Volume 26, Issue 3
March 2008
New Dry Eye Criteria from the
International Dry Eye Workshop
Michael A. Lemp, M.D.
Clinical Professor of Ophthalmology, Georgetown and George Washington Universities
F
ifteen years ago the first international
workshop on dry eye was organized
to bring together experts from
around the world to discuss and establish
the first internationally recognized criteria
for definition, classification, diagnosis
and treatment of dry eye disease. These
deliberations, which took place over a
two-year period, resulted in the publication of a major report in 1995. This
report has stood as the standard reference document for clinicians and researchers throughout the world.
As major advances have developed in the fields of molecular biology, cellular
mechanisms, and new technologies, which allow researchers to explore important facets of the disease, our new understanding has led to significant discoveries, the development of more effective treatments and the promise of a new
generation of pharmaceutical products.
With this background of change, a new international dry eye workshop was
organized over the last four years. Over 70 experts from diverse scientific disciplines gathered at several meetings and produced a new updated report which
has just been published. As Chair of the Subcommittee on Definition and Classification, I will summarize the most important aspects of this new report.
You might ask, “Why is it important to define dry eye?” There has been much
confusion about the nature of this condition since it is associated with a number of other conditions such as systemic autoimmune disease, aging, hormonal
insufficiency, drugs and refractive surgery. What is now clear is that dry eye is a
real disease with specific changes in the tear film and surface of the eye regardless of which risk factor(s) led to its onset.
Scientists Discover
Candidate Salivary
Markers for
Sjögren’s Syndrome
[this article is reprinted from the National Institute of Dental and Craniofacial
Research’s website The Inside Scoop.
Here they speak with researcher
Dr. David Wong, a scientist at the
University of California at Los Angeles
School of Dentistry]
T
hree years ago, scientists supported by the National Institute
of Dental and Craniofacial Research (NIDCR), part of the National
Institutes of Health, began taking the
first full inventory of the proteins that
normally are produced in our salivary
glands. Now, one of those scientists
and his colleagues offer a first glimpse
into how this new research tool can
be applied to detect subtle changes
in the protein content of a person’s
saliva that may be linked to an oral or
systemic disease. As reported in the
November issue of the journal Arthri-
continued page 2 t
In This Issue
7 In Memoriam
8 In Honor
13 Food & Inflammation
continued page 4 t
17 Lip Biopsies
2
March 2008 / The Moisture Seekers
“Dry Eye Criteria” continued from page 1 t
Founded by
Elaine K. Harris in 1983
Board of Directors
Chairman of the Board
Bobette Morgan
Chairman-Elect
Gary Foulks, MD, FACS
Treasurer
David P. Babinski
Secretary
Cathy A. Davison, PhD
Estrella Bibbey
Steven E. Carsons, MD
Lynne Parkhurst Ciuba, Esq.
Troy E. Daniels, DDS, MS
Peter C. Donshik, MD
Fred R. Fernandez
Linda S. Knox, PhD, RN
Austin K. Mircheff, PhD
Lynn M. Petruzzi, RN
Nelson L. Rhodus, DMD, MPH
Sara J. Sise
Janine A. Smith, MD
Frederick B. Vivino, MD, FACR
Medical & Scientific
Advisory Board
Chairman
Frederick B. Vivino, MD, FACR
Richard Brasington, MD
Steven E. Carsons, MD
Troy E. Daniels, DDS, MS
H. Kenneth Fisher, MD
Gary Foulks, MD, FACS
Philip C. Fox, DDS
Tara Mardigan, MS, RD, MPH
Austin K. Mircheff, PhD
John Daniel Nelson, MD, FACS
Kelly Nichols, OD
Athena Papas, DMD, PhD
Ann Parke, MD
Andres Pintos, DMD
Nelson L. Rhodus, DMD, MPH
Daniel Small, MD, FACP
Neil I. Stahl, MD
Pamela Stratton, MD
Chief Executive Officer
Steven Taylor
In addition, new discoveries have shown that dry eye disease has significant
effects on vision as the tear film breaks up between blinks, leading to difficulties in driving and reading. Other new discoveries relate to the role of inflammation in damaging the cells of the eye surface. So an updated definition was
formulated to reflect these new findings and relate them to the well-established
hallmarks of dry eye disease (i.e. tear film instability and increased concentration of salts in the tears also known as increased tear osmolarity). The new definition of dry eye disease in the Dry Eye Workshop (DEWS) report is as follows:
Dry eye is a multifactorial disease of the tears and ocular surface that results
in symptoms of discomfort, visual disturbance, and tear film instability, with
potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation in the ocular surface.
This definition emphasizes the most important features of dry eye disease
which lead to the symptoms of discomfort, pain, blurred vision and damage
to the surface of the eye. The reason this is so important is that scientists and
practicing doctors now will have a framework to better understand what has
gone awry. This is a prerequisite to developing an effective treatment plan.
In the previous dry eye workshop in the early 1990s the experts identified
two major types of dry eye disease. The first of these is a deficiency of tear
production by the tear-producing lacrimal glands. In addition, there is a second very common form of the disease in which there is excessive loss of tears
through evaporation into the atmosphere. This latter condition occurs most
often when the oil glands of the eyelid, which retard the loss of tears, are not
working well. In fact, this feature of dry eye disease may be more common even
than the deficient production of tears. Recent studies have shown that in most
patients there is a combination of both elements. This should not be surprising
since some of the same cellular and chemical abnormalities affect both the tearproducing and the oil-producing glands.
The DEWS report confirms the previous classification but further develops this concept and explains how events occurring in the tear film, such as a
break-down in the tear film and an increased concentration of salts, are closely
related to damage to the cells of the cornea and conjunctiva. In fact, these
abnormal changes at the surface of the eye lead to symptoms of pain, blurred
vision, a decrease in reading time, difficulties driving and a general decline in
the quality of life. One study assessing the impact of dry eye disease on quality
of life equated this disease with severe cardiac disease.
The subcommittee report emphasized that the two essential features of all
types of dry eye are a tear film that is breaking up between blinks and a highly
concentrated tear film which is injurious to the cells of the eye surface which it
bathes. The effect is tears which are high in salt content rather like the water of
Moisture Seekers Editor
Thomas Haynes
The Moisture Seekers® Newsletter is published by the Sjögren’s Syndrome Foundation Inc., 6707 Democracy
Blvd., Ste 325; Bethesda, MD 20817. Copyright © 2008 Sjögren’s Syndrome Foundation Inc. ISSN 0899-637.
e-mail: [email protected]
www.sjogrens.org
DISCLAIMER: The Sjögren’s Syndrome Foundation Inc. in no way endorses any of the medications, treatments,
or products mentioned in advertisements or articles. This information is intended only to keep you apprised of
developments in the field of Sjögren’s syndrome research. We strongly advise that you discuss any research news,
drugs, treatments or products mentioned with your own healthcare providers.
