded to chronology according to the Sharp/van der Heijde method. Annual radiographic progression rates during the DMARD (prebaseline to baseline x-ray) and TNF-I (baseline to follow-up x-ray) periods were calculated. Results: 517 RA patients (76% women, 80% IgM rheumatoid factor positive, 65% anticyclic citrullinated peptide positive, 40% current smokers, age 54 years (range 21-86), median disease duration 5 years (range 0-57)) were included. Patients were treated with infliximab (61%), etanercept (15%) or adalimumab (24%). During the DMARD period 85% of patients received methotrexate, 51% sulphasalazine and 78% prednisolone. The median DMARD period was 733 days (IQR 484-1002) and the median TNF-I period was 562 days (IQR 405-766). The median radiographic progression rate decreased from 0.7 (IQR 0-2.9) total Sharp score units/year (dTSS) in the DMARD period to 0 (0-0.9) units/year in the TNF-I period (p<0.0001, Wilcoxon). Corresponding mean dTSS values were 2.1 (SD 3.7) versus 0.7 (SD 2.3) units/year (p<0.0001, paired t test). 305 patients progressed (dTSS >0) in the DMARD period compared with 158 patients in the TNF-I period (p<0.0001, χ2). Conclusion: This nationwide observational study of RA patients documented significantly reduced radiographic progression during TNF-I treatment compared with the previous period of DMARD treatment.

PubMed | Holbaek Hospital, Randers Hospital, Copenhagen University, Slagelse Hospital and 14 more.
Type: Journal Article | Journal: Rheumatology (Oxford, England) | Year: 2016

To investigate the association between tobacco smoking and disease activity, treatment adherence and treatment responses in patients with AS treated with their first tumour necrosis factor-alpha inhibitor (TNFi) therapy in routine care.Observational cohort study based on the Danish nationwide DANBIO registry. Kaplan-Meier plots, Cox and logistic regression analyses by smoking status (current/never/previous) were calculated for treatment adherence and BASDAI 50%/20 mm-response. Additional stratified analyses were performed for gender and TNFi-type.Of 1576 AS patients included in the study, 1425(90%) had known smoking status (current/never/previous: 43%/41%/16%). The median follow-up time was 2.02 years (IQR 0.69-5.01). At baseline, current smokers compared with never smokers had longer disease duration (4 years (1-12)/2 years (0-10)), higher BASDAI (61 mm (47-73)/58 mm (44-70)), BASFI (53 mm (35-69)/46 mm (31-66)) and BASMI (40 mm (20-60)/30 mm (10-50)) scores (all P < 0.01). Current and previous smokers had shorter treatment adherence than never smokers (current: 2.30 years (1.81-2.79) (median (95% CI)); previous: 2.48 years (1.56-3.40), never: 4.12 years (3.29-4.95)), P < 0.0001). Similar results were found in multivariate analyses (current versus never smokers, HR 1.41 (95% CI 1.21-1.65), P < 0.001), most pronounced among men. Current smokers had poorer 6 months BASDAI50%/20 mm-response rate than never smokers (42%/58%, P < 0.001). In multivariate analyses, current smokers had lower odds of achieving BASDAI50%/20 mm-response than never smokers, both overall (OR 0.48 (95% CI 0.35-0.65), P < 0.0001) and for the different TNFi-types (adalimumab 0.45 (0.27-0.76)/etanercept 0.24 (0.10-0.61)/infliximab 0.57 (0.34-0.95)).In this study of TNFi-treated AS patients in clinical practice, current and previous smokers had significantly poorer patient-reported outcomes at baseline, shorter treatment adherence and poorer treatment response compared with never smokers.

Glintborg B.,Gentofte University Hospital | Ostergaard M.,Copenhagen University | Krogh N.S.,Zitelab Aps | Dreyer L.,Rigshospitalet | And 2 more authors.
Annals of the Rheumatic Diseases | Year: 2010

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.

