Ocular Toxoplasmosis in Tropical Areas: Analysis and Outcome of 190 Patients from a Multicenter Collaborative Study

Purpose: To describe clinical findings and outcomes for ocular toxoplasmosis in an international multicenter collaborative study.

Methods: Retrospective analysis of 190 patients diagnosed with ocular toxoplasmosis from three study sites (Brazil, India, and Singapore).

Results: There were 93 (48.9%) females with a mean age of 32.8 years. The most common symptoms were isolated blurring of vision (36.8%), followed by blurring of vision with floaters (21.1%). Treatment regimens varied largely from monotherapy to multiple combination therapies. Final visual acuity of ≥20/40 was achieved in 106 (74.2%) patients. In a median follow-up period of 31 weeks (range 12–749 weeks), 83/190 (43.7%) patients suffered a relapse.

Conclusions: There appears to be geographical variation in the presentation of ocular toxoplasmosis. Compared to previous studies, we did not observe the ‘“dual peak” phenomenon of chronic and active disease based on age at presentation, and there was less bilateral and macular involvement (but more peripheral involvement).     

Regional Differences in the Clinical Manifestation of Ocular Toxoplasmosis Between the Center and Northeast of Argentina

Purpose: To compare the clinical characteristics of patients with active episodes of ocular toxoplasmosis from three provinces, Misiones, Santa Fe, and Buenos Aires, Argentina.

Methods: Patients with a diagnosis of ocular toxoplasmosis from three databases of four tertiary referral uveitis centers were reviewed. Collected data included presentation of the retinochoroiditis, location of the active lesions, associated inflammatory ocular signs and complications.

Results: Three hundred thirty-four patients were included in this study. Bilateral involvement of the ocular disease occurred in 26 patients in Misiones (35.14%), 21 patients (12.8%) in Santa Fe, and 9 patients in Buenos Aires (9.4%) (p < 0.001). Extensive retinitis was observed in 49 patients (66.2%) in Misiones, 39 patients (23.8%) in Santa Fe, and 12 patients (12.5%) in Buenos Aires (p < 0.001).

Conclusion: The results indicate that there are differences in the clinical characteristics of ocular toxoplasmosis in patients from Misiones, Santa Fe, and Buenos Aires.     

Spectrum of Newly Diagnosed Cytomegalovirus Retinitis in a Developing Country in the HAART Era

ABSTRACT

Purpose: To characterize the presenting features of cytomegalovirus (CMV) retinitis in HIV-positive patients in a developing country in the HAART era.

Methods: Retrospective chart review of all patients with CMV retinitis seen at a tertiary-care referral center between January 2006 to June 2017. Demographic and clinical data were collected to study the presenting features and risk factors for blindness.

Results: Fifty-five patients with treatment-naïve CMV retinitis were enrolled; 75% were males. CD4 counts were below 50 cells/µL in 51.1%. Bilateral presentation was seen in 61.5%. Half (50.6%) of the eyes were blind at first examination. Zone 1 involvement was present in 46% of the eyes. Retinal area involvement > 25% was the only factor associated significantly with higher incidence of blindness (p = 0.016).

Conclusions: There was extensive and bilateral presentation of CMV retinitis due to delayed presentation. Screening for CMV retinitis, irrespective of CD4 counts, may help in developing nations.     

Mucous membrane pemphigoid and pseudopemphigoid

PURPOSE: To describe the clinical characteristics of patients with mucous membrane pemphigoid (MMP) and pseudopemphigoid. DESIGN: Retrospective cohort study. PARTICIPANTS: Two hundred eighty consecutive patients referred for the evaluation of possible ocular MMP from January 1, 1985, to December 31, 2001. METHODS: Information on patients presenting for evaluation of possible MMP was entered prospectively into a database, which was supplemented by a retrospective chart review. Mucous membrane pemphigoid was diagnosed in patients with a compatible clinical picture by the linear deposition of antibodies to the basement membrane zone (BMZ) on direct immunofluorescent analysis of a mucous membrane biopsy specimen or by the presence of circulating autoantibodies to epithelial BMZ. MAIN OUTCOME MEASURES: Demographic and clinical characteristics of MMP and pseudopemphigoid; risk of ocular MMP among patients presenting with extraocular MMP without ocular disease. RESULTS: Among patients with ocular MMP, extraocular disease was common (82.4% of patients). The risk of ocular involvement among patients with MMP seen without ocular disease was approximately 5% per year over the first 5 years of follow-up (cumulative risk at 5 years, 22%). Although immunohistologic confirmation of the diagnosis was obtained in all patients, the initial conjunctival biopsy was positive for MMP in 80% of the patients diagnosed with ocular MMP. The most frequent presumed causes of pseudopemphigoid were topical glaucoma medications (28.3%), rosacea blepharoconjunctivitis (20.0%), atopic keratoconjunctivitis (8.3%), and conjunctival lichen planus (8.3%). CONCLUSIONS: Patients with ocular MMP typically have other systemic manifestations of MMP. Patients who are initially seen with extraocular MMP without ocular involvement are at risk for ocular disease developing. The clinical characteristics of ocular MMP and pseudopemphigoid are similar; therefore, immunohistologic evaluation of biopsied tissue is needed to confirm the diagnosis of MMP.     

