Shots:

• The P-IIIb C-OPTIMISE study assessing Cimzia (200mg- q2w with a loading dose of 400mg @ 0- 2 & 4wks.) vs PBO during 48wks. open-label induction period in adults with early active axSpA. At 48wks.- patients in sustained remission (ASDAS <1.3 @wks. 32/36 & 48) were randomized to Cimzia 200mg- q2w (full maintenance dose) & 200mg q4w (reduced maintenance dose) or PBO (withdrawal) for an additional 48wks.
• The EMA label extension is based on the results of the C-OPTIMISE study that demonstrated @48wks. 43.9% of patients achieved sustained remission- @96wks. 84%- 79% & 20% of patients receiving the full maintenance dose- reduced maintenance dose or PBO respectively remained flare-free
• The approval makes Cimzia the only biologic in EU with a dose reduction option in its label for patients in the broad axSpA population

­ Ref: UCB | Image: CHE Manager