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Cystoid macular oedema after fingolimod treatment in multiple sclerosis
Edema macular quístico por fingolimod en esclerosis múltiple
V.M. Asensio-Sánchez
, L. Trujillo-Guzmán, R. Ramoa-Osorio
Corresponding author
Servicio de Oftalmología, Hospital Clínico Universitario, Valladolid, Spain
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Engrosamiento macular central con quistes intrarretinianos y un desprendimiento focal del epitelio pigmentario. Derecha: SD-OCT del ojo izquierdo 2 meses después de retirar el tratamiento; barrido pasando por la fóvea con igual dirección que el de la figura anterior. Se aprecia la irreversibilidad del proceso.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "V.M. Asensio-Sánchez, L. Trujillo-Guzmán, R. Ramoa-Osorio" "autores" => array:3 [ 0 => array:2 [ "nombre" => "V.M." "apellidos" => "Asensio-Sánchez" ] 1 => array:2 [ "nombre" => "L." "apellidos" => "Trujillo-Guzmán" ] 2 => array:2 [ "nombre" => "R." 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"apellidos" => "Baviera-Sabater" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0365669113003845" "doi" => "10.1016/j.oftal.2013.11.006" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0365669113003845?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173579414000747?idApp=UINPBA00004N" "url" => "/21735794/0000008900000003/v1_201407160916/S2173579414000747/v1_201407160916/en/main.assets" ] "en" => array:20 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Short communication</span>" "titulo" => "Cystoid macular oedema after fingolimod treatment in multiple sclerosis" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "104" "paginaFinal" => "106" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "V.M. Asensio-Sánchez, L. Trujillo-Guzmán, R. Ramoa-Osorio" "autores" => array:3 [ 0 => array:4 [ "nombre" => "V.M." "apellidos" => "Asensio-Sánchez" "email" => array:1 [ 0 => "victor_asensio@orangemail.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">¿</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "L." "apellidos" => "Trujillo-Guzmán" ] 2 => array:2 [ "nombre" => "R." "apellidos" => "Ramoa-Osorio" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Oftalmología, Hospital Clínico Universitario, Valladolid, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "<span class="elsevierStyleItalic">Corresponding author</span>." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Edema macular quístico por fingolimod en esclerosis múltiple" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 499 "Ancho" => 1349 "Tamanyo" => 135936 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Left: Right eye spectral domain optic coherence tomography (SD-OCT) at month 4 of treatment with fingolimod: scan passing through the fovea. Cystic macular edema with intraretinal and subretinal liquid without hyaloid traction. Right: right eye SD-OCT two months after treatment withdrawal: scan passing through the fovea in the same direction as the previous figure. Very little changes are evidenced.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system which predominantly affects young women. It is the first cause of neurological disability in young people.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> In the past 20 years significant developments occurred in MS breakouts therapy. Fingolimod is a modulator of the sphingosine-1-phosphate receptor (RE-1-F) recently approved at a dose of 0.5<span class="elsevierStyleHsp" style=""></span>mg/day orally administered.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,3</span></a> This drug has brought about a revolution in the treatment of MS (outbreaks, administration groups) although it exhibits significant side effects such as bradycardia in the first few hours and macular edema in the first few months of administration. A patient is described with severe vision loss and cystoid macular edema with fingolimod which was not resolved with drug withdrawal.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Clinic case</span><p id="par0010" class="elsevierStylePara elsevierViewall">Female patient who in 2002, at the time aged 31, exhibited peripheral vertigo. In 2004, she visited the emergency service due to acute pain in the left abdomen. In 2005, she exhibited bilateral pars planitis. In 2006, dysesthesia appeared in the lower limbs. In 2009, dysesthesia also expressed in the upper limbs together with voiding urgency. Resonance was performed with gadolinium, evoked potential and cerebrospinal fluid study which gave a diagnostic of MS. Treatment was established with immunosuppressants and symptomatic treatment, despite which the patient exhibited arthrokinetic symptomatology and disabling motor alteration in the left lower limb with outbreaks. In 2011, she visited with cerebellum dysfunction and cognitive involvement. In May 2011, with previous ophthalmological study, she began treatment with Gilenya<span class="elsevierStyleSup">®</span> (Gilenya<span class="elsevierStyleSup">®</span> 0.5<span class="elsevierStyleHsp" style=""></span>mg, Novartis Pharma Stein AG, Stein, Switzerland). The patient did not refer ophthalmological symptoms and visual acuity was of one in both eyes. Anterior