Seasonal adherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: Results of the 1-year, observational GEPAT-SMART study
Ημερομηνία
2018Γλώσσα
en
Λέξη-κλειδί
Επιτομή
Background: Little is known about whether tolerability and adherence to treatment can be influenced by weather and temperature conditions. The objective of this study was to assess monthly and seasonal adherence to and safety of sc IFN-β1a (Rebif®, Merck) in relapsing-remitting multiple sclerosis (RRMS) patients using the RebiSmart® electronic autoinjector. Methods: A multicentre, prospective observational study in Greece in adult RRMS patients with EDSS < 6, under Rebif®/RebiSmart® treatment for ≤6 weeks before enrollment. The primary endpoint was monthly, seasonal and annual adherence over 12 months (defined in text). Secondary endpoints included number of relapses, disability, adverse events. Results: Sixty four patients enrolled and 47 completed all study visits (Per Protocol Set - PPS). Mean annual adherence was 97.93% ± 5.704 with no significant monthly or seasonal variations. Mean relapses in the pre- and post- treatment 12-months were 1.1 ± 0.47 and 0.2 ± 0.54 (p < 0.0001, PPS). 10 patients (22%) showed 3-month disability progression, 19 (40%) stabilization and 18 (38%) improvement. EDSS was not correlated to pre- (r = 0.024, p = 0.87) or post-treatment relapses (r = 0.022, p = 0.88). Conclusion: High adherence with no significant seasonal or weather variation was observed over 12 months. While the efficacy on relapses was consistent with published studies, we could not identify a relationship between relapses and disability. Trial registration: Greek registry of non-interventional clinical trials ID: 200136, date of registration: February 18th, 2013. © 2018 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, ...