Ocular Whipple Disease: Report of Three Cases

Purpose: To emphasize the different manifestations of ocular involvement in Whipple disease with challenge in establishing the diagnosis as clinical, laboratory, and histological features could mimic other uveitis entities.

Methods: Case reports of three patients.

Results: The first patient was an African male suffering from a chronic bilateral keratoconjunctitivitis that was initially misdiagnosed as a chronic allergic conjunctivitis. The second patient was an Italian female who presented with bilateral vitritis, whereas the third patient was an Italian male suffering from a chronic bilateral panuveitis. The diagnosis of ocular Whipple in the first and third case was made by a positive T. whipplei PCR from the ocular specimen, and the second patient had detection of T. whipplei from extraocular sites.

Conclusions: Whipple disease can have protean manifestations in the eye including an isolated ocular surface involvement manifested as keratitis.     

Clinical Manifestations and Cerebrospinal Fluid Status in Ocular Syphilis

Purpose: To review the clinical manifestations, cerebrospinal fluid findings and outcomes of patients diagnosed with ocular syphilis.

Methods: Retrospective case review of all patients treated with ocular syphilis at Groote Schuur Hospital in Cape Town, South Africa between January 2008 and January 2013.

Results: A total of 77 eyes of 49 patients were included. Panuveitis was the most common presenting sign (48.9%). A lumbar puncture was performed on 37 patients (75.5%) and 64.8% (24/37) of samples had positive treponemal testing (CSF-FTA) while 24.3% (9/37) had positive non-treponemal testing (CSF-VDRL). Elevated CSF lymphocyte cell count was a strong predictor of neurosyphilis (p = 0.06 for CSF-FTA positive samples and p = 0.03 for CSF-VDRL positive samples).

Conclusion: The majority of patients (64.8%) who underwent lumbar puncture had cerebrospinal fluid findings suggestive of neurosyphilis. Elevated CSF lymphocyte cell count and total protein count are highly suggestive of neurosyphilis.     

Extraocular Muscle Involvement in Marginal Zone B-Cell Lymphomas of the Orbit

Introduction: Marginal zone B-cell lymphoma is the most frequent ocular adnexal lymphoma. It may involve the conjunctiva, lacrimal gland, eyelid, extraocular muscle, and orbital connective tissue. Extraocular muscle infiltration is rare. Methods: We report here a series of 5 patients presenting with extraocular muscle infiltration due to marginal zone B-cell lymphoma, extracted from a retrospective study of 39 patients with primitive ocular adnexal marginal zone B-cell lymphoma presenting within a 15-year period, from 1993 to 2007, at two university hospitals. Results: Out of 39 patients, two females and three males presented with extraocular muscle involvement (one levator muscle, one medial rectus muscle, one lateral rectus muscle, one inferior rectus muscle, and one inferior oblique muscle). In 4 cases, the right eye was involved. The median age of presentation was 60 years. Proptosis and diplopia were the main clinical signs. A mean duration of symptoms was 12 months before diagnosis was given. Three patients were stage IE at the diagnosis, according to Ann Arbor classification, and one was at stage IV. Three patients received radiotherapy and two received chemotherapy. Three patients underwent local relapses at a median time of 40 months. The patients with relapses were treated with chemotherapy alone in one case, radiotherapy alone in one case, and immunotherapy and chemotherapy in one case. The mean follow-up period was 54 months. Discussion: When compared to other locations of marginal zone B-cell lymphomas of the orbit, extraocular involvement occurred in younger patients and had similar prognosis. Conclusion: Extraocular muscle involvement is a rare location of marginal zone B-cell lymphoma that had to be known and can simulate thyroid orbitopathy.     

