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© Jacqueline Hirscher

Strangfeld group

Assessing benefits and risks of new treatments in rheumatology

Introduction
Members
Cooperation partners
Research Networks
Selected Publications

Pharmacoepidemiology

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.

Keywords
disease register
observational cohort
long-term safety
effectiveness

RABBIT - german biologics register
Rhekiss - pregnancy and rheumatism register
RABBIT Spa register
Head of Programme Area 2 & Pharmacoepidemiology Prof. Dr. med. Anja Strangfeld Phone +49 (0)30 28460-635 strangfeld@drfz.de more
Continue to Members

Group Leader:
Prof. Dr. med. Anja Strangfeld

Deputy Group Leader:
 PD Dr. med. Anne Regierer

Scientists:
Franziska Frederking, Dr. Doreen Huschek, PhD, Malte Kramer, Dr. rer. medic. Yvette Meißner, Dr. Adrian Richter, Dr. rer. nat. Martin Schäfer, Dr. rer. nat. Vera Zietemann, MPH

Medical documentalists/Data manager:
Tanja Ellmann, Mandy Grope, Juliana Hoffmann, Ulrike Kamenz, Hannah Krop, Jacqueline Lohr, Steffen Meixner, Jasmin Sandor, Samuel Ofori Sasu, Gisela Schulze, Corina Walter, Birgit Wuthe, Susanna Zernicke

Project coordination:
Dr. rer. nat. Eva Voll

Database development/Interfaces:
Claudia Fritz, Dina Schreckeis

Doctoral students:
Alina Purschke, Ronja Ramien, Tatjana Rudi

Student assistants:
Isabel Böttcher, Felix Butzke, Nora Dreger, Laura Grope, Joshua Rau, Janne Marie Schmutzler

Continue to Cooperation partners

Currently, about 300 rheumatological clinics and practices throughout Germany actively participate in the registries.

Scientific advisory boards
Prof. Dr. med. Xenofon Baraliakos, Herne
PD Dr. med. Frank Behrens, Frankfurt am Main
Prof. Dr. med. Peter Herzer, München
Prof. Dr. med. Jörn Kekow, Vogelsang-Gommern
Prof. Dr. med. Bernhard Manger, Erlangen
Prof. Dr. med. Denis Poddubnyy, Berlin
Prof. Dr. med. Jutta Richter, Düsseldorf
Prof. Dr. med. Georg Schett, Erlangen
Prof. Dr. med. Matthias Schneider, Düsseldorf
Dr. med. Susanna Späthling-Mestekemper, München
Prof. Dr. med. Christof Specker, Essen
Prof. Dr. rer. pol. 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)

