2024
Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab Summary of Cases during Clinical Trial Development
Eichenbaum D, Freeman W, Chang M, Brooks L, Chaudhry N, Dadgostar H, McCannel C, Michels M, Mittra R, Wolfe J, Beindl V, Jaycock P, Bobbala A, Gune S, Spicer G, Callaway N. Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab Summary of Cases during Clinical Trial Development. Ophthalmology Retina 2024, 9: 127-143. PMID: 39154860, DOI: 10.1016/j.oret.2024.08.005.Peer-Reviewed Original ResearchPort Delivery SystemEndophthalmitis casesConjunctival complicationsFollow-upNeovascular age-related macular degenerationBox warningTreated with intravitreal antibioticsAge-related macular degenerationMonthly intravitreal ranibizumabRisk of endophthalmitisPDS implantUS prescribing informationImmediate postoperative periodClinical trial developmentETDRS lettersIntravitreal antibioticsIntravitreal ranibizumabDelivery systemSafety populationVisual outcomeMacular degenerationOcular proceduresRetrospective reviewVision lossEndophthalmitisBrodalumab: 5-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Martin G, Rawnsley N, Goehring E, Jacobson A. Brodalumab: 5-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 14: 1349-1357. PMID: 38724839, PMCID: PMC11116300, DOI: 10.1007/s13555-024-01162-8.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyInterleukin-17 receptor A antagonistPharmacovigilance dataPsoriasis Longitudinal AssessmentMajor adverse cardiovascular eventsLong-term clinical trialsUS prescribing informationAdverse cardiovascular eventsPlaque psoriasisReported malignanciesSafety profileAdult patientsCardiovascular eventsBrodalumabBox warningUS patientsPharmacovigilance reportsFungal infectionsClinical trialsPrescribing informationSafety signalsSuspected COVID-19 casesPatientsPackage inserts
2016
Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS
Fox R, Chan A, Gold R, Phillips J, Selmaj K, Chang I, Novas M, Rana J, Marantz J, Ambler Z, Ehler E, Havrdova E, Meluzinova E, Rektor I, Talab R, Gold R, Hartung H, Csanyi A, Csiba L, Jakab G, Hintzen R, Polman C, Drozdowski W, Fryze W, Kochanowicz J, Kwiecinski H, Maciejek Z, Schimrigk S, Selmaj K, Szczudlik A, Wajgt A, Belova A, Boiko A, Elchaninov A, Kozlov V, Odinak M, Shvarkov S, Skoromets A, Stolyarov I, Vorobieva O, Zavalishin I, Hillert J, Olsson T, Kappos L, Eraksoy M, Karabudak R, Siva A, Giovannoni G, Hawkins C, Sharief M, Sharrack B, Confavreux C, Ware J, Barnett M, Paine M, Lechner-Scott J, Beran R, Chapman C, Schwartz R, Butzkueven H, Casse R, Macdonell R, Berger T, Fazekas F, Ransmayr G, Vass K, Belachew S, De Deyn P, Decoo D, Dubois B, Medaer R, Seeldrayers P, Sindic C, Gaer L, Vanopdenbosch L, Grgic S, Bar-Or A, Bhan V, Bouchard J, Christie S, Grammond P, Jacques F, Veloso F, Vorobeychik G, Brinar V, Demarin V, Rudež J, Soldo-Butković S, Vurdelja R, Ambler Z, Doležil D, Havrdova E, Kanovsky P, Meluzinova E, Nova'k J, Rektor I, Skoda O, Duchcovská M, Camu W, Antoanela P, Coman I, Confavreux C, Edan G, Gout O, Lebrun-Frenay C, Papeix A, Vermersch P, Bachus-Banaschak K, Berghoff M, Bethke F, Boldt H, Chan A, Diener H, Eisensehr I, Emrich P, Griewing B, Haas