A newly developed scoring tool enables better identification of patients with relapsing-remitting multiple sclerosis (RRMS) as well as those transitioning or already diagnosed with secondary progressive MS (SPMS).
The research about that finding, “Validation of the Scoring Algorithm for a Novel Integrative Secondary Progressive Multiple Sclerosis (SPMS) Screening Tool,” was presented at the 2019 American Academy of Neurology (AAN) Annual Meeting, held in Philadelphia May 4–10.
At onset, about 85% of MS patients are diagnosed with RRMS; but with time, most of these patients progress to a SPMS disease course. The transition mechanisms from RRMS to SPMS are not clearly understood, making a timely diagnosis of SPMS a challenge in clinical practice.
To address that need, a team from Germany, Canada, Novartis, and Adelphi Values have developed a screening tool to enable early detection of patients who have progressed, or are at risk of progressing, from RRMS to SPMS. This algorithm-based digital tool is called MS Progression Discussion Tool, or MSProDiscuss.
To create the digital tool and its scoring algorithm, scientists used qualitative research with patients and clinicians, as well as data from a large real-world observational study with 2,791 participants.
The tool was developed based on the patients’ neurological history, symptoms, disease activity, and daily life experiences in the past six months.
Aiming to establish the tool’s sensitivity and specificity to support SPMS diagnosis in clinical practice, 20 experienced neurologists in the U.S., Canada, and Germany completed a web-based version of the tool for up to 10 patients each (198 patients total; mean age of 44.8 years). These patients had a diagnosis of RRMS, SPMS, or the clinician suspected transition to SPMS.
Results showed that patients with SPMS scored higher on the MSProDiscuss tool. The mean scores for people with SPMS, those suspected to be progressing to SPMS, and those with RRMS, were 69.6, 55.2, and 38.1, respectively.
Specifically, a score of 58.85 or higher identified patients with SPMS with a 0.82 sensitivity and a 0.84 specificity. In turn, a score of 51.60 or lower identified RRMS patients with a sensitivity of 0.83 and a specificity of 0.82, while a higher threshold at 53.85 had higher sensitivity (0.89) but lower specificity (0.76).
Of note, SPMS and transitioning patients were affected more by disease symptoms, compared to RRMS patients. The most pronounced differences between RRMS and SPMS patients were in motor/ambulatory symptoms (35% vs. 94%), and balance/coordination (31% vs. 89%); followed by cognitive symptoms (18% vs. 66%), and bowel and bladder symptoms (20% vs. 65%).
Based on the results, the team concluded that “the SPMS screening tool was able to differentiate between RRMS and SPMS patients with high sensitivity and specificity, and thus also identify patients in transition.”
The team also emphasized that physicians have responded positively to the tool, which supports its implementation in clinical practice.
Tjalf Ziemssen, MD, professor at Dresden University of Technology, in Germany, and a study investigator, said in a Novartis press release: “One of the greatest challenges in MS is diagnosing the transition from RRMS to SPMS as the course of the disease is unique for every MS patient. The study results are a promising step toward having a scientifically-validated tool for clinical use that can facilitate physician-patient conversations, and ultimately help to get ahead of MS progression.”
According to Novartis, the digital tool is now in the final development stage, and is being tested in several centers in the U.S. Worldwide rollout is planned for early 2020.
“With this innovative digital tool, we aim to reimagine clinical practice for neurologists and MS patients,” Danny Bar-Zohar, MD, global head of neuroscience development at Novartis, said. “MSProDiscuss was developed in collaboration with renowned MS researchers, physicians and patients and is a testament to the Novartis commitment to improve the lives of MS patients beyond the development of drugs.”