Dr. Jerry Bagel discusses his research on the Mind.px machine learning-based test to predict psoriasis patient responses to biologic therapy and the potential for this test to become part of precision medicine in dermatology practice.
Jerry Bagel, MD, MS
Windsor Dermatology and The Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey, Clinical Professor of Dermatology, Mount Sinai School of Medicine, New York, New York
“Here at the Psoriasis Treatment Center of Central New Jersey we were the number one enroller in the Mindera Health Mind.px clinical trial called STAMP. What we did in the clinical trial is we utilized a dermal biomarker patch … the Mind.px, which is a transcriptome analysis test. We would put this biomarker patch on a person’s plaque of psoriasis for 5 minutes the day they started a biologic agent—either a tumor necrosis factor (TNF) inhibitor or an interleukin (IL)-17 antibody or IL-23 antibody,” said Jerry Bagel, MD, MS, who led the original research on the technology published November 2021 in Skin.1
“We would measure these plaques with the same transcriptome, which basically is measuring various amounts of RNA in each individual’s plaque over time. And we were doing it on day zero, month 1, month 2, month 3, and month 4. The endpoint was to see at week 12 which people developed a [Psoriasis Area Severity Index 75] PASI 75 response, then going backwards, looking at their transcriptome analysis….”
Once Dr. Bagel and colleagues conducted testing with the patches and had data on the transcriptomes measuring the different RNAs, they could see who responded and whether the test accurately predicted which patients would most likely respond to which biologic agent, said Dr. Bagel.
“What this all really boils down to is precision medicine, which the American Academy of Dermatology and the National Psoriasis Foundation have both stated that there is a significant need for identification of biomarkers that may guide the effort of biologic selection.”
Study Results
To that point, Dr. Bagel said that, according to the STAMP-1 and STAMP-2 studies analyzed in his paper, the Mind.px predicts 91% of the time which patients will at least develop a PASI 75 by week 12. That’s whether they’re bio-naive or bio-experienced.
“Therefore, people won’t have to keep switching [biologics] or utilizing new loading doses, which cost more money. If you get it right the first time, it’s better for the patient; it’s better for the physician; it’s better for the staff because they don’t have to get another drug approved; it’s also better for the economics of the individual and society.”
In a survey of community dermatologists asking about their biologic therapy utilization for psoriasis patients, researchers found that 82% of dermatologists switch 10% to 30% of their patients in the first year and 98% switch intra-class for at least 50% of non-responding patients.2
The observational STAMP-1 and -2 studies included 242 psoriasis patients, of which 118 were treated with IL-23 inhibitors, 79 with IL-17 inhibitors, and 35 with TNF alpha inhibitors. Positive predictive values for IL-23 inhibitors, IL-17 inhibitors, and TNF alpha inhibitors were 93.1%, 92.3%, and 85.7%, respectively, according to the paper in Skin.
False positives with the Mind.px test are a possibility, according to Dr. Bagel.
“You’re dealing with lots of different RNA. So sometimes there can be a crosslink associated with it.”
Is It Covered?
While some carriers cover the cost of the test, most don’t, yet, said Dr. Bagel.
Currently, Mindera has a pilot with a national insurance plan. For nongovernmental patients there is no cost to the patient. The company offers a financial assistance plan for those who qualify, which ranges from $0 to $150 based on income. Mindera Health also offers billing options, according to Dr. Bagel.
“Insurance companies may find that this is really a very important step to be able to predict right from the beginning who is going to respond. But not everybody is covered. Mindera is working to get people covered,” he said.
An Easy Test
The test is easy to do, both for dermatologists and their patients, said Dr. Bagel.
“Basically, the provider writes for Mind.px. It goes through [the electronic health record EMA] … and Mindera picks it up and sends somebody to the patient’s house. They apply the patch, which takes 5 minutes. The whole process takes 15 minutes. Within 2 weeks, the provider gets a report as to what percentage of the time these individual patients would respond to these three groups of drugs.”
Dr. Bagel said that since conducting the research, he has been using the test in practice and finds that younger patients are more likely to embrace the technology’s potential than older patients.
“The young patients think that precision medicine—pharmacogenetics—is the wave of the future and I think so, too.”
Candidate Considerations
Whether the Mind.px technology would work for Janus kinase (JAK) inhibitors used to treat patients with psoriasis remains a question, but Dr. Bagel said he doesn’t see why it wouldn’t be able to predict which patients would respond to which JAK inhibitor class. Still, that has not been proven in studies, he said.
Patients have to have a plaque on their skin in order to do the test. Those who are clear would not be candidates. Others who might not be good candidates for the test are those who are flaring and don’t want to wait the 2 weeks to process results, said Dr. Bagel.
“Otherwise, I think anybody that is going on a biologic agent could be considered for this test.”
The Mind.px could be a gamechanger in the treatment of psoriasis, according to Dr. Bagel. Initially, however, he didn’t think there would be a great need when he considered that in research studies biologics have been shown to work from 70% to 90% of the time in subjects.
“So, why would I need this test? Then I started thinking … that in clinical trials you get that really high efficacy with drugs because patients are very compliant. We’re utilizing patients that tend to be healthier, that don’t have as many comorbidities that might interfere in the efficacy of the drug. We don’t have as high a yield in the clinical space in response to biologics as we do in clinical trials.”
“Therefore, it behooves us to use a pharmacogenetic process if it’s inexpensive, which this is, and if it’s convenient, which this is.”
- Bagel, J., Wang, Y., Montgomery, III, P., Abaya, C.E., Andrade, E., Boyce, C., et al. A Machine Learning-Based Test for Predicting Response to Psoriasis Biologics. SKIN The Journal of Cutaneous Medicine. 2021;5(6): 621-638. https://doi.org/10.25251/skin.5.6.5.
- Strober B, Pariser D, Deren-Lewis A, Dickerson TJ, Lebwohl M, Menter A. A Survey of Community Dermatologists Reveals the Unnecessary Impact of Trial-and-Error Behavior on the Psoriasis Biologic Treatment Paradigm. Dermatol Ther (Heidelb). 2021;11(5):1851-1860. doi:10.1007/s13555-021-00573-1.
Disclosure: Dr. Bagel conducted research for Mindera Health.