Sjögren’s disease, despite its prevalence and growing campaigns such as #ThisIsSjögrens run by the Sjögren’s Foundation, is still relatively unknown to many. Every year on July 23, World Sjögren’s Day shines a spotlight on a patient community of over 4 million, who often feel overlooked and misunderstood. For sponsors developing treatments for autoimmune and rarer diseases, this presents both a challenge and an opportunity.
Patients living with Sjögren’s disease frequently face long diagnostic journeys, complex symptoms, and a lack of understanding from healthcare systems and society alike. At Clariness, we believe better patient recruitment starts with understanding the lived experiences of patients. We go beyond clinical terminology to learn how people talk about their conditions and the challenges they face every day. These insights shape everything from recruitment messaging and creatives to patient outreach strategies. As part of this approach, we performed a qualitative analysis in addition to the typical quantitative analysis by inviting people living with Sjögren’s disease to share their experience in their own words. Our findings were significant: this overlooked population has a voice that wants to be heard; this article is designed to amplify them and to facilitate the design of more patient-centric clinical trials.
In this article, Shambhavi Chidambaram, Patient Insights Manager at Clariness, draws on findings from our recent patient survey to explore the lived reality of Sjögren’s disease and what it can teach us about reaching, engaging, and supporting patients in the field of clinical research.
TL; DR (for the busy sponsors):
- Sjögren’s disease affects up to 1% of the global population, yet diagnosis can take years, leaving many patients undiagnosed and underserved.
- Moving beyond traditional quantitative surveys, Clariness encouraged patients to tell their own stories, generating qualitative insights that provide deeper contexts for patient recruitment.
- Hundreds of patients voluntarily shared detailed accounts of their symptoms, daily challenges, and motivations, revealing the significant physical, emotional, and social burden of living with the disease.
- Patient insights help sponsors identify hidden recruitment barriers and design more patient-centric trials that improve enrolment and retention.
Recruiting for rare indications: Sjögren’s disease in facts and figures
Autoimmune diseases, where the body’s immune system attacks the body itself, are challenging to treat and often mean a lifelong battle with debilitating symptoms. They are also far from rare. About 10% of the population worldwide has at least one autoimmune disease, and a majority of them are women. People with one autoimmune condition very often have another, and women generally find it more difficult than men to get doctors to take their symptoms seriously: As a consequence, getting the diagnosis itself can take months or even years.
Sjögren’s disease is just such an autoimmune condition. Though it is nowhere near as famous or common as, say, asthma, the prevalence of Sjögren’s disease worldwide is roughly the same as that of rheumatoid arthritis: 0.2-1% vs 0.5-1% respectively. The disease is in fact suspected to be underdiagnosed: it can manifest in a variety of ways, as the body’s autoimmune system attacks moisture-producing glands (affecting the nose, mouth, eyes, and so on). Symptoms typically manifest in middle age, with diagnosis often following years or even decades later (as some of our respondents report). This is a period of life wherein one typically has a family, career, and other responsibilities, all of which feel the impact of the disease.
Insights from the Clariness Sjögren’s survey: In patients’ own words
Understanding the everyday experience of having such a disease is crucial for effective patient recruitment, and one way Clariness gets such understanding is by running targeted surveys in the countries of interest. The surveys run for 2-10 days, usually getting responses from a few hundred participants. This allows us to draw conclusions through qualitative and basic quantitative analysis, which we then use to develop pre-screeners for specific clinical trials. to develop pre-screeners for specific clinical trials.
Surveys are primarily composed of multiple-choice questions, but have the advantage of potentially yielding qualitative and personalized insights through open-ended questions: “How would you say your condition impacts your daily life?”
On the one hand, text answers tend to be hard to understand, especially when written in a language the survey-taker does not speak fluently. Such questions are not standardized or easy to quantify the way multiple-choice answers are. On the other hand, the insights from multiple-choice answers are necessarily limited by the knowledge of the survey-designer who wrote them: open-ended textual questions yield insights that the designer did not know to ask for in the first place.