Long-term follow-up after vertical extraocular muscle surgery to correct abnormal vertical head posture

Purpose: To report outcomes of vertical extraocular muscle surgery to correct abnormal vertical head posture in children with horizontal infantile nystagmus.

Methods: Retrospective case series of seven patients evaluated at one institution with abnormal vertical head position (chin-up or chin-down) in the setting of horizontal infantile nystagmus. All patients underwent bilateral vertical extraocular muscle surgery with the same surgeon. Pre- and postoperative vertical head position under binocular viewing conditions was the primary outcome measure. Secondary outcomes included visual acuity, stereopsis, degree of cyclotorsion, and residual ocular alignment.

Results: Seven children with infantile nystagmus syndrome, ranging in age from 4 months to 5 years at presentation, underwent extraocular muscle surgery to correct chin-down or chin-up head position associated with a null position in the setting of horizontal nystagmus. Five children had other ocular pathology (albinism, n = 4; cone-rod dystrophy, n = 1). Five of the seven patients had combined vertical recti and oblique muscle surgery. Three of the patients had additional extraocular muscle surgery to correct horizontal misalignment (exotropia, n = 2; esotropia, n = 1). One patient underwent a separate Kestenbaum procedure (bilateral horizontal resection/recession) to correct concomitant horizontal face turn. Median postoperative follow-up was 8.0 years (range 1–9.5 years). Postoperatively, three patients had complete resolution of their abnormal head position, and three had an improvement in their head posture, with a mean reduction in original vertical head position of 25 degrees. One of these patient had a reversal of their head position from a chin-up to a small chin-down position. Only one patient had no clinically significant improvement in their head position. No patients had signs or symptoms of cyclotorsion postoperatively.

Conclusion: Combined vertical recti and oblique muscle surgery can successfully improve and even resolve vertical head posture, and prevents cyclorotary disorders postoperatively.     

Frequency of IWOS Suggestive Ocular Signs in Slovenian Uveitis Patients with Confirmed Pulmonary Sarcoidosis

Purpose: To investigate the prevalence of suggestive signs for ocular sarcoidosis proposed by the International Workshop on Ocular Sarcoidosis (IWOS) in patients with sarcoidosis-associated uveitis.

Methods: A retrospective study included 53 patients (77% female), with uveitis, who were seen in the period of 2010–2013 at the University Eye Hospital Ljubljana, Slovenia. All patients had confirmed pulmonary sarcoidosis based on clinical presentation, imaging and lung biopsy according to the ATS/ERS criteria. The presence of the seven clinical signs, suggested by the IWOS was determined in 47 patients with sufficient clinical data.

Results: Patients commonly exhibited bilaterality (79%), keratic precipitates/iris nodules (49%), and multiple chorioretinal peripheral lesions (36%). Three or more signs were observed in 40% (19/47) of patients or 79% (11/14) of patients with primary ocular involvement.

Conclusions: Results add to the validation of IWOS criteria and emphasize the high percentage of at least three suggestive for ocular sarcoidosis in patients with primary ocular involvement.     

Intravitreal chemotherapy and laser for newly visible subretinal seeds in retinoblastoma

Background: There has been no effective method for treating newly visible (“new”) subretinal seeding in retinoblastoma except enucleation. The objective of this report is to determine whether intravitreal chemotherapy combined with 810 nm indirect laser can successfully treat retinoblastoma eyes with “new” subretinal seeding which appeared after intra-arterial chemotherapy (ophthalmic arterial chemosurgery: OAC).

Material and Methods: Single center retrospective study from a tertiary cancer hospital of a case series of 14 eyes treated with combined intravitreal chemotherapy and laser from 2012 to 2017. Ocular salvage, patient survival, recurrence-free ocular survival, metastases, and extraocular extension were assessed.

Results: A total of 14 eyes in 13 unilateral or bilateral retinoblastoma patients with “new” subretinal seeding after initial eye salvage therapy were treated with combined intravitreal injection of melphalan (30 ug) or melphalan (30 ug) and topotecan (20 ug) and with 810 nm indirect continuous wave laser. All eyes were salvaged. Only two eyes (14%) recurred again for subretinal seeds after 6 and 8 months, respectively, and required additional cycles of intravitreal injections and laser. Combined intravitreal injection of melphalan or melphalan plus topotecan with 810 nm indirect continuous wave laser was not associated with any metastatic events, patient deaths, extraocular extension, or need for enucleation.

