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Sjögren's Disease
Published in Jason Liebowitz, Philip Seo, David Hellmann, Michael Zeide, Clinical Innovation in Rheumatology, 2023
The current diagnostic approach requires a multidisciplinary evaluation in most patients. The ophthalmologist seeks evidence of aqueous-deficient dry eye disease, with an assessment of the tear meniscus, tear debris, corneal filaments, ocular surface staining with vital dyes, and measurement of tear flow (generally with Schirmer test strips) and, occasionally, tear osmolarity. An oral medicine specialist or dentist measures salivary flow and examines the oral cavity for signs of salivary hypofunction, including root and incisal caries (relatively unique to salivary hypofunction) and chronic erythematous candidiasis (51). A minor salivary gland biopsy (MSGB) provides the most direct evidence for glandular involvement by SjD, with the finding of focal lymphocytic sialadenitis of sufficient severity to have one or more focal lymphocytic aggregates per 4 mm2 of glandular tissue (focus score ≥1). Finally, the rheumatologist evaluates for systemic manifestations, including serologic abnormalities, and the presence of other autoimmune diseases. Each element of the diagnostic evaluation must be interpreted in the context of the others. None has absolute specificity for the diagnosis.
Chronic Fatigue Syndrome: Limbic Encephalopathy in a Dysregulated Neuroimmune Network
Published in Jay A. Goldstein, Chronic Fatigue Syndromes, 2020
CFS patients are often thirsty. The traditional regulators of thirst are osmoreceptors controlling release of vasopressin, and volume receptors which secrete atrial natriuretic peptide. CGRP (calcitonin gene-related peptide) has recently been added to the list as a promo-tor of venous capacitance. There is little evidence to suggest that these mechanisms are operative in CFS. Psychogenic polydipsia is sometimes seen. The most powerful stimulus to thirst is angiotensin II, and the receptors for this peptide in the brain may be dysregu-lated in CFS. Treatment with angiotensin-converting enzyme inhibitors is sometimes effective.80 Nitric oxide acts as an inhibitory mechanism when thirst is stimulated by water deprivation or angiotensin II in the preoptic area.81 If nitric oxide synthase is inhibited, psychogenic polydipsia could ensue. Sicca syndrome is frequently seen in the CFS patient. Sjogren antibodies are not present although enhancement of the salivary glands on MRI in CFS patients with positive antinuclear antibodies is rarely present. The Schirmer test is often positive. This deficit is probably due to dysfunctional autonomic control of tear and saliva secretion and waxes and wanes along with other symptoms. It could also be caused via descending pathways to brain stem parasympathetic nuclei.
Sjögren Syndrome
Published in Dongyou Liu, Handbook of Tumor Syndromes, 2020
According to the 2016 classification criteria for pSS developed by the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR), an individual achieving a total score of ≥4 points, derived from the weighted sum of the five items, and after application of inclusion and exclusion criteria, is classified as having pSS: (i) abnormal unstimulated salivary flow rate (≤0.1 mL/min) (1 point); (ii) abnormal Schirmer test (<5 mm in 5 min) (1 point); (iii) abnormal findings with lissamine green or fluorescein staining: ≥5 in ocular staining score or ≥4 in Van Bijsterveld score (1 point); (iv) presence of anti-SSA/Ro antibody positivity (3 points); (v) histological evidence of focal lymphocytic sialadenitis in lower lip biopsy, with a focus score ≥1 focus/4 mm2 (1 focus = 50 lymphocytes/4 mm2) (3 points); inclusion criteria: dryness of eyes or mouth for at least 3 months, not explained otherwise (e.g., medications, infection); exclusion criteria: status post head/neck radiation, HIV/AID; sarcoidosis, active infection with hepatitis C virus (PCR replication rate), amyloidosis, graft versus host disease, IgG4-related disease [34,35].
The Effect of OTX-101 on Tear Production in Patients with Severe Tear-deficient Dry Eye Disease: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies
Published in Current Eye Research, 2022
Melissa Toyos, Preeya K. Gupta, Brittany Mitchell, Paul Karpecki
Currently, there is no gold standard diagnostic test for DED.13 The Schirmer test is commonly used in ophthalmic examination and/or clinical trials to measure tear production for the diagnosis of conditions, such as KCS, that generally refer to dry eye. It is an easy and economic clinical test to perform, and an abnormal finding indicates a tear deficiency. A score of greater than 10 mm in 5 minutes is accepted as normal. As defined in our pooled analysis, the unanesthetized Schirmer’s score <5 mm after 5 minutes is highly suggestive of severely aqueous deficient dry eye. Overall, the Schirmer test score is one of the proven criteria for outcome measures in other ophthalmological studies, despite the controversies concerning its variations and repeatability.4,14
A Comprehensive Review of the Clinical Trials Conducted for Dry Eye Disease and the Impact of the Vehicle Comparators in These Trials
Published in Current Eye Research, 2021
Kelly K. Nichols, David G. Evans, Paul M. Karpecki
The same vehicle was used across all 3 OPUS studies.14–16 The vehicle was comprised of sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide and/or hydrochloric acid, and sterile water.9 In the OPUS-1 trial, OSDI visual-related function subscale scores showed no statistical difference between treatment groups at day 84 for lifitegrast and vehicle (P = .7894). Lifitegrast demonstrated a statistically significant reduction in inferior zone CFS vs vehicle (P = .0007).14 There was also no statistically significant difference between the treatment and vehicle groups for Schirmer’s test at any visit.14 In the OPUS-2 trial, there was no difference between the treatment group and vehicle group in inferior CFS scores (P = .6186); this was one of the coprimary efficacy endpoints, which was not met.15 The other coprimary efficacy endpoint of eye dryness had a significant change from baseline for all treatment arms (treatment effect P < .0001).15 In OPUS-3, the ODS was decreased from baseline, but the differences between treatment groups were not significant (at day 84 P = .8893).16 The eye dryness score change from baseline at day 84 was significant for patients receiving lifitegrast vs vehicle only (P = .0007).16
Efficacy and safety of iguratimod on patients with primary Sjögren’s syndrome: a randomized, placebo-controlled clinical trial
Published in Scandinavian Journal of Rheumatology, 2021
Q Shao, S Wang, H Jiang, L Liu
The primary endpoint was the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score at week 24. The secondary endpoints were mental discomfort visual analogue scale (VAS) score, patient global assessment (PGA) (normal–severe, 0–10), EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score, Schirmer’s test values, and salivary flow values. Schirmer’s test was carried out by placing a tear test filter paper in the lower fornix of the conjunctiva of the eye. The length of wetting was measured after 5 min. Salivary flow was measured using the whole saliva technique. Participants were instructed to withhold their dose of any secretagogue (pilocarpine or cevimeline) for 48 h before the visit and to take nothing by mouth for 60 min or longer before saliva collection. The unstimulated whole salivary flow (UWSF) was measured for 15 min. Each follow-up examination was undertaken in the outpatient department, at weeks 4, 8, 12, 18, and 24 ± 3 days.