Medical DevicesUCB's CIMZIA(R) (certolizumab Pegol) Approved By The U.S. FDA For Adult Patients Suffering From Moderate To Severe Rheumatoid Arthritis
UCB announced that the U.S. Food and Drug Administration (FDA) approved Cimzia®, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia® can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered.
In clinical trials with Cimzia®, together with methotrexate (MTX), patients experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within one to two weeks, compared with MTX alone. Additionally, radiographic data showed Cimzia®, together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared with MTX alone (p CIMZIA