March 2008 / The Moisture Seekers
the Dead Sea or the Great Salt Lake. In both of these environments very few living things will grow. In like manner,
the cells of the eye surface are damaged and inflammation
is stimulated which further damages the cells, resulting in
premature cell death and frank sores on the eye.
These processes are particularly apparent in Sjogren’s
syndrome-associated dry eye disease. In this condition
there is a systemic component in which inflammatory
cells from the general circulation are added to the ongoing inflammation on the eye surface leading to extensive
destruction of the tissue with more severe symptoms,
including pain and visual loss.
Another factor to consider is the effect on the patient’s
environment both within the body and outside. Aggravating internal conditions which worsen the disease process
include a decrease in blinking which reforms the tear film,
abnormalities in lid movement which may worsen loss of
tears to evaporation, and the use of a variety of systemic
and local eye drugs. Systemic drugs which adversely affect
tear production include antihistamines, beta-blockers
which are used for cardiac conditions, anti-spasmodics
used to control bowel activity, diuretics and some psychiatric drugs. A good rule of thumb is that any pill which
3
produces dry mouth can decrease tear production.
External environmental factors can exert a significant
stress on an already compromised tear film. The most
commonly encountered external factors include climate
conditions and artificial environments with low humidity, such as the interior of an airplane. This is particularly
noticeable on long plane trips. Occupational and recreational activities can stress the tear film, such as the use of
computer screens over three hours per day (this results in
a decrease in blinking). Bicycle and motorcycle riding create significant wind stress. In all of these situations there
is increased loss of tears to evaporation.
The report on definition and classification is but one
subcommittee report among a number of others which
deal with other topics such as diagnosis, management
and treatment, clinical studies to develop new treatments,
studies on how widespread the disease is and recommendations for future research. Progress is being made on all
these fronts, and while it is never fast enough for those
suffering, it is indeed encouraging and augurs well for
significant advances in the coming years. n
Steven Taylor
Chief Executive Officer
Friends Helping Friends Campaign
There is still time to send in your donations!
If you have collected donations from friends and/or family for our 2008 Friends Helping Friends campaign,
please remember to return them to the SSF by March 14th along with your Collection Summary Form.
Sjögren’s Syndrome Foundation-FHF
6707 Democracy Blvd., Suite 325
Bethesda, MD 20817
If you have any questions please contact the Foundation office at 800-475-6473, ext. 217
Thank you for joining us in this effort to increase awareness, one friend at a time!
4
“Salavary Markers” continued from page 1 t
tis and Rheumatism, the scientists detected 42 proteins
and 16 peptides in saliva that clinically discriminated
between people with the primary form of Sjögren’s syndrome and healthy volunteers. These data far surpass previous efforts to identify protein biomarkers for primary
Sjögren’s syndrome, a chronic autoimmune condition of
the salivary and tear glands that affects about two million
Americans, mainly women. The scientists also identified 27 distinct gene transcripts that were over produced
in the saliva of those with primary Sjögren’s syndrome.
The Inside Scoop spoke with the study’s senior author Dr.
David Wong, a scientist at the University of California at
Los Angeles School of Dentistry. He offered his thoughts
on the paper’s findings, its implications, and the recent
research progress with salivary diagnostics.
Some people have asked “Why develop saliva as a diagnostic
fluid? Isn’t blood good enough?”
One part of the answer is saliva can be readily collected.
That’s a big plus. As most dentists and physicians will tell
you, they treat patients everyday who wince at a needle
poking their skin or mouth. Saliva also is easier than
blood to store and, if needed, to ship. But there’s a second
part to this answer that really is worth emphasizing.
What’s that?
The salivary glands do not exist in isolation from the
rest of the body. In other words, they are not just a series
of glands that secrete fluid into the mouth. The salivary
glands are connected to the rest of the body through blood
vessels that nourish them and neural networks that innervate them. So, they contain information about health and
disease and, with its ease of collection, saliva could serve
as an ideal diagnostic fluid. That’s been the vision that has
moved the concept forward through the years.
That movement was relatively slow during the 20th century.
Where did things stand with salivary diagnostics just five
years ago?
Well, salivary diagnostics was fairly well defined in
terms of its physiology and biochemistry. The scientific
gaps arose in defining its clinical utility. As I mentioned,
we didn’t know whether or not saliva could become a
mainstream diagnostic fluid. It’s still not a mainstream
diagnostic fluid, but things have changed in a very good
way over the last few years.
March 2008 / The Moisture Seekers
How so?
A real turning point was NIDCR’s support of a consortium of laboratories – which included my lab at UCLA
– to inventory for the first time the proteins produced in
the major salivary glands. Here at UCLA, we also assembled independently a companion inventory of over
3,000 gene transcripts produced in the saliva. With these
two toolboxes – I call them diagnostic alphabets – we can
begin to evaluate more methodically and systematically
the potential of saliva as a diagnostic fluid for oral and
systemic diseases.
You can cast a wide net.
Exactly. Before the arrival of these toolboxes, we basically
were shooting in the dark. If we heard a research group
had found a promising biomarker in blood or urine for a
given disease, we looked in saliva to see if it was there, too.
We were playing a “me-too” game. What was lacking was
a solid scientific foundation to develop the full diagnostic potential of saliva. With these toolboxes now in hand,
the game has changed. We can look de novo for signs of a
given disease. In other words, we know healthy people have
on average 1,166 distinct proteins in their saliva. That gives
us 1,166 places to look for measurable changes in protein
expression that might be indicative of disease.
And you can do so by comparing the molecular content of saliva from a healthy person with that of an individual known
to have Sjögren’s or another disease? Is this what you and
your colleagues did in this paper?
That’s exactly right. In our pilot study, we collaborated
with Dr. Arjan Vissink and his group in the Netherlands. Arjan has studied Sjögren’s for many years, and he
provided saliva samples from 10 people diagnosed with
primary Sjögren’s. We compared the samples with those
from 10 healthy volunteers. We cast our investigative net,
measured the protein content in both groups, and pulled
out 42 proteins and 16 peptides that were either over or
under expressed in the Sjögren’s group. So, these data really highlight the maturation of the salivary proteome as a
diagnostic tool.
What about the other toolbox?
We opened the transcriptome toolbox and profiled the
gene transcripts in the saliva. Using very stringent criteria,
we found 27 gene transcripts that were significantly
continued page 7 t
YOU
FORTHE
TREATMENT FORTHE
DRYMOUTH
!RE
AWARETHATTHEREIS
3JÚGRENS
SYNDROME SYMPTOMSOF
This woman is.
If you are one of the thousands of Sjögren’s syndrome patients1-4 who is experiencing
difficulty chewing and swallowing food, speaking, or even sleeping at night because of a chronic dry mouth, consult your health care
provider and ask if EVOXAC ® (cevimeline HCl) is right for you. EVOXAC is available by prescription only.
