On 27/11/2008 Ustekinumab, the first in a new class of biologics, has received a positive opinion for the treatment of moderate to severe plaque psoriasis from the European Committee for Medical Products for Human Use (CHMP). The CHMP's positive opinion is now referred for final action to the European Commission.
The CHMP recommended approval of ustekinumab is for adults who have failed to respond to, have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (a light sensitising medication, combined with exposure to ultraviolet light A).
This positive opinion is based on data from two large pivotal Phase 3 (PHOENIX 1 & 2), multi-centre, randomised, double blind, placebo controlled trials involving nearly 2,000 patients in whom the efficacy and tolerability of ustekinumab in the treatment of moderate to severe plaque psoriasis was evaluated.1,2 More than two-thirds of patients achieved the primary endpoint of each pivotal study, at least 75% reduction in psoriasis using the Psoriasis and Severity Index (PASI 75) at week 12, after just two doses at weeks 0 and 4. Significant maintenance of PASI 75 response through at least one year in patients receiving maintenance therapy every 12 weeks was also demonstrated using a randomised withdrawal design in the first pivotal study (PHOENIX 1). Rates of serious adverse events, including serious infections, malignancies and cardiovascular events, were low and consistent with the expected background rates. The most common adverse events in Phase 3 clinical trials were arthralgia, cough, headache, injection site erythema, nasopharyngitis and upper respiratory tract infection.
This group does not have any discussions yet.