FATIGUE AS A LEADING PATIENT-REPORTED DISEASE BURDEN DRIVER ACROSS MULTIPLE SCLEROSIS SUBTYPES: A MULTINATIONAL QUALITATIVE STUDY
Author(s)
Dorsa Khazaei, MSc1, Katja Rudell, PhD2, Cécile Gousset, Pharm D3, Lita Araujo, PhD4, Nele Von Horsten, MSc5, Lisa Emrich, DMA6, Tommi Tervonen, PhD7, Guillaume Montagu, MSc3.
1Kielo Research, London, United Kingdom, 2Kielo Research, Cambridge, United Kingdom, 3Sanofi, Gentilly, France, 4Sanofi, Cambridge, MA, USA, 5Patient advocate, Pirna, Germany, 6Patient advocate, Accelerated Cure Project, Waltham, MA, USA, 7Kielo Research, Zug, Switzerland.
1Kielo Research, London, United Kingdom, 2Kielo Research, Cambridge, United Kingdom, 3Sanofi, Gentilly, France, 4Sanofi, Cambridge, MA, USA, 5Patient advocate, Pirna, Germany, 6Patient advocate, Accelerated Cure Project, Waltham, MA, USA, 7Kielo Research, Zug, Switzerland.
OBJECTIVES: While motor impairment dominates MS clinical assessments, the patient-lived burden of non-motor symptoms - particularly fatigue - remains poorly described. This qualitative study aimed to comprehensively describe how symptoms impact daily life from the patient perspective across relapsing-remitting MS (RRMS), non-relapsing secondary progressive MS (nrSPMS), and primary progressive MS (PPMS).
METHODS: Semi-structured interviews (50-90 minutes) were conducted remotely with N=45 adults across the US, UK, and Germany (15 RRMS, 15 nrSPMS, 15 PPMS; 5 per subtype per country). Interviews explored symptoms, functional impacts, and disease progression perspectives. Transcripts were coded deductively and inductively in Atlas.ti; Sankey diagrams were generated in R to represent symptom-to-impact relationships. Patient-Determined Disease Steps (PDDS) captured disability severity.
RESULTS: Participants median age: 50 years (range 30-76); 29/45 female. Mean PDDS scores: 2.9 (RRMS), 5.3 (PPMS), 5.7 (nrSPMS).
Fatigue was endorsed by 42/45 (RRMS: 15/15, nrSPMS: 14/15, PPMS: 13/15), with 23/45 reporting constant fatigue. Fatigue was ranked among the top three most bothersome symptoms by 21/45 participants, the highest proportion. Patients ranked fatigue and cognition as the second most important domains they didn’t want to worsen.
In RRMS, fatigue and cognitive difficulties spanned all life domains, impacting work productivity, physical activities, social functioning, and personal care. In nrSPMS, fatigue, cognitive difficulties, and motor functions were equally impacting. In PPMS, motor functions were the most impacting; fatigue being second.
Fatigue linked strongly to reduced home/work productivity (38/45), reduced work ability (36/45), and impaired relationships (33/45). Notably, 6/15 of RRMS participants identified fatigue as the most rapidly worsening symptom over 12 months.
CONCLUSIONS: This study establishes fatigue as one of the most impactful symptoms across all MS subtypes. It underscores the importance of fatigue as a core patient-centered outcome for clinical evaluation and therapeutic intervention. These findings support the systematic inclusion of patient-reported fatigue measures in MS drug development programs.
METHODS: Semi-structured interviews (50-90 minutes) were conducted remotely with N=45 adults across the US, UK, and Germany (15 RRMS, 15 nrSPMS, 15 PPMS; 5 per subtype per country). Interviews explored symptoms, functional impacts, and disease progression perspectives. Transcripts were coded deductively and inductively in Atlas.ti; Sankey diagrams were generated in R to represent symptom-to-impact relationships. Patient-Determined Disease Steps (PDDS) captured disability severity.
RESULTS: Participants median age: 50 years (range 30-76); 29/45 female. Mean PDDS scores: 2.9 (RRMS), 5.3 (PPMS), 5.7 (nrSPMS).
Fatigue was endorsed by 42/45 (RRMS: 15/15, nrSPMS: 14/15, PPMS: 13/15), with 23/45 reporting constant fatigue. Fatigue was ranked among the top three most bothersome symptoms by 21/45 participants, the highest proportion. Patients ranked fatigue and cognition as the second most important domains they didn’t want to worsen.
In RRMS, fatigue and cognitive difficulties spanned all life domains, impacting work productivity, physical activities, social functioning, and personal care. In nrSPMS, fatigue, cognitive difficulties, and motor functions were equally impacting. In PPMS, motor functions were the most impacting; fatigue being second.
Fatigue linked strongly to reduced home/work productivity (38/45), reduced work ability (36/45), and impaired relationships (33/45). Notably, 6/15 of RRMS participants identified fatigue as the most rapidly worsening symptom over 12 months.
CONCLUSIONS: This study establishes fatigue as one of the most impactful symptoms across all MS subtypes. It underscores the importance of fatigue as a core patient-centered outcome for clinical evaluation and therapeutic intervention. These findings support the systematic inclusion of patient-reported fatigue measures in MS drug development programs.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR235
Topic
Patient-Centered Research
Disease
Neurological Disorders, No Additional Disease & Conditions/Specialized Treatment Areas