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001-es BibID:	BIBFORM081583
035-os BibID:	(WOS)000531365800016 (Scopus)85075957157
Első szerző:	Szekanecz Zoltán (reumatológus, belgyógyász, immunológus)
Cím:	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. Szekanecz, Á. Koncz, J. Dunkel, J. Vencovský, CIMDORA collaborators
Dátum:	2019
Megjegyzések:	Objective 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. Conclusion After 104 weeks of CZP treatment, patients demonstrated similar DAS28(ESR) improvements, irrespective of smoking history.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk rheumatoid arthritis cigarette smoking anti-rheumatic agents tumour necrosis factor-alpha
Megjelenés:	Clinical and Experimental Rheumatology. - 37 : 6 (2019), p. 1010-1018. -
További szerzők:	Koncz Ágnes Dunkel, J. Vencovsky, Jiri CIMDORA collaborators
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat
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