Conclusion: There has been no effective treatment for “new” subretinal seeding after OAC except enucleation or second course OAC. Combined intravitreal chemotherapy with 810 nm indirect laser may be an effective and safe alternative to enucleation.     

Elevated Tear Human Neutrophil Peptides 1-3, Human Beta Defensin-2 Levels and Conjunctival Cathelicidin LL-37 Gene Expression in Ocular Rosacea

Purpose: To investigate the role of innate immunity in ocular rosacea.

Methods: Thirty-two patients with ocular rosacea patients (group-1) and 28 healthy volunteers (group-2) who served as controls were enrolled in the study. Tear function parameters were assessed, conjunctival impression cytology was performed and tear samples were collected. Human-neutrophil-peptides (HNP) 1–3 and human-beta-defensin-2 (hBD-2) levels were measured in tears by using ELISA tests. Cathelicidin leucin-leucin-37 (LL-37), hBD-2, human-beta-defensin-9 (hBD-9) gene expression levels were measured in the conjunctival impression cytology samples using real-time polymerase chain reaction.

Results: Tear HNP1-3 (p = 0.024), hBD-2 (p < 0.001), conjunctival LL-37 gene expression rate (p = 0.014) and ocular surface disease index scores (p = 0.001) were higher and the tear break-up time was lower (p = 0.003) in group-1. No other differences were found between the groups.

Conclusion: The results of this study suggest the role of abnormal innate immunity in the pathophysiology of ocular rosacea by revealing elevated antimicrobial peptide levels.     

Repeat Conjunctival Biopsy after Immunomodulatory Therapy for Ocular Mucous Membrane Pemphigoid

Purpose: To evaluate whether conjunctival biopsy findings in patients with ocular mucous membrane pemphigoid (MMP) persist as positive or revert to negative following treatment with immunomodulatory therapy (IMT).

Methods: Patients with biopsy-proven MMP were treated with IMT for at least 2 years before undergoing repeat conjunctival biopsy for immunofluorescence microscopy. Their records were reviewed and findings evaluated to ascertain which patients’ biopsies showed antibody deposition on the conjunctival basement membrane.

Results: Following 2 years of IMT, conjunctival biopsies showed persistent antibody deposition in two patients, and were negative in four patients.

Conclusions: Conjunctival biopsies in patients with ocular MMP may show reversion to inactive disease following IMT. Post-treatment biopsy might be clinically useful as a means of evaluating the efficacy of therapy in this chronic disease.     

Association of Low Vitamin D Levels with Noninfectious Uveitis and Scleritis

Purpose: To determine whether an association between Vitamin D and noninfectious ocular inflammation exists.

Methods: Retrospective case-control study with 765 patients (333 uveitis cases, 103 scleritis cases, 329 controls). Logistic regression models examined the relationship between hypovitaminosis D and ocular inflammation.

Results: The odds of having uveitis were 1.92 times higher for patients with hypovitaminosis D compared to patients with normal Vitamin D levels in the multivariate analysis [odds ratio (OR) = 1.92, 95% Confidence Interval (CI) = 1.36–2.72, p = 2.32 × 10^–4]. A secondary analysis demonstrated that the odds of developing uveitis or scleritis were 5% lower and 4% lower, respectively, for every unit increase in Vitamin D level (uveitis: OR = 0.95, 95% CI = 0.94–0.97, p = 9.87 × 10^–6; scleritis: OR = 0.96, 95% CI = 0.93–0.99, p = 0.009).

Conclusion: Hypovitaminosis D was associated with increased risk of ocular inflammation in this retrospective study.     

Occurrence of and Risk Factors for Ocular Hypertension and Secondary Glaucoma in Juvenile Idiopathic Arthritis-associated Uveitis

Purpose: To describe the incidence of ocular hypertension (OHT) and secondary glaucoma (SG) in JIA-associated uveitis, identify risk factors for development of these complications, and describe their effect on visual outcomes.

Methods: A retrospective cohort of 108 patients (196 eyes) with JIA-associated uveitis seen over 30 years at an academic practice.

Results: Of examined eyes, 40% had OHT or SG at presentation. These eyes had a nearly three-fold higher incidence of legal blindness during follow-up, compared with eyes without OHT or SG. An additional 41 eyes developed OHT or SG during follow-up. Presenting with anterior uveitis, active inflammation, and using systemic corticosteroids were risk factors for developing OHT, while use of immunosuppressive medication at presentation reduced this risk. Risk factors for developing SG included anterior uveitis and use of systemic corticosteroids.

