Clinical Characteristics and Disease Course in Patients Treated With Efalizumab Following Suspension of Marketing Authorization by the European Medicines Agency: A Multicenter Observational Study

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"apellidos" => "Morell" "email" => array:1 [ 0 => "laiamorell@hotmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "J.M." "apellidos" => "Carrascosa" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] 2 => array:3 [ "nombre" => "C." "apellidos" => "Ferrándiz" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "M." "apellidos" => "García-Bustinduy" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] 4 => array:3 [ "nombre" => "E." "apellidos" => "Fonseca" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] 5 => array:3 [ "nombre" => "G." 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"apellidos" => "Belinchón" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "k" "identificador" => "aff0055" ] ] ] 13 => array:3 [ "nombre" => "Luis" "apellidos" => "Puig" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "l" "identificador" => "aff0060" ] ] ] 14 => array:1 [ "colaborador" => "on behalf of the Spanish Psoriasis Group" ] ] "afiliaciones" => array:12 [ 0 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitario de Canarias, Islas Canarias, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Juan Canalejo, La Coruña, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitario de Canarias Dr. Negrín, Islas Canarias, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Universitario de la Princesa, Madrid, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital de Calatayud, Instituto Aragonés de Ciencias de la Salud, Zaragoza, Spain" "etiqueta" => "f" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital de Alcorcón, Madrid, Spain" "etiqueta" => "g" "identificador" => "aff0035" ] 7 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital del Mar, Barcelona, Spain" "etiqueta" => "h" "identificador" => "aff0040" ] 8 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital del Sagrat Cor, Barcelona, Spain" "etiqueta" => "i" "identificador" => "aff0045" ] 9 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital Clínic i Provincial, Barcelona, Spain" "etiqueta" => "j" "identificador" => "aff0050" ] 10 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital General de Alicante, Alicante, Spain" "etiqueta" => "k" "identificador" => "aff0055" ] 11 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain" "etiqueta" => "l" "identificador" => "aff0060" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "*" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Perfil clínico y curso evolutivo de los pacientes tratados con efalizumab tras la suspensión de su autorización por la EMEA. Estudio observacional y multicéntrico" ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2010-10-22" "fechaAceptado" => "2010-12-20" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec84921" "palabras" => array:4 [ 0 => "Efalizumab" 1 => "European Medicines Agency" 2 => "Rebound" 3 => "Generalized inflammatory flare" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec84920" "palabras" => array:4 [ 0 => "Efalizumab" 1 => "EMEA" 2 => "Rebote" 3 => "Exacerbación inflamatoria generalizada" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "Background and objectivesThe withdrawal of marketing authorization for efalizumab by the European Medicines Agency in February, 2009 provided a unique opportunity to assess the course of disease in patients who were not subject to the selection criteria and biases that were common in the pivotal trials. The aim of this study was to evaluate the course of psoriasis following forced suspension of efalizumab in a group of patients treated in normal clinical practice. As secondary objectives, we sought to assess the relationships between clinical characteristics, treatment response, and disease course during efalizumab treatment and 12 and 24 weeks after suspension. Patients and methodsInformation on the epidemiological profile and disease course during treatment and following suspension of the drug was collected from a group of patients treated with efalizumab. Statistical analyses were performed to identify predictive factors. ResultsOne hundred forty-seven patients from 12 Spanish hospitals were included in the study. During treatment, 4% of patients were diagnosed with generalized inflammatory flares. Most patients could be classified as having a good (55%) or moderate (18%) response to treatment. Rebound following withdrawal of efalizumab was observed in 30% of patients. The likelihood of rebound was independent of clinical characteristics, treatment response, or therapeutic approach used by the dermatologist following suspension. ConclusionsThere was a high frequency of rebound following suspension of efalizumab, exceeding the rate reported in pivotal trials. This is particularly noteworthy given the large proportion of patients with a good response to treatment and therefore believed to have a better prognosis. Other significant findings were the higher frequency of positive treatment response than observed in previous studies (possibly influenced by the mean treatment duration) and the high frequency of generalized inflammatory flares." ] "es" => array:1 [ "resumen" => "IntroducciónLa reciente resolución de la EMEA con respecto a la suspensión de efalizumab, ocurrida en febrero del año 2009, ha proporcionado una oportunidad única para comprobar la evolución de un grupo de pacientes en cuya selección no intervinieron los filtros ni los sesgos habituales de los estudios pivotales. El objetivo planteado fue evaluar el curso de la psoriasis tras la suspensión forzosa de efalizumab en un grupo de pacientes tratados en el ámbito clínico. Como objetivos secundarios se planteó investigar su perfil clínico, la respuesta y evolución durante el tratamiento y el curso evolutivo a las 12 y 24 semanas tras la suspensión. Pacientes y métodosSe recogió información procedente de un grupo de pacientes tratados con efalizumab referida al perfil epidemiológico, al curso de la dermatosis durante el tratamiento y a su evolución al suspenderlo. Se llevaron a cabo estudios estadísticos con vistas a identificar variables predictivas de los distintos objetivos investigados. ResultadosSe incluyeron 147 pacientes procedentes de 12 centros hospitalarios nacionales. Durante el tratamiento un 4% de los pacientes fue diagnosticado de exacerbación inflamatoria generalizada. La mayor parte de los pacientes pudieron ser clasificados como buenos respondedores (55%) o respondedores moderados (18%). Un 30% de los pacientes presentaron rebote tras la suspensión de efalizumab. La probabilidad de rebote fue independiente del perfil clínico, la respuesta al tratamiento o la actitud terapéutica del dermatólogo al suspenderlo. Discusión y conclusionesSe comprobó una elevada ocurrencia de fenómeno de rebote tras la suspensión de efalizumab, superior a la descrita en los ensayos clínicos pivotales y especialmente significativa si se tiene en cuenta la elevada incidencia de buenos respondedores durante el tratamiento, considerados de mejor pronóstico. Otros datos significativos son la superior perspectiva de respuesta clínica –presumiblemente condicionada por el tiempo medio de tratamiento–, y la elevada incidencia de episodios de exacerbación inflamatoria generalizada." ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:29 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1." 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Original Article

