Long-term data on efficacy and safety of adalimumab in Behçet's disease.

INTRODUCTION: Behçet's disease (BD) is a systemic, inflammatory disorder affecting multiple organ systems, frequently treated with TNF-α blocking agents, as infliximab and adalimumab. Insights about long-term use of adalimumab are lacking. Therefore, we conducted a study into the long-term efficacy and safety of adalimumab in BD. METHODS: A retrospective cohort study from patients with BD treated with adalimumab in the Erasmus Medical Center was performed. Patients included were at least 18 years of age, diagnosed according to ISG criteria, and uninterruptedly used adalimumab for at least 36 months. RESULTS: In a population of 39 BD patients using adalimumab, 29 patients persisted treatment >36 months (range 37-206 months). Indications for treatment were uveitis (n = 15) 51.7%, mucocutaneous involvement (n = 9) 31%, arthritis (n = 2) 6.9%, intestinal disease (n = 3) 10.3%. Overall, adalimumab decreased the occurrence of flares from 0.64 to 0.17 flares per year and BCVA improved subsequently. Also, a steady decline in BDCAF is reported over the course of at least 5 years. Subsequently, 79% was able to reduce their use of immunosuppressive agents aside from adalimumab. Adverse effects were reported in, (n = 15) 51.7% of which (n = 13) 86.6% were infectious complications. Two of those required inpatient hospital care. CONCLUSION: Our study illustrates durable long-term efficacy of adalimumab treatment in patients with BD. In our patient cohort long-term adalimumab treatment is safe, with a low incidence of serious adverse events.

Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade® to Remsima®? An Observational Study.

Background: Since the late '90s, infliximab (Remicade®) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima® were introduced in clinical practice. Aim: To investigate the interchangeability of Remicade® (originator infliximab) and its biosimilar Remsima® in patients with rare immune-mediated inflammatory diseases (IMIDs). Methods: This two-phased prospective open label observational study was designed to monitor the transition from Remicade® to Remsima® in patients with rare IMIDs. All included patients were followed during the first 2 years. The primary endpoint was the demonstration of non-difference in quality of life and therapeutic efficacy, as measured by parameters including a safety monitoring program, physicians perception of disease activity (PPDA) and patient self-reported outcomes (PSROs). Secondary outcomes included routine blood analysis, pre-infusion serum drug concentration values and anti-drug antibody formation. Results: Forty eight patients treated with Remicade® were switched to Remsima® in June-July 2016 and subsequently monitored during the first 2 years. The group consisted of patients with sarcoidosis (n = 17), Behçet's disease (n = 12), non-infectious uveitis (n = 11), and other diagnoses (n = 8). There were no significant differences in PPDA, PSROs, clinical and laboratory assessments and pre-infusion serum drug concentrations between the groups. De novo anti-drug antibodies were observed in two patients. Seven patients with sarcoidosis and five with another diagnosis developed a significant disease relapse (n = 7) or adverse events (n = 5) within 2 years; 10 of these patients discontinued Remsima® treatment, one withdrew from the study and one received additional corticosteroid therapy. Conclusions: We observed no significant differences in PSROs, PPDA and laboratory parameters after treatment was switched from Remicade® to Remsima®. However, disease relapse or serious events were observed in 12 out of 48 patients when treatment was switched from Remicade® to Remsima®. The choice to switch anti-TNF alpha biologics in patients with rare IMIDs, particularly in sarcoidosis, requires well-considered decision-making and accurate monitoring due to a possibly higher incidence of disease worsening.

Suspected bacterial endophthalmitis following intravitreal anti-VEGF injection: case series and literature review.