Conclusions: OHT and SG were common in patients with JIA-associated uveitis. Use of immunosuppressive drugs may decrease the risk of developing OHT.     

Anxiety and Depression among Patients with Uveitis and Ocular Inflammatory Disease at a Tertiary Center in Southern Thailand: Vision-Related Quality of Life,Sociodemographics, and Clinical Characteristics Associated

Purpose: To estimate the prevalence of positive anxiety and depression screening in patients with ocular inflammatory disease (OID). The predictors associated with anxiety and depressive symptoms were investigated.

Methods: A cross-sectional study was conducted. The Thai Hospital Anxiety and Depression Scale (HADS), a sociodemographic questionnaire, and the Thai Visual Functioning Questionnaire 28 were administered to all participants. Associations were estimated using the Cox regression.

Results: Of the 86 participants, 12.8% and 8.1% screened positive for anxiety and depression, respectively. Predictors of an increase in both HADS-Anxiety and HADS-Depression scores comprised poor understanding of OIDs [adjusted relative probability (aRP) = 1.56; p = 0.021 and 1.59; p = 0.012, respectively], and low overall composite score (aRP = 1.45; p = 0.022 and 1.6; p = 0.002, respectively).

Conclusions: Approximately one-tenth of our patients screened positive for anxiety and depression. Patients with poor understanding of their OID and poor self-reported visual function were at an increased risk.     

Clinical Features and Prognosis of Uveitis in a Turkish Patient Population with Ankylosing Spondylitis: Incidence and Management of Ocular Complications

Purpose: To investigate clinical features, visual prognosis, and ocular complications in patients with ankylosing spondylitis (AS)-associated anterior uveitis (AU).

Methods: Data of 211 eyes of 145 patients with AU associated with AS were reviewed retrospectively.

Results: Mean follow-up time was 6.31 ± 6.33 years. Men were younger than women at AS diagnosis (p = 0.035). The mean number of uveitis flares was highest during the first quarter of the year and lowest during the third quarter (p = 0.017). Immunosuppressive agent use was higher in women than men (p = 0.052). Ocular complications developed in 120 eyes (56.9%), and the complication rate was 0.146/eye year. Males developed cystoid macular edema more frequently than females (p = 0.05). Glaucoma was observed more often in early-onset disease (age at AS onset <45 years) than late-onset disease (p = 0.028).

Conclusions: Visual prognosis of AU in patients with AS was good, although more than half of the eyes developed ocular complications (56.9%).     

儿童眼肌型重症肌无力发生眼肌麻痹的相关因素研究

目的:探讨儿童眼肌型重症肌无力(OMG)患儿发生眼肌麻痹的相关因素。方法:回顾性分析2011-11/2020-05期间就诊于我院的203例儿童OMG患儿,将其分为眼肌麻痹组97例和非眼肌麻痹组106例,对两组患儿的临床资料进行单因素统计分析,对有统计学差异的指标进一步行多因素回归分析。结果:纳入的203例儿童OMG患儿发生眼肌麻痹者97例(47.8%),69例(71.1%)表现为斜视,其次为歪头视物(18例,18.6%)。97例患儿中单眼79例(81.4%),单条眼外肌受累53例(54.6%),其中内直肌19例(35.8%)。眼肌麻痹组和非眼肌麻痹组患儿年龄,血清免疫球蛋白M(IgM),血清游离三碘甲状腺原氨酸(FT3),血清甲状腺球蛋白(TG),采用激素联合治疗(72.2%vs 38.7%)均有统计学意义(P<0.05)。血清FT3水平(OR=2.006,95%CI:1.233~3.263)和采用激素联合治疗(OR=4.328,95%CI:1.936~9.677)是影响儿童OMG患儿发生眼肌麻痹的相关因素。结论:儿童OMG患儿发生眼肌麻痹较常见,单眼多发,内直肌最易受累,较少出现复视。血清FT3可作为评估儿童OMG患儿发生眼肌麻痹的重要免疫指标。     

Adalimumab in Active and Inactive,Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials

Purpose: Report global adalimumab safety and efficacy outcomes in patients with non-infectious uveitis.

Methods: Adults with non-infectious intermediate, posterior, or panuveitis were randomized 1:1 to receive placebo or adalimumab in the VISUAL I (active uveitis) or VISUAL II (inactive uveitis) trials. Integrated global and Japan substudy results are reported. The primary endpoint was time to treatment failure (TF).

