Publications

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100 Publications visible to you, out of a total of 100
[Latest findings from the RABBIT register]

Abstract (Expand)

Since 2001 rheumatologists throughout Germany have been recruiting patients with rheumatoid arthritis into the biologics register (rheumatoid arthritis: observation of biologics treatment, RABBIT) to … investigate the long-term safety and efficacy of modern antirheumatic treatment. Over the past 20 years more than 20,000 patients have been enrolled in the prospective cohort study. This article summarizes the research findings published in 2020/2021, focusing on safety aspects, factors influencing treatment efficacy and patient-reported outcomes. With herpes zoster, facial nerve palsy and psoriasis, several adverse events were investigated that were either reported as a safety signal from clinical trials or through the EudraVigilance database or occurred as a paradoxical reaction under drug treatment. For these events, the influence of biological disease-modifying antirheumatic drug (DMARD) treatment was analyzed. In the publication on herpes zoster, we also considered drug treatment with Janus kinase inhibitors. Severe overweight can influence the success of treatment. There are gender-specific differences and the mode of action of a treatment also determines whether obesity reduces the response to treatment. The majority of patients observed in RABBIT were satisfied with the treatment they have received after 1 year. We were able to show which factors either favor or negatively influence satisfaction with the effectiveness and safety of the treatment. This review article shows that long-term observational studies such as the RABBIT register contribute to the understanding of treatment risks and can identify factors that influence the effects of treatment even after two decades of data collection.

Authors: Y. Meissner, A. Strangfeld

Date Published: 2022

Publication Type: Journal

Pregnancy and neonatal outcomes in women with axial spondyloarthritis: pooled data analysis from the European Network of Pregnancy Registries in Rheumatology (EuNeP)

Abstract (Expand)

OBJECTIVE: To investigate outcome and course of pregnancies in women with axial spondyloarthritis (axSpA) in a pooled data analysis of pregnancy registries in rheumatology. METHODS: Prospectively … followed women with axSpA, fulfilling ASAS classification criteria and for whom a pregnancy outcome was reported, were eligible for the analysis. Anonymised data of four registries was pooled. Rates of adverse pregnancy outcomes were calculated. Systemic inflammation, disease activity and treatment patterns with tumour necrosis factor inhibitor (TNFi) before, during and after pregnancy were analysed. RESULTS: In a total of 332 pregnancies from 304 axSpA women, 98.8% of the pregnancies resulted in live birth. Mean maternal age was 31 years and disease duration 5 years. Most of these patients received pre-conception counselling (78.4%). Before pregnancy, 53% received TNFi treatment, 27.5% in first and 21.4% in third trimester. Pregnancy and neonatal outcomes were favourable with rates of 2.2% for pre-eclampsia, 4.9% for preterm birth, 3.1% for low birth weight and 9.5% for small for gestational age. Neonates were delivered by caesarean section in 27.7% of pregnancies, of which 47.4% were emergencies. Pooled mean CRP was 4 mg/L before conception peaking in the second trimester at 9.4 mg/L. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was below 4 at all time-points. CONCLUSIONS: Pooled rates of most outcomes were better than what had been reported in the literature and within expected rates of those reported for the general population. Pre-conception counselling, planned pregnancies and a tight management in expert centres applying a tailored treatment approach may have contributed to the favourable pregnancy outcomes.

Authors: Y. Meissner, A. Strangfeld, A. Molto, F. Forger, M. Wallenius, N. Costedoat-Chalumeau, H. Bjorngaard, M. Couderc, R. M. Flipo, G. Guettrot-Imbert, I. Haase, B. Jakobsen, H. S. S. Koksvik, C. Richez, J. Sellam, A. Weiss, A. Zbinden, R. Fischer-Betz, P. collaborator group EuNe

Date Published: 2022

Publication Type: Journal

Risk of herpes zoster (shingles) in patients with rheumatoid arthritis under biologic, targeted synthetic and conventional synthetic DMARD treatment: data from the German RABBIT register

Abstract (Expand)

