Patient-reported outcomes are the strongest predictors of disease disability in intramuscular interferon ß-1a users.

Introduction: Patient-reported outcomes (PROs) are valuable measures for routine clinical care of people with multiple sclerosis (pwMS). Materials: 646 pwMS treated with interferon-ß-1a (IFN-ß-1a) were retrospectively included from the New York State Multiple Sclerosis Consortium. Clinical and PRO data at enrollment and 3 year follow-up were collected. PwMS with stable disease and disability worsening were matched (1:1) based on age, Expanded Disability Status Scale (EDSS) scores and disease duration. Disability worsening was determined based on trial criteria. Results: PwMS with future EDSS worsening had higher baseline and follow-up timed-25-foot walk (6.6 vs 5.5 s; 9.1 vs 5.5 s; p < 0.001) when compared with stable pwMS. Worsening pwMS reported higher baseline difficulties in getting up (odds ratio [OR] = 2.4; p = 0.009), climbing stairs (OR = 1.6; p = 0.024) and standing (OR = 2.2; p < 0.001). Worsening pwMS reported greater lower limb limitations (OR = 2.3; p = 0.004) and fatigue (OR = 1.8; p = 0.002). Conclusion: Higher fatigue and lower limb functional limitations are significant predictors of future disability worsening in pwMS.

A large retrospective study was carried out on people with multiple sclerosis (PwMS) being treated with intramuscular interferon-ß medication from the New York State Multiple Sclerosis Consortium. The aim of the study was to look at whether patient-reported and clinical measures could be used early on to predict whether PwMS have worsening of their disease. The study demonstrated that patient-reported levels of limitations in multiple physical and mental symptoms can predict future worsening in objectively quantified disability in PwMS who take intramuscular interferon-ß medication. Reported limitations in lower extremities and fatigue were the most predictive of future disability worsening.

A prospective study to validate the expanded timed get-up-and-go in a population with multiple sclerosis.

Background: Timed 25-foot walk (T25FW) test serves as gold standard in care of persons with multiple sclerosis (PwMS) and as walking measure of regulatory trials. Objective: To validate and determine the clinical utility of Expanded Timed Get-Up and Go (ETGUG) as a disability measure in MS. Methods: ETGUG intra-rater and inter-rater reproducibility was determined in 65 PwMS that were examined twice in two centres over 1-week. Values below the 5th and above the 95th percentile were considered minimally detectable change. A longitudinal cohort (32.4 months) of 145 PwMS from New York State MS Consortium (NYSMSC) was used for clinical validation as a predictor of disability worsening measured by Expanded Disability Status Scale (EDSS). Results: ETGUG and T25FW had noteworthy intra-rater and inter-rater reproducibility (Cronbach coefficient>0.949). One-week ETGUG difference ranged from 15.07% to -14.84% (5th and 95th percentile). Over the NYSMSC follow-up, PwMS had significant slowing in walking as measured by ETGUG (20.8 to 25.9s, p = 0.009) but not by T25FW. 15% ETGUG worsening had similar ability to predict EDSS worsening when compared to 20% T25FW worsening (AUC 0.596 vs. 0.552). Conclusion: Over 32-month follow-up, PwMS experience slowing in ETGUG walking time but not in T25FW. Although the scoring may be more challenging, ETGUG could be more sensitive to change and provide more comprehensive measure of lower extremity performance and ambulation in PwMS.