Ocular adverse events from pharmacological treatment in patients with multiple sclerosis—A systematic review of the literature

Muñoz-Ortiz, Juliana; Reyes-Guanes, Juliana; Zapata-Bravo, Estefanía; Mora-Muñoz, Laura; Reyes-Hurtado, Juan Antonio; Tierradentro-García, Luis Octavio; Rojas-Carabali, William; Gómez-Suarez, Marcela; de-la-Torre, Alejandra

doi:10.1186/s13643-021-01782-7

Systematic Reviews

Table 1 Characteristics of studies

From: Ocular adverse events from pharmacological treatment in patients with multiple sclerosis—A systematic review of the literature

Author	Year	Study design	Country	Sex	Patients with TEAEs	TEAE	Post-TEAE
ALEMTUZUMAB
Tsourdi et al [59]	2015	Case series	Germany	Both	2/5	Thyroid eye disease	Definitive treatment still discussed / Near-total thyroidectomy and 100 μg levothyroxine per day
Trinh et al [53]	2015	Case report	USA	Female	1/1	Thyroid eye disease	Improvement after thyroidectomy and conservative management
Roos et al [61]	2018	Case series	England	Both	6/162	Thyroid eye disease	Three patients required systemic immunosuppression and three were managed conservatively
Tuohy et al [70]	2014	Cross-sectional	England	Both	2/87	Herpes zoster ophthalmicus	Not reported
Willis et al [72]	2016	Cross-sectional	Wales and England	Both	1/100	Conjunctivitis	Not reported
AMANTADINE
Jeng et al [35]	2008	Case report	USA	Both	3/3	Corneal edema	Improvement after treatment withdrawal in two patients. One patient required penetrating keratoplasty
Esquenazi [30]	2009	Case report	USA	Female	1/1	Corneal edema	Improvement after treatment withdrawal and topical prednisolone 1%
FINGOLIMOD
Calabresi et al [9]	2014	RCT	Multicentric	Both	9/1083	Macular edema	Improvement after treatment withdrawal
Cohen et al [10]	2010	RCT	Multicentric	Both	6/1292	Macular edema	Improvement after treatment withdrawal
Akiyama et al [21]	2016	Case report	Japan	Female	1/1	Macular edema	Patient refused treatment withdrawal and macular edema resolved
Chui et al [27]	2013	Case report	Australia	Female	1/1	Macular edema	Patient refused treatment withdrawal and improvement was observed after treatment with ketorolac and dexamethasone
Jasani et al [34]	2017	Case report	England	Female	1/1	Macular edema	Improvement after treatment withdrawal
Kim et al [37]	2015	Case report	USA	Female	1/1	Macular edema	Improvement after treatment withdrawal, topical ketorolac and topical prednisolone
Minuk et al [41]	2013	Case report	USA	Female	1/1	Macular edema	Patient refused treatment withdrawal and improvement was observed after sub-tenon triamcinolone injection
Schröder et al [48]	2015	Case report	Germany	Female	1/1	Macular edema	Treatment was discontinued when ischemic findings appeared
Thoo et al [52]	2014	Case report	Australia	Female	2/2	Macular edema	Patient refused treatment withdrawal and improvement was observed after intravitreal triamcinolone injection
Turaka et al [54]	2012	Case report	USA	Male	1/1	Macular edema	Improvement after treatment withdrawal
Cifuentes-Canorea et al [57]	2019	Case report	Spain	Female	1/1	Macular edema	Improvement after treatment withdrawal and reappearance after restart
Husmann et al [58]	2020	Case report	USA	Female	1/1	Macular edema	Treatment was not withdrawn. Macular edema improved with topical nepafenac
Lapierre et al [63]	2016	Cross-sectional	Canada	Both	11 and 2/2399	Macular edema and uveitis	Improvement after treatment withdrawal
Laroni et al [64]	2016	Cross-sectional	Italy	Both	3/825	Macular edema	2/3 patients withdrew treatment; one remained with macular edema and one improved. In the last patient, treatment was temporarily interrupted and restarted after improvement
Ontaneda et al [67]	2012	Cross-sectional	USA	Both	3/317	Macular edema	Undetermined
Afshar et al [20]	2013	Case series	USA	Both	3/3	Cystoid macular edema	Improvement after treatment withdrawal was seen in two patients. One patient continued fingolimod, with improvement after treatment with nepafenac and diflurprednate
Asensio-Sánchez et al [22]	2014	Case report	Spain	Female	1/1	Cystoid macular edema	No improvement after treatment withdrawal
Fan Gaskin et al [33]	2015	Case report	Australia	Female	1/1	Cystoid macular edema	Improvement after treatment withdrawal, topical diclofenac and topical prednisolone
Pul et al [44]	2016	Case report	Germany	Female	1/1	Cystoid macular edema	Improvement after treatment withdrawal and intravitreal ranibizumab injection
Ueda et al [55]	2015	Case report	Japan	Male	1/1	Cystoid macular edema and retinal hemorrhages	Macular edema was treated with betamethasone after a 13-week persistence and hemorrhages resolved after 24 weeks
Zarbin et al [73]	2013	Cross-sectional	Multicentric	Both	19 and 1/2615	Macular edema and retinal branch vein occlusion	Improvement after treatment withdrawal
Bhatti et al [24]	2013	Case report	USA	Female	1/1	Macular hemorrhage	Improvement after treatment withdrawal
Christopher et al [26]	2017	Case report	USA	Female	1/1	Conjuctival lymphoma	Improvement after treatment withdrawal and rituximab treatment