Leffers H.C.,Copenhagen University | Ostergaard M.,Copenhagen University | Glintborg B.,Holbaek Hospital | Krogh N.S.,Zitelab Aps | And 9 more authors.
Annals of the Rheumatic Diseases | Year: 2011

Objectives: To describe drug survival, disease activity and clinical response in patients with rheumatoid arthritis (RA) treated with abatacept or tocilizumab in routine care, based on prospectively registered observational data from the nationwide Danish DANBIO registry. Methods: 150 Patients with RA treated with abatacept and 178 treated with tocilizumab were identified. Drug survival was investigated. Response data were available in 104 and 97 patients, respectively. Changes in 28-joint Disease Activity Score (DAS28) based on C-reactive protein (CRP) and European League Against Rheumatism (EULAR) response after 24 and 48 weeks were investigated. No direct comparison of drugs was made. Results: Median (IQR) disease duration was 8.5 (3-14)/9 (3-12) years (abatacept/tocilizumab). 95%/93% of patients had previously received one or more tumour necrosis factor inhibitor (TNFi). After 48 weeks, 54%/64% of patients (abatacept/tocilizumab) maintained treatment. Among patients with available response data, DAS28 was 5.3 (4.7-6.1), 3.4 (2.7-4.9) and 3.3 (2.5-4.3) at baseline, weeks 24 and 48, respectively, in the abatacept group and 5.4 (4.7-6.2), 2.9 (2.3-4.0) and 2.5 (1.9-4.5) in the tocilizumab group. At weeks 24 and 48, the remission rates for abatacept/tocilizumab were 19%/39% and 26%/58%, respectively. EULAR good-or-moderate response rates were 70%/88% and 77%/84%, respectively. The decline in DAS28 variables over time appeared similar between drugs, except for CRP, which seemed to decline more rapidly among tocilizumabtreated patients. Conclusions: In patients with RA (≥90% TNFi failures), a good-or-moderate EULAR response was achieved in ≥70% of patients treated with abatacept or tocilizumab for 24 weeks in routine care. Apparent declines in DAS28 variables over time were similar between drugs, except for the more rapid CRP decline among tocilizumab-treated patients, directly caused by interleukin 6 inhibition.

Hetland M.L.,Glostrup Hospital | Hetland M.L.,Copenhagen University | Jensen D.V.,Glostrup Hospital | Jensen D.V.,Gentofte Hospital | Krogh N.S.,Zitelab ApS
Clinical and Experimental Rheumatology | Year: 2014

Objective. Advances in aggressive use of conventional synthetic diseasemodifying anti-rheumatic drugs (csDMARDs) as well as biological DMARDs (bDMARDs) have improved the treatment armamentarium for rheumatologists, and modern treatment principles include a treat-to-target (T2T) strategy. However, little is known about the feasibility of a T2T strategy in patients with rheumatoid arthritis (RA) treated in routine care. The aim of the present study was to (i) present the annual number of patients included in DANBIO between 2006 and 2013 and their disease characteristics and (ii) estimate coverage of DANBIO by 2013. Methods. Patients who were registered with RA for the first time in the nationwide Danish DANBIO database between year 2006 and 2013 were included. Baseline characteristics were assessed in patients treated with bDMARDs and csDMARDs, respectively. The fraction of patients with low/ moderate/high disease activity (i.e. DAS28 (CRP-based, 4 variables) was calculated for each calendar year. Results. From 2006-2013 the number of patients increased from 2,395 to 14,249. By 2013, 29.8% of patients were receiving bDMARD. Patients in the csDMARD group were older, had shorter disease duration, lower disease activity, less disability and radiographic damage. By 2013, 19% of csDMARD (15% of bDMARD) patients were in ACR/Boolean remission. Coverage had increased to between 41% and 79% for patients with RA, for the bDMARD group it was 94%. Conclusion. Systematic monitoring of RA patients with real-time feedback to the physician is feasible, although the goal of treat-to-target is not achieved in a substantial proportion of patients in routine care. © Clinical and Experimental Rheumatology 2014.