J, Heesen C, Hoffmann F, Hufnagel A, Heidenreich F, Kleiter I, Lüer W, Marckmann-Böenke S, Marziniak M, Stangel M, Oschmann P, Rosenkranz T, Schneider H, Siefjediers V, Springub J, Stangel M, Stögbauer F, Bergh F, Tiel-Wilck K, Tinschert K, Grigoriadis N, Karageorgiou C, Kyritsis A, Papadimitriou A, Thomaides T, Vlaikidis N, Salguero Gonzalez L, Chon D, Ordoñez Sarg H, Agrawal C, Behari M, Cu V, Dwivedee S, Kothari S, Kulkarni R, Kushwaha S, Meena A, Mehndiratta M, Chandra Mukherjee S, Pandit L, Shah A, Shukla R, Vijayan K, Achiron A, Flechter S, Milo R, Vaknin-Dembinsky A, Pozzilli C, Daskalovska V, Castro Farfan F, Rangel Guerra R, Leyva I, Oropeza de Alba J, Revilla R, Rivera J, Gavriliuc M, Groppa S, Odainic O, Sanders E, Hupperts R, Mason D, Timmings P, Willoughby E, Czlonkowska A, Dorobek M, Drozdowski W, Fryze W, Hertmanowska H, Kleczkowska M, Kochanowicz J, Kwieciński H, Nowacki P, Podemski R, Potemkowski A, Selmaj K, Stelmasiak Z, Wajgt A, Zielinski T, Daskalovska V, Bajenaru A, Muresanu F, Nica S, Simu M, Drakulić S, Nadj C, Obradovic D, Vojinovic S, Turčáni P, Kahancová E, Kurca E, Lisý L, Krajnak V, Badenhorst F, Green J, Heckmann J, Isaacs M, Kappos L, Linnebank M, Müller S, Buchakchyys'ka N, Goloborodko A, Kobys T, Lebedynets V, Lytvynenko N, Nehrych T, Pasyura I, Ryabichenko T, Voloshina N, Duddy M, Hawkins C, Nicholas R, Palace J, Sharrack B, Silber E, Turner B, Camac A, Chumley W, Crayton H, Dixit S, Edwards K, English J, Freedman S, Gordon N, Gazda S, Goldstick L, Gottschalk P, Grazioli E, Grainger W, Green B, Grelinger B, Gudesblatt M, Gupta A, Hayat G, Hendin B, Henson L, Hentati A, Herrman C, Itkin A, Janus T, Kasper L, Lathi E, Mowry E, Parry G, Perel A, Rao T, Riskind P, Rizvi S, Rossman H, Scott T, Shafer S, Storey J, Thrower B, Rossen M, Tosches W, Trefts L, Turel A, Weinstock-Guttman B, Gold R, Kappos L, Arnold D, Bar-Or A, Giovannoni G, Selmaj K, Dawson K, Gallacher P, Milla C, Yang M, Antel J, Bakris G, Chung R, Kowey P, Polman C, Richert J, Seibert B, Ware J, Brandes D, Brassat D, Cohen B, Diem R, Goldman M, Herndon R, Miller A, Tumani H, Kneebone C, Fedulau A, Likhachev S, Mikhailova E, Naumova H, Decoo D, Sindic C, Gaer L, Grgic S, Sinanovic O, Suljic E, Deleva N, Georgiev D, Haralanov L, Ivanova S, Manchev I, Minchev D, Stamenova P, Tournev I, Vacheva E, Zahariev Z, Howell R, Vindas A, Bar-Or A, Blevins G, Kremenchutzky M, Veloso F, Witt N, Habek M, Rudež J, Soldo-Butković S, Vurdelja R, Doležil D, Havrdova E, Nova'k J, Vaclavik D, Antsov K, Gross-Paju K, Haldre S, Palu A, Toomsoo T, Al Khedr A, Camu W, De Seze J, Debouverie M, Defer G, Labauge P, Moreau T, Rumbach L, Angnstwurm K, Benes H, Berthele A, Boldt H, Christopher A, Derfuß T, Eisensehr I, Emrich P, Feneberg W, Hoffmann F, Hohlfeld R, Hüntemann R, Kallmann B, Kieseier B, Kleiter I, Landefeld H, Lüer W, Masri S, Mäurer M, Nelles G, Oschmann P, Paschen C, Reifschneider G, Sailer M, Schimrigk S, Spiegel-Meixensberger M, Steinbrecher A, Storch-Hagenlocher B, Tackenberg B, Tiel-Wilck K, Karageorgiou C, Papathanasopoulos P, Thomaides T, Vlaikidis N, Arjundas D, Behari M, Shah S, Ghosh A, Ghosh P, Ichaporia N, Khurana D, Kulkarni R, Mehndiratta