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Effectiveness and safety of 12-month certolizumab pegol treatment for axial spondyloarthritis in real-world clinical practice in Europe.


ABSTRACT:

Objectives

The efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA.

Methods

CIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12?months in a real-world axSpA cohort. The primary outcome was change from baseline in BASDAI to week 52, with additional outcomes pertaining to effectiveness and safety. Patients who received ?1 dose CZP were followed up for adverse events, and those with baseline and ?1 post-baseline BASDAI assessment were included in effectiveness analyses.

Results

A total of 672 patients (r-axSpA: 469; nr-axSpA: 201; unconfirmed diagnosis: 2) from 101 sites received ?1 dose of CZP, of whom 564 (r-axSpA: 384; nr-axSpA: 179; unconfirmed: 1) were included in the effectiveness analyses. The mean baseline BASDAI was 6.1 in the overall axSpA population and r-axSpA and nr-axSpA subpopulations. At week 52, the mean (s.d.) change in BASDAI was -2.9 (2.3; n?=?439); for r-axSpA and nr-axSpA, it was -2.9 (2.2; n?=?301) and -2.8 (2.4; n?=?137), respectively (P <0.0001 for all). Similar improvements were seen across other axSpA disease measures. In total, 37.9% (255/672) patients experienced adverse events, and 1.8% (12/672) experienced ?1 serious adverse events.

Conclusion

Improvements observed in signs and symptoms of axSpA following one year of CZP treatment in real-world clinical practice were similar to those from previous randomized clinical trials, with no new safety concerns.

SUBMITTER: Baraliakos X 

PROVIDER: S-EPMC7785316 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Effectiveness and safety of 12-month certolizumab pegol treatment for axial spondyloarthritis in real-world clinical practice in Europe.

Baraliakos Xenofon X   Witte Torsten T   De Clerck Luc L   Frediani Bruno B   Collantes-Estévez Eduardo E   Katsifis Gkikas G   VanLunen Brenda B   Kleine Elisabeth E   Hoepken Bengt B   Bauer Lars L   Goodson Nicola N  

Rheumatology (Oxford, England) 20210101 1


<h4>Objectives</h4>The efficacy and safety of certolizumab pegol (CZP), an Fc-free, PEGylated anti-TNF, in axial spondyloarthritis (axSpA) has been established in clinical trial settings. We report CZP effectiveness and safety in European clinical practice in patients with axSpA, including radiographic (r-) and non-radiographic (nr-) axSpA.<h4>Methods</h4>CIMAX (NCT02354105), a European non-interventional multicentre prospective study, observed CZP treatment response and safety over 12 months in  ...[more]

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