Baraliakos, XenofonWitte, TorstenDe Clerck, LucFrediani, BrunoCollantes-Estevez, EduardoKatsifis, GkikasVanLunen, BrendaKleine, ElisabethHoepken, BengtBauer, LarsGoodson, Nicola2023-02-092023-02-092020-03-17Baraliakos X, Witte T, De Clerck L, Frediani B, Collantes-Estévez E, Katsifis G, et al. Effectiveness and safety of 12-month certolizumab pegol treatment for axial spondyloarthritis in real-world clinical practice in Europe. Rheumatology (Oxford). 2021 Jan 5;60(1):113-124http://hdl.handle.net/10668/15824The 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. 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. 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  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.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/Axial spondyloarthritisCertolizumab pegolNon-interventionalAdultAgedAntirheumatic agentsCertolizumab pegolFemaleHumansMaleMiddle agedProspective studiesSeverity of illness indexSpondylarthritisYoung adultresearch article32584415open accessAntirreumáticosEspondiloartritisEstudios prospectivosPersona de mediana edadÍndice de severidad de la enfermedad10.1093/rheumatology/keaa1811462-0332PMC7785316https://academic.oup.com/rheumatology/article-pdf/60/1/113/35433472/keaa181.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785316/pdf