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Cigarette smoking and clinical response to certolizumab pegol treatment in Hungarian, Czech, and Slovak patients with rheumatoid arthritis: 104-week data from the CIMDORA prospective, non-interventional study
Z. Szekanecz1, Á. Koncz2, J. Dunkel3, J. Vencovský4
- University of Debrecen, Faculty of Medicine, Debrecen, Hungary.
- UCB Pharma, Budapest, Hungary.
- UCB Pharma, Monheim, Germany.
- Institute of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic. vencovsky@revma.cz
on behalf of the CIMDORA collaborators
CER11805
2019 Vol.37, N°6
PI 1010, PF 1018
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PMID: 30963993 [PubMed]
Received: 09/10/2018
Accepted : 12/02/2019
In Press: 09/04/2019
Published: 02/12/2019
Abstract
OBJECTIVES:
Smoking has been shown to influence rheumatoid arthritis (RA) severity and reduce response to some anti-tumour necrosis factor (anti-TNF) therapies. CIMDORA assessed the association between cigarette smoking and clinical effectiveness of certolizumab pegol (CZP) in Hungarian, Slovak, and Czech RA patients.
METHODS:
CIMDORA was a prospective, non-interventional, 104-week study (Feb 2011-Aug 2015). The primary endpoint was association between change in 28-joint Disease Activity Score (DAS28[ESR]) from baseline to Week 12, and baseline cigarette pack-year history. Secondary endpoints included association between change in DAS28(ESR) and daily number of cigarettes smoked. The full analysis set (FAS) included all patients receiving ≥1 dose of CZP with all necessary assessments for the primary endpoint. Treatment-emergent adverse events (TEAEs) were reported for all patients receiving ≥1 dose of CZP.
RESULTS:
The FAS included 218/273 enrolled patients: 155 Hungarian, 46 Czech and 17 Slovak. Hungarian and Czech patients completed 104 weeks (n=141); Slovak patients completed 52 weeks. Mean change in DAS28(ESR) [SD] at Week 12 (-2.78 [1.47]) was not significantly associated with baseline cigarette pack-year history (slope estimate [SE]: 0.03, 95% confidence interval [CI]: -0.16, 0.21 [p=0.77]). Mean DAS28(ESR) [SD] reductions to Week 52 (-3.33 [1.33]) were not significantly associated with daily number of cigarettes smoked in the previous month (SE: 0.001, CI: -0.05, 0.05 [p=0.95]). Two deaths were reported but neither of them was related to CZP. No new safety signals were identified and the safety profile was consistent with previous CZP studies.
CONCLUSIONS:
After 104 weeks of CZP treatment, patients demonstrated similar DAS28(ESR) improvements, irrespective of smoking history.
