Exhausting.

It’s a common word used by the 23.5 million Americans living with autoimmune diseases, like lupus and multiple sclerosis, to describe their experience. It’s exhausting to deal with the comings and goings of symptoms, seemingly at random. It’s exhausting to take medications with plenty of side effects but limited effectiveness. It’s exhausting to deal with a hospital bill while feeling like another trip to the emergency room is inevitable. The list goes on…

Overcoming these challenges, as a patient and as a company, is no small feat. Autoimmune diseases have complex etiologies and extreme heterogeneity among patients. This slows the identification and validation of new interventions. 9 years ago, Benlysta was approved for the treatment of lupus. It was the first new lupus medication approved in over 50 years.

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The 5 Key Elements of Healthcare

Quite simply, healthcare is the (1) delivery of (2) statistically-proven interventions based on (3) validated measures by an (4) expert. All of these elements are in support of, and working alongside, the (5) patient.

Progentec is using new science and developing technologies to improve all 5 elements. In doing so, we will lighten the load for people living with autoimmune diseases and improve outcomes.

It all starts with validated measures.

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Validated measures support proactive decision making regarding treatments. The lack of current lupus measures put clinicians on the defensive.

Accurate, repeatable measurements are essential to health. They are used in every step of the process from measuring the effectiveness of new treatments in clinical trials to diagnosing patients and determining the most appropriate course of action.

There are many types of well-know health measures. When you visit the doctor, a medical assistant will typically “room” you which includes measuring your vital signs: body temperature, blood pressure, pulse, and breathing rate. Vital signs provide insight into heart health and can prepare a doctor to discuss common health problems like hypertension and high blood pressure.

People with type II diabetes are familiar with the A1C, a laboratory test that measures blood sugar levels. A1C results support a doctor’s diagnosis and treatment plan.

But, for autoimmune diseases, few objective measurements exist. Clinicians rely on scoring rubrics that include a combination of lab values and doctor-rated symptoms to measure lupus disease activity. Because of this, patients’ disease activity can be influenced by non-health factors like their doctor’s experience treating lupus (SLE).

Patient have little insight into how those assessments are used. In a LupusCorner survey, 78% of people with lupus did not know how their treatment team measured lupus disease activity. Even for patients being tracked with SLEDAI or other rubric-based tools, the value may be limited. Lupus disease activity can change rapidly. Triggers, like ultraviolet light exposure, stress, and diet can launch a disease flare.

Lupus flares are critical care moments. Not only do they drive high use of health services, they are periods of increased inflammation and progressive, irreversible organ damage. Plus, most people feel incredibly fatigued during flares. Flares interrupt life, making it hard for a person to hold a job or even perform activities of daily living. It’s no wonder that the unpredictability of flares is the #1 challenge for people with lupus.

When it comes to diagnosing lupus, it doesn’t get any better for patients. Today, patients provide clinicians with their medical and family history plus a log of their symptoms. The rheumatologist may order an antinuclear antibody test (ANA), but this test is neither conclusive nor consistent over time. (The ANA and other blood tests were added as comments by the people reporting “Other” in the graph above.)

As a result, it takes nearly 6 years on average to be diagnosed with lupus. And, 35% of patients had to see 6 or more doctors before being properly diagnosed. All the while, they experience a range of symptoms and progressive organ damage.

Progentec’s next-gen lupus measures are multifaceted. Biomarker-based laboratory tests elucidate previously unmeasured changes in the body and digital biomarkers capture variation between clinic visits.

As was the case for other therapeutic areas, developing validated measures is an essential step towards improving health outcomes for patients. Progentec is finalizing the validation of 3 new laboratory tests. The tests have been developed with support from expert lupus researchers, Dr. Judith James and Dr. Melissa Munroe, of the Oklahoma Medical Research Foundation (OMRF), a NIH Autoimmunity Center of Excellence.

These laboratory tests are now possible thanks to increased understanding of immune system signaling pathways, cytokine involvement, and artificial intelligence (AI).

• aiSLE DX Flare Prediction Test (expected availability Q2 2020)
• aiSLE DX Disease Classification Test (expected availability Q3 2020)
• aiSLE DX Disease Activity Test (expected availability Q1 2021)

Additionally, Progentec has launched studies using patient-reported outcomes (PROs) and digital data sources to measure and predict changes in lupus disease activity. Digital data sources include:

• Activity, sleep, and heart rate data gathered via a Withings Steel HR smartwatch
• Heart rate variability recorded using just the flashlight and camera of a smartphone
• Assessment surveys

Launched April 29, 2020, the OASIS Study lets people with lupus contribute to research without leaving home or changing their treatment plan.

“OASIS is a 100% remote clinical research study. Participants can sign up online and complete the study without ever visiting a clinician,”

Eldon Jupe, Ph.D., the Principal Investigator for the study and the Chief Research Officer at Progentec.

The OASIS study is the continuation of efforts to develop digital biomarkers. Similar to the aiSLE DX suite of laboratory tests, digital biomarkers provide clinically-validated insight into changes in disease activity. Used together, the laboratory tests and digital technologies provide lupus patients and their clinicians the data needed to diagnose lupus, pick the optimal treatment plan, and make proactive changes before lupus flares.

Join us on our journey.

Healthcare is a collaborative process. From research to care delivery, we work together to share what works and what doesn’t.

Keep up with Progentec here and on our website: www.progentec.com

We’ll be sharing:

• Sharable technologies, including our 21 CFR Part 11-compliant research app
• Data insights from our apps and patient communities
• Problems we overcome and challenges that we face

Thoughts? Questions? You can email us: info@progentec.com

The Pathway to Better Autoimmune Disease Outcomes was originally published in Progentec on Medium, where people are continuing the conversation by highlighting and responding to this story.