Retrospective study focused on patients who remained symptomatic despite evidence-based medicine or standard diet protocols
NEW YORK, Nov. 11, 2022 /PRNewswire/ -- Mymee, Inc., a pioneer in self-evidence-based research for people who struggle with symptoms associated with long COVID and rheumatic autoimmune diseases, announced the completion of a multi-year retrospective study designed to assess the program's impact on health-related quality of life (HRQoL) and the use of personal data to identify unique sensitivities to hidden triggers within their food and environment. The majority of patients in the study were diagnosed with Lupus (SLE), Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Mixed Connective Tissue Disease or Long COVID.
The retrospective study also included an audited value impact sub-analysis of patients taking biologic disease modifying anti-rheumatic therapies. That analysis evaluated the average economic impact of this approach as calculated by Rx savings.
In the study, patients used Mymee's self-evidence data platform to draw direct correlations between their symptoms and atypical combinations of sensitivities to their food or environment. Each patient was provided a dedicated certified health and nutrition coach with intensive training on Mymee's data platform and the special needs of rheumatic autoimmune disease and Long COVID patients managing debilitating symptoms. Patients were evaluated to determine the impact on HRQoL using clinically validated PROMIS scores across ten domains. In addition, patients completed a symptoms assessment questionnaire to evaluate 59 separate disease manifestations. Time in the program averaged 17 weeks from beginning to endpoint, with an average of 756 observations recorded per patient.
"For decades, rheumatologists have stressed that patients with significant disease activity need to be careful with fasting and elimination diets," said Mymee CEO and founder, Mette Dyhrberg. "The real-world evidence from the study reinforces why even following standard guidelines that provide benefits to the average person, can be dangerous for some patients: No two individuals in the study reported the same combination of symptoms and sensitivities. The more sensitive a patient is to their food and environment, the greater their symptoms, and the more a precision approach based on their own evidence becomes necessary."
Key study characteristics and highlights include:
- 77% of 202 patients in the study were between the ages of 35 and 64 years old and shared symptoms such as fatigue, pain, brain fog, difficulty managing symptoms, and anxiety; 78% of patients were women.
- At baseline over 93% of the Long COVID patients self-reported pains or aches in joints, over 73% reported stiffness or limitation of movement, and over 97% reported fatigue, all typical symptoms associated with rheumatic autoimmune diseases.
- Statistically significant PROMIS improvements were seen in all ten HRQoL domains assessed: fatigue, anxiety, pain interference, pain intensity, social roles, sleep disturbance, cognitive function, physical function, and ability to manage symptoms. The more severe the symptoms at baseline, the higher the average improvements at the endpoint.
- Improvements included substantial decreases in fatigue, one of the most common and hardest to treat symptoms associated with rheumatic autoimmune disease and long COVID. Study results also demonstrated a high correlation between a patient's ability to manage symptoms and pain intensity and their levels of anxiety.
- Patients used the Mymee adaptive mobile app which is continuously adjusted based on their symptoms and environment. As patients started to improve and add back activities, they continued to monitor their symptoms and exposure to potential new triggers to ensure safe reentry in real world settings.
"The findings demonstrate the power of self-evidence in helping patients with heterogeneous sensitivities improve their quality of life when RCT-based solutions fall short," said Dr. Nicole Bundy, a board-certified rheumatologist and Mymee's Medical Director, "The most important qualitative findings were the significant improvements in those patients who had tried 1-size-fits-all diet and lifestyle interventions but found no relief or got worse. The retrospective included patients who had tried the Mediterranean diet, the Autoimmune Protocol Diet or an elimination diet without benefit. The timing couldn't be better, with ACR's latest guidelines released this week encouraging rheumatologists to consider diet and other integrative interventions in treatment".
Patients enrolled in Mymee uncovered sensitivities such as sunflower seed butter, vanilla extract, cinnamon, kale, ginger, probiotics and supplements. On top of uncovering hidden triggers, the personalized solution is built to help patients identify the time delay between exposures and symptoms and the cross reactivity and dosing tolerance between different sensitivities.
Mymee decided to do the study in a real world setting to accommodate patients who often don't meet RCT inclusion criteria either because of multiple autoimmune diagnosis, comorbidities or other exclusions. Two reports from industry stakeholders in 2020 highlighted the need for research to address the huge gap in evidence-based solutions available for those who fail to reach remission or continue to progress in severity on currently available medications and diet protocols: The American College of Rheumatology released a report that 83% of patients face activity limitations, with 44% restricted or unable to work, and The Institute for Clinical and Economic Review (ICER) issued final guidance on the JAK inhibitor clinical data in pivotal Phase III randomized control trials with the headline that results may not be generalizable to patients in the real world. Since then, published studies now cite that women, who make up the majority of patients with rheumatic autoimmune diseases, respond less to biologics and experience more side effects and that 41% of patients who still have Long COVID after 12 months show rheumatic autoimmune disease biomarkers.
Study data and additional information are available upon request. To schedule a meeting at ACR Convergence, November 11 - 14, 2022, contact Mymee's Medical Director, Nicole Bundy, at [email protected]
Mymee, Inc is a pioneer in precision health for autoimmune diseases, with a clinically validated solution that allows symptomatic rheumatic autoimmune and Long COVID disease patients to use personal data to lower, predict, and better control their symptoms in the real world. Mymee combines an adaptive mobile application, a coach trigger analytics platform and highly specialized certified health and nutrition coaches. Mymee's research matched over 150 unique symptoms to over 90 unique triggers and clinically tested over 50 types of personalized interventions. Mymee also offers support through Emilyn, the #1 ranked app for individuals suffering from MS.
In 2022, Mymee joined NYCHBL's Digital Health 100 as a women's health company to watch and one of the most innovative health startups in New York. Mymee received the Platinum Award in the category of Precision Medicine from Juniper Research. Additionally, Mymee was nominated for the 2021 Annual Galien Foundation Awards and received an honorable mention in Fast Company's World Changing Ideas Awards.
For more information or to learn more about Mymee's clinical validation visit