Real-World Assessment of Quality of Life in Patients with Relapsing Remitting Multiple Sclerosis Treated with Teriflunomide for Two Years: Patient-Reported Outcomes from the AURELIO Study in Greece
Ημερομηνία
2022Γλώσσα
en
Λέξη-κλειδί
Επιτομή
Introduction: Multiple sclerosis (MS) is a highly heterogeneous inflammatory disease of the central nervous system. Patient-reported outcomes (PROs) in a real-world clinical setting can provide detailed information about MS from the patient's perspective. PROs were used here to assess quality of life (QoL), treatment satisfaction, clinical efficacy, and safety outcomes in a Greek cohort of relapsing remitting MS (RRMS) patients treated with oral teriflunomide (14 mg/day). Methods: AURELIO was a 2-year, prospective, observational study whose QoL primary endpoint was assessed with the Multiple Sclerosis Impact Scale (MSIS-29). Secondary endpoints included analyses of Patient Determined Disease Steps (PDDS), Treatment Satisfaction Questionnaire for Medication (TSQM), Expanded Disability Status Scale (EDSS), annualized relapse rate (ARR), adherence, and safety outcomes. Results: AURELIO enrolled 282 patients (62.8% female; mean age 44.8 [SD ± 11] years; EDSS 2.0 [SD ± 1.6]; 44.6% treatment-naïve), with 212 patients (75%) remaining on treatment at study end. MSIS-29 total scores remained stable, while the MSIS-29 psychological scale showed significant improvement (p = 0.0015) at 2 years vs. baseline. TSQM scores at 2 years showed significant improvements in effectiveness (+ 6.6, p = 0.0001), convenience (+ 1.9, p = 0.0256), and global satisfaction (+ 8.1, p = 0.0001) vs. baseline. Disease progression was stable as indicated by non-significant changes in PDDS and EDSS vs. baseline. The ARR was low at 0.065, with a slightly higher ARR in previously treated (0.070) vs. naïve patients (0.058). Adherence was high at > 90%. Overall, 91 patients (32.3%) in the study reported a total of 215 safety events (32 serious, of which 21 were classified as mild–moderate). No new safety signals were observed. Conclusions: These data highlight the importance of PROs to facilitate personalized treatment strategies in MS. In line with other teriflunomide studies, AURELIO showed stable QoL, efficacy and safety outcomes, and good treatment satisfaction both in treatment-naïve and previously treated patients in this Greek cohort of patients with RRMS. © 2022, The Author(s).
Collections
Related items
Showing items related by title, author, creator and subject.
-
EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): Study protocol for a multicentre, observational trial
Weiss R., Saadat-Gilani K., Kerschke L., Wempe C., Meersch M., Zarbock A., Makhloufi H., Cherak A., Ghanem L.L., Gouaglia Z., Guadouri D.N., Hama F.N., Kara M., Saadi O., Sakhraoui R., Bourou F., Cherifi A., Sadaoui R.G., Ouyahia A., Ouahab I., Bouaoud S., Abdoun M., Tidjane A., Tabeti B., Boudjenan-Serradj N., Rivera C.J.P., Cabrer P., Corso J., García J.P., Idarraga S., Montoya C., Figueroa R., Aldana E., Torrado M.A., Peng K., Ma Z.-M., Yang Y.-F., Zhu Y.-J., Sklienka P., Frelich M., Jarkulis V., Sevcik P., Vodicka V., Elbahnasawy M.G., Elsalhawy S., Motawea S., Othman Z., Sahma M., Nafea A.M., Ahmed N., Attia D.A., Emara M.M., Bonna M.M., Gabr M.A., Tarbay A.I., Abdehaleem I.A., Mohamed E.E., Eldeeb A.M., Abbas A.M., Magdy J.A., Hamed Z.H., Osman H.M.E., Abbas M.S., Joannes-Boyau O., Barraud N., Berthelot C., Camus T., Dahmi A., Defaye M., Derville S., El-Boustani Y., Deloge E., Jacob H., Monziols S., Priem F., Robin J.-J., Legros V., Floch T., Muccio S., Geneve C., Legouge M.L., Mauny S.T., Mfam W., Pascot L., Aveline C., Chartier M., Duteurtre B., Gautier J.F., Cousin A.L., Vautier P., Nadaud J., Begel N., Chekirine C.