EVOXAC is indicated for the treatment of
symptoms of dry mouth in patients with
Sjögren’s syndrome.
Every patient reacts differently to medication and some may
not experience positive results.
The information provided in this ad is not intended to replace
a health care provider consultation. Ultimately, your health care
provider will determine whether EVOXAC is right for you.
Please consult your health care provider about this information
and about the risks and benefits of EVOXAC.
For more information, please visit www.evoxac.com
or call 1-866-3EVOXAC.
Safety considerations
• The most common side effects are: excessive sweating, headache,
nausea, sinusitis, upper respiratory infections, rhinitis, and diarrhea
• You should not take EVOXAC if you have uncontrolled asthma,
eye inflammation, narrow-angle (angle-closure) glaucoma, or
allergies to EVOXAC
• Before taking EVOXAC, tell your doctor if you have a heart condition,
controlled asthma, chronic bronchitis, emphysema, a history of kidney
disease or gallstones, or if you are taking any heart medications,
especially “beta-blockers.” If you have any of these conditions,
your doctor will monitor you under close medical supervision while
you are taking EVOXAC
• Tell your doctor and pharmacist if you are taking prescription
or over-the-counter medications to avoid any possible
drug interactions
• The safety and effectiveness of EVOXAC in patients under
18 years of age have not been established
• Special care should be taken if you are elderly
• You should be careful when driving at night or performing
hazardous activities in reduced lighting while taking EVOXAC
• If you sweat excessively while taking EVOXAC, you may
become dehydrated. To prevent this, drink extra water and
talk to your doctor
Please see brief summary of full prescribing information on following page.
EVOXAC® Capsules
(cevimeline hydrochloride)
In addition, the following adverse events (*3% incidence) were reported in the Sjögren’s clinical trials:
Cevimeline
Placebo
Cevimeline
Placebo
30 mg (tid)
(tid)
30 mg (tid)
(tid)
Adverse Event
n*= 533
n = 164
Adverse Event
n*= 533
n = 164
EVOXAC® Capsules
(cevimeline hydrochloride)
Brief Summary
Consult package insert for full prescribing information.
INDICATIONS AND USAGE: Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with
Sjögren’s Syndrome.
CONTRAINDICATIONS: Cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity
to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.
WARNINGS:
Cardiovascular Disease: Cevimeline can potentially alter cardiac conduction and/or heart rate. Patients with significant cardiovascular disease may potentially be unable to compensate for transient changes in hemodynamics
or rhythm induced by EVOXAC ®. EVOXAC ® should be used with caution and under close medical supervision
in patients with a history of cardiovascular disease evidenced by angina pectoris or myocardial infarction.
Pulmonary Disease: Cevimeline can potentially increase airway resistance, bronchial smooth muscle tone, and
bronchial secretions. Cevimeline should be administered with caution and with close medical supervision to
patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease.
Ocular: Ophthalmic formulations of muscarinic agonists have been reported to cause visual blurring which
may result in decreased visual acuity, especially at night and in patients with central lens changes, and to cause
impairment of depth perception. Caution should be advised while driving at night or performing hazardous activities in reduced lighting.
PRECAUTIONS:
General: Cevimeline toxicity is characterized by an exaggeration of its parasympathomimetic effects. These may
include: headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal spasm, nausea,
vomiting, diarrhea, atrioventricular block, tachycardia, bradycardia, hypotension, hypertension, shock, mental
confusion, cardiac arrhythmia, and tremors.
Cevimeline should be administered with caution to patients with a history of nephrolithiasis or cholelithiasis.
Contractions of the gallbladder or biliary smooth muscle could precipitate complications such as cholecystitis,
cholangitis and biliary obstruction. An increase in the ureteral smooth muscle tone could theoretically precipitate
renal colic or ureteral reflux in patients with nephrolithiasis.
Information for Patients: Patients should be informed that cevimeline may cause visual disturbances, especially
at night, that could impair their ability to drive safely.
If a patient sweats excessively while taking cevimeline, dehydration may develop. The patient should drink extra
water and consult a health care provider.
Drug Interactions: Cevimeline should be administered with caution to patients taking beta adrenergic antagonists,
because of the possibility of conduction disturbances. Drugs with parasympathomimetic effects administered
concurrently with cevimeline can be expected to have additive effects. Cevimeline might interfere with desirable
antimuscarinic effects of drugs used concomitantly.
Drugs which inhibit CYP2D6 and CYP3A3/4 also inhibit the metabolism of cevimeline. Cevimeline should be used
with caution in individuals known or suspected to be deficient in CYP2D6 activity, based on previous experience,
as they may be at a higher risk of adverse events. In an in vitro study, cytochrome P450 isozymes 1A2, 2A6, 2C9,
2C19, 2D6, 2E1, and 3A4 were not inhibited by exposure to cevimeline.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Lifetime carcinogenicity studies were conducted in
CD-1 mice and F-344 rats. A statistically significant increase in the incidence of adenocarcinomas of the uterus
was observed in female rats that received cevimeline at a dosage of 100 mg/kg/day (approximately 8 times the
maximum human exposure based on comparison of AUC data). No other significant differences in tumor incidence were observed in either mice or rats.
Cevimeline exhibited no evidence of mutagenicity or clastogenicity in a battery of assays that included an Ames
test, an in vitro chromosomal aberration study in mammalian cells, a mouse lymphoma study in L5178Y cells,
or a micronucleus assay conducted in vivo in ICR mice.
Cevimeline did not adversely affect the reproductive performance or fertility of male Sprague-Dawley rats when
administered for 63 days prior to mating and throughout the period of mating at dosages up to 45 mg/kg/day
(approximately 5 times the maximum recommended dose for a 60 kg human following normalization of the
data on the basis of body surface area estimates). Females that were treated with cevimeline at dosages up to
45 mg/kg/day from 14 days prior to mating through day seven of gestation exhibited a statistically significantly
smaller number of implantations than did control animals.
Pregnancy: Pregnancy Category C.
Cevimeline was associated with a reduction in the mean number of implantations when given to pregnant
Sprague-Dawley rats from 14 days prior to mating through day seven of gestation at a dosage of 45 mg/kg/day
(approximately 5 times the maximum recommended dose for a 60 kg human when compared on the basis of
body surface area estimates). This effect may have been secondary to maternal toxicity. There are no adequate
and well-controlled studies in pregnant women. Cevimeline should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is secreted in human milk. Because many drugs are excreted
in human milk, and because of the potential for serious adverse reactions in nursing infants from EVOXAC ®, a
decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Although clinical studies of cevimeline included subjects over the age of 65, the numbers were
not sufficient to determine whether they respond differently from younger subjects. Special care should be exercised when cevimeline treatment is initiated in an elderly patient, considering the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in the elderly.
