Sjögren's Foundation 2022 Impact Statement
Reflecting on the Foundation’s accomplishments, we are immensely proud of what we have achieved to support and educate patients and to drive change in the Sjögren’s community. We believe that there has never been a more promising time for Sjögren's patients than right now. We are excited to see the impact from our work and to highlight some of the major successes from the past year.
We remain committed to maintaining our support group network and continue to have more than 60 support groups in the United States. Support Groups are going back live while many continue to take advantage of meeting virtually. The Foundation is focused on strengthening these groups moving forward and is regularly working to retain existing volunteers and recruiting new ones to serve as Support Group Leaders (SGLs). The Foundation also has four focused support groups in addition to our regionalized groups which include women in their 20s & 30s, men with Sjögren's, childhood Sjögren's, and spouses & partners.
The Foundation also continues to have more than 100 Patient Support Volunteers (PSVs) across the country who serve as a valuable resource for patients looking for answers and support in their local area.
The Foundation provides formal trainings for both the Support Group Leaders and Patient Support Volunteers. Two (2) trainings were held for SGLs to refamiliarize them with current standards and best practices as well as new information regarding group guidelines and how to be the best possible support group leader. A formal flipbook was created for the very first time to be used as a reference “manual” for all existing and new SGLs. The PSV training also focuses on best practices as well as provides valuable tips and talking points.
The most recent National Patient Conference was held on April 29th and 30th and was once again held virtually. The Foundation had a record number of registrants as we welcomed more than 1,100 registrants for the two-day program. The conference covered several topics including some not as commonly covered such as gastrointestinal issues and Sjögren's, the impact of Sjögren's on organs, and musculoskeletal pain and Sjögren's. In the Fall, the Foundation held a Fall Focus virtual patient conference on October 15th which took a different approach than past conferences and focused on wellness strategies for living well with Sjögren's. There were more than 800 registrants for the one-day conference which included presentations on managing symptoms by managing stress, sleep, mental health, diet, and exercise.
Additionally, the fifth edition of The Sjögren’s Book was published and released. Recognized as the bible for Sjögren’s sufferers, The Sjögren's Book is a comprehensive and authoritative guide, produced by the Sjögren’s Foundation and its medical advisors and edited by a leading authority on autoimmune diseases and the first place for patients to look when they have questions about this disabling disease. This expanded edition provides readers with the best medical and practical information on this disease, bringing together current thinking about Sjögren’s in an easily readable and understandable book and providing important new content on areas not covered in previous editions. With more than fifty chapters written by leading experts, this book illuminates the major clinical aspects of the disease and is loaded with practical tips and advice as well as scientific advancements in the field.
The Sjögren's Foundation developed a new comprehensive Living with Sjögren's patient survey to gain insight and better understand the experiences of Sjögren's patients, including not only physical symptoms, but the mental, emotional, and financial impact of the disease as well. A total of 3,622 completed responses were received and which met all inclusion criteria. Survey results will provide researchers with valuable information about the variety and severity of experiences patients with Sjögren’s live with; create greater awareness in the Sjögren’s community at large about the complexities of the disease; and educate regulatory agencies and pharmaceutical companies about the need for new and systemic therapeutics for Sjögren’s.
The Foundation produced a Summary of Major Findings which is a comprehensive and detailed analyses of the findings and data obtained through the survey. The Foundation held a Town Hall with nearly 1,000 registrants, to provide a high-level overview of the findings. The Town Hall also highlighted key data obtained from the survey and shared plans for how the Foundation will use the data moving forward to benefit the Sjögren's community.
The patient survey data was presented at two different professional conferences, an abstract was submitted at American Academy of Neurology national meeting and the data being analyzed by multiple pharmaceutical companies. It was also featured in an issue of Sjögren’s Quarterly and Conquering Sjögren’s, addressed at the April National Patient Conference, and sent to several publications targeted to the related medical specialties.
