Patient-reported outcomes associated with transition to secondary progressive multiple sclerosis.

To investigate patient-reported outcome (PRO) measures in patients with relapsing–remitting multiple sclerosis (RRMS) who transition to secondary progressive multiple sclerosis (SPMS). Subjects enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at Brigham and Women’s Hospital (CLIMB) who completed PRO measures in the RRMS and SPMS phases were identified (n = 52). The PRO measures were Medical Outcomes Study Short-Form 36 Health Survey (SF-36), the Modified Fatigue Impact Scale (MFIS), and the Center for Epidemiologic Studies Depression Scale (CESD). Two control groups of RRMS CLIMB patients who did not progress to SPMS were identified based on different matching criteria related to age, sex, disease duration and Expanded Disability Status Scale (EDSS). Summary statistics for each PRO were calculated at the last RRMS measurement and first SPMS measurement, and the change over this transition was calculated using a paired t-test. Patients who transitioned were compared to the control groups using linear regression to adjust for age, disease duration and EDSS and a mixed model to further account for the matching with a random effect for matched group. Patients who transitioned from RRMS to SPMS had noticeable deficits in terms of Quality of Life (QOL) and fatigue at the visit prior to the transition. Patients worsened in terms of SF-36 Role Physical (− 3.6 [− 6.6, − 0.7]), Social Functioning (− 3.7 [− 6.4, − 1.0]), and Physical Component Summary (− 2.3 [− 4.5, − 0.1]) during the transition from RRMS to SPMS. When patients who transitioned were compared to the matched subjects, they had worse scores on several outcomes, including Physical Functioning (adjusted mean difference =  − 10.8 [− 14.1, − 7.5]), Physical Component Summary (− 5.2 [− 9.3, − 1.0]), fatigue (8.9 [1.7, 16.1]), and depression (3.1 [0.3, 5.9]). Patients in the period closely preceding transition from RRMS to SPMS have worse physical QOL and fatigue compared to subjects who remain RRMS.