ADVERSE REACTIONS: Cevimeline was administered to 1777 patients during clinical trials worldwide, including
Sjögren’s patients and patients with other conditions. In placebo-controlled Sjögren’s studies in the U.S., 320
patients received cevimeline doses ranging from 15 mg tid to 60 mg tid, of whom 93% were women and 7%
were men. Demographic distribution was 90% Caucasian, 5% Hispanic, 3% Black, and 2% of other origin. In
these studies, 14.6% of patients discontinued treatment with cevimeline due to adverse events.
The following adverse events associated with muscarinic agonism were observed in the clinical trials of cevimeline
in Sjögren’s syndrome patients:
Cevimeline
Placebo
Cevimeline
Placebo
30 mg (tid)
(tid)
30 mg (tid)
(tid)
Adverse Event
n*= 533
n = 164
Adverse Event
n*= 533
n = 164
Excessive Sweating
Nausea
Rhinitis
Diarrhea
Excessive Salivation
18.7%
13.8%
11.2%
10.3%
2.2%
2.4%
7.9%
5.4%
10.3%
0.6%
Urinary Frequency
Asthenia
Flushing
Polyuria
0.9%
0.5%
0.3%
0.1%
1.8%
0.0%
0.6%
0.6%
*n is the total number of patients exposed to the dose at any time during the study
References: 1. Kassan SS. Sjögren’s syndrome. In: Paget SA, Gibofsky A, Beary JF III, eds.
Manual of Rheumatology and Outpatient Orthopedic Disorders. 4th ed. Philadelphia, Pa:
Lippincott Williams & Wilkins; 1999:230-235. 2. Gabriel SE. The epidemiology of rheumatoid
arthritis. Rheum Dis Clin North Am. 2001;27:269-281. 3. Talal N. What is Sjogren’s syndrome?
An overview. In: Carsons S, Harris EK, eds. The New Sjogren’s Syndrome Handbook. New York,
NY: Oxford University Press, Inc; 1998:3-10. 4. McArthur CP, Daniels PJ, Tishk M, Mayberry WE.
Dental professionals’ role in diagnosing Sjögren’s syndrome. Gen Dent. 1997;45:62-65.
Headache
Sinusitis
Upper Respiratory
Tract Infection
Dyspepsia
Abdominal Pain
Urinary Tract Infection
Coughing
Pharyngitis
Vomiting
Injury
Back Pain
Rash
14.4%
12.3%
20.1%
10.9%
11.4%
7.8%
7.6%
6.1%
6.1%
5.2%
4.6%
4.5%
4.5%
4.3%
9.1%
8.5%
6.7%
3.0%
3.0%
5.4%
2.4%
2.4%
4.2%
6.0%
Conjunctivitis
Dizziness
Bronchitis
Arthralgia
Surgical Intervention
Fatigue
Pain
Skeletal Pain
Insomnia
Hot Flushes
Rigors
Anxiety
4.3%
4.1%
4.1%
3.7%
3.3%
3.3%
3.3%
2.8%
2.4%
2.4%
1.3%
1.3%
3.6%
7.3%
1.2%
1.8%
3.0%
1.2%
3.0%
1.8%
1.2%
0.0%
1.2%
1.2%
*n is the total number of patients exposed to the dose at any time during the study
The following events were reported in Sjögren’s patients at incidences of <3% and ≥1%: constipation, tremor,
abnormal vision, hypertonia, peripheral edema, chest pain, myalgia, fever, anorexia, eye pain, earache, dry mouth,
vertigo, salivary gland pain, pruritus, influenza-like symptoms, eye infection, post-operative pain, vaginitis, skin
disorder, depression, hiccup, hyporeflexia, infection, fungal infection, sialoadenitis, otitis media, erythematous
rash, pneumonia, edema, salivary gland enlargement, allergy, gastroesophageal reflux, eye abnormality, migraine,
tooth disorder, epistaxis, flatulence, toothache, ulcerative stomatitis, anemia, hypoesthesia, cystitis, leg cramps,
abscess, eructation, moniliasis, palpitation, increased amylase, xerophthalmia, allergic reaction.
The following events were reported rarely in treated Sjögren’s patients (<1%): Causal relation is unknown:
Body as a Whole Disorders: aggravated allergy, precordial chest pain, abnormal crying, hematoma, leg pain,
edema, periorbital edema, activated pain trauma, pallor, changed sensation to temperature, weight decrease,
weight increase, choking, mouth edema, syncope, malaise, face edema, substernal chest pain
Cardiovascular Disorders: abnormal ECG, heart disorder, heart murmur, aggravated hypertension, hypotension,
arrhythmia, extrasystoles, t wave inversion, tachycardia, supraventricular tachycardia, angina pectoris, myocardial
infarction, pericarditis, pulmonary embolism, peripheral ischemia, superficial phlebitis, purpura, deep thrombophlebitis, vascular disorder, vasculitis, hypertension
Digestive Disorders: appendicitis, increased appetite, ulcerative colitis, diverticulitis, duodenitis, dysphagia, enterocolitis, gastric ulcer, gastritis, gastroenteritis, gastrointestinal hemorrhage, gingivitis, glossitis, rectum hemorrhage, hemorrhoids, ileus, irritable bowel syndrome, melena, mucositis, esophageal stricture, esophagitis, oral
hemorrhage, peptic ulcer, periodontal destruction, rectal disorder, stomatitis, tenesmus, tongue discoloration,
tongue disorder, geographic tongue, tongue ulceration, dental caries
Endocrine Disorders: increased glucocorticoids, goiter, hypothyroidism
Hematologic Disorders: thrombocytopenic purpura, thrombocythemia, thrombocytopenia, hypochromic anemia,
eosinophilia, granulocytopenia, leucopenia, leukocytosis, cervical lymphadenopathy, lymphadenopathy
Liver and Biliary System Disorders: cholelithiasis, increased gamma-glutamyl transferase, increased hepatic
enzymes, abnormal hepatic function, viral hepatitis, increased serum glutamate oxaloacetic transaminase (SGOT)
(also called AST-aspartate aminotransferase), increased serum glutamate pyruvate transaminase (SGPT) (also
called ALT-alanine aminotransferase)
Metabolic and Nutritional Disorders: dehydration, diabetes mellitus, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, thirst
Musculoskeletal Disorders: arthritis, aggravated arthritis, arthropathy, femoral head avascular necrosis, bone
disorder, bursitis, costochondritis, plantar fasciitis, muscle weakness, osteomyelitis, osteoporosis, synovitis,
tendinitis, tenosynovitis
Neoplasms: basal cell carcinoma, squamous carcinoma
Nervous Disorders: carpal tunnel syndrome, coma, abnormal coordination, dysesthesia, dyskinesia, dysphonia,
aggravated multiple sclerosis, involuntary muscle contractions, neuralgia, neuropathy, paresthesia, speech disorder, agitation, confusion, depersonalization, aggravated depression, abnormal dreaming, emotional lability,
manic reaction, paroniria, somnolence, abnormal thinking, hyperkinesia, hallucination
Miscellaneous Disorders: fall, food poisoning, heat stroke, joint dislocation, post-operative hemorrhage
Resistance Mechanism Disorders: cellulitis, herpes simplex, herpes zoster, bacterial infection, viral infection,
genital moniliasis, sepsis
