The 9-Hole Peg Test (9-HPT) Has a Stronger Correlation than the Expanded Disability Status Scale (EDSS) with Patient-Reported Upper Extremity Impairment As Assessed Using ABILHAND in Patients with Secondary Progressive Multiple Sclerosis (SPMS): Analysis of Baseline Data from the ASCEND Study (P7.222)

OBJECTIVE: To determine if the 9HPT and the EDSS correlate with measures of upper extremity (UE) impairment by employing patient-reported outcomes of activities of daily living (ADLs) from the ABILHAND instrument using baseline data from the ASCEND study of SPMS. BACKGROUND: UE dysfunction is a clinically important aspect of MS disability. However, research into which outcome measures of UE function optimally capture clinically meaningful impairment has been limited. DESIGN/METHODS: ASCEND is an ongoing, phase 3b, randomized, double-blind, placebo-controlled study evaluating natalizumab treatment in patients with SPMS. The primary endpoint is a composite of the EDSS, the Timed 25-Foot Walk, and the 9HPT. All patients also completed the ABILHAND questionnaire assessing ability to perform everyday manual activities, with 56 items scored on a 3-level response scale: 0=impossible; 1=difficult; 2=easy. Spearman’s rank correlation coefficient (rho) was used to calculate pairwise correlations between ABILHAND scores, EDSS scores, and 9HPT times (dominant and nondominant hand) using blinded pretreatment (baseline) data. RESULTS: Among the 889 patients enrolled, mean baseline EDSS score was 5.6. In the overall population at baseline, mean (median [range]) 9HPT times were 34.86 (28.55 [15.0-300.0]) and 37.15 (29.55 [15.5-426.2]) seconds for the dominant and nondominant hands, respectively. Baseline mean total ABILHAND score was 83.60 (median [range]: 88.39 [27.7-100.0]). Total ABILHAND scores were moderately correlated with 9HPT times (rho: dominant hand, −0.47; nondominant hand, −0.37), and weakly correlated with EDSS scores (rho: −0.27). CONCLUSIONS: The 9HPT has a stronger correlation than the EDSS with patient-reported impairment in UE-dependent ADLs, as assessed by ABILHAND. These results indicate that the EDSS provides only a limited measure of UE function and support the current use of the 9HPT as one of the primary efficacy measures in ASCEND to better assess treatment effects on UE impairment in SPMS. Study Supported by: Biogen Idec. Disclosure: Dr. Mikol has received personal compensation for activities with Biogen Idec as an employee. Dr. Goldman has received personal compensation for activities with Concert Pharmaceuticals. Dr. Hartung has holds stock and/or stock options from Opexa Therapeutics. Dr. Havrdova has received research support from the Czech Ministries of Education and Health. Dr. Jeffery has received personal compensation for activities with Bayer Pharmaceuticals, Biogen Idec, Teva, Serono, Acorda Therapeutics, Novartis, Genzyme, Genentech, GlaxoSmithKline, and Questcor Diagnostics as a speaker and/or consultant. Dr. Kapoor received personal compensation for activities with Biogen Idec, Novartis, Genzyme, and Teva. Dr. Miller has received research support for participation in clinical trials from Acorda, Biogen Idec, Genentech, Genzyme/sanofi-aventis, Novartis, Questcor, and Roche. Dr. Sellebjerg has received personal compensation for activities with Biogen Idec, Novartis, Merck & Co., Inc., Teva Neuroscience, Genzyme Corporation as a consultant. Dr. Chen has received personal compensation for activities with Biogen Idec as an employee. Dr. Watson has received personal compensation for activities with Biogen Idec as an employee. Dr. Cadavid has received personal compensation for activities with Biogen Idec as an employee.