Clinical Characteristics and Disease Course in Patients Treated With Efalizumab Following Suspension of Marketing Authorization by the European Medicines Agency: A Multicenter Observational Study

Perfil clínico y curso evolutivo de los pacientes tratados con efalizumab tras la suspensión de su autorización por la EMEA. Estudio observacional y multicéntrico

L. Morella,

Corresponding author

laiamorell@hotmail.com

Corresponding author.

, J.M. Carrascosaa, C. Ferrándiza, M. García-Bustinduyb, E. Fonsecac, G. Carreterod, E. Daudéne, S.E. Marrónf, J.L. López-Estebaranzg, M. Ferránh, M. Sánchez-Regañai, C. Muñoz-Santosj, I. Belinchónk, Luis Puigl, on behalf of the Spanish Psoriasis Group

a Servicio de Dermatología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

b Servicio de Dermatología, Hospital Universitario de Canarias, Islas Canarias, Spain

c Servicio de Dermatología, Hospital Juan Canalejo, La Coruña, Spain

d Servicio de Dermatología, Hospital Universitario de Canarias Dr. Negrín, Islas Canarias, Spain

e Servicio de Dermatología, Hospital Universitario de la Princesa, Madrid, Spain

f Servicio de Dermatología, Hospital de Calatayud, Instituto Aragonés de Ciencias de la Salud, Zaragoza, Spain

