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