Continue to Research Networks

EULAR COVID-19 database

COVID-19 Global Rheumatology Alliance

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

Continue to Selected Publications
  1. Rhekiss-The German Register for Child Wish and Pregnancies in Inflammatory Rheumatic Diseases. Strangfeld A, Meissner Y, Weiß A, Rudi T, Zink A, Ellmann T, Filla T, Aries P, Baraliakos X, Bungartz C, Glaser C, Henes J, Lorenz HM, Schneider M, Späthling-Mestekemper S, Specker C, Richter JG, Fischer-Betz R. Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5867. doi: 10.1002/pds.5867. PMID: 39138926
  2. Impact of DMARD treatment and systemic inflammation on all-cause mortality in patients with rheumatoid arthritis and interstitial lung disease: a cohort study from the German RABBIT register. Rudi T, Zietemann V, Meissner Y, Zink A, Krause A, Lorenz HM, Kneitz C, Schaefer M, Strangfeld A. RMD Open. 2024 Apr 4;10(2):e003789. doi: 10.1136/rmdopen-2023-003789. PMID: 38580343 Free PMC article.
  3. Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: a comprehensive evaluation of randomised controlled trials and observational studies. Simon TA, Dong L, Suissa S, Michaud K, Pedro S, Hochberg M, Boers M, Askling J, Frisell T, Strangfeld A, Meissner Y, Khaychuk V, Dominique A, Maldonado MA. Ann Rheum Dis. 2024 Jan 11;83(2):177-183. doi: 10.1136/ard-2023-224356. PMID: 37932010
  4. Risk of major adverse cardiovascular events in patients with rheumatoid arthritis treated with conventional synthetic, biologic and targeted synthetic disease-modifying antirheumatic drugs: observational data from the German RABBIT register. Meissner Y, Schäfer M, Albrecht K, Kekow J, Zinke S, Tony HP, Strangfeld A. RMD Open. 2023 Oct;9(4):e003489. doi: 10.1136/rmdopen-2023-003489. PMID: 37880180 Free PMC article.
  5. Charakterisierung von Patienten mit Psoriasisarthritis in der dermatologischen und rheumatologischen Versorgung: Analyse von zwei Registern: Characterization of patients with psoriatic arthritis in dermatologic and rheumatologic care: analysis of two registries. Augustin M, Lindner L, Kühl L, Weiss A, Rustenbach SJ, Stephan B, Feuchtenberger M, Mrowietz U, Thaçi D, Staubach P, Baraliakos X, Strangfeld A, von Kiedrowski R, Behrens F, Regierer AC. J Dtsch Dermatol Ges. 2023 Oct;21(10):1170-1178. doi: 10.1111/ddg.15178_g. PMID: 37845069
  6. Depressive symptoms are associated with fatigue, poorer functional status and less engagement in sports in axSpA and PsA: an analysis from the RABBIT-SpA cohort. Reich A, Weiß A, Lindner L, Baraliakos X, Poddubnyy D, Zinke S, Stille C, Strangfeld A, Regierer AC. Arthritis Res Ther. 2023 Aug 2;25(1):136. doi: 10.1186/s13075-023-03127-2. PMID: 37533077 Free PMC article.
  7. Malignancy outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study. Simon TA, Suissa S, Boers M, Hochberg MC, Skovron ML, Askling J, Michaud K, Strangfeld A, Pedro S, Frisell T, Meissner Y, Dominique A, Gomez A. Semin Arthritis Rheum. 2023 Jun 30:152240. doi: 10.1016/j.semarthrit.2023.152240. Online ahead of print. PMID: 37500379
  8. Comparison of patients with axial PsA and patients with axSpA and concomitant psoriasis: an analysis of the German register RABBIT-SpA. Regierer AC, Weiß A, Proft F, Baraliakos X, Behrens F, Poddubnyy D, Schett G, Lorenz HM, Worsch M, Strangfeld A. RMD Open. 2023 Mar;9(1):e002837. doi: 10.1136/rmdopen-2022-002837.PMID: 36898762 Free PMC article.
  9. Response to: ‘Correspondence on ‘EULAR recommendations for a core data set for pregnancy registries in rheumatology” by De Cock et al. Meissner Y, Fischer-Betz R, Zink A, Strangfeld A. Ann Rheum Dis. 2023 Feb;82(2):e45. doi: 10.1136/annrheumdis-2020-219478. Epub 2020 Nov 25. PMID: 33239275 No abstract available.