biomicroscopy study was normal, as well as ocular fundus without evidence of macular edema. After 4 months treatment with Gilenya<span class="elsevierStyleSup">®</span> visual acuity was of 0.2 in the right eye (RE) and 0.4 in the left eye (LE). The anterior segments did not exhibit alterations but through funduscopy and optic coherence tomography (Topcon OCT, 3D OCT-2000) bilateral cystic macular edema was observed (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a> left and <a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a> left). The drug was withdrawn but the macular edema did not improve after 2 months, with a visual acuity remaining unchanged (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a> right and <a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a> right). The macular edema was not treated due to the patient refusal upon severe worsening of systemic pathology.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Discussion</span><p id="par0015" class="elsevierStylePara elsevierViewall">In 1993, standard therapy for MS was introduced, i.e., interferon beta-1a injections.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Since then other drugs (Avonex, Copaxone, Rebif and Tysabri) have been developed with varied results, all being injectable. Clinical trials have demonstrated that 2 oral immunosuppressants (fingolimod and cladribine) are efficient and superior to interferon and reduce outbreaks between 50% and 60%. Fingolimod (Gilenya<span class="elsevierStyleSup">®</span>) has been recently authorized by the Spanish medication and health products agency (registration number 11677005). This drug is a selective immunosuppressant that modulates the sphingosine receptor (RE-1-F) and redistributes lymphocytes, preventing infiltration into the central nervous system.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,3</span></a> It is indicated in patients with highly active remitting-recurring MS which does not respond to interferon or those in which sclerosis evolves very quickly.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,3</span></a> RE-1-F is distributed throughout the body and for this reason fingolimod has the potential of exhibiting a broad range of side effects. In clinical studies, macular edema expressed in 0.4% of cases, against 0.1% of controls, particularly in the first 4 months of treatment. If the patient had a history of diabetes or uveitis, the risk of macular edema was 20%.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,3</span></a> Saab et al.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> described one case of reversible macular edema in a kidney transplant patient treated with fingolimod. This drug can produce loss of vision secondary to macular edema which is dose-dependent and typically resolves when treatment is withdrawn.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Infrequently, vision loss is permanent after drug withdrawal, as in the described case, where macular edema persisted 2 months after withdrawing the drug. Accordingly, an ophthalmological study is recommended before establishing treatment and after 4 months. At present there is no conclusion for issues such as course (irreversibility) and best treatment of macular edema caused by fingolimod. Patients with a history of diabetes mellitus and/or uveitis are at greater risk of macular edema and possibly a more torpid course, although both processes do not constitute contraindications for treatment.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Conflict of interests</span><p id="par0020" class="elsevierStylePara elsevierViewall">No conflict of interests has been declared by the authors.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:9 [ 0 => array:2 [ "identificador" => "xres352610" "titulo" => array:3 [ 0 => "Abstract" 1 => "Case report" 2 => "Discussion" ] ] 1 => array:2 [ "identificador" => "xpalclavsec334073" "titulo" => "Keywords" ] 2 => array:2 [ "identificador" => "xres352611" "titulo" => array:3 [ 0 => "Resumen" 1 => "Caso clínico" 2 => "Discusión" ] ] 3 => array:2 [ "identificador" => "xpalclavsec334074" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Clinic case" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Discussion" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Conflict of interests" ] 8 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2011-11-25" "fechaAceptado" => "2012-07-09" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec334073" "palabras" => array:5 [ 0 => "Fingolimod" 1 => "Multiple sclerosis" 2 => "Macular edema" 3 => "Visual acuity" 4 => "Irreversible" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec334074" "palabras" => array:5 [ 0 => "Fingolimod" 1 => "Esclerosis múltiple" 2 => "Edema macular" 3 => "Agudeza visual" 4 => "Irreversible" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0010">Case report</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">A woman, treated with immunomodulatory and immunosuppressive drugs for multiple sclerosis, developed macular edema 4 months after oral fingolimod administration. The patient was previously seen by an ophthalmologist, with a normal anterior segment and funduscopic examination. Four months after the treatment she referred to decreased visual acuity in both eyes. The funduscopic and OCT examination now revealed cystoid macular edema (CME).