COSENTYX (secukinumab), anti-interleukin-17A immunosuppressant
RHEUMATOLOGY - New medicinal product
Opinions on drugs - Posted on Aug 23 2016
Reason for request
Extension of Inclusion
No clinical benefit demonstrated by comparison with anti-TNF therapy and ustekinumab in the treatment of psoriatic arthritis
- COSENTYX has Marketing Authorisation, alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
- Its efficacy versus placebo has been demonstrated in terms of ACR 20 response (primary endpoint) in anti-TNF naïve patients (dosages of 150 and 300 mg) and in patients who have previously received one or more TNF inhibitors (300 mg dosage only). The effect on the progression of joint damage was not assessed at the recommended dosage regimens.
- As with ustekinumab, its place compared to TNF inhibitors in the treatment of psoriatic arthritis in case of failure of conventional non-biologic DMARD treatments cannot be specified due to the lack of comparative data and demonstration of a structural effect at the dosage regimens recommended by the Marketing Authorisation.
Clinical Added Value
|no clinical added value||
Évaluation des médicaments