Glintborg B.,Gentofte University Hospital | Ostergaard M.,Copenhagen University | Krogh N.S.,Zitelab Aps | Tarp U.,Aarhus University Hospital | And 13 more authors.
Annals of the Rheumatic Diseases | Year: 2013

Objective: To investigate frequencies and reasons for switching, treatment responses and drug survival in patients with ankylosing spondylitis (AS) switching tumour-necrosis-factor-α inhibitor (TNFi) treatment in routine clinical care. Methods: AS patients were identified in the Danish nationwide DANBIO registry. Disease activity, treatment responses (50% or 20 mm reduction in Bath AS Disease Activity Index (BASDAI)), duration and rates of drug survival and predictors thereof were studied in patients receiving ≥2 different biological drugs. Results: Of 1436 AS patients starting TNFi treatment, 432 patients (30%) switched to a second and 137 (10%) to a third biological drug. Compared with non-switchers, switchers were more frequently women (33%/22%), had shorter disease duration (3 years/5 years) and higher BASDAI (62(52-76) mm/56(43-69) mm (median (interquartile-range))), Bath AS Functional Index (BASFI) (54(39-71) mm/47(31-65) mm) and visual-analoguescale (VAS) global, pain and fatigue scores when they started the first TNFi (all p<0.01). Main reason for switching was lack of response (56%). During the first, second and third treatment BAS- and VAS scores had decreased after 6 months' treatment (all p<0.05). Median drug survivals were 3.1, 1.6 and 1.8 years respectively ( p<0.001). After 2 years of treatment 52% of switchers and 63% of non-switchers had achieved response (number needed to treat 1.9 and 1.6, respectively, p=0.01). Drug survivals were similar regardless of the reason for switching. Male gender and low BASFI predicted drug survival of the second TNFi. Conclusions: Nearly one-third of AS patients in clinical practice switched biological treatment. Response rates and drug survivals were lower among switchers, however, half of switchers achieved treatment response.

Glintborg B.,Gentofte University Hospital | Astergaard M.,Copenhagen University | Dreyer L.,Copenhagen University | Krogh N.S.,Zitelab Aps | And 5 more authors.
Arthritis and Rheumatism | Year: 2011

Objective. To investigate disease activity, treatment response, and drug survival, and predictors thereof, among Danish patients with psoriatic arthritis (PsA) receiving their first treatment series with a tumor necrosis factor α (TNFα) inhibitor. Methods. Patients with PsA were identified from a prospective nationwide rheumatologic database, the Danish biologics registry DANBIO, using data registered from 2000-2009. Information was obtained on the patients' clinical response to anti-TNFα treatment (defined as achievement of the American College of Rheumatology 20% [ACR20], ACR50, and ACR70 improvement criteria or a European League Against Rheumatism [EULAR] good response at least once during the first 6 months of treatment) and duration and rate of drug adherence (referred to as drug survival), as well as predictors thereof. Results. Of 764 patients with PsA, 320 received adalimumab, 260 infliximab, and 184 etanercept. Median drug survival was 2.9 years, and 1-year and 2-year drug survival rates were 70% and 57%, respectively. Clinical parameters that showed improvement over 6 months were the C-reactive protein (CRP) level, Health Assessment Questionnaire score, and 28-joint Disease Activity Score. Male sex, CRP level >10 mg/liter, concomitant methotrexate use, and low patient health visual analog scale score at baseline were associated with longer drug survival. Improvement was achieved by 59%, 45%, 24%, and 54% of patients according to the ACR20, ACR50, ACR70 response criteria and EULAR good response, respectively. A CRP level >10 mg/liter was predictive of the improvement responses (odds ratio [OR] 2.6 for ACR20, OR 3.0 for ACR50, OR 3.6 for ACR70, and OR 2.2 for EULAR good response). Conclusion. In these patients with PsA treated with their first TNFα inhibitor in clinical practice, high drug adherence and responder rates were observed. Moreover, increased levels of CRP at baseline were associated with both good treatment responses and continued treatment, which may be of clinical value in selecting the patients most likely to benefit from treatment with TNFα inhibitors. © 2011 by the American College of Rheumatology.

