The impact of a recent relapse on patient-reported outcomes in subjects with multiple sclerosis Brian C. Healy • Irene R. Degano • Ana Schreck • David Rintell • Howard Weiner • Tanuja Chitnis • Bonnie I. Glanz Accepted: 27 December 2011 / Published online: 12 January 2012 Ó Springer Science+Business Media B.V. 2012 Abstract Purpose In this study, we estimate the impact of a recent relapse on physical and mental health in subjects with relapsing-remitting multiple sclerosis (RRMS) using vali- dated patient-reported outcome (PRO) measures. Methods Subjects enrolled in the Comprehensive Longi- tudinal Investigation of MS at the Brigham and Women’s Hospital with RRMS were eligible for enrollment. Subjects with a clinical visit within 45 days of a relapse were identified and divided into groups based on whether the relapse occurred before (recent relapse) (n = 59) or after the visit (pre-relapse) (n = 31). A group of subjects with no relapses was also identified (remission) (n = 336). PRO measures in these three groups were compared. All out- comes were compared using a t test and linear regression controlling for age, disease duration, sex, and EDSS. Results Subjects with a recent relapse had significantly worse functioning on several physical and mental health scales compared to subjects in remission even after adjusting for potential confounders. Subjects with a recent relapse also showed significant deterioration on PRO measures over 1 year compared to subjects in remission (P \ 0.05 for each comparison). Subjects in the pre-relapse group were not significantly different than subjects in remission. Conclusions Clinical relapses have a measurable effect on PRO in subjects with RRMS. Keywords Clinical relapse Á Depression Á Fatigue Á Health related quality of life Á Multiple sclerosis Introduction Extensive research has focused on patient-reported outcomes (PRO) including health related quality of life (HRQOL), fatigue, and depression in patients with multiple sclerosis (MS). Previous work has demonstrated that MS patients have reduced quality of life and increased fatigue and depression compared to normal controls [1, 2] and patients with other chronic illnesses such as epilepsy and diabetes [3]. In addition, PRO have been compared in subgroups of MS patients, including those with relapsing-remitting (RR) MS, secondary progressive (SP) MS, primary progressive (PP) MS, and benign disease. In general, patients with greater disability and longer duration of disease demonstrate greater impairment on PRO measures [4–7]. HRQOL endpoints have also been used in phase III clinical trials and in post-marketing research for disease modifying therapies (DMT) for MS. Rudick et al. [8], for example, reported improvements on some dimensions of HRQOL in patients with mild disability being treated with interferon-beta. A potential influence on PRO in MS is the occurrence of a relapse. Patients with RRMS experience relapses early in the course of the disease, and these relapses often cause Electronic supplementary material The online version of this article (doi:10.1007/s11136-011-0108-0) contains supplementary material, which is available to authorized users. B. C. Healy (&) Á I. R. Degano Á A. Schreck Á D. Rintell Á H. Weiner Á T. Chitnis Á B. I. Glanz Partners Multiple Sclerosis Center, Brigham and Women’s Hospital, 6th Floor, 1 Brookline Place, Brookline, MA 02445, USA e-mail: bchealy@partners.org B. C. Healy Á D. Rintell Á H. Weiner Á T. Chitnis Á B. I. Glanz Department of Neurology, Harvard Medical School, Brookline, MA, USA B. C. Healy Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA 123 Qual Life Res (2012) 21:1677–1684 DOI 10.1007/s11136-011-0108-0