g Servicio de Dermatología, Hospital de Alcorcón, Madrid, Spain

h Servicio de Dermatología, Hospital del Mar, Barcelona, Spain

i Servicio de Dermatología, Hospital del Sagrat Cor, Barcelona, Spain

j Servicio de Dermatología, Hospital Clínic i Provincial, Barcelona, Spain

k Servicio de Dermatología, Hospital General de Alicante, Alicante, Spain

l Servicio de Dermatología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Background and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The withdrawal of marketing authorization for efalizumab by the European Medicines Agency in February&#44; 2009 provided a unique opportunity to assess the course of disease in patients who were not subject to the selection criteria and biases that were common in the pivotal trials&#46; The aim of this study was to evaluate the course of psoriasis following forced suspension of efalizumab in a group of patients treated in normal clinical practice&#46; As secondary objectives&#44; we sought to assess the relationships between clinical characteristics&#44; treatment response&#44; and disease course during efalizumab treatment and 12 and 24 weeks after suspension&#46;</p> <span class="elsevierStyleSectionTitle">Patients and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Information on the epidemiological profile and disease course during treatment and following suspension of the drug was collected from a group of patients treated with efalizumab&#46; Statistical analyses were performed to identify predictive factors&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">One hundred forty-seven patients from 12 Spanish hospitals were included in the study&#46; During treatment&#44; 4&#37; of patients were diagnosed with generalized inflammatory flares&#46; Most patients could be classified as having a good &#40;55&#37;&#41; or moderate &#40;18&#37;&#41; response to treatment&#46; Rebound following withdrawal of efalizumab was observed in 30&#37; of patients&#46; The likelihood of rebound was independent of clinical characteristics&#44; treatment response&#44; or therapeutic approach used by the dermatologist following suspension&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">There was a high frequency of rebound following suspension of efalizumab&#44; exceeding the rate reported in pivotal trials&#46; This is particularly noteworthy given the large proportion of patients with a good response to treatment and therefore believed to have a better prognosis&#46; Other significant findings were the higher frequency of positive treatment response than observed in previous studies &#40;possibly influenced by the mean treatment duration&#41; and the high frequency of generalized inflammatory flares&#46;</p>"
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        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La reciente resoluci&#243;n de la EMEA con respecto a la suspensi&#243;n de efalizumab&#44; ocurrida en febrero del a&#241;o 2009&#44; ha proporcionado una oportunidad &#250;nica para comprobar la evoluci&#243;n de un grupo de pacientes en cuya selecci&#243;n no intervinieron los filtros ni los sesgos habituales de los estudios pivotales&#46; El objetivo planteado fue evaluar el curso de la psoriasis tras la suspensi&#243;n forzosa de efalizumab en un grupo de pacientes tratados en el &#225;mbito cl&#237;nico&#46; Como objetivos secundarios se plante&#243; investigar su perfil cl&#237;nico&#44; la respuesta y evoluci&#243;n durante el tratamiento y el curso evolutivo a las 12 y 24 semanas tras la suspensi&#243;n&#46;</p> <span class="elsevierStyleSectionTitle">Pacientes y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se recogi&#243; informaci&#243;n procedente de un grupo de pacientes tratados con efalizumab referida al perfil epidemiol&#243;gico&#44; al curso de la dermatosis durante el tratamiento y a su evoluci&#243;n al suspenderlo&#46; Se llevaron a cabo estudios estad&#237;sticos con vistas a identificar variables predictivas de los distintos objetivos investigados&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 147 pacientes procedentes de 12 centros hospitalarios nacionales&#46; Durante el tratamiento un 4&#37; de los pacientes fue diagnosticado de exacerbaci&#243;n inflamatoria generalizada&#46; La mayor parte de los pacientes pudieron ser clasificados como buenos respondedores &#40;55&#37;&#41; o respondedores moderados &#40;18&#37;&#41;&#46; Un 30&#37; de los pacientes presentaron rebote tras la suspensi&#243;n de efalizumab&#46; La probabilidad de rebote fue independiente del perfil cl&#237;nico&#44; la respuesta al tratamiento o la actitud terap&#233;utica del dermat&#243;logo al suspenderlo&#46;</p> <span class="elsevierStyleSectionTitle">Discusi&#243;n y conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Se comprob&#243; una elevada ocurrencia de fen&#243;meno de rebote tras la suspensi&#243;n de efalizumab&#44; superior a la descrita en los ensayos cl&#237;nicos pivotales y especialmente significativa si se tiene en cuenta la elevada incidencia de buenos respondedores durante el tratamiento&#44; considerados de mejor pron&#243;stico&#46; Otros datos significativos son la superior perspectiva de respuesta cl&#237;nica &#8211;presumiblemente condicionada por el tiempo medio de tratamiento&#8211;&#44; y la elevada incidencia de episodios de exacerbaci&#243;n inflamatoria generalizada&#46;</p>"
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Article information