PubMed | Aarhus University Hospital, University of Southern Denmark, ZiteLab ApS and Copenhagen University
Type: | Journal: Trials | Year: 2015

Rheumatoid arthritis (RA) is a chronic, progressive joint disease, which frequently leads to irreversible joint deformity and severe functional impairment. Although patients are treated according to existing guidelines and reach clinical remission, erosive progression still occurs. This demonstrates that additional methods for prognostication and monitoring of the disease activity are needed. Bone marrow edema (BME) detected by magnetic resonance imaging (MRI) has proved to be an independent predictor of subsequent radiographic progression. Guiding the treatment based on the presence/absence of BME may therefore be clinically beneficial. We present the design of a randomized controlled trial (RCT) aiming to evaluate whether an MRI-guided treatment strategy compared to a conventional treatment strategy in anti-CCP-positive erosive RA is better to prevent progression of erosive joint damage and increase the remission rate in patients with low disease activity or clinical remission.The study is a non-blinded, multicenter, 2-year RCT with a parallel group design. Two hundred anti-CCP-positive, erosive RA patients characterized by low disease activity or remission, no clinically swollen joints and treatment with synthetic disease-modifying antirheumatic drugs (DMARDs) will be included. Patients will be randomized to either a treatment strategy based on conventional laboratory and clinical examinations (control group) or a treatment strategy based on conventional laboratory and clinical examinations as well as MRI (intervention group). Treatment is intensified according to a predefined treatment algorithm in case of inflammation defined as a disease activity score (DAS28) >3.2 and at least one clinically swollen joint (control and intervention groups) and/or MRI-detected BME (intervention group only). The primary outcome measures are DAS28 remission (DAS28<2.6) and radiographic progression (Sharp/vdHeijde score).The perspectives, strengths and weaknesses of this study are discussed. This study has been approved by The Regional Scientific Ethical Committees for Southern Denmark, S-20110109. Dissemination will occur through presentations and publication in international peer-reviewed journals.The study is registered in http://www.ClinicalTrials.gov identifier: NCT01656278 (5 July 2012).

PubMed | University of Southern Denmark, Zitelab ApS, Rigshospitalet, Sygehus Lillebaelt and Copenhagen University
Type: Review | Journal: Clinical and experimental rheumatology | Year: 2016

Electronic platforms have been developed to help the clinician monitor disease activity in rheumatoid arthritis (RA) to support at treat-to-target strategy. We present an initiative to interactively improve disease control in patients with rheumatoid arthritis.In patients who presented with one or more swollen joints AND moderate/high disease activity (i.e. either CDAI10.1 and/or DAS-28CRP>3.2, which is automatically calculated in the DANBIO registry), a red alert was shown, which activated a pop-up: This patient has at least one swollen joint AND either CDAI 10.1 or DAS28CRP>3.2. Which action do you as a physician take today: Intensify treatment, Treatment intensification is not possible currently/awaiting results of additional investigations, No further treatment intensification is possible, The patient does not want to intensify treatment, Other decisions taken RESULTS: Of 21,056 patients with RA, 40% fulfilled the criteria for getting the alert message. The pop-up was activated and completed by the physician in 65% of those (5,428 patients). Treatment was intensified in 67%. In 2% of patients, no additional treatment intensification was possible, and 8% of the patients objected to intensification.In >8,000 RA patients who presented with objective signs of active disease in routine care, an interactive feature of the DANBIO registry was introduced, which prompted the physician to take action and consider treatment intensification. In two-thirds of the cases, the treating physician reported that treatment was intensified.

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