Respiratory Disorders: asthma, bronchospasm, chronic obstructive airway disease, dyspnea, hemoptysis, laryngitis, nasal ulcer, pleural effusion, pleurisy, pulmonary congestion, pulmonary fibrosis, respiratory disorder
Rheumatologic Disorders: aggravated rheumatoid arthritis, lupus erythematosus rash, lupus erythematosus syndrome
Skin and Appendages Disorders: acne, alopecia, burn, dermatitis, contact dermatitis, lichenoid dermatitis,
eczema, furunculosis, hyperkeratosis, lichen planus, nail discoloration, nail disorder, onychia, onychomycosis,
paronychia, photosensitivity reaction, rosacea, scleroderma, seborrhea, skin discoloration, dry skin, skin
exfoliation, skin hypertrophy, skin ulceration, urticaria, verruca, bullous eruption, cold clammy skin
Special Senses Disorders: deafness, decreased hearing, motion sickness, parosmia, taste perversion, blepharitis,
cataract, corneal opacity, corneal ulceration, diplopia, glaucoma, anterior chamber eye hemorrhage, keratitis, keratoconjunctivitis, mydriasis, myopia, photopsia, retinal deposits, retinal disorder, scleritis, vitreous detachment, tinnitus
Urogenital Disorders: epididymitis, prostatic disorder, abnormal sexual function, amenorrhea, female breast
neoplasm, malignant female breast neoplasm, female breast pain, positive cervical smear test, dysmenorrhea,
endometrial disorder, intermenstrual bleeding, leukorrhea, menorrhagia, menstrual disorder, ovarian cyst, ovarian
disorder, genital pruritus, uterine hemorrhage, vaginal hemorrhage, atrophic vaginitis, albuminuria, bladder discomfort, increased blood urea nitrogen, dysuria, hematuria, micturition disorder, nephrosis, nocturia, increased
nonprotein nitrogen, pyelonephritis, renal calculus, abnormal renal function, renal pain, strangury, urethral disorder, abnormal urine, urinary incontinence, decreased urine flow, pyuria
In one subject with lupus erythematosus receiving concomitant multiple drug therapy, a highly elevated ALT level
was noted after the fourth week of cevimeline therapy. In two other subjects receiving cevimeline in the clinical trials, very high AST levels were noted. The significance of these findings is unknown.
Additional adverse events (relationship unknown) which occurred in other clinical studies (patient population
different from Sjögren’s patients) are as follows:
cholinergic syndrome, blood pressure fluctuation, cardiomegaly, postural hypotension, aphasia, convulsions,
abnormal gait, hyperesthesia, paralysis, abnormal sexual function, enlarged abdomen, change in bowel habits,
gum hyperplasia, intestinal obstruction, bundle branch block, increased creatine phosphokinase, electrolyte
abnormality, glycosuria, gout, hyperkalemia, hyperproteinemia, increased lactic dehydrogenase (LDH), increased
alkaline phosphatase, failure to thrive, abnormal platelets, aggressive reaction, amnesia, apathy, delirium, delusion, dementia, illusion, impotence, neurosis, paranoid reaction, personality disorder, hyperhemoglobinemia,
apnea, atelectasis, yawning, oliguria, urinary retention, distended vein, lymphocytosis
Post-Marketing Adverse Events: cholecystitis
MANAGEMENT OF OVERDOSE: Management of the signs and symptoms of acute overdosage should be handled
in a manner consistent with that indicated for other muscarinic agonists: general supportive measures should be
instituted. If medically indicated, atropine, an anti-cholinergic agent may be of value as an antidote for emergency
use in patients who have had an overdose of cevimeline. If medically indicated, epinephrine may also be of value
in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if cevimeline is dialyzable.
DOSAGE AND ADMINISTRATION: The recommended dose of cevimeline hydrochloride is 30 mg taken three times
a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient
evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.
Rx Only
Distributed and Marketed by:
Daiichi Pharmaceutical Corporation, Montvale, NJ 07645
Revised 6/2005
Printed in U.S.A.
EVOXAC is a registered trademark of
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For additional information
please call toll free:
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© 2005 Daiichi Pharmaceutical Corporation
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8/05
March 2008 / The Moisture Seekers
“Salavary Markers” continued from page 4 t
upregulated in the Sjögren’s group. What’s really striking
here is 19 of the 27 genes are involved in various aspects
of the inflammatory process.
So that tells you that you’re in the right ballpark? Sjögren’s
syndrome is an autoimmune disease, and the inflammatory
process is reflected in the saliva.
Correct. This suggests to me that saliva contains the
constituents to reconstruct the disease process. It will be
exciting to explore this possibility further and tease out
more information of potential diagnostic value. Right
now, a person faces a battery of expensive and time
consuming tests to get a diagnosis of primary Sjögren’s
syndrome. Salivary diagnostics could make it simple,
quick, and painless.
What is the sensitivity and specificity of the markers that you
found? How tightly do they correlate with the disease?
That hasn’t been determined yet. Nor do we know
which of these molecules might be associated with early
disease and thus might be important for early detection.
Keep in mind, our findings are only research leads at this
point. Each protein and gene transcript must be validated
in at least two follow up studies to be considered as a
marker of disease.
Do you plan to follow up these leads in the near future?
Absolutely. We are in the midst of planning a larger
validation study right now.
What do you have in mind?
We’ll need to have at least 50 people with primary
Sjögren’s and 50 healthy volunteers. That’s the general
design. But we’ll need to do these independent validation
studies at least twice. You do the first study to validate the
markers and then, based on its findings, you build a prediction model. In the second validation study, you independently test the reliability of the prediction model. If the
outcome is good, you can begin to envision an algorithm,
possibly combine the most informative molecules into a
panel of diagnostic markers, and proceed to clinical testing.
You’ve already ploughed through this validation process in
your work with salivary markers for oral cancer.
