Assessing benefits and risks of new treatments in rheumatology
Within large clinical-epidemiological cohort studies, the Pharmacoepidemiology Working Group comparatively examines the long-term safety and effectiveness of new antiinflammatory rheumatic drugs. Our goal is to provide physicians and patients with reliable evidence of the safety profile under everyday conditions and thus to increase the safety of therapy for risk groups.
Since 2001, patients with rheumatoid arthritis have been included in the Biologics Register RABBIT. These patients start therapy with a biological, biosimilar, JAK inhibitor or, as a comparison group, a conventional synthetic DMARD after failure of a previous DMARD. They are monitored for at least 5 and up to 10 years. About 450 institutions throughout Germany have documented almost 20,000 patients so far.
Numerous new and clinically significant insights have been gained, e.g. on the risk of infection, mortality, rare adverse events and their risk factors, efficacy under everyday conditions or quality of life (see drug safety). RABBIT is one of the world’s largest biologics registries in rheumatology and cooperates closely with other European registries.
In 2017, RABBIT-SpA was launched as a further disease registry for patients with axial spondyloarthritis and psoriatic arthritis, whose disease progression is observed under conventional or new therapies similar to RABBIT. As of September 2020, 2,000 patients are included. For the analysis of biomarkers we cooperate with the Fraunhofer Institute for Molecular Biology in Frankfurt (IME).
Within the framework of the BMBF funding of musculoskeletal research networks, we have been coordinating the TARISMA (Targeted Risk Management in Musculoskeletal Diseases) network since May 2020, in which a total of 6 network partners from Berlin, Bremen and Greifswald are involved. Using data from RABBIT, we are investigating the significance of chronic comorbidities such as interstitial lung disease, heart failure or depression for disease progression and mortality. In RABBIT-SpA detailed data on medication, adherence and patient-reported outcomes are collected with the help of a medical app and linked to existing clinical data.
There is a large evidence gap regarding the drug therapy of pregnant women with rheumatic diseases. Since 2015, in cooperation with the Heinrich-Heine-University of Düsseldorf we have therefore been investigating the course of pregnancies from the time of the actual desire to have children in the Rhekiss Pregnancy Register. We collect prospective data on the course and outcome of the pregnancy and the development of the child until its second birthday. The results will help to improve the counselling and management of women suffering from rheumatic diseases during the desire for children and during pregnancy.
Together with the European network of pregnancy registers EuNeP, which is also led by our group and supported by the FOREUM Foundation, collaborative evaluations on the course and outcome of pregnancy will be carried out.
In view of the COVID-19 pandemic, the group has actively participated in the establishment of the German and European COVID-19 registry. Anja Strangfeld and Anne Regierer are members of the steering committee of the German and Anja Strangfeld is a member of the steering committee of the European registry. Due to the international cooperation, important insights into the special situation of patients with autoimmune diseases under immunosuppression could be gained very quickly.
The group is continuously developing both the technical prerequisites of data acquisition (online registry, patient apps, automated monitoring) and the methodological basis of data analysis.
PD Dr. med. Anja Strangfeld
Deputy Group Leader:
PD Dr. med. Anne Regierer
Dr. Doreen Huschek, Dr. Yvette Meißner, Dr. Imke Redeker, Dr. Martin Schäfer, Anja Weiß MSc
Medical documentalists/Data manager:
Felix Butzke, Tanja Ellmann, Mandy Grope, Juliana Hoffmann, Ulrike Kamenz, Lisa Lindner, Jacqueline Lohr, Steffen Meixner, Andreas Reich, Jasmin Sandor, Gisela Schulze, Franca Stein, Carina Wittkopp, Corina Walter, Birgit Wuthe, Susanna Zernicke, Steffi Zühlke
Christina Bungartz, Dr. Eva Gutschke
Claudia Fritz, Siegfried Kindler, Dina Schreckeis,
Madlen Spilka, Ronja Ramien, Tatjana Rudi
Hannah Krop, Julia Leskow
Currently, about 300 rheumatological clinics and practices throughout Germany actively participate in the registries.
