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Strangfeld lab

Safety and effectiveness of drug treatment in daily rheumatologic care

Introduction
Members
Cooperation partners
Research Networks
Selected Publications

Pharmacoepidemiology

Our group investigates the safety and effectiveness of new therapies after licensing. At approval of treatments, the knowledge on their (long-term) safety and effectiveness is limited due to the selection of patients enrolled in randomized controlled trials (RCTs), the relatively small sample sizes and the short duration of RCTs. Our research group’s goal is to close these gaps in knowledge by conducting long-term registry studies on new therapies in rheumatology.

We have developed several long-term registers, one of the largest being RABBIT (Rheumatoid Arthritis: oBservation of BIologics Therapy). Here more than 17,500 patients with rheumatoid arthritis have been enrolled so far starting either a treatment with a newly approved drug or, as an internal control group, patients treated with a conventional synthetic treatment. Patients of both groups are regularly documented for five to ten years by around 300 institutions throughout Germany.

The overarching aim of RABBIT and other registers is to provide clinicians with reliable data on the risks of specific treatments in different groups of patients in order to tailor treatment to the features of individual patients. An example is the RABBIT risk score for serious infection which takes into account patient characteristics, medical history, co-morbidity, treatment of interest as well as concomitant treatment. It allows weighing the risks of biologics treatment with an increase in the incidence of serious infection to the competing risks of insufficient control of disease activity. A web-based risk calculator (www.biologika-register.de) allows immediate calculation of this risk and is frequently used by rheumatologists. With data of the RABBIT cohort, we could confirm that older patients and those with a chronic renal disease are more likely to develop sepsis after a serious infection. The highlight of the analysis was a significantly lower risk for sepsis in patients treated with a biologic drug at the time of the serious infection compared to patients on conventional synthetic DMARD treatment. This result, for the first time and with striking effect size, confirmed observations from animal studies with epidemiologic data. This had not been possible in humans before.

With the Rhekiss register, started in 2015, we run a prospective cohort study dedicated to investigate the safety of therapies in pregnancy and lactation. We aim to add substantial evidence to the limited knowledge about the course and outcome of pregnancies in patients with various inflammatory rheumatic diseases and the influence of drug treatment. Women wishing for a child or at the beginning of pregnancy can be enrolled. The course of pregnancy including treatments and complications, the outcome, and the first two years of child development are reported from rheumatologists and patients. One hundred forty rheumatology units enrolled more than 1,100 patients until August 2018. 860 of them have been pregnant and of 676 pregnancies, the outcome is known. In contrast to RABBIT, Rhekiss is a web-based system.

In May 2017, the web-based disease registry RABBIT-SpA was launched, which monitors patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) under new therapies. Sixteen months after the start of the registry, more than 700 patients have been enrolled.

The results of our projects are highly relevant for clinicians and are directly transferred into daily clinical practice. The identification of prognostic factors or better treatment strategies for specific groups of patients, but as well the detection of risk factors for specific adverse events help clinicians to individualize treatments and to find the most suitable therapy for each patient.

Group Leader
    Dr. med. Anja Strangfeld

Dr. med. Anja Strangfeld

Deutsches Rheuma-Forschungszentrum Berlin
Pharmacoepidemiology
Charitéplatz 1
10117 Berlin
Germany

Phone +49 (0)30 28460-635
Fax +49 (0)30 28460-626
strangfeld@drfz.de

Keywords
Pharmacovigilance
Drug safety
Real world effectiveness
Observational long-term cohort
New therapies

RABBIT – Biologics Therapy Register

Rhekiss – Pregnancy Register

RABBIT-SpA – Register for axial spondyloarthritis and psoriatic arthritis

Continue to Members

Group leader
Dr. med. Anja Strangfeld

Deputy group leader
PD Dr. med. Anne Regierer

Scientists
Lisa Baganz, M.Sc.
Dr. Doreen Huschek
Dipl. Wi. Ing. Dörthe Kühl-Habich
Dr. rer. nat. Joachim Listing
Dr. rer. medic. Yvette Meissner
Dr. rer. nat. Martin Schäfer
Anja Weiß, M.Sc.

Project coordinator
Christina Bungartz

Doctoral students
Madlen Spilka

Medical documentalists
Tanja Ellmann
Claudia Fritz
Mandy Grope
Juliana Hoffmann
Ulrike Kamenz
Siegfried Kindler
Lisa Lindner
Steffen Meixner
Andreas Reich
Juliane Reinke
Dina Schreckeis
Franca Stein
Corina Walter
Carina Wittkopp
Birgit Wuthe
Susanna Zernicke
Steffi Zühlke

Group Leader
    Dr. med. Anja Strangfeld

Dr. med. Anja Strangfeld

Deutsches Rheuma-Forschungszentrum Berlin
Pharmacoepidemiology
Charitéplatz 1
10117 Berlin
Germany

Phone +49 (0)30 28460-635
Fax +49 (0)30 28460-626
strangfeld@drfz.de

Keywords
Pharmacovigilance
Drug safety
Real world effectiveness
Observational long-term cohort
New therapies

RABBIT – Biologics Therapy Register

Rhekiss – Pregnancy Register

RABBIT-SpA – Register for axial spondyloarthritis and psoriatic arthritis

Continue to Cooperation partners

About 300 practices and clinics of rheumatologists in Germany are participating.