Gallego-Pinazo et al [32]	2011	Case report	Spain	Female	1/1	Retinal branch vein occlusion	Improvement after treatment withdrawal and intravitreal ranibizumab injection
Lim et al [76]	2019	Cross-Sectional	Multicentric	Both	27/27,528	Uveitis complicated with macular edema	One case required glaucoma topical treatment, two cases oral prednisone and the remaining cases received topical steroid preparations
STEROIDS
Saatci et al [45]	2010	Case report	Turkey	Male	1/1	Acute retinal necrosis	No improvement after treatment withdrawal. Vitrectomy and photocoagulation were required, and retinal detachment occurred after 2 months
Sheikh et al [49]	2016	Case report	USA	Female	1/1	Acute retinal necrosis	No improvement after treatment withdrawal
CTLA4Ig
Viglietta et al [17]	2008	Non-RCT	USA	Both	1/20	Visual field defect	Not reported
ESTRIOL
Voskuhl et al [16]	2016	RCT	USA	Both	4/158	Visual defects (blurred vision or diplopia)	Not reported
INTERFERON-β
Bakri et al [23]	2015	Case report	USA	Female	1/1	Intraretinal hemorrhages	Treatment was continued under strict follow-up as the patient was asymptomatic
Massougnes et al [28]	2016	Case report	Switzerland	Male	2/2	Retina peripheral bilateral telangiectasiae	Treatment was not withdrawn, and no progression was evidenced
De Santi et al [29]	2005	Case report	Italy	Female	1/1	Sicca syndrome	Treatment was not withdrawn and improvement was observed with oral methylprednisolone treatment
Gaetani et al [31]	2015	Case report	Italy	Female	1/1	Retinopathy	Improvement after treatment withdrawal
Jenisch et al [36]	2012	Case report	Germany	Female	1/1	Branch arterial occlusions and central vein occlusion	Treatment was not withdrawn. Visual acuity improvement was observed after hydroxyethyl- starch and salicylic acid treatment
Longmuir et al [39]	2007	Case report	USA	Male	1/1	Retinopathy	Improvement after treatment temporal suspension
Mallada-Frechín et al [40]	2005	Case report	Spain	Female	1/1	Retinopathy	Improvement after treatment withdrawal
Ohira et al [42]	2009	Case report	Japan	Female	1/1	Retinopathy	Improvement after treatment withdrawal
Post et al [43]	2009	Case report	Canada	Female	1/1	Visual field disturbance	Improvement after treatment withdrawal
Saito et al [46]	2007	Case report	Japan	Male	1/1	Retinopathy	Improvement after treatment withdrawal
Sallansonnet-Froment et al [47]	2009	Case report	France	Male	1/1	Retinopathy	Improvement after treatment withdrawal
Sommer et al [50]	2001	Case report	France	Male	1/1	Retinopathy	Improvement after treatment withdrawal
Spierer et al [51]	2011	Case report	Israel	Female	1/1	Idiopathic orbital inflammation	Treatment was not withdrawn. Symptoms improved with oral prednisolone
Williams et al [60]	2004	Case series	USA	Both	3/3	Neuroretinitis	Not reported
Makioka et al [66]	2017	Cross-sectional	Japan	Both	1/1476	Retinopathy	No improvement after treatment withdrawal
Smith et al [69]	2015	Cross-sectional	USA	Both	Incidence rate of 4.04 / 100 patients per year of 8107 adults	Abnormal vision and xerophthalmia	Undetermined
Tremlett et al [8]	2008	Cross-sectional	Canada	Both	1/888**	Papilledema	Not reported
Liscić et al [65]	2004	Cross-sectional	Croatia	Both	2/9	Abnormal visual evoked potentials	No improvement after treatment withdrawal
Gugliandolo et al [74]	2018	Cross-sectional	Italy (three regions: Liguria, Sicily, and Sardinia)	Both	2/6039	Eyelid edema and visual field defect	Visual field defect resolved within a day
Pakdaman et al [18]	2018	RCT	Iran	Both	Avonex: 3/89 Cinnovez: 1/93	Visual disturbance	Not reported
Comi et al [77]	2019	RCT	Multicentric	Both	Ozanimod 1 mg: 1/447 Ozanimod 0.5 mg: 1/451 Interferon-B1a: 1/448	Macular edema	Not reported
NATALIZUMAB
Boster et al [25]	2013	Case report	USA	Male	1/1	Progressive Multifocal Leukoencephalopathy by JCV	Patient passed away
Zecca et al [56]	2009	Case report	Switzerland	Male	1/1	Ocular toxoplasmosis reactivation	Treatment withdrawal and treatment with pyrimethamine sulfadiazine, prednisolone and folinic acid with lesion reduction
Holmén et al [62]	2011	Cross-sectional	Sweden	Both	19/85	Ocular inflammation	Not reported
Saida et al [13]	2016	RCT	Japan	Both	1/12	Retinal detachment	Undetermined
HYPERBARIC OXYGEN
Lambrou et al [38]	1987	Case report	France	Female	1/1	Slow-recovering central bilateral scotoma	Improvement after treatment withdrawal
RITUXIMAB
Rommer et al [68]	2015	Cross-sectional	Germany	Both	1/56	Ocular inflammation	Not reported
SIPONIMOD
Selmaj et al [14]	2013	RCT	Multicentric	Both	1/297	Macular edema and optic neuritis	Undetermined
Kappos et al [12]	2018	RCT	Multicentric	Both	18/1099	Macular edema	Not reported
TERIFLUNOMIDE
Vermersch et al [15]	2013	RCT	Multicentric	Both	Teriflunomide 7 mg: 3/111	Optic neuritis, macular edema, and optic ischemic neuropathy	Not reported
TOVAXIN
Fox et al [11]	2012	RCT	USA	Both	1/100	Diplopia	Not reported

** This study measured TEAEs, not patients

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