OBJECTIVE: To compare event and incidence rates of herpes zoster (HZ), also known as shingles, in patients with rheumatoid arthritis under treatment with conventional synthetic (cs), targeted synthetic … (ts) or biologic (b) disease-modifying antirheumatic drugs (DMARDs). METHODS: Patients were prospectively enrolled from 2007 until October 2020. Reported HZ events were assigned to ongoing treatments or those terminated within 1 month prior to the HZ event. Exposure-adjusted event rates (EAERs) of HZ were calculated per 1000 patient years (py) and adjusted HRs with 95% CIs computed. Inverse probability weights (IPW) were used to adjust for confounding by indication. RESULTS: Data of 13 991 patients (62 958 py) were analysed, with 559 HZ events reported in 533 patients. The EAER of HZ was highest for tsDMARDs (21.5, 95% CI 16.4 to 27.9), followed by B cell targeted therapy (10.3, 95% CI 8.0 to 13.0), monoclonal antitumour necrosis factor (anti-TNF) antibodies (9.3, 95% CI 7.7 to 11.2), interleukin 6 inhibitors (8.8, 95% CI 6.9 to 11.0), soluble TNF receptor fusion protein (8.6, 95% CI 6.8 to 10.8), T cell costimulation modulator (8.4, 95% CI 5.9 to 11.8) and csDMARDs (7.1, 95% CI 6.0 to 8.3). Adjusted for age, sex and glucocorticoids and weighted with IPW, tsDMARDs (HR 3.66, 95% CI 2.38 to 5.63), monoclonal anti-TNF antibodies (HR 1.63, 95% CI 1.17 to 2.28) and B cell targeted therapy (HR 1.57, 95% CI 1.03 to 2.40) showed a significantly higher risk compared with csDMARDs. CONCLUSION: Our results provide evidence for a 3.6-fold increased risk of HZ associated with tsDMARDs and an increased risk of HZ under bDMARDs compared with csDMARDs.

Authors: I. Redeker, K. Albrecht, J. Kekow, G. R. Burmester, J. Braun, M. Schafer, A. Zink, A. Strangfeld

Date Published: 2022

Publication Type: Journal

[Celebrating 33 years of the DRFZ: Epidemiology and Health Services Research]

Abstract (Expand)

The scientific focus of the DRFZ’s Programme Area Epidemiology and Health Services Research is, on the one hand, investigating the health care situation of people with rheumatic diseases in Germany, … including its deficits, progress and trends. On the other hand, an essential goal is to uncover risk factors for unfavourable disease trajectories, but also protective factors, through the long-term observation of disease courses in large cohorts. With the approval of innovative, targeted therapies at the beginning of this millennium, the question of the real-world safety and effectiveness of the various anti-rheumatic therapies became a key issue for doctors and patients. The biologics registers have developed into central instruments of the programme area, which enable questions on comparative drug safety, but also on therapy effectiveness and risk reduction through effective therapy, to be answered in a robust manner.In this article, selected results of epidemiological research at the DRFZ are presented. The overall goal of the research was and is to contribute to improving the quality of life of children and adults with rheumatic and musculoskeletal diseases. This is the purpose of clinical-evaluative health services research as well as the acquisition of knowledge that supports effective, individualised therapy. Large, long-term patient cohorts and a stable network with clinical rheumatologists and those affected have proven to be indispensable instruments.

Authors: A. Strangfeld, K. Albrecht, A. Regierer, J. Callhoff, A. Zink, K. Minden

Date Published: 2022

Publication Type: Journal

Compact plug and play optical frequency reference device based on Doppler-free spectroscopy of rubidium vapor

Abstract (Expand)

Compactness, robustness and autonomy of optical frequency references are prerequisites for reliable operation in mobile systems, on ground as well as in space. We present a standalone plug and play … optical frequency reference device based on frequency modulation spectroscopy of the D2-transition in rubidium at 780 nm. After a single button press the hand-sized laser module, based on the micro-integrated laser-optical bench described in [J. Opt. Soc. Am. B38, 1885 (2021)10.1364/JOSAB.420875], works fully autonomous and generates 6 mW of frequency stabilized light with a relative frequency instability of 1.4x10(-12) at 1 s and below 10(-11) at 10(5) s averaging time. We describe the design of the device, investigate the thermal characteristics affecting the output frequency and demonstrate short-term frequency stability improvement by a Bayesian optimizer varying the modulation parameters.

Authors: A. Strangfeld, B. Wiegand, J. Kluge, M. Schoch, M. Krutzik

Date Published: 2022

Publication Type: Journal

[Risk profile of disease-modifying antirheumatic drugs: an update from the RABBIT register]

Abstract (Expand)

This article provides an overview of current results from the German biologics register RABBIT on the safety of biologic and targeted synthetic disease-modifying antirheumatic drugs in rheumatoid … arthritis. Collaborative data from the European biologics registries show no evidence for an overall increased risk of malignancy with TNF inhibitors. Venous thromboembolism occurs less frequently under TNF inhibitors than under conventional synthetic DMARDs. Regarding interleukin-6 inhibitors, the incidence of lower intestinal tract perforations is increased with tocilizumab and presents with atypical symptoms. There is no evidence of increased facial paresis with tocilizumab. Janus kinase inhibitors increase the risk for the occurrence of herpes zoster. New data on biosimilars suggest that they can be used with a comparable safety profile to originator drugs.

Authors: K. Albrecht, A. Strangfeld

Date Published: 2021

Publication Type: Journal

[Relevant information on reproduction and rheumatism]

Abstract

Not specified

Authors: R. Fischer-Betz, A. Strangfeld, F. Forger

Date Published: 2021

Publication Type: Journal

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