Rheumatoide Arthritis – Einordnung der neuen Sicherheitswarnungen für JAK-Inhibitoren

Was ist neu?

Neue Sicherheitsdaten für Januskinase-Inhibitoren In der ORAL-SURVEILLANCE-Studie haben sich Hinweise auf ein erhöhtes Risiko für kardiovaskuläre Ereignisse, Thromboembolien und bestimmte Malignome unter einer Therapie mit Tofacitinib bei rheumatoider Arthritis ergeben. Betroffen sind Patient*innen >65 Jahre, aktuelle oder frühere Raucher und –im Falle kardiovaskulärer Ereignisse – Patient*innen, die schon mal ein solches Ereignis erlebt haben.

Erneuerte Empfehlungen Die JAK-Inhibitoren sollen daher in dieser Patientengruppe nur eingesetzt werden, wenn keine geeigneten Therapiealternativen zur Verfügung stehen.

Abstract

Januskinase-Inhibitors (JAKI) are highly effective substances (JAKi) for the treatment of rheumatoid arthritis (RA). In terms of efficiency in reduction of disease activity and induction of remission they are partially prior to biologic (b) DMARDs. Presently the four substances tofacitinib, baricitinib, upadacitinib and filgotinib are approved for the treatment of RA. The prospective controlled ORAL-SURVEILLANCE-trial investigated the safety of tofacitinib in comparison to TNF-inhibitors. Current results now show that treatment with tofacitinib might be associated with an increased risk for cardiovascular events, thromboembolism and certain malignancies. Affected are patients >65y, current or former smoker and, regarding cardiovascular events, patients who already had such an event.

On the basis of this trial the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) formulated actual recommendations for prescription of JAKi in order to reduce the risk of severe undesirable effects. These apply not only for tofacitinib but as well for all other JAKI named above, as a class effect was supposed. The data and their consequences are discussed and evaluated in this work.

Schlüsselwörter

Rheumatoide Arthritis - Januskinase-Inhibitoren - kardiovaskuläre Ereignisse - Thromboembolien - Malignome

Keywords

rheumatoid arthritis - janus kinase inhibitors - cardiovascular events - thromboembolism - malignancies

Publication History

Article published online:
27 February 2024

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