-A., Derlon V., Grein E., Lehair M.-A., Magazzeni L., Magazzeni P., Potter C., Roth C., Voivret F., Rimmelé T., Cerro V., Suria S., Elmawieh J., Stoclin A., Cirenei C., Andrieu G., Couloumy S., Falcone J., Fajardy M., Gagneuil A., Girardet E., Mazereeuw A., Ponsonnard S., Egreteau P.-Y., Bertel M., Bocher S., Carn V., Guen L.L., Loup G.L., Lefevre M., Ichai C., Diop A., Jean-Michel V., Devlieger S., Duthoit J., El Kadiri M., Léger M., Cassisa V., Lasocki S., Masson C., Rineau E., Verrier P., Coquerel A., Montravers P., Atchade E., Rochon C.-E., Delerue C., Quentin V., Latry V., Queixalos N., Cottenceau V., Braun T., Bouzoubaa S., Christ B., Geiger A., Gomille J., Kieffer V., Mangeant S., Prochilo C., Schmitt C., Skwirba S., Grand H., Boury F., Mayeur N., Pasquie M., Garçon P., Bruckert V., Arnould V., Bonciu M., Chapelle T., Facchino L., Fagot-Gandet F., Iachim A., Mannu E., Perus O., Plattier R., Rozier R., Pradel G., Boudinaud M., Hausermann M.-H., Nguyen M.H., Ramorasata A., Barreau A., Boivin A.-H., Ravry C., Mottard N., Beuvelot J., Bossion F.P., Desebbe O., Zarbock A., Dörr C., von Groote T.C., Küllmar M., Massoth C., Meersch M., Saadat-Gilani K., Weiss R., Wempe C., Ziemann S., Grüßer L., Kowark A., Wittig P., Brandenburger T., Dimski T., Döhmen N., Huthmann L., Kaierle D., Pelletier C., Schleß M., Hohn A., Cleophas S., Haunhorst S., Jansen M., Schmitt A., Soisch J., Sturm K., Rosenberger P., Bendig A., Flohr L., Häberle H., Hofmann P., Kuhle J., Leser N.M., Pfister K., Prohaska S., Sennholz F., Stetz L., Weber K., Stehr S., Klaus S., Sadlo M., Boschin M., Sengelhoff C., Göbel U.M., Haaker J.G., Göttker C.-K., Gründel M., Heringlake M., Baumgärtel R., Berggren A., Gülzow M., Muras L., Paarmann H., Thal S., Bentley A., El-Masri D., Sebastiani A., Arnaoutoglou E., Ntalouka M., Stratigopoulou P., Analytis A., Mavrommatis E., Tzimas P., Karakosta A., Pantazi D., Dimakopoulou A., Dimitropoulou K., Ioannidis O., Jalaawiy H., Anwar A., Hashim H.T., Aldawoody H.I.R., Cortegiani A., Catalisano G., Ingoglia G., Ippolito M., De Rosa S., Cattin L., Bianchin A., Barone M., Paternoster G., Cutuli S.L., Russo A., Sollazzi L., Cascarano L., Antonelli M., Aceto P., Romanò B., Spadaro S., Tripodi V.F., Rossi M., Scappatura R., Vadalà M.C., Fiume D., Strano M.T., Oddo G., Santorsola C., Hussain B.A., Alnaser A.R., Ghassan A.H., Hasanein K., Theab M., Shin S., Jung S., Lee K., Jung S.M., Baek J., Elhadi M.K., Aldressi W.W.O., Abuzeid I., Albaraesi M., Aldressi S., Khalel W., Abdulwahed E., Abujrad A.A.A., Almaghrabi A., Alteleeb M., Alshareea E.A.A., Biala M.I., Deeknah A., Gheddim D.A., Ghmagh R., Ikhrays N.S.A.A., Sinan M., Soula E., Bahroun S.G., Derwish K., Mohamed A.M., Younes E.S., Al Islam Benjouira R., Aliwa M., Altashani N.A., Alteb M.O., Msherghi A., Alagelli F., Albarouni S., Albishti A., Aljamal S., Alsori M., Ekhuja T., Elzwai S., Ghula M., Mustafa T., Tuwaib A., Zriba H., Agilla H.M., Rafanomezantsoa T.A., Podesta A.M.C., Bonnici D.M., Pirotta T., López G.A.G., Mijovska M.M., Davitkovska T., Gavrilovska A., Lukikj S., Vesova M., Zafirova D., Amro S., Hajjaj B.N.F., Alkhazendar M., Barakat Y., Elejla S.A., Elhissi A., Khader A., Salem A., de Freitas Regufe R., de Oliveira Eloy A.F., Perdigão L.M.N.C., Grigoriev E., Ivkin A., Kornelyuk R., Yaroustovsky M., Abramyan M., Komardina E., Lesteva N., Aybazova M., Kumykova E., Lesina S., Rybakov G., Shestov A., Barmou A.A.A., Ahmed B.L.A., Eliyas A.M., Emadeldin Y., Kaserer A., Castellucci C., Rössler J., Akbas S., Petrun A.M., Gregorcic I., Sok V., Cicak R., Bárcena E., Guisado A., Wi I., Melchor J.R., Becerra-Bolaños Á., Cabrera-Doreste