In February 2025, Clariness ran a survey for ten days in three countries: Germany, Poland and the USA. The aim was to understand the prevalence and severity of Sjögren’s disease in a potential patient population as well as the survey respondents’ relationship with their disease.
For example:
- What do they call their condition?
- How did they prefer to receive information about Sjögren’s?
- What were their symptoms like?
- What was it like to live with those symptoms?
- Would they participate in a clinical trial?
The majority of survey respondents were middle-aged, between 40–70 years old (Figure 1), and 94% said they were assigned female at birth.
Figure 1: Age distribution of respondents in the Clariness Sjögren's disease survey across Germany, Poland, and the USA.
Respondents reported dryness in the mouth, nose and eyes; fatigue; and muscle and joint pain as their most common symptoms. A majority of respondents were also willing to participate in a clinical trial for a Sjögren’s treatment, 72% rating their willingness as 5 or higher on a scale from 1-10 (10 being the most willing). A fear of side effects and the desire for approval from their primary care doctors were the most-cited barriers to participation, and getting better medical care, the most-cited motivation to participate (see Figure 2 and 3).
Figure 2: Barriers to clinical trial participation reported by respondents in the Clariness Sjögren's disease survey
Figure 3: Motivations for clinical trial participation reported by respondents in the Clariness Sjögren's disease survey
The lived reality of Sjögren’s disease
“My activity level is greatly decreased due to fatigue and pain. I can’t take care of my house by myself. My sleep is generally poor due to waking up several times a night due to pain. I have five to seven broken teeth due to dryness. My eyes burn often despite using Restasis and lubricating drops. I developed fibromyalgia after my Sjogren’s dx. I am on floating FMLA so I won’t lose my job due to disease flares. I have grown apart from family and friends because I am too tired for visits and phone calls.”
~ 61-year-old respondent from the USA.
These results from the standard, multiple-choice questions were highly consistent with both published literature and past surveys of patient populations done by Clariness. Truly new insights, however, came from the answers to the question: “Could you explain in your own words about the impact of each of these individual symptoms on your quality of life? This question is not mandatory and can be skipped.” A total of 317 survey respondents answered this question, some of whom took several paragraphs to explain their lived reality of a Sjögren’s diagnosis.
Note: The following respondent answers have been edited to remove only spelling errors and some punctuation errors to aid comprehension. Grammar has not been edited.
Almost everyone who described their symptoms had something to say about dryness: its severity, its secondary effects, and the consequent impact on their lives.
“It affects my eyes the most. The burning is unbearable.”
“Causes extreme dry eye which has led to chronic migraines which impacts living almost every day.”
“… My dry eyes have damaged the surface of both eyeballs, causing a crater effect….”
“In vielen Lebensbereichen beeinträchtigt mich vor allem die Trockenheit der Augen.” (More than anything, the dryness in my eyes impacts many areas of my life)”
Respondents reported impaired, pained, or blurred vision, which significantly impacted their ability to read and drive. The sleep quality of patients already suffering from fatigue was further compromised by the fact that the dryness seemed to get worse at night, including dryness of the mouth and skin. Several patients even reported that their itchy skin kept them awake at night:
“I get random rashes that I scratch at night in my sleep and wake up with sores particularly on my forearms and shins.”
Ciągła suchość w ustach sprawia, że muszę pić w nocy, chodzić do łazienki. Nie wysypiam się. Swędzą oczy. (My mouth is constantly dry, so I have to drink water at night and go to the bathroom. I don’t get enough sleep. My eyes itch).”
“My eyes feel as if I have sand in them particularly at night even though I use prescription eye drops. My mouth is dry so I drink water all and even through the night.”
Saliva plays a critical role in keeping the mouth healthy, enables swallowing, and is crucial to the sense of taste. Decreased saliva production is debilitating and causes a host of health issues, as patients report bleeding lips and gums, cavities, mouth sores, and even choking.
