Effectiveness and drug adherence of biologic monotherapy in routine care of patients with rheumatoid arthritis: a cohort study of patients registered in the Danish biologics registry

Jørgensen, Tanja Schjødt; Kristensen, Lars Erik; Christensen, Robin; Bliddal, Henning; Lorenzen, Tove; Hansen, Michael Sejer; Østergaard, Mikkel; Jensen, Jens‐Erik Beck; Zanjani, L.; Laursen, Toke; Butt, Sheraz; Dam, Mette Yde; Lindegaard, Hanne; Espesen, Jakob; Hendricks, Oliver; Kumar, Prabhat; Kincses, Anita; Larsen, Line H; Andersen, Murray N.; Næser, Esben; Jensen, Dorte Vendelbo; Grydehøj, Jolanta; Unger, Barbara; Dufour, N.; Sørensen, Vibeke; Vildhøj, Sara; Hansen, Inger Marie Jensen; Raun, Johnny Lillelund; Krogh, Niels Steen; Hetland, Merete Lund

doi:10.1093/rheumatology/kev216

Cited by 40 publications

(39 citation statements)

References 27 publications

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“…In the case of treatment success, Austrian rheumatologists follow the EULAR recommendations for adopting therapy when the treatment target is reached [18]. bDMARD monotherapy seems not to be exceptional in Europe, even though lower rates are commonly reported (19–27 %) [32, 33]. …”

Section: Discussionmentioning

confidence: 99%

Validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology: current practice of bDMARD therapy in rheumatoid arthritis in Austria

Rintelen

Zwerina

Herold

et al. 2016

BMC Musculoskelet Disord

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BackgroundThe purpose of the present study was to check the validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology, and to elucidate eventual differences with respect to disease activity (DA) in patients with rheumatoid arthritis (RA) on established biological DMARDs (bDMARDs) before inclusion into the register (EST) and beginners at the time point of inclusion (NEW) after 1 year of treatment.MethodsRA patients with a complete follow-up of 1 year in BIOREG were divided into EST and NEW and compared with respect to DA, remission rates, concomitant synthetic DMARDs (csDMARDs) and glucocorticoid therapy (GC) at baseline and after 1-year follow-up. Safety concerns are listed. Descriptive statistics are applied.ResultsFor 346 RA patients (284 EST, 62 NEW) out of 970 RA patients included into BIOREG, a full data set for a 1-year follow-up was available. No differences in DA were observed after 1 year as expressed by DAS28 or RADAI-5, and small differences as expressed by remission rates according to DAS28, RADAI-5 or Boolean criteria (namely approximately 1/2, 1/3 to 1/4 and 1/4 to 1/5 of the patients respectively). Sixty-four adverse events (AEs) were noted in 56 (20 %) of EST and 20 in 19 (31 %) of NEW patients. Malignancy occurred in four patients. After 1 year, 48 % of EST patients but only 16 % of NEW patients were on bDMARD monotherapy.ConclusionRegarding DA, the date collected in BIOREG appeared to be valid. After 1 year of bDMARD therapy, all patients, whether EST or NEW, achieved a similar level of DA. AEs occurred more frequently during the early phase of bDMARD treatment. Austrian rheumatologists initiate bDMARD therapy in patients with lower disease levels than in other European countries, leading to high remission rates.

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Section: Discussionmentioning

confidence: 99%

Validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology: current practice of bDMARD therapy in rheumatoid arthritis in Austria

Rintelen

Zwerina

Herold

et al. 2016

BMC Musculoskelet Disord

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“…The modest reductions in DAS28-ESR over 6 months for the bDMARDs in the OPAL patient cohort appear to be lower than what might have been expected based on previously reported RCTs [15–18] and other observational studies [5, 6, 19–22]. There are a number of reasons why this might be the case.…”

Section: Discussionmentioning

confidence: 57%

The CEDAR Study: A Longitudinal Study of the Clinical Effects of Conventional DMARDs and Biologic DMARDs in Australian Rheumatology Practice