That’s right. In December 2004, my lab published a
paper that reported on four gene transcripts that were
continued page 8 t
7
In Memoriam
In Memory of Agnes Chaytor
Ruth Anne Gillett
Maureen Craddock
In Memory of Agnes Lerch
Craig, Laura & Nash Bangor
In Memory of Bernice Cleveland
Albert & Kathleen Szyluk
In Memory of Elizabeth McCambridge
Shirley Steffke
In Memory of Gladys Beach
Charlotte Marie Beach Hankins
In Memory of Jeannette Logan Pouncey
Margaret Moskau
The David T. Young Family
In Memory of Laura M. Vaughan
Project Discovery of Virginia, Inc. & Staff
In Memory of Lorraine & Richard Morgan
Sharon & Dick White
In Memory of Marguerite Ann Kant
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Kristine Kant Miller
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In Memory of Pati Frederisy
Lori Carlson
In Memory of Patricia A. Boyer
Strikes Unlimited Bowling League
Deborah Amaya
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Pam and Tom Haddrill
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The Dwelling Place
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West Utica Elementary Staff
Sherry Keeler
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Friends of Barb Schoenemann
In Memory of Rita Blasi
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In Memory of Suzann Henderson
Andrea Hitt
8
March 2008 / The Moisture Seekers
“Salavary Markers” continued from page 7 t
elevated in the saliva of patients with oral squamous cell
carcinoma. Since then, my lab has worked extremely hard
to take these markers through the validation process.
I’m pleased to say that a few weeks ago, these salivary
oral cancer RNA biomarkers were validated as markers
for oral squamous cell carcinoma by the Early Detection
Research Network, or EDRN. The EDRN is an initiative
supported by the National Cancer Institute that develops
and validates markers for the early detection of cancer.
Where do these gene transcripts come from?
They come from almost every conceivable source. The
transcripts are in the ductal fluid secreted into the mouth
as saliva. They’re obviously in the acinar and ductal cells
of the salivary glands, as well as in gingival crevicular
fluid. That leaves open the issue of transcripts reaching
the salivary glands from a distant disease site, and we’re
studying that question right now using animal models.
Hopefully, these studies will fill in some of the blanks.
But, as mentioned earlier, the larger point is you cannot draw a line between the mouth and the rest of the
body. If a part of the body is unhealthy, it will be reflected
elsewhere. The real blessing here is that this information
seems to be reflected in a non-invasive fluid that we can
readily collect in the mouth.
In the Sjogren’s paper, you evaluated saliva collected from the
parotid gland, one of the major salivary glands, and whole
saliva. Whole saliva is the total secretion from all of the major
and minor salivary glands. You found that whole saliva had
more diagnostic value. Was this surprising and why?
It was surprising. If you had asked me to guess beforehand, I would have said the parotid fluid would be more
informative. That’s because most of the oral pathology
that we are aware of with Sjögren’s occurs in the parotid
gland. It would seem like a logical place to look for signs
of disease, particularly because whole saliva contains
other glandular constituents as well as gingival crevicular
fluid. So, it was an unexpected but welcome outcome.
Why “welcome?”
Let’s say a rheumatologist wants to take a saliva sample.
He or she won’t need to ask a patient to sit down for an
hour to have a parotid gland drained. The doctor can collect a whole saliva sample in a matter of seconds.
It sounds like this paper has ramped up your work load?
Well, it’s a good position to be in. I might add that
about 5 percent of those with Sjögren’s syndrome develop
malignant lymphoma, and we’re looking into that, too.
Now that we have these toolboxes, I think the field will
move much faster to crack saliva’s diagnostic codes. But
we still need that one big research victory. Imagine the
day when there’s a news headline that saliva can be used
for the early detection of a systemic disease. If the science
is good and credible, you can almost begin to see how the
table will turn. Now we knock on doors for help. The day
that happens, they will be knocking our doors. n
In Honor
Barbara S. Mand
Elaine Haumann
Margaret Mondlak
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March 2008 / The Moisture Seekers
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Last Name
First
MI
State
ZIP
2. Circle your out-of-pocket purchase price on the receipt.
3. Mail this certificate along with your original pharmacy receipt
(proof of purchase) to Allergan RESTASIS® Ophthalmic Emulsion
$20 Rebate Program, P.O. Box 6513, West Caldwell, NJ 07007
Street Address
City
For more information, please visit our Web site, www.restasis1.com.
❑ Enroll me in the My Tears, My Rewards ® program to save more!
RESTASIS® Rebate Terms and Conditions: To receive a rebate for the amount of your prescription co-pay (up to $20), enclose this certificate and the ORIGINAL pharmacy receipt in an envelope and mail to Allergan RESTASIS®
Ophthalmic Emulsion $20 Rebate Program, P.O. Box 6513, West Caldwell, NJ 07007. Please allow 8 weeks for receipt of rebate check. Receipts prior to March 1, 2007 will not be accepted. One rebate per consumer. Duplicates will
not be accepted. See rebate certificate for expiration date. Eligibility: Offer not valid for prescriptions reimbursed or paid under Medicare, Medicaid, or any similar federal or state healthcare program including any state medical or
pharmaceutical assistance programs. Void in the following state(s) if any third-party payer reimburses you or pays for any part of the prescription price: Massachusetts. Offer void where prohibited by law, taxed, or restricted. Amount
of rebate not to exceed $20 or co-pay, whichever is less. This certificate may not be reproduced and must accompany your request for a rebate. Offer good only for one prescription of RESTASIS® Ophthalmic Emulsion and only in the
USA and Puerto Rico. Allergan, Inc. reserves the right to rescind, revoke, and amend this offer without notice. You are responsible for reporting receipt of a rebate to any private insurer that pays for, or reimburses you, for any part of
the prescription filled, using this certificate.
© 2008 Allergan, Inc., Irvine, CA 92612
®
marks owned by Allergan, Inc. Please allow 8 weeks for delivery of your rebate check.
APC020822007
Certificate expires 8/31/2008
March 2008 / The Moisture Seekers
13
Help Control Inflammation
by Eating Right
by Aimee Magrath, BHSc (Nat.), ND, Dip., Nut., Cert. IV Rem. Mass.,
MATMS [the following article is reprinted from the September 2007 issue of
Lupus Links, the newsletter of The Lupus Association NSW in Australia.]
A
imee was diagnosed with SLE as a young teenager and
struggled with ill-health throughout her schooling
years. Now, more than 15 years on, Aimee is a qualified
naturopath and nutritionist, working from a practice located
in the heart of Pennant Hills, Australia. She has been medication free for over 10 years now, managing her condition
with a combination of natural therapies. Aimee consults on a
wide variety of conditions, with a special interest in allergies,
chronic fatigue conditions and children’s illnesses. She treats
people of all ages, from infants to the elderly, using a diverse
range of modalities including herbal medicine, nutrition, iridology, homeopathy, counseling and flower essences.
As many of us suffer from inflammation and pain at times,
it is beneficial to be aware of particular foods that may help to
reduce or promote inflammation. Foods work synergistically,
so the more you can eat combinations of the anti-inflammatory foods listed below, the more powerful the effect. These
are general guidelines only and any major dietary change
should be discussed with a medical professional so your individual medical needs can be taken into account.