“Konieczność częstych wizyt stomatologicznych, stałej higieny jamy ustnej, gum, cukierków po posiłkach, duża ilość nawodnienia. Suchość głównie w stresie i niepewność.” (“The need for frequent dental visits, consistent oral hygiene, gum, candy after meals, and plenty of fluids. Dry mouth, mainly due to stress and anxiety.”)
“Eating is a scary game, you are afraid of suffocating, drink a lot of water, even after every bite, eyes often very inflamed, if I don’t care for the nose consistently, the nose bleeds, food gets stuck in the esophagus.”
“…I’ve had four root canals in the past four years.”
“My teeth constantly have cavities that need filling, crowned or sometimes pulled. My tongue gets white spots and constantly sticks to the roof of my mouth… I’ve tried saliva inducing meds but can’t deal with the side effects. Didn’t help!”
“…Also I lost my taste and smell due to Sjogrens. I hate this disease…”
One respondent summed it up as follows:
“When flaring, it impacts my life significantly. I’ve gotten coronal ulcers from eye dryness and needed my eyes patched, I constantly need dental work, I have had multiple surgeries for tendon issues with no injuries.”
Sjögren’s disease induces pain all over the body, including the mouth and jaw, as one respondent reports:
“Parotid glands swollen, cough, hyper inflated lungs, joint pain, all interfere with daily life. Joint pain and swollen glands have worst effect on my daily life.”
The physical pain of Sjögren’s disease is enough to disrupt anybody’s life – as this respondent put it:
“The pain is unexplainable constant and some days are unbearable💔And you never know what the day are night will be like.”
Fatigue is a characteristic symptom of the disease with 13 possible subtypes. Our survey respondents describe some of these subtypes vividly.
Many report basic fatigue:
“Being continuously tired and achy makes me just want to sit on the couch all day. No motivation at all.”
As well as sudden fatigue:
“On certain days and times it can be debilitating , the fatigue and random out of the blue muscle pain.”
Fatigue is often worsened by other symptoms that disrupt what might otherwise be a decent night’s sleep, also known as flare-related fatigue or fatigue related to other physical causes:
“Night sweats wake me up a few times a night.”
“…Also, my bladder is involved. I have to go to bathroom at least every hour.”
“The dryness is hard to deal with and the sweats, not just night sweats, do not allow me to get a good night’s sleep.”
Where even a healthy person would be dull and unalert without sleep, Sjögren’s patients must cope with brain fog in addition to the effects of sleep deprivation. As one respondent reported on their fatigue that impairs concentration:
“I am constantly exhausted even after napping or taking breaks. I can’t concentrate and my memory is awful.”
And another on their tired-wired fatigue:
“Feels like my brain is on over drive.”
A secondary symptom of all this is the feeling of being unable to think or plan, and so being mentally disconnected from the world.
“Najgorzej jest z koncentracją i pamięcią… (My biggest problems are with concentration and memory)”
“I have problems with thinking and I get brain fog.”
“Often my brain fog is bad enough that I feel like people are playing tricks on me.”
These factors combine and compound in many patients, resulting in a “slower pace of life”, as one patient put it, worsening overall health and sometimes even in strange physical sensations:
“…I get electric shocks down my left arm, stabbing sensations sometimes, and sometimes it feels like a warm spot on my leg as if there was an iron on it. I have neuropathy in my hands… This disease is much more than dry mouth and eyes.”
“Always dry. Feel like I’m always sucking in air to breathe. Very tired. Earring loss in one ear. Always constipated. Had to have part of my colon removed. Muscles and joints hurt. Extremely dry eyes.”
“…Czasem boję się zasypiać, bo oprócz suchości mam zapalenie błony śluzowej przełyku i zatok i związane z tym wydzielanie śluzu który zakleja przełyk, jest bardzo gęsty i klejący…” (“Sometimes I’m afraid to fall asleep because, in addition to dryness, I have inflammation of the esophageal and sinus mucosa, and the resulting mucus secretion clogs my esophagus—it’s very thick and sticky.”)
Sjögren’s disease often co-occurs with other conditions, the symptoms playing off each other and further worsening quality of life:
“Hard to determine if its cause is sjogrens or one of the 4 other autoimmune I have”
“It has completely disabled me. I have RA [Rheumatoid Arthritis], but now Sjogrens too… It did me in.”
