Dtsch Med Wochenschr 2021; 146(15): 998-1002
DOI: 10.1055/a-1334-7609
Klinischer Fortschritt
Rheumatologie

Risikoprofil rheumatologische Basistherapie – ein Update aus dem RABBIT-Register

Risk profile of disease-modifying antirheumatic drugs: an update from the RABBIT register
Katinka Albrecht
Deutsches Rheuma-Forschungszentrum Berlin Programmbereich Epidemiologie und Versorgungsforschung
,
Anja Strangfeld
Deutsches Rheuma-Forschungszentrum Berlin Programmbereich Epidemiologie und Versorgungsforschung
› Author Affiliations

Was ist neu?

TNF-alpha-Inhibitoren Unter TNF-alpha-Inhibitoren (TNFi) zeigt sich kein Hinweis für ein insgesamt erhöhtes Malignomrisiko. Venöse Thromboembolien treten unter TNFi seltener auf als unter konventionellen synthetischen Disease-modifying antirheumatic Drugs (csDMARDs).

IL-6-Rezeptor-Inhibitoren Die Inzidenz von Perforationen des unteren Darmtrakts ist unter einer Behandlung mit Tocilizumab erhöht und präsentiert sich mit untypischer Symptomatik. Es gibt keinen Hinweis auf vermehrte Fazialisparesen unter Tocilizumab.

JAK-Inhibitoren Januskinase-Inhibitoren erhöhen das Risiko für das Auftreten eines Herpes zoster.

Biosimilars Originalprodukte und Biosimilars zeigen ein vergleichbares Sicherheits- und Wirksamkeitsprofil.

Abstract

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.



Publication History

Article published online:
03 August 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • Literatur

  • 1 Albrecht K, Regierer A, Strangfeld A. Risikostratifizierung für Therapieentscheidungen bei Rheumatoider Arthritis. Akt Rheumatol 2021; 46: 1-6
  • 2 Strangfeld A, Eveslage M, Schneider M. et al. Treatment benefit or survival of the fittest: what drives the time-dependent decrease in serious infection rates under TNF inhibition and what does this imply for the individual patient?. Ann Rheum Dis 2011; 70: 1914-1920 DOI: 10.1136/ard.2011.151043.
  • 3 Richter A, Listing J, Schneider M. et al. 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; 75: 1667-1673 DOI: 10.1136/annrheumdis-2015-207838.
  • 4 Mercer LK, Regierer AC, Mariette X. et al. Spectrum of lymphomas across different drug treatment groups in rheumatoid arthritis: a European registries collaborative project. Ann Rheum Dis 2017; 76: 2025-2030 DOI: 10.1136/annrheumdis-2017-211623.
  • 5 Mercer LK, Askling J, Raaschou P. et al. 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; 76: 386-391 DOI: 10.1136/annrheumdis-2016-209285.
  • 6 Regierer AC, Strangfeld A. Rheumatoid arthritis treatment in patients with a history of cancer. Curr Opin Rheumatol 2018; 30: 288-294 DOI: 10.1097/BOR.0000000000000492.
  • 7 Meissner Y, Zink A, Kekow J. et al. Impact of disease activity and treatment of comorbidities on the risk of myocardial infarction in rheumatoid arthritis. Arthritis Res Ther 2016; 18: 183 DOI: 10.1186/s13075-016-1077-z.
  • 8 Singh S, Fumery M, Singh AG. et al. Comparative Risk of Cardiovascular Events With Biologic and Synthetic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis: A Systematic Review and Meta-Analysis. Arthritis Care Res (Hoboken) 2020; 72: 561-576 DOI: 10.1002/acr.23875.
  • 9 Meissner Y, Richter A, Manger B. et al. Serious adverse events and the risk of stroke in patients with rheumatoid arthritis: results from the German RABBIT cohort. Ann Rheum Dis 2017; 76: 1583-1590 DOI: 10.1136/annrheumdis-2017-211209.
  • 10 Schäfer M, Schneider M, Graeßler A. et al. TNF inhibitors are associated with a reduced risk of venous thromboembolism compared to csdmards in RA patients. EULAR E-Congress. Ann Rheum Dis 2020; 79: 8-9 DOI: 10.1136/annrheumdis-2020-eular.1505.
  • 11 Baganz L, Listing J, Kekow J. et al. Different risk profiles of biologic agents for new-onset psoriasis in patients with rheumatoid arthritis. Semin Arthritis Rheum 2020; 50: 36-41 DOI: 10.1016/j.semarthrit.2019.07.004.
  • 12 Strangfeld A, Richter A, Siegmund B. et al. 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; 76: 504-510 DOI: 10.1136/annrheumdis-2016-209773.
  • 13 Meissner Y, Schafer M, Schneider M. et al. Incidence of facial nerve palsies stratified by DMARD treatment in patients with rheumatoid arthritis: data from the RABBIT register. RMD Open 2020; 6 DOI: 10.1136/rmdopen-2020-001403.
  • 14 Strangfeld A, Manger B, Worsch M. et al. OP0116 Elderly patients are not at increased risk of serious infections when receiving bDMARDs or JAK inhibitors compared to csDMARD treatment. eular e-congress. Ann Rheum Dis 2021; 80: 64-65
  • 15 Alten R, Mischkewitz M, Stefanski AL. et al. [Janus kinase inhibitors: State of the art in clinical use and future perspectives]. Z Rheumatol 2020; 79: 241-254 DOI: 10.1007/s00393-020-00768-5.
  • 16 Strangfeld A, Redeker I, Kekow J. et al. OP0238 Risk of herpes zoster in patients with rheumatoid arthritis under biological, targeted synthetic, and conventional synthetic DMARD treatment. Ann Rheum Dis 2020; 79: 150-151
  • 17 Kremer JM, Bingham 3rd CO , Cappelli LC. et al. Postapproval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year Results from a United States-Based Rheumatoid Arthritis Registry. ACR Open Rheumatol 2021; 3: 173-184 DOI: 10.1002/acr2.11232.
  • 18 Strangfeld A, Regierer A, Zink A. Biosimilars in den deutschen Biologika-Registern RABBIT und RABBIT-SpA. Kompendium Biosimilars 2021; 24-33