</p> <span class="elsevierStyleSectionTitle" id="sect0015">Discussion</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Attention to visual changes and periodic funduscopic examinations are an important part of monitoring while using fingolimod. In our patient early recognition and discontinuation of fingolimod did not result in resolution of the CME.</p>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span class="elsevierStyleSectionTitle" id="sect0025">Caso clínico</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Mujer, tratada con inmunomoduladores e inmunosupresores por esclerosis múltiple, desarrolló edema macular 4 meses después de iniciar terapia oral con fingolimod. Previamente la paciente fue explorada por un oftalmólogo: el segmento anterior y el fondo de ojo fueron normales. Cuatro meses después del tratamiento refirió disminución de la agudeza visual en ambos ojos; el estudio fundoscópico y la OCT muestra edema macular quístico (EMQ).</p> <span class="elsevierStyleSectionTitle" id="sect0030">Discusión</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Atención a los cambios en la visión y estudios periódicos del fondo de ojo son importantes en la monitorización del paciente tratado con fingolimod. En nuestro paciente la identificación precoz y la retirada del esfingolimod no resolvió el EMQ.</p>" ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Asensio-Sánchez VM, Trujillo-Guzmán L, Ramoa-Osorio R. Edema macular quístico por fingolimod en esclerosis múltiple. archsocespoftalmol. 2014;89:104–106.</p>" ] ] "multimedia" => array:2 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 499 "Ancho" => 1349 "Tamanyo" => 135936 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Left: Right eye spectral domain optic coherence tomography (SD-OCT) at month 4 of treatment with fingolimod: scan passing through the fovea. Cystic macular edema with intraretinal and subretinal liquid without hyaloid traction. Right: right eye SD-OCT two months after treatment withdrawal: scan passing through the fovea in the same direction as the previous figure. Very little changes are evidenced.</p>" ] ] 1 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 541 "Ancho" => 1344 "Tamanyo" => 94049 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Left: left eye spectral domain optic coherence tomography (SD-OCT) at month 4 of treatment with fingolimod: scan passing through the fovea. Central macular thickening with intraretinal cysts and focal detachment of pigment epithelium. Right: left eye SD-OCT two months after withdrawing treatment; scan passing through the fovea in the same direction as the previous figure. The irreversible nature of the process is evidenced.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Potential impact of B cells on T cell function in multiple sclerosis" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "S. Ireland" 1 => "N. 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Brennan" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1001/archophthalmol.2007.23" "Revista" => array:6 [ "tituloSerie" => "Arch Ophthalmol" "fecha" => "2008" "volumen" => "126" "paginaInicial" => "140" "paginaFinal" => "141" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/18195237" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/21735794/0000008900000003/v1_201407160916/S2173579414000668/v1_201407160916/en/main.assets" "Apartado" => array:4 [ "identificador" => "5812" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Short communications" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/21735794/0000008900000003/v1_201407160916/S2173579414000668/v1_201407160916/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173579414000668?idApp=UINPBA00004N" ]
| Year/Month | Html | Total | |
|---|---|---|---|
| 2018 February | 30 | 1 | 31 |
| 2018 January | 29 | 1 | 30 |
| 2017 December | 29 | 0 | 29 |
| 2017 November | 29 | 1 | 30 |
| 2017 October | 17 | 1 | 18 |
| 2017 September | 10 | 2 | 12 |
| 2017 August | 19 | 1 | 20 |
| 2017 July | 18 | 2 | 20 |
| 2017 June | 17 | 7 | 24 |
| 2017 May | 30 | 4 | 34 |
| 2017 April | 36 | 19 | 55 |
| 2017 March | 39 | 10 | 49 |
| 2017 February | 43 | 1 | 44 |
| 2017 January | 24 | 0 | 24 |
| 2016 December | 45 | 8 | 53 |
| 2016 November | 43 | 3 | 46 |
| 2016 October | 39 | 8 | 47 |
| 2016 September | 32 | 6 | 38 |
| 2016 August | 38 | 1 | 39 |
| 2016 July | 22 | 2 | 24 |
| 2016 June | 26 | 7 | 33 |
| 2016 May | 24 | 4 | 28 |
| 2016 April | 14 | 0 | 14 |
| 2016 March | 19 | 2 | 21 |
| 2016 February | 19 | 12 | 31 |
| 2016 January | 29 | 4 | 33 |
| 2015 December | 25 | 6 | 31 |
| 2015 November | 13 | 9 | 22 |
| 2015 October | 24 | 5 | 29 |
| 2015 September | 30 | 3 | 33 |
| 2015 August | 30 | 6 | 36 |
| 2015 July | 17 | 6 | 23 |
| 2015 June | 15 | 4 | 19 |
| 2015 May | 14 | 3 | 17 |
| 2015 April | 14 | 7 | 21 |
| 2015 March | 21 | 4 | 25 |
| 2015 February | 17 | 1 | 18 |
| 2015 January | 21 | 5 | 26 |
| 2014 December | 38 | 13 | 51 |
| 2014 November | 25 | 5 | 30 |
| 2014 October | 35 | 9 | 44 |
| 2014 September | 51 | 15 | 66 |
| 2014 August | 6 | 1 | 7 |
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