M, Mehta N, Misra U, Mukherji J, Nellikunja S, Radhakrishnan S, Salem A, Sethi P, Singh G, Lines C, Singh M, Singh Y, Srinivasa R, Vijayan K, Hutchinson M, Sweeney B, Gilad R, Shahien R, Metra M, Paegle A, Daskalovska V, Delgado C, Escamilla J, Estañol B, Lopez N, Macias M, Punzo G, Quiñones S, Renteria M, Santos C, Gavriliuc M, Groppa S, Odainic O, Timmings P, Czlonkowska A, Dorobek M, Drozdowski W, Fryze W, Hertmanowska H, Kaminska A, Kapelusiak-Pielok M, Kleczkowska M, Kochanowicz J, Kwieciński H, Losy J, Nowacki P, Nyka W, Pierzchala K, Podemski R, Potemkowski A, Selmaj K, Stelmasiak Z, Szczudlik A, Tutaj A, Wajgt A, Zielinski T, Chinea A, Balasa R, Ionescu-Dimancea V, Mihancea P, Popescu C, Protosevici L, Drakulić S, Nadj C, Raicevic R, Vojinovic S, Kahancová E, Kurca E, Lisý L, Turčáni P, Arroyo R, Fernández O, Guijarro C, Izquierdo G, Montalbán X, Oreja-Guevara C, Prieto J, Lopez F, Buchakchyys'ka N, Chmyr G, Goloborodko A, Grytsay N, Kobys T, Kushnir G, Lebedynets V, Lytvynenko N, Moskovko S, Nehrych T, Palamar B, Pasyura I, Ryabichenko T, Voloshina N, Apperson M, Applebee A, Asher S, Ayala R, Ayres D, Azizi S, Baker M, Bauer B, Bomprezzi R, Buckler R, Carlini W, Cohan S, Crowell G, Edwards K, Eubank G, Felton W, Fodor P, Foley J, Ford C, Forester M, Fox E, Fox R, Freedman S, Garmany G, Gazda S, Giang D, Glaun B, Gold S, Gottesman M, Gudesblatt M, Herbert J, Herskowitz A, Honeycutt W, Huddlestone J, Hull R, Hunter S, Hutton G, Jacobs D, Janicki M, Khatri B, Kinkel R, Kita M, Krolczyk S, Krupp L, LaGanke C, Levin M, Licht J, Luzzio C, Lynch S, Mattson D, Mikol D, Miller T, Minagar A, Mitchell G, Moses H, Negroski D, Newman S, Pardo G, Patel M, Perel A, Phillips J, Picone M, Rammohan K, Rao T, Rinker J, Sadiq S, Schaeffer J, Sheremata W, Shin R, Shubin R, Silverman S, Smith R, Stein L, Stein M, Steiner D, Steingo B, Sullivan H, Sunter W, Vaishnav A, Vasquez A, Voci J, Warach J, Weinstock-Guttman B, Williams M, Wray S, Fox R, Phillips J, Hutchinson M, Havrdova E, Kita M, Wilson K, Yang M, Dawson K, Antel J, Ware J, Polman C, Kowey P, Chung R, Bakris G, Richert J, Seibert B, Brandes D, Brassat D, Cohen B, Diem R, Goldman M, Herndon R, Miller A, Tumani H, Alfaro-Vidal T, Crespo C, Foster J, Hunter K, Garcia-Gomez A, MacManus D, Miller D, Santana V, Tozer D, Kingshott-Wheeler C, Yousry T. Characterizing absolute lymphocyte count profiles in dimethyl fumarate–treated patients with MS. Neurology Clinical Practice 2016, 6: 220-229. PMID: 27347439, PMCID: PMC4909524, DOI: 10.1212/cpj.0000000000000238.Peer-Reviewed Original ResearchDelayed-release dimethyl fumarateAbsolute lymphocyte countMultiple sclerosisLymphocyte countDelayed-release dimethyl fumarate treatmentDMF discontinuationMean absolute lymphocyte countsEarly identification of patientsRelapsing-remitting multiple sclerosisUS prescribing informationTreatment of patientsIdentification of patientsComplete blood countDisease-modifying therapiesWhite blood cellsLymphocyte monitoringProlonged lymphopeniaBlood countClinical trialsPrescribing informationPatientsExtension studyBlood cellsDimethyl fumarateNeuroprotective effects
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