Choose Anti-Inflammatory Foods
Eaten regularly, the following foods can have anti-inflammatory effects in the body:
Garlic & Onions – Also contain sulfur for the repair and
rebuilding of connective tissue.
Celery – Eat raw at least 3 times per week.
Fresh Papaya – Contains papain which reduces swelling
and inflammation, and helps improve digestion.
Bioflavonoids – Rutin, quercetin and hesperidin are all
types of bioflavonoids found in onions, berries and citrus
fruits. They are powerful antioxidants and anti-inflammatory.
Cinnamon – Also aids digestion and improves circulation. This can be useful in Raynauds syndrome.
Chili/Cayenne – Contains capsaicin which decreases pain
sensation by inhibiting the release of Substance P, a neurotransmitter responsible for transmitting pain sensations.
It is also anti-inflammatory (However, it is a member of the
nightshade family, so use with care).
Ginger – Potent anti-inflammatory, aids digestion, improves circulation and helpful for Raynauds syndrome. Add to
cooking and drink ginger tea. Avoid excessive amounts if taking
blood-thinning medication.
Turmeric – Contains curcumin, a potent anti-inflammatory agent. Add to cooking.
Oily fish (tuna, salmon, sardines), Flaxseeds, Walnuts
– Contain omega 3 essential fatty acids which increase the
production and activity of anti-inflammatory substances in
the body.
Fresh Pineapple – Contains the enzyme bromelain which
reduces swelling, inflammation and pain. Bromelain also improves digestion and can reduce excess mucus. It’s vital that
the fruit is fresh, as freezing or canning processes destroy beneficial enzymes. Eat half a fresh pineapple or papaya daily.
Some other substances are also available in a supplement
form, however, please see a naturopath for advice.
Avoid Pro-Inflammatory Foods
The following foods are known to promote the formation
of inflammatory compounds in the body:
• Avoid alfalfa as it contains substances known to
cause lupus flare-ups.
• Plants from the nightshade family – these are potato, tomato, eggplant, chili and capsicum – contain
solanine, which can interfere with certain enzymes
in the muscles and may cause pain and discomfort.
People with chronic inflammatory conditions are
often highly sensitive to this compound.
• Red meat has a form of fat that encourages inflammatory agents in the body. Choose lean cuts of
meat, and try to vary your protein sources with
fish and plant based protein such as legumes.
• Dairy products are broken down to pro-inflammatory substances in the body.
Aimee can be reached via her website:
www.inbalancehealth.com.au. n
14
March 2008 / The Moisture Seekers
Remembering Your Mother
or Another Fabulous Lady
on Mother’s Day
M
ake a donation in honor or in memory of your mother or
a mother that you know! Your honoree or family member will receive a personalized Mother’s Day acknowledgement before May 11th from the Sjögren’s Syndrome
Foundation. It will notify them of your thoughtful and generous gift in their honor. The Foundation will also acknowledge your gift in an upcoming issue of The Moisture Seekers newsletter.
Please choose a donation amount: o $25
o $50 o $100 o other ________________________
Name of person this donation is in honor of _ _______________________________________________________________________________________________________
Name of person this donation is in memory of _ ____________________________________________________________________________________________________
Who would you like the acknowledgment sent to?
Name __________________________________________________________________________________________________________________________________________________________
Street Address _______________________________________________________________________________________________________________________________________________
City ________________________________________________________________ State ________________________________ Zip ___________________
How would you like to be recognized on this letter? ________________________________________________________________________________________________
Please provide your mailing address:
Name __________________________________________________________________________________________________________________________________________________________
Street Address _______________________________________________________________________________________________________________________________________________
City ________________________________________________________________ State ________________________________ Zip ___________________
Telephone ____________________________________________ E-mail _____________________________________________________________________________________________
Payment: o Check (enclosed)
o VISA / Mastercard / American Express (circle)
CC Number: ____________________________________________________________________________ Expiration Date: _____________________________________________
Name as appears on card: ________________________________________________________________________________________________________________________________
Signature: _ _______________________________________________________________________________ Date: _____________________________________________
Mail to: Sjögren’s Syndrome Foundation, 6707 Democracy Blvd., Suite 325, Bethesda, MD 20817
Fax to: 301-530-4415 (credit card payment only)
For moderate to severe dry eye
Conserve tears for
all-day relief.
Once-daily,* preservative-free LACRISERT®
Extends tear life for all-day lubrication and protection
4Unlike artificial tears, LACRISERT® works continuously to stabilize and thicken tears for all-day relief1
4LACRISERT® begins to gently dissolve and lubricate within minutes2
69% of Sjögren’s syndrome patients in a clinical study preferred
LACRISERT® over artificial tears due to increased comfort†2
Most adverse reactions were mild and transient and included transient blurring of vision, ocular discomfort
or irritation, matting or stickiness of eyelashes, photophobia, hypersensitivity, edema of the eyelids, and
hyperemia. LACRISERT® is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.
If improperly placed, LACRISERT® may result in corneal abrasion.
*Some patients may require the flexibility of twice-daily dosing for optimal results.1
†
In a 2-phase study of patients with dry eye: phase 1 was a 6-month, comparative, randomized,
crossover study in 40 patients (37 with Sjögren’s syndrome); phase 2 was an open-label, follow-up
study in 37 patients for 2 months to 18 months.2
References: 1. LACRISERT® [package insert]. Lawrenceville, NJ: Aton Pharma, Inc.; 2007. 2. Lamberts DW,
Langston DP, Chu W. A clinical study of slow-releasing artificial tears. Ophthalmology. 1978;85:794-800.
For more information, visit www.LACRISERT.com or call 1-877-ATON-549.
Please see brief summary of Prescribing Information on adjacent page.
© 2007 Aton Pharma, Inc.
LAC037
12/07
16
March 2008 / The Moisture Seekers
Would you like to help raise awareness
SAVE THE DATE!
of Sjögren’s syndrome in your community?
If so, contact us here at the office
by calling toll-free (800) 475-6473 or
through e-mail at [email protected].
It’s more than a walk… The Sjögren’s Walkabout is a national awareness and fundraising event for the Sjögren’s Syndrome Foundation. The non-competitive, family-fun event
focuses on awareness of Sjögren’s syndrome while helping
to raise money to support the SSF’s research and education
programs. Please come out and show your support.
Lawrenceville, NJ 08648, USA
Here’s our Spring 2008
Sjögren’s Walkabout Schedule:
Rx Only
LACRISERT® (hydroxypropyl cellulose) OPHTHALMIC INSERT
DESCRIPTION
LACRISERT® Ophthalmic Insert is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made
of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye.
Each LACRISERT is 5 mg of hydroxypropyl cellulose. LACRISERT contains no preservatives or other
ingredients. It is about 1.27 mm in diameter by about 3.5 mm long. LACRISERT is supplied in
packages of 60 units, together with illustrated instructions and a special applicator for removing
LACRISERT from the unit dose blister and inserting it into the eye.