  10. After JAK inhibitor failure: to cycle or to switch, that is the question – data from the JAK-pot collaboration of registries. Pombo-Suarez M, Sanchez-Piedra C, Gómez-Reino J, Lauper K, Mongin D, Iannone F, Pavelka K, Nordström DC, Inanc N, Codreanu C, Hyrich KL, Choquette D, Strangfeld A, Leeb BF, Rotar Z, Rodrigues A, Kristianslund EK, Kvien TK, Elkayam O, Lukina G, Bergstra SA, Finckh A, Courvoisier DS. Ann Rheum Dis. 2023 Feb;82(2):175-181. doi: 10.1136/ard-2022-222835. Epub 2022 Sep 13. PMID: 36100351
  11. The Sensitivity to Change of the ASAS Health Index in an Observational Real-Life Cohort Study. Regierer AC, Weiß A, Kiltz U, Sieper J, Schwarze I, Bohl-Bühler M, Kellner H, Poddubnyy D, Zink A, Braun J, Listing J, Strangfeld A. J Rheumatol. 2023 Feb;50(2):185-191. doi: 10.3899/jrheum.220212. Epub 2022 Aug 1. PMID: 35914790
  12. 2022 EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in adults with autoimmune inflammatory rheumatic diseases.  Fragoulis GE, Nikiphorou E, Dey M, Zhao SS, Courvoisier DS, Arnaud L, Atzeni F, Behrens GM, Bijlsma JW, Böhm P, Constantinou CA, Garcia-Diaz S, Kapetanovic MC, Lauper K, Luís M, Morel J, Nagy G, Polverino E, van Rompay J, Sebastiani M, Strangfeld A, de Thurah A, Galloway J, Hyrich KL. Ann Rheum Dis. 2023 Jun;82(6):742-753. doi: 10.1136/ard-2022-223335. Epub 2022 Nov 3. PMID: 36328476
  13. Pregnancy and neonatal outcomes in women with axial spondyloarthritis: pooled data analysis from the European Network of Pregnancy Registries in Rheumatology (EuNeP).  Meissner Y, Strangfeld A, Molto A, Forger F, Wallenius M, Costedoat-Chalumeau N, Bjørngaard H, Couderc M, Flipo RM, Guettrot-Imbert G, Haase I, Jakobsen B, Koksvik HSS, Richez C, Sellam J, Weiß A, Zbinden A, Fischer-Betz R; EuNeP collaborator group. Ann Rheum Dis. 2022 Nov;81(11):1524-1533. doi: 10.1136/ard-2022-222641. Epub 2022 Aug 12.PMID: 35961759
  14. [Celebrating 33 years of the DRFZ: Epidemiology and Health Services Research]. Strangfeld A, Albrecht K, Regierer A, Callhoff J, Zink A, Minden K. Z Rheumatol. 2022 Oct;81(8):642-651. doi: 10.1007/s00393-022-01187-4. Epub 2022 Apr 5. PMID: 35380251 Free PMC article. Review. German.
  15. Effectiveness of TNF-inhibitors, abatacept, IL6-inhibitors and JAK-inhibitors in 31 846 patients with rheumatoid arthritis in 19 registers from the ‘JAK-pot’ collaboration. Lauper K, Iudici M, Mongin D, Bergstra SA, Choquette D, Codreanu C, Cordtz R, De Cock D, Dreyer L, Elkayam O, Hauge EM, Huschek D, Hyrich KL, Iannone F, Inanc N, Kearsley-Fleet L, Kristianslund EK, Kvien TK, Leeb BF, Lukina G, Nordström DC, Pavelka K, Pombo-Suarez M, Rotar Z, Santos MJ, Strangfeld A, Verschueren P, Courvoisier DS, Finckh A. Ann Rheum Dis. 2022 Oct;81(10):1358-1366. doi: 10.1136/annrheumdis-2022-222586. Epub 2022 Jun 15. PMID: 35705376 Free PMC article.
  16. Consensus statement on blocking interleukin-6 receptor and interleukin-6 in inflammatory conditions: an update. Aletaha D, Kerschbaumer A, Kastrati K, Dejaco C, Dougados M, McInnes IB, Sattar N, Stamm TA, Takeuchi T, Trauner M, van der Heijde D, Voshaar M, Winthrop KL, Ravelli A, Betteridge N, Burmester GR, Bijlsma JW, Bykerk V, Caporali R, Choy EH, Codreanu C, Combe B, Crow MK, de Wit M, Emery P, Fleischmann RM, Gabay C, Hetland ML, Hyrich KL, Iagnocco A, Isaacs JD, Kremer JM, Mariette X, Merkel PA, Mysler EF, Nash P, Nurmohamed MT, Pavelka K, Poor G, Rubbert-Roth A, Schulze-Koops H, Strangfeld A, Tanaka Y, Smolen JS. Ann Rheum Dis. 2023 Jun;82(6):773-787. doi: 10.1136/ard-2022-222784. Epub 2022 Aug 11. PMID: 35953263
  17. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Smolen JS, Landewé RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, Caporali R, Edwards CJ, Hyrich KL, Pope JE, de Souza S, Stamm TA, Takeuchi T, Verschueren P, Winthrop KL, Balsa A, Bathon JM, Buch MH, Burmester GR, Buttgereit F, Cardiel MH, Chatzidionysiou K, Codreanu C, Cutolo M, den Broeder AA, El Aoufy K, Finckh A, Fonseca JE, Gottenberg JE, Haavardsholm EA, Iagnocco A, Lauper K, Li Z, McInnes IB, Mysler EF, Nash P, Poor G, Ristic GG, Rivellese F, Rubbert-Roth A, Schulze-Koops H, Stoilov N, Strangfeld A, van der Helm-van Mil A, van Duuren E, Vliet Vlieland TPM, Westhovens R, van der Heijde D. Ann Rheum Dis. 2023 Jan;82(1):3-18. doi: 10.1136/ard-2022-223356. Epub 2022 Nov 10. PMID: 36357155