Results: In the integrated studies, TF risk was significantly reduced (hazard ratio [95% CI]) with adalimumab versus placebo (VISUAL I: HR = 0.56 [0.40–0.76], p < 0.001; VISUAL II: HR = 0.52 [0.37–0.74], p < 0.001). In Japan substudies, no consistent trends were observed between groups (VISUAL I: HR = 1.20 [0.41–3.54]; VISUAL II: HR = 0.45 [0.20–1.03]). Adverse event rates were similar between treatment groups in both studies (854 to 1063 events/100 participant-years).

Conclusions: Adalimumab lowered time to TF versus placebo in the integrated population; no consistent trends were observed in Japan substudies. Safety results were consistent between studies.     

Prognostic factors in Vogt-Koyanagi-Harada disease

Purpose To identify prognostic factors for final visual outcome, development of complications, and recurrent inflammation in patients with Vogt-Koyanagi-Harada (VKH) disease. Methods All patients diagnosed with acute uveitis associated with VKH disease at the King Khaled Eye Specialist Hospital and King Abdulaziz University Hospital between January 1999 and February 2004 were reviewed. Data collected included age, gender, initial and final visual acuities, clinical findings at presentation, interval between onset of disease and starting treatment, treatment received, complications, number of recurrences, extraocular manifestations, and duration of follow-up period. Results Sixty-eight patients were identified. There were 51 (75%) females and 17 (25%) males with a mean age of 25.04 ± 10.28 years (range 7–55 years). The mean follow-up period was 34.4 ± 20.1 months (range 8–62 months). The following factors were significantly associated with final visual acuity of 20/20 by univariate analysis: good initial visual acuity of better than 20/200 (p = 0.0415), absence of posterior synechiae of the iris at presentation (p = 0.0106), use of systemic corticosteroids for longer than nine months (p = 0.0479), slow tapering of systemic corticosteroids (p = 0.0024), absence of complications (p < 0.001), and absence of extraocular manifestations (p = 0.0124). Logistic regression analysis identified the use of systemic corticosteroids for longer than nine months to be associated with final visual acuity of 20/20 [odds ratio = 3.4; 95% confidence interval (CI) = 1.14–10.1]. The following factors were significantly associated with the development of complications by univariate analysis: age older than 18 years (p = 0.0161), initial visual acuity of 20/200 or worse (p = 0.0011), and presence of posterior synechiae of the iris at presentation (p = 0.0453). Factors identified after logistic regression analyses were age older than 18 years (odds ratio = 3.3; 95% CI = 1.33–8.17), and presence of posterior synechiae of the iris at presentation (odds ratio = 3.42; 9% CI = 1.38–8.47). Initial visual acuity of better than 20/200 was significantly associated with a lower risk of developing complications (odds ratio = 0.283; 95% CI = 0.129–0.629). The following factors were significantly associated with recurrent inflammation of three times or more by univariate analysis: initial visual acuity of 20/200 or worse (p = 0.0179), anterior chamber reaction of more than 2+ at presentation (p < 0.001), rapid tapering of systemic corticosteroids (p < 0.001), and development of extraocular manifestations (p = 0.0277). Conclusions Clinical findings at presentation, duration and method of tapering of systemic corticosteroids, and development of extraocular manifestations are significantly associated with final visual acuity, development of ocular complications, and recurrent inflammation. The development of ocular complications was significantly associated with a worse final visual acuity.     

Use of Gevokizumab in Patients with Behçet’s Disease Uveitis: An International,Randomized, Double-Masked,Placebo-Controlled Study and Open-Label Extension Study

Purpose: The purpose of this article is to demonstrate the superiority of gevokizumab as compared to placebo, on top of current standard of care, in reducing the risk of Behçet’s disease uveitis (BDU) exacerbations.

Methods: Randomized, double-masked, placebo-controlled, parallel group, event-driven trial in BDU patients having recently experienced an ocular exacerbation, subsequently undergoing a tapering procedure from high-dose corticosteroids and receiving 60 mg gevokizumab or placebo every 4 weeks subcutaneously (EYEGUARD B—ClinicalTrials.gov NCT 01965145).

Results: A total of 83 patients (40 gevokizumab, 43 placebo) were included. Gevokizumab did not significantly affect the risk of occurrence of ocular exacerbations. However, data suggested that gevokizumab could preserve visual acuity, reduce the uveitis severity, decrease the emergence of macular edema, and have a corticosteroid sparing effect. Gevokizumab was well tolerated.

Conclusions: While the primary efficacy endpoint was not met with gevokizumab, the control of IL-1β pathway in patients with BDU may still be a relevant target.