“… prócz tego mam jeszcze Zakrzepice żył głębokich, SM, nadciśnienie.” (“In addition, I also have deep vein thrombosis, MS, and high blood pressure.”)
“As for joint pain, it hard to say it Sjorgrens or just arthritis, do that I have both.”
“Have had Sjogren’s for 30 years. I have 4 other autoimmune issues, but Sjogren’s came first.”
“…my symptoms come and go. Originally was told lupus with Sjögren but then was told it was a mixed connective tissue disease. Now added IgAN to the mix.”
The onset of Sjögren’s disease is typically in middle age, 40-60 years old, and can take years to definitively diagnose. At this stage of life, many adults have jobs, careers, spouses, children, elderly parents to care for, hobbies they enjoy, and a host of other responsibilities, all of which are impacted by the symptoms of the disease.
“Destrukcyjnie wpływu na funkcjonowanie, w tym na pracę zawodową.” (“A detrimental impact on functioning, including professional performance.”)
“Sicca Symptomatik beeinflusst mich besonders bei der täglichen Bildschirmarbeit…” (“The symptoms of Sicca affect me particularly when I’m working at a computer screen every day”)
“Die Anstrengung und der Anspruch ist so hoch, dass ich abends erschöpft und mit schmerzen einbreche. Aber ich muss ganztags arbeiten.”
Care-giving and household responsibilities in particular fall disproportionately on women, who make up about 90% of the population afflicted with Sjögren’s disease (as also demonstrated by our survey).
“I tend to stay home more, and put most chores on hold, it takes forever to clean the house.”
“Living alone and struggling to take care of myself as well as caring for my 96 year old mother and 6 year old grandson with heart problems is exhausting in itself. Dealing with Sjögrens on top of that is often debilitating. Stress seems to make it worse.”
“I have not been myself. I am a mother of 4 and I have missed out on my children growing up because of this syndrome. My business suffers also.”
“…My joints ache and I am fatigued which makes time with my grandchildren difficult.”
As some respondents noted, what little energy they have is taken up by work and precious little is left for their social lives and hobbies:
“Durch die ständige Erschöpfung fällt es mir schwer meiner Arbeit nachzugehen. Nach der Arbeit habe ich meistens keine Energie mehr für Freizeitaktivitäten und soziale Kontakte.” (“Because I’m constantly exhausted, I find it hard to do my job. After work, I usually don’t have any energy left for leisure activities or socializing.”)
Indeed, relationships and hobbies suffer across the board: patients cannot physically enjoy their sex lives, put energy into their social relationships, or indulge in their hobbies:
“I also have dryness in my vagina, which affected my sex life.”
“Suchość w pochwie uniemożliwia mi współżycie.” (Vaginal dryness prevents me from having sex)
“Ich plane sehr ungern, da ich nie weiss, wie es mir an dem geplanten Tag geht. Dadurch habe ich mich sehr zurückgezogen, da viele Bekannte und Freunde mit dieser Erkrankung wenig Verständnis haben, wenn ich absagen muss.” (I really don’t like making plans, because I never know how I’ll feel on the day. This has caused me to become very withdrawn, since many of my acquaintances and friends have little understanding of this condition when I have to cancel.)
“Keeps me from doing the things I love to do often”
“Sh***y, hardly any social contacts anymore.”
“Unable to enjoy what I used to. Hiking/biking/yardwork/socializing with friends.”
“Mental fatigue translates into not doing things I enjoy at home like handcrafts.”
Patients lose the ability to manage their lives, enjoy their relationships or leisure time – mental health inevitably suffers:
“Bei Sicca-Symptomen ist es eher die Angst vor Verschlechterung.” (With Sicca symptoms, it is more the fear of the condition worsening.)
“All symptoms are puzzling… It’s non stop worry and questioning why is this happening to me. Lots of mental stress.”
“Doprowadziła do depresji.” (It led to depression)
“The whole thing causes a lack of humor, even depressive states.”
