STELARA (ustekinumab), immunosuppressive interleukin inhibitor
Reason for request
No demonstrated clinical benefit in the management of severe chronic plaque psoriasis in adolescents
- STELARA now has marketing authorisation in the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
- It should be reserved for treatment of chronic and severe plaque psoriasis defined by:
- failure (insufficient response, contraindication or intolerance) to at least two treatments including
nonbiologic systemic treatments and phototherapy
- an extensive form and/or substantial psychosocial impact.
- The safety profile of ustekinumab is similar in adults and adolescents.
Improvement in actual benefit