Scientific Advisory Board:
Dr. Frank Behrens, Frankfurt am Main; Prof. Jürgen Braun, Herne; PD Dr. Rebecca Fischer-Betz, Düsseldorf; Prof. Peter Herzer, München; Prof. Jörn Kekow, Vogelsang-Gommern; Prof. Bernhard Manger, Erlangen; PD Dr. Jutta Richter, Düsseldorf; Prof. Georg Schett, Erlangen; Prof. Matthias Schneider, Düsseldorf; Prof. Joachim Sieper, Berlin; Dr. Susanna Späthling-Mestekemper, München; Prof. Christof Specker, Essen

International:
BSRBR (Manchester, GB), ARTIS (Stockholm, S), DANBIO (Kopenhagen, DK), BIOBADASER (Madrid, E), RATIO (Paris, F), AIR (Montpellier, F), ORA (Straßburg, F), REGATE (Straßburg, F), ATTRA (Prag, CZ), GISEA (Bari, I), SCQM (Genf, S), Rheuma.pt (Lissabon, P)

Group Leader
    Dr. med. Anja Strangfeld

Dr. med. Anja Strangfeld

Deutsches Rheuma-Forschungszentrum Berlin
Pharmacoepidemiology
Charitéplatz 1
10117 Berlin
Germany

Phone +49 (0)30 28460-635
Fax +49 (0)30 28460-626
strangfeld@drfz.de

Keywords
Pharmacovigilance
Drug safety
Real world effectiveness
Observational long-term cohort
New therapies

RABBIT – Biologics Therapy Register

Rhekiss – Pregnancy Register

RABBIT-SpA – Register for axial spondyloarthritis and psoriatic arthritis

Continue to Research Networks

EULAR Working Group RODS (Register and Observational Drugs Studies), ENCePP (European Network of Centers of Pharmacovigilance and Pharmacoepidemiology), EuNeP (European Network of Pregnancy Registers in Rheumatology)

Group Leader
    Dr. med. Anja Strangfeld

Dr. med. Anja Strangfeld

Deutsches Rheuma-Forschungszentrum Berlin
Pharmacoepidemiology
Charitéplatz 1
10117 Berlin
Germany

Phone +49 (0)30 28460-635
Fax +49 (0)30 28460-626
strangfeld@drfz.de

Keywords
Pharmacovigilance
Drug safety
Real world effectiveness
Observational long-term cohort
New therapies

RABBIT – Biologics Therapy Register

Rhekiss – Pregnancy Register

RABBIT-SpA – Register for axial spondyloarthritis and psoriatic arthritis

Continue to Selected Publications

Regierer AC, Strangfeld A. Rheumatoid arthritis treatment in patients with a history of cancer. Curr Opin Rheumatol 2018 May;30(3):288-294.

Mercer LK, Regierer AC, Mariette X, Dixon WG, Baecklund E, Hellgren K, Dreyer L, Hetland ML, Cordtz R, Hyrich K, Strangfeld A, Zink A, Canhao H, Hernandez MV, Tubach F, Gottenberg JE, Morel J, Zavada J, Iannone F, Askling J, Listing J. Spectrum of lymphomas across different drug treatment groups in rheumatoid arthritis: a European registries collaborative project. Ann Rheum Dis. 2017 Dec;76(12):2025-2030.

Meissner Y, Richter A, Manger B, Tony HP, Wilden E, Listing J, Zink A, Strangfeld A. Serious adverse events and the risk of stroke in patients with rheumatoid arthritis: results from the German RABBIT cohort. Ann Rheum Dis. 2017 Sep;76(9):1583-1590.

Albrecht K, Richter A, Meissner Y, Huscher D, Baganz L, Thiele K, Schneider M, Strangfeld A, Zink A. Wie häufig sind prognostisch ungünstige Faktoren bei Patienten mit rheumatoider Arthritis? Eine Abschätzung anhand von 3 epidemiologischen Kohorten. Z Rheumatol. 2017 Jun;76(5):434-442.

Strangfeld A, Richter A, Siegmund B, Herzer P, Rockwitz K, Demary W, Aringer M, Meißner Y, Zink A, Listing J. Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs. Ann Rheum Dis. 2017 Mar;76(3):504-510.

Mercer LK, Askling J, Raaschou P, Dixon WG, Dreyer L, Hetland ML, Strangfeld A, Zink A, Mariette X, Finckh A, Canhao H, Iannone F, Zavada J, Morel J, Gottenberg JE, Hyrich KL, Listing J. Risk of invasive melanoma in patients with rheumatoid arthritis treated with biologics: results from a collaborative project of 11 European biologic registers. Ann Rheum Dis. 2017 Feb;76(2):386-391.

Richter A, Listing J, Schneider M, Klopsch T, Kapelle A, Kaufmann J, Zink A, Strangfeld A. Impact of treatment with biologic DMARDs on the risk of sepsis or mortality after serious infection in patients with rheumatoid arthritis. Ann Rheum Dis. 2016 Sep;75(9):1667-1673.

Group Leader
    Dr. med. Anja Strangfeld

Dr. med. Anja Strangfeld

Deutsches Rheuma-Forschungszentrum Berlin
Pharmacoepidemiology
Charitéplatz 1
10117 Berlin
Germany

Phone +49 (0)30 28460-635
Fax +49 (0)30 28460-626
strangfeld@drfz.de

Keywords
Pharmacovigilance
Drug safety
Real world effectiveness
Observational long-term cohort
New therapies

RABBIT – Biologics Therapy Register

Rhekiss – Pregnancy Register

RABBIT-SpA – Register for axial spondyloarthritis and psoriatic arthritis

Continue to Introduction