by Dr. David Borenstein M.D. updated 07/2020
Certolizumab pegol is an anti-Tumor Necrosis Factor antibody that decreases the increased levels of this inflammatory mediator in a variety of autoimmune disorders including rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis (AS), among others.New drugs get approval for use by the public after undergoing clinical trials with controlled populations. Controlled populations are individuals with a specific disorder who have no other complicating disorders. While studies completed with these selected people makes data from these investigations easier to interpret, they do not reflect the usual individual who may have an illness like ankylosing spondylitis in the non-study situation. Phase 4 trials are undertaken after an agent is approved to determine if the drug will work as well in a more general population of patients.CIMAX is a European, 12 month study of certolizumab pegol (Cimzia) for its effectiveness and safety treatment of ankylosing spondylitis (AS) in the real world. A total of 672 patients (469 with AS, and 201 with nonradiographic spondyloarthrits (nr-AS) were recruited for the study. The only entry criteria to be included in the study was an appropriate diagnosis and the absence of Cimzia in their therapy.At a year, 384 AS and 179 nr-AS patients had received at least 1 dose of Cimzia and were included in the results of the study. The measuring instrument of improvement was the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). This instrument measures fatigue, back pain, swelling in joints, areas tender to touch, the severity of morning stiffness, and its duration. A scale of 0 to 10 is used with levels above 4 considered significant disease activity. The average initial BSDAI was 6.1 in AS and nr-AS patients. At week 52, the average change in BASDAI was minus 2.9. Adverse events occurred in 37.9% of patients. However, serious infections occurred in 12 of 672 patients (1.8%). These included herpes zoster and skin cancers.Overall, the CIMAX study showed that certolizumab pegol is a safe and effective agent for the treatment of AS and nr-AS in the general population.
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- Baraliakos X et al: Effectiveness and safety of 12-month certolizumab Pegol for Axial Spondyloarthritis in real-world clinical practice in Europe. Rheumatology2020;0:1-12 Doi:10.1093/rheumatology/keaa181d