UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum

 UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum

UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum

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

Click here ­to­ read full press release/ article | Ref: UCB | Image: CHE Manager

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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