Patient Reported Outcomes in Primary Progressive Multiple Sclerosis

Background: Primary progressive multiple sclerosis (PPMS) makes up about 10% of the total MS population. Although patient reported outcomes (PROs) have been examined in the general MS population, less is known about PROs in PPMS patients. In addition, little is known about how PROs compare in PPMS and relapsing-onset MS.

Objectives: To examine PRO measures of health-related quality of life, depression, fatigue, and anxiety in PPMS, and to compare PROs in PPMS and relapsing-onset MS.

Methods: Subjects were selected from the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women’s Hospital, Partners MS Center (CLIMB). The CLIMB study is an ongoing prospective observational cohort study that began enrolling subjects in 2000. CLIMB participants undergo neurological examinations and EDSS ratings annually. A subgroup of participants completes PRO measures annually including the Medical Outcomes Survey Short Form 36 (SF-36), Center for Epidemiological Studies Depression Rating Scale (CES-D), Modified Fatigue Impact Scale (MFIS) and State-Trait Anxiety Inventory (STAI). For the SF-36, the mental composite (MCS) and physical composite (PCS) scores were used.  STAI measures of state and trait anxiety were also included. Twenty five patients were classified as PPMS.  A group of 418 study patients classified as relapsing-onset were used for comparison and consisted of both relapsing-remitting (n=368) and secondary progressive (n=50) patients. PRO data were compared in the PPMS and relapsing-onset cohorts using linear regression to adjust for EDSS score, age and gender.

Results: PPMS patients had a mean (SD) age of 58.9 (8.2) and 52% of the group was male.  As expected, the PPMS patients were older, more likely to be male and more disabled than the relapsing-onset patients (p<0.005 for each comparison).  In terms of PROs, PPMS patients had mean (SD) scores of 52.5 (9.8) on the MCS of the SF-36, 34.1 (10.4) on the PCS of the SF-36, 29.1 (6.8) on the CES-D, 33.5 (19.0) on the MFIS, 32.2 (11.4) on the STAI-state, and 33.5 (10.7) on the STAI-trait.  Although reported scores were worse in the PPMS than relapsing-onset cohorts on each of the PROs, the differences between the groups were not statistically significant after adjusting for EDSS, age and gender.

Conclusions: There were no significant differences between PPMS and relapsing-onset patients in terms of health-related quality of life, depression, fatigue or anxiety.