Cimzia (certolizumab pegol) is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:
Ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis)
Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Axial spondyloarthritis without radiographic evidence of AS (also known as non-radiographic axial spondyloarthritis)
Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs.
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C-VIEW study overview
If you would like more information on the C-View study, please contact UCB Medical Information.
C-VIEW is an open label study investigating the impact of Cimzia on acute anterior uveitis (AAU) flares, the most common extra-articular manifestation in patients with axSpA flares in patients with severe active axSpA at high risk of recurrent AAU.1
Patients 18 years or older with HLA-B27, human leukocyte antigen B27, positive active axSpA were included in the study.1
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C-VIEW: Interim analysis from the first 48 weeks of trial
Primary outcome
The primary efficacy analysis consisted of a comparison of the frequency of AAU flares in the pre-study period with that observed during the study.
In the pre-treatment period of 48 weeks, the mean (SD, standard deviation) number of AAU flares across all patients was 1.3 (0.7) per patient.1
During the first 48 weeks on Cimzia treatment, the mean (SD) numbers of flares per patient reduced to 0.2 (0.4), with 12% (11/89) experiencing one AAU flare and only 2% (2/89) experiencing two flares. No patient experienced more than two AAU flares during this observational period.1
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C-VIEW: Key Safety Profile Data
58 patients experienced 190 adverse events. Of these, five patients experienced nine events classed as serious by the investigator. Of the serious adverse events, three were considered by the investigator to be related to Cimzia (2 cases of uveitis and 1 case of sarcoidosis). There were no deaths or serious cardiovascular events during the study.1
Safety outcomes
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Adverse events are reported using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0.
* Serious AEs (recorded as such by the investigator) include vestibular disorder, two cases of uveitis, incarcerated hernia, sarcoidosis, tenosynovitis, hemangioma, prostate cancer, and pregnancy.
# number of occurrences; AE, adverse event; CZP, certolizumab pegol; Q2W, every 2 weeks.
Adapted from van der Horst-Bruinsma, I. et al., 2020.
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Conclusion
There was a significant reduction in the AAU flare rate in patients with severe active axSpA during 48 weeks of Cimzia treatment, compared to the pre-treatment period: p<0.001.1
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References
1. Van der Horst-Bruinsma, I., et al. The impact of certolizumab pegol treatment on the incidence of anterior uveitis flares in patients with axial spondyloarthritis: 48- week interim results from C-VIEW. RMD, Open. 2020; 6: e001161.
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Because we're in this together...
Report adverse events
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk and hpra.ie/homepage/about-us/report-an-issue.
Adverse events should also be reported to UCB Pharma Ltd Email: UCBCares.UK@ucb.com and UCBCares.IE@ucb.com.
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Date of preparation: February 2023
IE-P-CZ-AS-2100015