New Real-World Evidence from Personalized Trials Calls for Rethinking the Standard of Care for Non-Responders to Autoimmune Therapies

2023-06-01

临床结果临床研究

Personalized trials help patients achieve major reductions in joint flares and concomitant Rx in 17 weeks, while delivering $11k average autoimmune biologic and targeted therapy savings per non-responder annually.

NEW YORK, June 1, 2023 /PRNewswire/ -- Today Mymee Inc, a pioneer in personalized trials & care for patients with uncontrolled autoimmune and long COVID disease flares, announced new peer-reviewed and payer-audited research that sheds light on the enormous challenges facing autoimmune patients with joint flares, >30 moderate to high frequency symptoms, and inadequate response to pharmacological treatments.

Of the 163 rheumatic patients in the personalized trial study, 73% had comorbidities and the majority were diagnosed with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lupus (SLE), MCTD, long COVID, psoriasis and IBD. 77% of patients were referred by payers and providers including Preferred One (UHC), Nielsen/WTW and Mount Sinai Hospital. Average autoimmune biologic and targeted therapy reductions reported in the study were validated through an independent analysis by a commercial insurer. The savings were based on current list prices (WAC) before rebates.

Findings explain why rheumatic patients are successfully able to reverse flares through personalized trials and care.

Tweet this

Findings explain why rheumatic patients are successfully able to reverse flares, improve quality of life and reduce medication through personalized trials & care, after evidence-based treatments and trial & error between alternative solutions fail them. Presented today at the annual IFM medical conference "Advances in Clinical Research and Innovative Practices", this research involved 121,852 patient-reported data captures and 3,391 personalized trial coach sessions delivered over an average 17 weeks. The data presented confirm:

70% of patients with moderate to severe flares as measured by 10 PROMIS® HRQoL reversed their level of severity within 17 weeks.

Mean reduction in moderate to high frequency symptoms, e.g.: joint pain (33%); fatigue (33%); limitation of movement (39%); muscle pain (40%); anxiety (41%); weakness (42%)

Patients reported working directly with their physicians to reduce 31% of immunotherapies, or 24% of biologics and DMARDs.

Non-adherence to therapy was not a driver of disease flares, with 5 average medications per patient at baseline (76% ≥ 1 immunosuppressant).

Patients cited 98% improvement in ability to work with physicians to manage symptoms.

A critical objective of the peer-reviewed study was to demonstrate the complexity that non-responders face when trying to control flares with a trial & error approach based on standard drug, supplement, nutrition & health guidelines. The visual in the peer-reviewed study highlights this complexity, showing the unique associations between diverse symptoms and combinations of exposome variables (food, drugs, supplements, excipients, allergens, pathogens, stresses, climate, etc). More than 225 symptoms and 534 triggers were tracked in patients' own words for observation and tested across the personalized trials, with correlations confirmed when modification reliably worsened or improved symptom response.

Dr. Kurt Herzer, Adjunct Professor at Johns Hopkins University and former Head of Population Health at Oscar Health, said, "Mymee's novel personalized trial & care research provides evidence that it is possible to develop new models addressing the challenges at-risk autoimmune patients face as they seek to control their flares, particularly those who are non-responders to standard therapies. It is clear industry stakeholders should take steps to improve the standard of care for this overlooked patient population."

Autoimmune drugs cost $100 billion annually, comprising 20% of total US drug costs and 54% of specialty pharmaceutical growth, attributable to only 1% of health plan members. The bigger challenge is that >65% of rheumatic patients have inadequate response to autoimmune drugs in the real world as measured by Rx and healthcare claims data. 44% of rheumatic patients face reduction or inability to work, as reported by the American College of Rheumatology 2020 Survey. These patients remain at risk of persistent, unpredictable disease flares due to unique sensitivities to their exposome.

Mymee CEO & Founder, Mette Dyhrberg said, "The great hope is one day all will have access to a therapy that allows for sustained remission for a lifetime. In the interim, this study demonstrates it's possible for personalized trials & care to help patients gain control of their flares and reclaim their health, when the standard of care fails them."

About Mymee

Mymee Inc is a pioneer in personalized trials & care for patients with uncontrolled autoimmune and long COVID disease flares. Mymee's proprietary personalized trial & care platform is clinically validated and SOC-II and HIPAA-compliant. In peer-reviewed studies, Mymee delivered statistically significant improvements in all ten HRQoL PROMIS® domains and a >40% mean reduction in 59 patient-reported symptoms. Peer-reviewed publications include Rheumatic & Musculoskeletal Disease Open Journal ('23), IFM Conf ('23 & '20), ACR Conf ('22), JMIR Lupus (SLE) Publication ('20) and IEEE conf ('20). Mymee has received industry recognition including Top 100 NY Healthcare Startups 2022 & 2023, Health 2.0 Outstanding Leadership Award: CEO & Founder 2022, Juniper Networks Awards 2022: #1 Most Innovative Precision Medicine Solution, Nominee Prix Galien Award: Digital Health, 2021, Honoree Fast Company World Changing Ideas Awards 2021.

To learn more about how Mymee is transforming autoimmune care, visit www.mymee.com or follow us on Twitter @mymeehealth.

SOURCE Mymee Inc.