  18. Maternal and infant outcomes in pregnancies of women with axial spondyloarthritis compared with matched controls: results from nationwide health insurance data. Redeker I, Strangfeld A, Callhoff J, Marschall U, Zink A, Baraliakos X. RMD Open. 2022 Jul;8(2):e002146. doi: 10.1136/rmdopen-2021-002146. PMID: 35840311 Free PMC article.
  19. [Latest findings from the RABBIT register]. Meißner Y, Strangfeld A. Z Rheumatol. 2022 Mar;81(2):100-109. doi: 10.1007/s00393-021-01139-4. Epub 2021 Dec 23. PMID: 34940891 Free PMC article. Review. German.
  20. 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 Redeker I, Albrecht K, Kekow J, Burmester GR, Braun J, Schäfer M, Zink A, Strangfeld A. Ann Rheum Dis. 2022 Jan;81(1):41-47. doi: 10.1136/annrheumdis-2021-220651. Epub 2021 Jul 28. PMID: 34321218
  21. [Risk profile of disease-modifying antirheumatic drugs: an update from the RABBIT register]  Albrecht K, Strangfeld A. Dtsch Med Wochenschr. 2021 Aug;146(15):998-1002. doi: 10.1055/a-1334-7609. Epub 2021 Aug 3. PMID: 34344036 German
  22. [Relevant information on reproduction and rheumatism]. Fischer-Betz R, Strangfeld A, Förger F. Z Rheumatol. 2021 Oct;80(8):697-698. doi: 10.1007/s00393-021-01108-x. Epub 2021 Oct 7. PMID: 34618198 German.
  23. Implementing an automated monitoring process in a digital, longitudinal observational cohort study. Lindner L, Weiß A, Reich A, Kindler S, Behrens F, Braun J, Listing J, Schett G, Sieper J, Strangfeld A, Regierer AC. Arthritis Res Ther. 2021 Jul 7;23(1):181. doi: 10.1186/s13075-021-02563-2. PMID: 34233730 Free PMC article.
  24. Pregnancy in women with psoriatic arthritis: A systematic literature review of disease activity and adverse pregnancy outcomes.  Meissner Y, Rudi T, Fischer-Betz R, Strangfeld A. Semin Arthritis Rheum. 2021 Jun;51(3):530-538. doi: 10.1016/j.semarthrit.2021.04.003. Epub 2021 Apr 15. PMID: 33887551 Review.
  25. 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 RJEM, Forger F, Goll D, Molto A, Nelson-Piercy C, Özdemir R, Raio L, Rodríguez-García SC, Sciascia S, Wallenius M, Zbinden A, Zink A, Strangfeld A. Ann Rheum Dis. 2021 Jan;80(1):49-56. doi: 10.1136/annrheumdis-2020-218356. Epub 2020 Oct 14. PMID: 33055080 Free PMC article.
  26. 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. Epub 2019 Jul 11. PMID: 3135005
  27. Incidence of facial nerve palsies stratified by DMARD treatment in patients with rheumatoid arthritis: data from the RABBIT register. Meissner Y, Schäfer M, Schneider M, Wilden E, Zinke S, Zink A, Strangfeld A. RMD Open. 2020 Oct;6(3):e001403. doi: 10.1136/rmdopen-2020-001403. PMID: 33070117 Free PMC article.
  28. [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. PMID: 30874933 German.
  29. 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.
  30. Factors associated with treatment satisfaction in patients with rheumatoid arthritis: data from the biological register RABBIT.  Schäfer M, Albrecht K, Kekow J, Rockwitz K, Liebhaber A, Zink A, Strangfeld A. RMD Open. 2020 Oct;6(3):e001290. doi: 10.1136/rmdopen-2020-001290. PMID: 33051270 Free PMC article.
  31. 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.
  32. 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.
  33. 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.
  34. 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.
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Further Research Groups

AG Regierer

Register Research in Rheumatology

Minden group

Optimization of health care for young people with rheumatic diseases

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