Spherix Global Insights

May 04, 2019

Identifying SPMS: Are U.S. Neurologists Aligned on the Most Influential Disease and Patient Metrics?

Authors: Robert T. Naismith; Patricia K. Coyle; Shiv Saidha; Jennifer Robinson; Virginia R. Schobel

To identify disease and patient characteristics used to diagnose secondary progressive (SPMS). We hypothesized that evidence of progression independent of relapse activity (PIRA) would be the most relied upon factor, along with other markers of neurodegeneration/progression.

SPMS is a retrospective diagnosis made without formal diagnostic guidelines. Emerging SPMS therapies may work optimally in younger, less disabled patients.

In 2018, 178 neurologists in the United States (US) completed an online survey on influential metrics for diagnosing SPMS. They also submitted 323 online chart audits for recent patients they had personally diagnosed as SPMS.

Influential disability-related metrics for identifying SPMS were PIRA (78% by self-report vs. 55% of chart audit submissions), accumulation of disability/lack of improvement between relapses (54% vs 39%), decreasing walking speed (45% vs. 17%), and worsening 6-month Expanded Disability Status Scale (EDSS) score (40% vs. 16%; Fig. 2). While most disability measures were consistent between self-report and audit, decline in activities of daily living (61% vs. 18%) and increasing brain atrophy (42% vs. 9%) were more influential in theory, as compared to clinical practice (Fig. 3). Disease activity metrics were also influential including: increasing lesion burden (61% self-report, 36% chart audit) and increasing relapse rate (28% vs. 14%). Absence of relapses (48% vs. 24%) was an influential factor, and, to a lesser degree, decreasing relapses (22% vs. 11%). Age did not appear to be a major influential factor (12% vs. 8%).

U.S. neurologists commonly rely on disability-related metrics of progression to identify SPMS transition. The absence of relapses was chosen more frequently than decreasing relapses, suggesting challenges in diagnosing active SPMS. While common core concepts of disease progression were influential, multiple heterogeneous factors are relied upon to conclude an SPMS diagnosis. This is an area that would benefit from clearer guidelines for the early identification of patients with continuous disability progression.

Patricia K. Coyle received consulting fees from Accordant, Alexion, Bayer, Biogen, Celgene, Genentech/Roche, Novartis, Sanofi Genzyme, Serono, and TG Therapeutics. She has received research support from Actelion, Alkermes, Genentech/Roche, MedDay, NINDS, and Novartis.

Robert T. Naismith consults for Acorda, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, Novartis, Teva.

Shiv Saidha has received consulting fees from Medical Logix for the development of CME programs in neurology and has served on scientific advisory boards for Biogen-Idec, Genzyme, Genentech Corporation, EMD Serono & Novartis. He is the PI of investigator-initiated studies funded by Genentech Corporation and Biogen Idec, and received support from the Race to Erase MS foundation. He has received equity compensation for consulting from JuneBrain LLC, a retinal imaging device developer. He is also the site investigator of a trial sponsored by MedDay Pharmaceuticals.

Jennifer Robinson is the founder of Spherix Global Insights, an independent market intelligence firm, and has received no industry funding to conduct and report on this study.

Virginia R. Schobel is an employee of Spherix Global Insights, an independent market intelligence firm, and has received no industry funding to conduct and report on this study.


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