Scientific advisory boards
PD Dr. Frank Behrens, Frankfurt am Main
Prof. Dr. Jürgen Braun, Herne
PD Dr. Rebecca Fischer-Betz, Düsseldorf
Prof. Dr. Peter Herzer, München
Prof. Dr. Jörn Kekow, Vogelsang-Gommern
Dr. Joachim Listing, Berlin
Prof. Dr. Bernhard Manger, Erlangen
Prof. Dr. Jutta Richter, Düsseldorf
Prof. Dr. Georg Schett, Erlangen
Prof. Dr. Matthias Schneider, Düsseldorf
Prof. Dr. Joachim Sieper, Berlin
Dr. Susanna Späthling-Mestekemper, München
Prof. Dr. Christof Specker, Essen
Prof. Dr. Angela Zink, Berlin
Cooperations with European registries
BSRBR (Manchester, GB)
ARTIS (Stockholm, S)
DANBIO (Kopenhagen, DK)
BIOBADASER (Madrid, E)
EGR2 (Paris, France)
RePreg (Bern, Switzerland)
RevNatus (Trondheim, Norway)
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)
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)
Characterising comorbidity in RA in Europe: a multi‐national analysis of big healthcare data (FOREUM grant)
German Covid-19 Register for patients with inflammatory rheumatic disease
- EULAR recommendations for a core data set for pregnancy registries in rheumatology. Meissner Y, Fischer-Betz R, Andreoli L, Costedoat-Chalumeau N, de Cock D, Dolhain R, Förger F, Goll D, Molto A, Nelson-Piercy C, Özdemir R, Raio L, Rodriguez-García S, Sciascia S, Wallenius M, Zbinden A, Zink A, Strangfeld A. Ann Rheum Dis. 2020 (Accepted)
- National registry for patients with inflammatory rheumatic diseases (IRD) infected with SARS-CoV-2 in Germany (ReCoVery): a valuable mean to gain rapid and reliable knowledge of the clinical course of SARS-CoV-2 infections in patients with IRD. Hasseli R, Müller-Ladner U, Schmeiser T, Hoyer B, Krause A, Lorenz HM, Regierer AC, Richter JG, Strangfeld A, Voll RE, Pfeil A, Schulze-Koops H, Specker C. RMD Open 2020:6:e001332. doi:10.1136/rmdopen-2020-001332
- Obesity reduces the real-world effectiveness of cytokine-targeted but not cell-targeted disease-modifying agents in rheumatoid arthritis. Schäfer M, Meißner Y, Kekow J, Berger S, Remstedt S, Manger B, Listing J, Strangfeld A, Zink A. Rheumatology (Oxford). 2020 Aug 1;59(8):1916-1926. doi: 10.1093/rheumatology/kez535.
- Methotrexate: what are the true risks of treatment? Strangfeld A, Burmester GR. Ann Rheum Dis. 2020 Jul 1:annrheumdis-2020-217207. doi: 10.1136/annrheumdis-2020-217207. Online ahead of print.
- Characteristics associated with hospitalisation for COVID-19 in people with rheumatic disease: data from the COVID-19 Global Rheumatology Alliance physician-reported registry. Gianfrancesco M, Hyrich KL, Al-Adely S, Carmona L, Danila MI, Gossec L, Izadi Z, Jacobsohn L, Katz P, Lawson-Tovey S, Mateus EF, Rush S, Schmajuk G, Simard J, Strangfeld A, Trupin L, Wysham KD, Bhana S, Costello W, Grainger R, Hausmann JS, Liew JW, Sirotich E, Sufka P, Wallace ZS, Yazdany J, Machado PM, Robinson PC; COVID-19 Global Rheumatology Alliance. Ann Rheum Dis. 2020 Jul;79(7):859-866. doi: 10.1136/annrheumdis-2020-217871. Epub 2020 May 29.
- Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3.
- EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, McInnes IB, Sepriano A, van Vollenhoven RF, de Wit M, Aletaha D, Aringer M, Askling J, Balsa A, Boers M, den Broeder AA, Buch MH, Buttgereit F, Caporali R, Cardiel MH, De Cock D, Codreanu C, Cutolo M, Edwards CJ, van Eijk-Hustings Y, Emery P, Finckh A, Gossec L, Gottenberg JE, Hetland ML, Huizinga TWJ, Koloumas M, Li Z, Mariette X, Müller-Ladner U, Mysler EF, da Silva JAP, Poór G, Pope JE, Rubbert-Roth A, Ruyssen-Witrand A, Saag KG, Strangfeld A, Takeuchi T, Voshaar M, Westhovens R, van der Heijde D.Ann Rheum Dis. 2020 Jun;79(6):685-699. doi: 10.1136/annrheumdis-2019-216655.
- [RABBIT-SpA: a new disease register for axial spondyloarthritis and psoriatic arthritis]. Regierer AC, Weiß A, Baraliakos X, Zink A, Listing J, Strangfeld A. Z Rheumatol. 2020 Mar;79(2):135-142. doi: 10.1007/s00393-019-0613-z. German.
- Different risk profiles of biologic agents for new-onset psoriasis in patients with rheumatoid arthritis. Baganz L, Listing J, Kekow J, Eisterhues C, Wassenberg S, Zink A, Strangfeld A. Semin Arthritis Rheum. 2020 Feb;50(1):36-41. doi: 10.1016/j.semarthrit.2019.07.004.
- European Network of Pregnancy Registers in Rheumatology (EuNeP)-an overview of procedures and data collection. Meissner Y, Strangfeld A, Costedoat-Chalumeau N, Förger F, Goll D, Molto A, Özdemir R, Wallenius M, Fischer-Betz R. Arthritis Res Ther. 2019 Nov 14;21(1):241. doi: 10.1186/s13075-019-2019-3.
- 2018 EULAR recommendations for a core data set to support observational research and clinical care in giant cell arteritis. Ehlers L, Askling J, Bijlsma HW, Cid MC, Cutolo M, Dasgupta B, Dejaco C, Dixon WG, Feltelius N, Finckh A, Gilbert K, Mackie SL, Mahr A, Matteson EL, Neill L, Salvarani C, Schmidt WA, Strangfeld A, van Vollenhoven RF, Buttgereit F. Ann Rheum Dis. 2019 Sep;78(9):1160-1166. doi: 10.1136/annrheumdis-2018-214755.