Along with anxiety and depression, many respondents reported a feeling of hopelessness, of hating life and a loss of their former identity:
“I feel I let myself and others down when I’m not able to be the person I was before I got sick.”
“It is a negative force to be reckoned with…”
“It has messed up most of my entire life with this and no relief.”
“It rules my world … Pain is out of control. It’s my life and daily partner…”
“This disease has impacted all aspects of my life. I am barely functioning and finding it hard to live every day with my symptoms. They seem to be getting much worse.”
“The symptoms affect my daily life and make it hard for me to have “normal “ experiences.”
“It has made life difficult to near impossible… Hate it!”
“My autoimmune started when I was 67 and has taken away my life as I knew it.”
“… Feels like a losing battle- honestly.”
Part of the deterioration in mental health seems to come from the inability of the world to see and empathize with Sjögren’s disease. The average time from the onset of symptoms to the diagnosis of Sjögren’s disease is 6 years, as one study reported, but can be much longer:
“18 years to get a diagnosis. The fatigue has altered my ADLs, my relationships, my family and my career.”
The fact that Sjögren’s often occurs alongside other conditions doesn’t make diagnosis any easier:
“Since childhood, my eyes felt scratchy. I was diagnosed with lupus until I was in my 50’s & Sjogren’s later. My eyes have usually been painful since I was young. Reading was quite difficult even though my visual acuity was 20/20. It is difficult to sort out the aches & pains from lupus & Sjogren’s.”
Finding support and empathy, even from doctors, is an ever-present challenge for many:
“My university Dr seems to know little to nothing about my disease but she does seem to know a lot about lupus. I feel like the only real suggestions I receive is from others with Sjogrens online.”
“Sometimes it’s hard and I don’t think other people understand.”
“My constant mental fog and fatigue are leaving a horrible impact in my life… If I work I can’t make anymore plans for the day because I need so much rest. I hate it. It’s painful and frustrating. People do not see it so they don’t understand.”
The lived reality of Sjögren’s disease was summarized by one respondent succinctly as follows:
“The dryness in the mouth is almost unbearable and I live in a cold climate and when I’m outside the dryness becomes even worse. My teeth constantly have cavities that need filling, crowned or sometimes pulled. My tongue gets white spots and constantly sticks to the roof of my mouth. I’ve developed extremely dry eyes and struggle greatly with my vision. Itching at night is extreme and nothing helps. I find it very difficult to socialize because it’s difficult to eat or drink. I’ve tried salvia [sic] inducing meds but can’t deal with the side effects. Didn’t help!”
Or even more succinctly by another as:
“Sucks.”
What does this mean for Sjögren’s disease patient recruitment?
Across several hundred responses, three clear themes emerged:
- The symptoms of Sjögren’s disease can be extensive and debilitating
- Other health problems often emerge as a consequence of the symptoms of Sjögren’s disease
- Despite its impact on patients, Sjögren’s disease remains invisible and frustratingly underdiagnosed
Patient recruitment for Sjogren’s disease is often thwarted by the most banal practicalities that are not visible to either sponsor or recruiter, such as:
- A patient’s physical pain making travel impossible
- Sleep deprivation causing a patient to give inaccurate pre-screener answers
- Missing documentation, because getting diagnosed is often fraught with challenges and delays
Knowing a patient’s lived reality of their disease sheds light on hidden obstacles and suggests ways to deal with them. For sponsors, these insights extend beyond recruitment. They inform how studies are designed, communicated, and delivered. Recruitment materials that reflect patients’ experiences, flexible participation options, and study designs that acknowledge the realities of living with Sjögren’s disease can improve both enrolment and retention. By listening to patients early, sponsors can build trials that are more accessible and better aligned with the people they are designed to serve, ultimately accelerating enrollment.
At Clariness, insights from patients’ reported experiences are translated into recruitment strategies that help connect the right patients with the right studies. We can provide this level of insight across hundreds of indications to improve enrollment outcomes, while ensuring that the patient’s voice remains at the center of clinical research.