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.
- MeSH
- antirevmatika * terapeutické užití MeSH
- certolizumab pegol terapeutické užití MeSH
- imunoglobuliny - Fab fragmenty MeSH
- kombinovaná farmakoterapie MeSH
- kouření cigaret * MeSH
- lidé MeSH
- methotrexát MeSH
- polyethylenglykoly MeSH
- prospektivní studie MeSH
- revmatoidní artritida * farmakoterapie MeSH
- TNF-alfa MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Maďarsko MeSH
- Slovenská republika MeSH
