Phase III, multi-centre, randomised, double blind, Placebo-controlled study for treatment of juvenile ankylosing spondylitis (AS) with Adalimumab

Results 17 patients were randomized to receive ADA 40mg/ 2wks and 15 patients received placebo. Stable doses of NSAIDs and low dose of corticosteroids (≤10 mg per day) were permitted. In the ADA group a decrease of all disease activity parameters was noted at wk 12: BASDAI spinal inflammation score -66% (p<0.001); back pain score -48% (p<0.005); BASFI score -47 % (p<0.02); CHAQ-DI score -65% (p<0.005); ESR -75% (p<0.05) and finally the CRP 80% (p=0.07). ASAS20 and 40 response rates after 4, 8 and 12 weeks were higher on ADA than in the PLC group (table 1) During the 12 wks controlled phase 26 AEs occurred in 10 pts. on PLC compared to 25 AEs in 11 pts on ADA. Injection site reactions were the most common adverse event (10 on PLC, 11 on ADA). There were 16 various infections occurring in the double blind phase, 6 on PLC, 10 on ADA. 2 SAEs occurred on ADA.