There is real hope for the first time ever for systemic therapies in Sjögren's. This is an incredibly exciting time with 21 potential systemic therapies in the pipeline for Sjogren’s. THREE (3) of these are going into Phase 3 trials while another TEN (10) are in Phase 2. There are also thirty-three (33) trials occurring in different phases for dry eye and Ophthalmic solutions and devices. And two dry mouth therapies in trial. The Foundation is heavily engaged with each company while ensuring that we do all we can to support and promote objectives that facilitate the design of the trials and that the patient voice is always represented. We are also invested in guaranteeing the success of the clinical trials and actively involved in working to get patients enrolled in each trial.
This Fall, the Foundation formed a U.S. Clinical Trials Task Force to discuss how to address barriers that are unique in the U.S. The Foundation brought together leading Sjögren's experts and principal investigators in academic centers as well as private practices to discuss clinical trial needs and next steps to address barriers. Three meetings have already been held. The Foundation also formed a Corporate Council to engage key Corporate Members in these discussions. In addition, the Sjögren’s Foundation Clinical Trials Consortium (CTC) which encompasses a much broader group than the Task Force, held three meetings this past year with committee and corporate members addressing patient stratification and the barriers to clinical trials in Sjögren's. Also, as part of the CTC, the Foundation continues to enhance our relationship with the Food & Drug Administration (FDA) as well as remains involved in the development of outcome measures for better clinical trial design.
The Sjögren's Foundation launched our new Sjögren's Training & Educational Platform (STEP). The online web-based, educational platform was developed to train medical providers, researchers, and clinical trial investigators on Sjögren’s disease and instruments needed to perform successful clinical trials with Sjögren’s patients. This platform can be used by biotechnology and pharmaceutical companies seeking standardized training for clinical trials, by investigators and their staff who participate in multi-center trials, and/or clinical research organization associates who monitor the correct use of Sjögren’s indices. The STEP program will help with higher quality clinical trials in Sjögren’s as well as diagnosis, management, and treatment of patients.
The initial STEP offering is training and certification for the European Sjögren’s Syndrome Disease Activity Index (ESSDAI), a clinical instrument used in the assessment of people with Sjögren’s. This is a valuable tool as corporations prepare for trial launch and to train trial investigators (PI) on accurate ESSDAI scoring to increase accuracy for patient measurement. The ESSDAI certification on STEP is available to users around the world and was created by a team of international experts who are members of the Sjögren’s Foundation Clinical Trials Consortium. STEP maintains the only continually monitored standard of the correct usage of the ESSDAI instrument in clinical trials. Numerous companies have licensed the ESSDAI Certification Program from the Foundation with hundreds of PIs having already participated and feedback of the program being extremely positive.
The Foundation’s largest research commitment to date is the transformative partnership called AMP® AIM. The Accelerated Medicines Partnership (AMP®) and Autoimmune Immune-Mediated Diseases (AIM) program is a five-year public-private partnership between the National Institutes of Health (NIH), Food & Drug Administration (FDA), non-profit patient advocacy groups, and industry. The initiative began with a focus on rheumatoid arthritis and lupus, and now, because of the Foundation’s advocacy efforts and significant investment, the initiative has expanded to include Sjögren’s.
The Foundation is proud to be in a leadership role with AMP® AIM with two seats on the Steering Committee which helps guide the program. The Foundation also appointed 3 medical and scientific investigators to AMP® AIM trans-disease committees. And this spring, the NIH award in Sjögren’s was given to a network of seven U.S. medical centers to investigate the scientific underpinnings of Sjögren’s and related autoimmune diseases. The “Sjögren’s Team for Accelerating Medicines Partnership” (STAMP) will apply cutting-edge technologies to interrogate the tissue and systems biology of Sjögren's. This research is expected to better understand the disease including disease progression and lead to more precise diagnosis and a better approach for assessing an individual’s risk for complications. Additionally, it should lead to the development of new and enhanced treatments by identifying better therapeutic targets. Kathy Hammitt is the chair of the Recruitment and Patient Perspective STAMP Subcommittee.
The Sjögren's Foundation was excited to support innovative Sjögren’s research once again with the selection of three new research grants including one High Impact Grant and two Pilot Grants. Additionally, the Foundation provided no-cost extensions to a portion of current grantees to allow for extra time due to continuing barriers to work that many have experienced because of the COVID-19 pandemic.