S., Domínguez-Arbelo A., Delgado-Alonso M.C., Muiño-Palomar V., Rodríguez-Pérez A., Estévez J.M., Munoz M.B.C., Matas J.M., Palao S.P., Quirós M.D.M., Teslev A.C., Argilaga M., Campos M., Bainac A., Batalla A., Alvarez M.G., Giné M., Herránz G., Hinojal I., Ejea M.L., de la Rosa Ruiz N., Abasolo M.G., Acuna C.R.H., Zaranton I.I., Mendigurenmurua A., Sanz M.J.M., de la Fuente E.O., Vaquero M.P.P., Iglesias A.S., Mieres A.U., Urrestizala A.U., Ferreira L., Lobato F., Sevilla M.A., Erazo A., Miró P., Sabaté S., Vernetta D., Perez A.A., Pagola M.A., Paulis B.C., del Val Peciña E., Odriozola A.G., Aizpurua A.L., Piquer O.P., Garcia P.P., Rezola P.O., Lopez A.O., de la Calle Gil I., Casado R.N., Adamove P., Domenge R.B., Blasco F.M.B., Villamizar A.A.R., Llaneras M.A.P., García-Sánchez J.I., Téllez L.F., Zamorano S.G., Herreros N.G., Esteve A.R., Rodríguez P.M., Trigo I.G., Alcaraz A., Jiménez A.L., Rubio I., García N., Callejas R., Toha A.M.C., Claros E., Cobeta P., Crespo P., Dorado T., Elías E., Felices J., Gil D., Gómez M., Mané N., Martín M., Martínez A., Pereira L., Samaranch A.B.N., Serrano A., Tiscar C., VillaHoz J., Menéndez P.G., Cardona E., Conesa A., Estepa V., Galán P., Espí L.L., Aldeán Y.L., Manrique S., Ariza V.M., Villa L.V., Suliman E.S.M.A., Hamid H., Ibrahim A.M., Saeed M.M., Mukadder O.S., Altun D., Canbolat N., Dinçer M.B., Seyhan T.Ö., Yildirim S.A., Iyigün M., Yapici D., Özdemir L., Sagun A., Boztug N., Cetintas Y., Dinc B., Gündüz E., Ünlügenç H., Tunay D.L., Karakaya D., Dost B., Komurcu O., Akcil E.F., Dilmen Ö.K., Tunali Y., Ok G., Alsina E.T., Hakli Ö., Polat C., Turgut N., Kizilcik N., Köner Ö., Sen Ö., Aydin N., Basaran B., Bingul E.S., Gürkan Y., Darcin K., Ugur S., Saracoglu K.T., Demir A., Aysegül Ö., Balci E., Girgin B., Guler A., Karadeniz Ü., Özaslan N., Hülya Y.Ö., Ozcan N., Postaci A., Sahap M., Salman N., Sagir Ö., Atik B., Bicakcioglu M., Demir H.F., Fatih U., Kocaoglu N., Toprak H.I., Aslan D.D., Colak Y.Z., Ozcan M.S., Yilmaz M., Karaca U., Sahin S.H., Karka Ö.E., Senoglu G.D., Karadag S.E., Alkis N., Baytas V., Akdogan A., Besir A., Erturk E., Kutanis D., Saylan S., Tugcugil E., Ayvat P., Günaydin B., Büyükgebiz B.M., Boran O.F., Calisir F., Orak Y., Balkan B.K., Büyükcoban S., Gökel E., Günenc S.F., Özbilgin S., Göre S., Akesen S., Cansabuncu S., Momot N., Panchenko A., Pittet J.-F., Rutledge K., the EPIS-AKI Investigators (2021)Introduction More than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. ... -
Direct oral anticoagulant-vs Vitamin K antagonist-related nontraumatic intracerebral hemorrhage
Tsivgoulis G., Lioutas V.-A., Varelas P., Katsanos A.H., Goyal N., Mikulik R., Barlinn K., Krogias C., Sharma V.K., Vadikolias K., Dardiotis E., Karapanayiotides T., Pappa A., Zompola C., Triantafyllou S., Kargiotis O., Ioakeimidis M., Giannopoulos S., Kerro A., Tsantes A., Mehta C., Jones M., Schroeder C., Norton C., Bonakis A., Chang J., Alexandrov A.W., Mitsias P., Alexandrov A.V. (2017)Objective: To compare the neuroimaging profile and clinical outcomes among patients with intracerebral hemorrhage (ICH) related to use of vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for nonvalvular ... -
Malignant mesothelioma cells secrete natriuretic peptides: Data and diagnostic clinical implications
Tsolaki V., Zarogiannis S., Zygoulis P., Kalomenidis I., Jagirdar R., Makris D., Daniil Z., Magkouta S., Triantafyllou I., Papanikolaou J., Gourgoulianis K.I., Zakynthinos E. (2020)Background and objective: Mesothelial cells and cardiomyocytes have shared embryonic mesodermal origin. Cardiomyocytes release BNP under stretch. We searched whether malignant mesothelioma cells also secrete BNP and if so, ...