2023-04-20 18:00:01
The Medicines Agency publishes several restrictions on the use of Janus kinase or JAKi inhibitors to reduce the risk of serious adverse effects. They are indicated in the treatment of inflammatory diseases such as polyarthritis.
Restriction of use of certain drugs. THE Janus Kinase inhibitors (JAKi)of the anti-inflammatory drugs indicated in the treatment of chronic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, alopecia areatajuvenile idiopathic arthritis, ulcerative colitis) are likely to cause serious side effects as cardiovascular disorders, blood clotsserious infections, cancers, even death and they should no longer be prescribed, especially in patients over 65insists theMedicines Agency (ANSM) in a press release dated April 17, 2023. Before starting treatment with JAKi, prescribing physicians (allergists, cardiologists, rheumatologists, dermatologists, oncologists, etc.) must inform patients of all risks which are associated with them.
Names and list of JAKi anti-inflammatories concerned
These risks apply to all JAKi indicated in chronic inflammatory diseases:
- Cibinqo® (abrocitinib)
- Jyseleca® (filgotinib)
- Olumiant® (baricitinib)
- Rinvoq® (upadacitinib)
- Xeljanz® (tofacitinib)
→ Are not affected by this reassessment: Jakavi (ruxolitinib) and Inrebic (fedratinib)JAKi used in hematology for the treatment of myeloproliferative disorders (tumorous diseases of the bone marrow characterized by excess production of blood cells)
What are the new contraindications for Janus Kinase inhibitors?
Following a European reassessment of these medicines launched by the European Medicines Agency in February 2022, JAKi should no longer be used, unless there is no therapeutic alternativein patients:
- aged 65 and over
- smokers or have smoked for a long time
- having other cardiovascular or malignant tumor risk factors.
What are the dangers of Janus Kinase inhibitors?
Data from a clinical trial conducted in patients with chronic inflammatory diseases and presenting certain risk factors (tobacco, cardiovascular history, etc.) who were taking these treatments revealed:
► And increased cardiovascular risk (this risk had already been highlighted with Xeljanz (tofacitinib), in comparison to the use of anti-TNF-alpha. in 2021)
► A risk of blood clot
► A risk of cancer, in particular skin cancer (a regular dermatological examination is recommended for all treated patients)
► A risk of venous thromboembolism
► A risk ofinfections graves
► A risk of death
JAKi package inserts and summaries of product characteristics are gradually being updated with new recommendations and associated warnings.
Source : Janus kinase inhibitors and treatment of chronic inflammatory diseases: restrictions of use to reduce the risk of serious adverse effects, ANSM, April 17, 2023
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