Sjögren’s is the second most identifiable cause of autonomic neuropathy and is increasingly recognized as a common cause of postural orthostatic tachycardia syndrome (POTS) The prevalence and impact of neurological symptoms and conditions in Sjögren’s are becoming increasingly recognized. Our recent Living with Sjögren’s patient survey found that neurological-related conditions ranked third highest in prevalence when looking at involvement of body systems – 83% of respondents had at least one neurological-related condition. With this knowledge, the Foundation has committed to learning more about this area.
The Foundation previously partnered with Dysautonomia International to fund a $150,000 research grant to study Sjögren's & POTS. This joint grant was awarded to Steve Vernino, MD, PhD at the University of Texas-Southwestern to study IVIg treatment for Sjögren's and POTS and continues to recruit patients. To help facilitate new discoveries and further understand dysautonomia in Sjögren’s patients, the Foundation is very excited to fund a brand new $50,000 grant to explore this area. This grant was recently awarded to Dr. Kamal Chemali, MD at the University Hospitals Cleveland Medical Center.
Inaugural State of Sjögren's
Healthcare professionals (HCPs) from a broad range of specialties, researchers, government officials, and pharma and biotech representatives joined the Sjögren’s Foundation in January, for the inaugural State of Sjögren’s. The theme of this year’s event was “The Need for Multidisciplinary Communication and Collaboration in Sjögren’s Clinical Trials and Patient Care” with the focus to deepen the conversation about engaging multiple disciplines in Sjögren’s to enable the best patient care and ensure successful clinical trials. The program was very well received and the second one is being planned for 2023.
The meeting included an update on the Foundation and highlights from the Foundation’s Living with Sjögren’s national patient survey. Dr. Alan Baer, MD, Chair of the Foundation’s Medical & Scientific Advisory Council, and Director of the Jerome L. Greene Sjögren’s Center at Johns Hopkins University School of Medicine, moderated the day’s program which included an overview of the state of Sjögren’s from the rheumatology perspective, a special focus on pulmonary and neurological manifestations of Sjögren’s, a panel discussion focused on the collaborative approach to patient care and creating a multidisciplinary team, and an overview of the state of research in Sjögren’s.
The Foundation once again partnered with Pri-Med, a leading provider of continuing medical education for primary care providers (PCPs) to deliver a program on Sjögren's: Spotting Sjögren's: Keys to Successful Diagnosis for PCPs. The one-hour program was presented by Donald Thomas, MD, rheumatologist, and Chair of the Foundation Board of Directors. The program educated PCPs on identifying the complex symptoms of Sjögren's, methods used for diagnosing the disease, and strategies for managing symptoms in a primary care setting.
33rd International Symposium of the Autonomic Nervous System
The Foundation attended and exhibited at the 33rd International Symposium on the Autonomic Nervous System hosted by the American Autonomic Society. This was the first time the Foundation was involved in this meeting and a meeting that was specifically for neurologists and autonomic specialists. The Foundation was excited to have an abstract accepted on Dysautonomia and Sjögren's which was presented during the poster session.
The American College of Rheumatology Annual Meeting returned to an in-person meeting for 2022 and was held in Philadelphia from November 11 through November 14. For the Foundation, this event represents one of the greatest opportunities to educate the rheumatology community on the complexities of Sjogren’s, and several Foundation staff attended this year’s meeting to engage with the broader community and learn of the most recent happenings in Sjogren’s. There were three Sjögren's-focused sessions and several poster sessions and oral abstract presentations. The Foundation held our annual luncheon which had nearly 100 attendees, a number that were first time attendees. The presentation and discussion topic of the luncheon was “Breaking the Barriers to Clinical Trials in Sjögren's”. During the luncheon, the Foundation also awarded an outstanding abstract award to Dr. Xiaomei Shan, PhD, a doctoral student whose project was titled “Early Histopathological Changes of the Salivary Glands Associated with the Development of Sjögren's.” Lastly, the Foundation was excited to debut an updated and redesigned booth structure. The booth was an opportunity to share a wide variety of materials including clinical practice guidelines and the new Sjögren's Book. In addition, conference attendees visited throughout the meeting and were encouraged to get information about the upcoming State of Sjögren's event, sign up for SQ, become more involved with Sjögren's clinical trials or learn more about applying for a research grant.