INDICATIONS AND USAGE
LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including
keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic
after an adequate trial of therapy with artificial tear solutions. LACRISERT is also indicated for
patients with exposure keratitis, decreased corneal sensitivity, and recurrent corneal erosions.
CONTRAINDICATIONS
LACRISERT is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.
WARNINGS
Instructions for inserting and removing LACRISERT should be carefully followed.
PRECAUTIONS
General
If improperly placed, LACRISERT may result in corneal abrasion.
Information for Patients
Patients should be advised to follow the instructions for using LACRISERT which accompany the package.
Because this product may produce transient blurring of vision, patients should be instructed to exercise
caution when operating hazardous machinery or driving a motor vehicle.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Feeding of hydroxypropyl cellulose to rats at levels up to 5% of their diet produced no gross or
histopathologic changes or other deleterious effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
ADVERSE REACTIONS
The following adverse reactions have been reported in patients treated with LACRISERT, but were in
most instances mild and transient: transient blurring of vision, ocular discomfort or irritation, matting or
stickiness of eyelashes, photophobia, hypersensitivity, edema of the eyelids, and hyperemia.
DOSAGE AND ADMINISTRATION
One LACRISERT ophthalmic insert in each eye once daily is usually sufficient to relieve the symptoms
associated with moderate to severe dry eye syndromes. Individual patients may require more flexibility
in the use of LACRISERT; some patients may require twice daily use for optimal results.
Clinical experience with LACRISERT indicates that in some patients several weeks may be required before
satisfactory improvement of symptoms is achieved.
Issued June 2007
Wilmington
March 15
Wrightsville Beach Park
Greater Washington Region
April 19
Reston Town Center
Salt Lake City
March 29
Valley Fair Mall
Dallas/Fort Worth
April 26
Grapevine Mills
Long Island
March 29
Broadway Mall
Philadelphia Tri-state
May 3
Tyler State Park
Denver
June 7
Denver Zoo
Want to participate in a Walkabout? Start today! Create
your own webpage at www.firstgiving.com/ssf
For more information or if you would
like to volunteer to help at a Walkabout
Please call 1-800-475-6473 ext 217
Special thanks to our
National Signature Sponsor
March 2008 / The Moisture Seekers
17
Is a lip biopsy 100% accurate?
by Philip C. Fox, DDS
T
he short answer is “yes …and no!” The lip biopsy, technically a labial minor salivary gland biopsy, is the single
most accurate means of diagnosing the salivary exocrine
component of Sjögren’s syndrome. However, it is not sufficient alone to establish a diagnosis of the entire syndrome.
In Sjögren’s syndrome, there are characteristic changes in the
minor salivary glands that can be seen when the tissues are
fixed, stained and examined microscopically. Specifically, certain salivary cells are lost (acinar cells) and prominent collections (foci) of inflammatory cells arise which cluster around
other salivary (ductal) cells. This is termed by pathologists a
“peri-ductal mononuclear cell infiltrate with acinar dropout.”
The pathologist actually assigns a score to the lip biopsy based
on the amount of inflammatory infiltration. While the changes seen are characteristic of Sjögren’s syndrome, there are
other conditions, such as graft-versus-host disease, hepatitis
C and HIV-salivary gland dysfunction, in which a lip biopsy
may appear similar on a routine exam. It is important to rule
out these situations during diagnosis. If the changes in the
minor glands appear to be the result of Sjögren’s syndrome,
one must still have evidence of other exocrine involvement
(lacrimal gland) in order to establish a definitive diagnosis of
Sjögren’s. The lip biopsy is accurate in diagnosing salivary involvement in Sjögren’s syndrome and is a critically important
part of the clinical evaluation.
The question that often arises is what does it mean when
the symptoms and other tests are very suggestive of Sjögren’s
syndrome – but the lip biopsy is negative? Patients may have
dry eyes and a dry mouth, both subjective complaints and
measurable decreases in tears and saliva, but the lip biopsy
does not show the characteristic tissue changes or there are
changes present but they are too mild. Patients – and their
doctors – ask, “is this Sjögren’s syndrome?”
There are a number of reasons why the lip biopsy may
be negative. First, the individual may not have Sjögren’s syndrome. There are many causes of dry eyes and mouth, and it
is important to search for these as a possible explanation. It
would be a mistake to overlook another condition. Second,
one could have Sjögren’s syndrome but minimal labial minor
gland involvement. With time, a subsequent biopsy might be
found to be positive. It is important to remember that the
current classification criteria
for Sjögren’s syndrome do
not demand a positive biopsy
to be considered a definitive case of Sjögren’s. The presence of
specific serum autoantibodies (SS-A (Ro) and/or SS-B (La))
may substitute for the positive lip biopsy as a required component. So, you may be diagnosed with Sjögren’s syndrome
without a positive lip biopsy.
Additionally, there are a number of possible technical
explanations for a negative biopsy. There may be an insufficient number of minor glands in the specimen. This is often
dependent on the procedure used and the experience of the
surgeon. (The pathologist needs at least 4-6 minor glands for
accurate reading.) Also, all minor glands in an individual are
not involved to the same extent. One often can see areas of
intense involvement adjacent to relatively normal-appearing
tissue. Therefore, the results may be skewed due to sampling
error – that is, by chance the sample may be a section with
little inflammation. If the specimen had been taken an inch to
either side, the results might be different. This is why obtaining a representative number of glands to examine is important. It is also possible that medications the patient has taken
could influence the specimen, particularly anti-inflammatory
agents. Finally, studies also have shown that different pathologists may score the same tissue differently. In practice, grading
biopsies is not an exact science, unless extremely detailed and
time-consuming methods are used. If the results of the biopsy
do not match the clinical picture, it may be worthwhile to
have the specimen re-read.
So, while a positive lip biopsy in a patient in whom confounding conditions have been ruled out is a very reliable
indicator of the salivary component of Sjögren’s syndrome,
a negative finding does not eliminate the possibility of a diagnosis of Sjögren’s. Diagnosis can be difficult, since there is
no single test for Sjögren’s syndrome and the condition can
present in so many different ways. Regardless of the cause,
symptoms and signs must be managed and good communication with your doctor is essential. The lip biopsy is a very
important tool in the evaluation of Sjögren’s syndrome, but it
represents only a part of the diagnostic picture. n
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•
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Friends of the Sjogren’s syndrome foundation
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To order online visit www.eyeeco.com. Select
desired product and follow directions to buy/
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AD_SSF4.indd 1
The Moisture Seekers
Sjögren’s Syndrome Foundation Inc.
6707 Democracy Blvd., Ste 325
Bethesda, MD 20817
Phone: 800-475-6473
Fax: 301-530-4415
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