ISSN: 15782190
Original language: English

DOI:10.1016/S1578-2190(11)70818-6

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Year/Month	Html	Pdf	Total

2024 November	2	8	10
2024 October	53	44	97
2024 September	53	31	84
2024 August	71	49	120
2024 July	57	34	91
2024 June	47	25	72
2024 May	53	28	81
2024 April	63	31	94
2024 March	56	34	90
2024 February	46	34	80
2024 January	34	39	73
2023 December	46	33	79
2023 November	48	42	90
2023 October	42	28	70
2023 September	49	29	78
2023 August	37	27	64
2023 July	50	66	116
2023 June	58	28	86
2023 May	35	28	63
2023 April	24	18	42
2023 March	27	24	51
2023 February	18	15	33
2023 January	23	26	49
2022 December	30	40	70
2022 November	16	30	46
2022 October	15	26	41
2022 September	16	43	59
2022 August	17	30	47
2022 July	21	30	51
2022 June	23	29	52
2022 May	23	42	65
2022 April	29	45	74
2022 March	27	47	74
2022 February	14	32	46
2022 January	18	48	66
2021 December	26	48	74
2021 November	20	52	72
2021 October	25	67	92
2021 September	30	52	82
2021 August	14	37	51
2021 July	15	34	49
2021 June	10	33	43
2021 May	11	22	33
2021 April	18	58	76
2021 March	29	29	58
2021 February	39	29	68
2021 January	20	14	34
2020 December	25	12	37
2020 November	12	17	29
2020 October	26	11	37
2020 September	32	11	43
2020 August	26	24	50
2020 July	8	13	21
2020 June	12	23	35
2020 May	35	18	53
2020 April	14	16	30
2020 March	29	26	55
2020 February	5	3	8
2020 January	0	2	2
2019 December	0	8	8
2019 November	0	1	1
2019 September	0	3	3
2019 July	0	2	2
2019 June	0	7	7
2019 May	0	44	44
2019 April	0	1	1
2019 March	0	9	9
2018 July	0	1	1
2018 June	0	3	3
2018 May	0	4	4
2018 April	0	2	2
2018 March	1	0	1
2018 February	17	4	21
2018 January	24	10	34
2017 December	17	8	25
2017 November	18	2	20
2017 October	12	6	18
2017 September	9	10	19
2017 August	16	9	25
2017 July	12	3	15
2017 June	16	12	28
2017 May	15	6	21
2017 April	12	18	30
2017 March	14	18	32
2017 February	21	7	28
2017 January	9	9	18
2016 December	22	9	31
2016 November	24	7	31
2016 October	22	7	29
2016 September	22	9	31
2016 August	41	10	51
2016 July	37	10	47
2016 June	15	0	15
2016 May	4	14	18
2016 April	3	0	3
2016 March	4	0	4
2016 February	12	4	16
2016 January	4	1	5
2015 December	11	1	12
2015 November	7	1	8
2015 October	12	3	15
2015 September	5	2	7
2015 August	19	6	25
2015 July	24	7	31
2015 June	20	2	22
2015 May	53	7	60
2015 April	39	7	46
2015 March	34	7	41
2015 February	20	2	22
2015 January	19	7	26
2014 December	26	4	30
2014 November	29	8	37
2014 October	30	14	44
2014 September	28	6	34
2014 August	23	17	40
2014 July	27	18	45
2014 June	40	9	49
2014 May	50	9	59
2014 April	33	11	44
2014 March	38	10	48
2014 February	28	16	44
2014 January	34	11	45
2013 December	38	16	54
2013 November	21	18	39
2013 October	27	18	45
2013 September	24	22	46
2013 August	25	14	39
2013 July	37	21	58
2013 June	34	25	59
2013 May	7	4	11
2013 April	9	6	15
2013 March	8	7	15
2013 February	5	5	10

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