AIM: To report an up-to-date overview of all patients reported in the literature with suspected bacterial endophthalmitis following anti-VEGF injection. Secondly, to identify specific symptoms and signs to differentiate between infectious and noninfectious endophthalmitis. METHODS: A Pubmed search retrieved 12 retrospective case series which had included a total of 118 patients with suspected bacterial endophthalmitis after anti-VEGF injection. Data of 15 patients from the Rotterdam Eye Hospital were added. Patients were divided into three groups: those who did not receive intravitreal antibiotics (group A), patients who received intravitreal antibiotics with biopsy-negative cultures (group B) and those with biopsy-positive cultures (group C). RESULTS: The median time between anti-VEGF injection and presentation with suspected bacterial endophthalmitis was 1 day in group A compared to 3 days in groups B and C. At presentation, patients of group A had a better median visual acuity (logMAR 1.0) compared to those in groups B and C (logMAR 2.1 and 2.5, respectively). CONCLUSION: This study suggests that patients presenting with a visual acuity of 20/200 (logMAR 1.0) or less and later than 24 h after injection are more likely to have bacterial endophthalmitis. To prevent undertreatment in these patients, the threshold to proceed to vitreous biopsy and empirical intravitreous antibiotics should be low.

Uveitis-like syndrome and iris transillumination after the use of oral moxifloxacin.

OBJECTIVE: To report a newly recognized adverse effect of oral moxifloxacin. DESIGN: Observational case reports. PARTICIPANTS: Five patients who used oral moxifloxacin therapy. MAIN OUTCOME MEASURES: In five patients, a uveitis-like episode followed oral moxifloxacin therapy, afterwards they experienced photophobia. At slitlamp investigation, the patients showed almost complete iris transillumination, not restricted to one sector, and persistent mydriasis of the pupil, with no reaction to light and no near reflex. Follow-up of 3 years in one of the patients showed no change of symptoms. Only in one patient, with a history of anterior uveitis, an anterior chamber tap was positive for herpes simplex genome. Only after the use of moxifloxacin did she experience continuous photophobia. CONCLUSIONS: Iris transillumination and sphincter paralysis is a newly recognized adverse effect of oral moxifloxacin therapy.

Use of ocular hypotensive prostaglandin analogues in patients with uveitis: does their use increase anterior uveitis and cystoid macular oedema?

AIM: A retrospective comparative case series was studied to determine whether the use of prostaglandin (PG) analogues to treat raised intraocular pressure (IOP) in patients with uveitis resulted in an increase in the frequency of anterior uveitis or cystoid macular oedema (CMO). METHODS: 163 eyes of 84 consecutive patients with uveitis and raised IOP treated with a PG analogue at two tertiary referral uveitis clinics were identified over a 3-month period. Control eyes were selected as those uveitic eyes of the same patients, which were treated with topical IOP-lowering agent(s) other than a PG analogue. Pretreatment IOP was compared with the mean IOP during PG analogue treatment. The frequency of anterior uveitis and CMO during PG analogue treatment was compared with the frequency of these complications in the control eyes during non-PG IOP-lowering treatment. RESULTS: Significant IOP reductions were observed during PG analogue treatment. There was no significant difference in the frequency of anterior uveitis in those eyes treated with PG analogues and those treated with non-PG agents (p = 0.87, Fisher exact test). None of the 69 uveitic eyes without a previous history of CMO developed this complication. There was no increase in the frequency of visually significant CMO during PG treatment compared with that during non-PG treatment (p = 0.19, Fisher exact test). CONCLUSION: This study demonstrates that PG analogues are potent topical medications for lowering raised IOP in patients with uveitis and are not associated with increased risk of CMO or anterior uveitis.

Somatostatin-related therapeutics in ophthalmology: a review.

Somatostatin and its derivatives have been predominantly studied and succesfully used in endocrinological diseases. This article reviews the rationale of the use of somatostatin and its derivatives in ophthalmology based on current understanding of its action in the eye and summarizes previously published controlled studies and case series. The article points out future possible applications. Larger randomised controlled studies are necessary to confirm its current and future use. New ways of application could facilitate its broader use in ophthalmology.

[Evaluation of the quality of life in ophthalmology]. / Evaluation de la qualité de vie en ophtalmologie.