Eyes on Dry Eye
The audience of ophthalmologists is particularly important to early diagnosis because they may be the first specialists to see a patient’s dry eye symptoms and should consider Sjögren’s. In March, Foundation President & CEO Janet Church was invited to speak at the Eyes on Dry Eyes conference, the eyecare industry’s largest virtual dry eye event. The title of the session was “When Dry Eye Might be a Serious Systemic Autoimmune Disease” and Janet stressed the important role eyecare providers have in potentially being the first doctor to correctly diagnose a Sjögren's patient.
The Foundation’s Awareness Ambassador Program continues to help the Foundation provide credible resources to healthcare professionals and their community. There are over 175 active Awareness Ambassadors across the United States. The spring/summer program focused on primary care providers and promoting the Pri-Med continuing medical education program on Sjögren's. In the fall / winter, Ambassadors have been distributing the Living with Sjögren's Executive Summary.
The Foundation also continues to publish Sjögren's Quarterly, a quality publication for healthcare professionals.
The Foundation is working diligently on completing the next Clinical Practice Guidelines (CPGs) focused on peripheral and autonomic nervous system involvement in Sjögren's. The behind-the-scenes work has included building and growing relationships the Foundation has with neurologists and building the guidelines to include diagnosis, patient work-up/testing, management, and treatment for cranioneuropathies, inflammatory neuropathies, polyneuropathies, vasculitis-related neuropathies, and autonomic nervous system (ANS) involvement.
The 15th International Symposium on Sjögren’s (ISSS) took place in Rome, Italy from September 7-10. The Foundation was honored and excited to be part of the Symposium which brings together key international leaders in Sjögren’s - healthcare professionals, researchers, industry, government agencies, and patient leaders - to hear the latest information on Sjögren’s and engage in discussions around current issues in research, management, and treatment. Foundation staff were lead authors on 3 posters promoting Foundation initiatives and co-authors on a total of 9 posters. Kathy Hammitt also presented as part of two oral sessions. And the Nomenclature Initiative which was launched by the Foundation and mentioned in further detail below, was a key part of the Symposium.
The Sjögren's Foundation recognized that the language we use around Sjogren’s is critical to communicating that it is serious and systemic! Therefore, we launched an initiative to change our nomenclature. We could not accomplish this alone or in a silo, so we invited Europe to join us. This new initiative is led by Medical and Scientific Advisory Council Chair, Dr. Alan Baer (healthcare professionals) and Sjögren's Foundation Vice President of Medical & Scientific Affairs, Kathy Hammitt (patients). After gathering input from patients on all continents, Kathy Hammitt, a patient herself, has conveyed the patient view on why some words are denigrating and make patient lives harder while a change in the words used can lift patients up and help validate their experiences. Words used to define and describe Sjögren's have repercussions for all stakeholders and especially patients. Hammitt serves on the Steering Committee of this international initiative and wrote a letter to the editor published in Arthritis & Rheumatology. Major presentations were given at the International Symposium on Sjögren's as well as addressed at the American College of Rheumatology Annual Meeting. The Foundation’s voice will continue to stay strong as we work to garner consensus on behalf of all patients around the world.
The Sjögren’s Foundation continues to work with several groups and coalitions on advocacy related issues to help maximize our reach and ensure the Sjögren’s community’s voice is heard. We have expanded our involvement and become more active in many groups while also representing the patient voice on coalitions and committees. These groups include:
- National Health Council
- National Institute of Dental & Craniofacial Research
- Friends of the National Institute of Dental & Craniofacial Research
- National Institute of Arthritis & Musculoskeletal & Skin Diseases Coalition
- American Association for Dental Research
- Autoimmune Association
- Research America
- Association for Accessible Medicines
- Alliance for Patient Access
- Pulmonary Hypertension & Associated Conditions
- NIH Autoimmune Disease Coordinating Committee
- Consortium for Medically Necessary Oral Health Coverage
- Childhood Sjögren’s International Working Group
The Foundation has also taken a lead role with the Foundation for the National Institutes of Health (FNIH). In addition to the AMP AIM program previously mentioned, the Foundation serves on the FNIH Biomarkers Consortium for Sjögren's and the FNIH Inflammation and Immunity Steering Committee.