Roberts

Tymms

Jager

et al. 2017

International Journal of Rheumatology

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Objectives To observe the choices of conventional disease modifying antirheumatic drugs (cDMARDs) and biologic DMARDs (bDMARDs) in the management of rheumatoid arthritis (RA) in Australian routine clinical practice, to assess treatment survival and determine the effect of cDMARDs/bDMARDs on disease activity. Methods Routinely collected, deidentified clinical data was sourced from 20 Australian rheumatology practices. RA patients aged ≥18 years, who had received cDMARDs/bDMARDs and a recorded subsequent visit, were included. A linear mixed model was used to determine the change over time and the percentage reduction in disease activity was summarized. Results 12,526 RA patients were included: 72% females, mean age 62 years. cDMARDs and bDMARDs were used in 92% and 30% of patients, respectively. The most commonly prescribed cDMARD was methotrexate (76% patients); median time to stopping treatment was 337 months [95% CI: 279–ND]. Etanercept was the most commonly prescribed bDMARD (12% patients); median time to stopping treatment was 79 months [95% CI: 57–93]. Of 5,341 patients with a first change in medication (cDMARD or bDMARD), 87% had therapy escalation and 13% deescalation. Reduction in DAS28-ESR, 6-month post-DMARDs initiation ranged from 3%, adalimumab, to 14%, leflunomide and tocilizumab. Conclusions In this large Australian cohort of unselected community RA patients, the choices of cDMARDs/bDMARDs are aligned with current international guidelines.

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“…; Jørgensen et al. ), the treatment regimen (switch, concurrent use) could not be assessed due to the cross‐sectional study design per calendar year.…”

Section: Discussionmentioning

confidence: 99%

Frequency and trends of disease‐modifying antirheumatic drug (DMARD) use in Germany

Fassmer

Garbe

Schmedt

2016

Pharmacology Res & Perspec

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The aim of this study was to analyze the population‐based frequency of classic (c‐) and biologic (b‐) disease‐modifying antirheumatic drug (DMARD) use over time, selected underlying indications and the specialty of the prescribing physicians in Germany. Based on the claims data of the German Pharmacoepidemiological Research Database (GePaRD), yearly cross‐sectional studies were conducted from 2004 to 2011. The prevalence of DMARD use was calculated as the number of persons with at least one dispensation per 1000 persons stratified by sex and age. In 2011, we also obtained the proportion of c‐ and b‐DMARDs users with diagnoses of selected indications and the proportion of dispensations by specialty of the physician. Between 2004 and 2011, the annual prevalence of b‐DMARD and c‐DMARD use increased from 0.35‰ to 1.54‰ and from 6.53‰ to 8.93‰, respectively. In 2011, the study population comprised 12.8 million insurants with a mean age of 44.0 years. During this year, among c‐DMARDs, methotrexate was prescribed most frequently (4.76‰), followed by azathioprine (1.72‰) and sulfasalazine (1.20‰). For b‐DMARDs, adalimumab (0.57‰), etanercept (0.46‰), and rituximab (0.23‰) were most frequently used. Notably, b‐DMARD users more often had a diagnosis of ankylosing spondylitis and psoriasis compared to c‐DMARD‐users (20.7% vs. 2.9% and 20.0% vs. 11.4%, respectively) and b‐DMARDs were more frequently prescribed by rheumatologists and other specialists. Our population‐based study highlights the increasing use of c‐ and b‐DMARDs in Germany. Compared to c‐DMARDs, b‐DMARDs were commonly used for indications besides rheumatoid arthritis. Future research should therefore also focus on their prescription patterns and safety aspects in indications other than RA.

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Effectiveness and drug adherence of biologic monotherapy in routine care of patients with rheumatoid arthritis: a cohort study of patients registered in the Danish biologics registry

Cited by 40 publications

References 27 publications

Validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology: current practice of bDMARD therapy in rheumatoid arthritis in Austria

Validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology: current practice of bDMARD therapy in rheumatoid arthritis in Austria

The CEDAR Study: A Longitudinal Study of the Clinical Effects of Conventional DMARDs and Biologic DMARDs in Australian Rheumatology Practice

Frequency and trends of disease‐modifying antirheumatic drug (DMARD) use in Germany

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