THE IMPORTANCE OF VISUAL FUNCTION IN THE ASSESSMENT OF QUALITY OF LIFE: The notion of visual function is related to visual acuity but also to many other parameters such as the visual field, perception of colour, contrasts, and the resistance to blinding. These factors are difficult to measure during routine ophthalmic examination but can be assessed during questionnaires on quality of life. MARKERS OF QUALITY OF LIFE IN OPHTHALMOLOGY: Various quality of life questionnaires have been developed in ophthalmology because the non-specific generic instruments appear inadequate. The SF 36 and SF 20 scales, which are generic instruments widely used in many fields, do not adequately explore the problems related to vision. The first efficient instrument is the VF 14, which is a questionnaire specific to ophthalmic diseases, developed by C. Mangione in 1992. This self-administered questionnaire permits calculation of a 0 to 100 score exploring 5 dimensions (long-sight acuity, near-sight acuity, unclear sight, and driving during the day and at night) during 14 activities with 18 questions. It was translated and adapted into French by Gresset in 1997. Today it is the most commonly used questionnaire in ophthalmology, particularly in the assessment of efficacy and impact in surgery. Along the other specific questionnaires developed, there is the NEI-VQF which was created in 1995 to assess vision and the impact of visual problems on the quality of life of patients, independently of an ophthalmic pathology. Many studies have been conducted on various diseases that affect vision, such as diabetes or hypertension. THE LIMITS OF EXISTING INSTRUMENTS: The specific scales appear far more sensitive and specific than generic scales with regard to ophthalmic problems, but they provide less information on the general status of the patient, except for the NEI-VQF. They are limited in some parameters and do not, unfortunately, take into account the patient's age. No specific scale has been developed for children or adolescents, although the impact of vision on daily life is fundamental. The complexity of vision means that the elaboration of an ideal instrument is difficult. However, in the meantime, it is essential that the practitioners continue to use and to test the instruments available in order to improve with regard to pathologies, or in particular sub-groups of the population.

Pitfalls in the diagnosis of craniopharyngioma: 2 case reports.

Two cases of craniopharyngioma with delayed diagnosis are presented. Patient 1 had mild visual loss that initially had been attributed to pigment epithelial detachment in the macular area. Patient 2 had blurred vision in the left eye, although visual acuity was 10/10 at both eyes. She had a history of a posttraumatic neurosurgical procedure and was treated for blepharospasm. Both patients had initially negative CT imaging. Visual field defects suggested a chiasmal lesion and incited to additional neuroradiological investigation. Magnetic resonance imaging revealed a craniopharyngioma in both cases.

Effect of sumatriptan, a 5HT1 agonist, on the frequency of transient lower esophageal sphincter relaxations and gastroesophageal reflux in healthy subjects.

OBJECTIVE: Meals increase the rate of transient lower esophageal sphincter (LES) relaxations, in part by gastric distension. The 5HT1 agonist sumatriptan reduces fasting fundic tone, prolongs the meal-induced fundic relaxation, and delays gastric emptying. We therefore hypothesized that sumatriptan might have a significant effect on the rate of postprandial transient LES relaxations and gastroesophageal reflux. We aimed to study the effect of sumatriptan on postprandial transient LES relaxations and reflux in healthy subjects. METHODS: Esophageal manometry and pH monitoring were performed in 13 healthy volunteers for 30 min before and 90 min after a semiliquid meal (790 kcal). Sumatriptan 6 mg subcutaneous (s.c.) or s.c. placebo were administered on separate days 30 min after the meal. RESULTS: Sumatriptan significantly increased postprandial LES pressure from 11.0 +/- 1.2 mm Hg to 17.6 +/- 1.2 mm Hg (p < 0.05). However, reflux events were not diminished. In the contrary, reflux was more frequent after sumatriptan than after placebo (3 [1.5-4.5]/30 min vs 2 [0-3]/30 min, p < 0.05). Transient LES relaxations were more frequent after sumatriptan, particularly in the second 30-min period after drug administration (3 [2.5-5]/30 min vs 2 [1.5-2]/30 min, p < 0.05). CONCLUSIONS: Sumatriptan prevents the natural decay in rate of transient LES relaxations that occurs after a meal and favors the occurrence of gastroesophageal reflux despite increasing LES pressure. The sustained postprandial high rate of transient LES relaxations after sumatriptan may be a consequence of a prolonged fundus relaxation and retention of meal in the proximal stomach.