There is need for a brief but comprehensive objective assessment tool to help clinicians evaluate relapse symptoms in patients with multiple sclerosis (MS) and their impact on daily functioning, as well as response to treatment. The 2-part Assessing Relapse in Multiple Sclerosis (ARMS) questionnaire was developed to achieve these aims. Part 1 consists of 7 questions that evaluate relapse symptoms, impact on activities of daily living (ADL), overall functioning, and response to treatment for previous relapses. Part 2 consists of 7 questions that evaluate treatment response in terms of symptom relief, functioning, and tolerability. The ARMS questionnaire has been evaluated in 103 patients with MS. The most commonly reported relapse symptoms were numbness/tingling (67%), fatigue (58%), and leg/foot weakness (55%). Over half of patients reported that ADL or overall functioning were affected very much (47%) or severely (11%) by relapses. Prescribed treatments for relapses included intravenous and/or oral corticosteroids (87%) and adrenocorticotropic hormone (13%). Nearly half of patients reported that their symptoms were very much (33%) or completely resolved (16%) following treatment. The most commonly reported adverse events were sleep disturbance (45%), mood changes (33%), weight gain (29%), and increased appetite (26%). Systematic assessment of relapses and response to relapse treatment may help clinicians to optimize outcomes for MS patients. 1. Introduction Multiple sclerosis (MS), particularly relapsing remitting MS (RRMS), the most common form of the disease, is characterized by relapses [1, 2]. These events vary considerably with respect to both the type and severity of symptoms [3, 4]. Relapses are cardinal events for patients with MS. They are associated with significant disability and increased cost of care; and they may result in residual deficits after resolution of the acute event [1–5]. Although relapses can be expected to resolve over time without intervention [2], treatment with high-dose corticosteroids or adrenocorticotropic hormone (ACTH) (e.g., H.P. Acthar Gel, repository corticotropin injection; Questcor Pharmaceuticals, Inc., Hayward, CA, USA) can shorten the time to recovery [6]. Assessment tools, such as the Expanded Disability Status Scale (EDSS) [7] and Multiple Sclerosis Functional Composite (MSFC) [8], have been developed to evaluate the status of patients and disease progression in MS patients not experiencing relapses. There is also need for a tool to facilitate identification of relapses, determination of symptom severity,
References
[1]
W. I. McDonald and M. A. Ron, “Multiple sclerosis: the disease and its manifestations,” Philosophical Transactions of the Royal Society B, vol. 354, no. 1390, pp. 1615–1622, 1999.
[2]
S. M. Leary, B. Porter, and A. J. Thompson, “Multiple sclerosis: diagnosis and the management of acute relapses,” Postgraduate Medical Journal, vol. 81, no. 955, pp. 302–308, 2005.
[3]
E. M. Mowry, M. Pesic, B. Grimes, S. Deen, P. Bacchetti, and E. Waubant, “Demyelinating events in early multiple sclerosis have inherent severity and recovery,” Neurology, vol. 72, no. 7, pp. 602–608, 2009.
[4]
M. A. Oleen-Burkey, J. Castelli-Haley, M. J. Lage, and K. P. Johnson, “Burden of a multiple sclerosis relapse: the patient's rerspective,” Patient, vol. 5, no. 1, pp. 57–569, 2012.
[5]
E. Leray, J. Yaouanq, E. Le Page et al., “Evidence for a two-stage disability progression in multiple sclerosis,” Brain, vol. 133, no. 7, pp. 1900–1913, 2010.
[6]
G. Filippini, F. Brusaferri, W. A. Sibley et al., “Corticosteroids or ACTH for acute exacerbations in multiple sclerosis,” Cochrane Database of Systematic Reviews, no. 4, Article ID CD001331, 2000.
[7]
J. F. Kurtzke, “Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS),” Neurology, vol. 33, no. 11, pp. 1444–1452, 1983.
[8]
R. A. Rudick, G. Cutter, and S. Reingold, “The Multiple Sclerosis Functional Composite: a new clinical outcome measure for multiple sclerosis trials,” Multiple Sclerosis, vol. 8, no. 5, pp. 359–365, 2002.
[9]
M. Nickerson and R. M. Marrie, “Intravenous and oral steroids may be insufficient for treating relapses in a significant proportion of patients with multiple sclerosis: patient experiences collected by NARCOMS,” Multiple Sclerosis Journal, vol. 17, no. 10, supplement, p. S446, 2011.
[10]
A. P. Ross, J. Halper, and C. J. Harris, “Assessing relapses and response to relapse treatment in patients with multiple sclerosis: a nursing perspective,” International Journal of MS Care, vol. 14, no. 3, pp. 148–159, 2012.
[11]
L. J. Cronbach, “Coefficient alpha and the internal structure of tests,” Psychometrika, vol. 16, no. 3, pp. 297–334, 1951.
[12]
N. M. Milligan, R. Newcombe, and D. A. S. Compston, “A double-blind controlled trial of high dose methylprednisolone in patients with multiple sclerosis: 1. Clinical effects,” Journal of Neurology Neurosurgery and Psychiatry, vol. 50, no. 5, pp. 511–516, 1987.
[13]
F. Sellebjerg, D. Barnes, G. Filippini et al., “EFNS guideline on treatment of multiple sclerosis relapses: report of an EFNS task force on treatment of multiple sclerosis relapses,” European Journal of Neurology, vol. 12, no. 12, pp. 939–946, 2005.
[14]
E. Sarnes, L. Crofford, M. Watson, G. Dennis, H. Kan, and D. Bass, “Incidence and US costs of corticosteroid-associated adverse events: a systematic literature review,” Clinical Therapeutics, vol. 33, no. 10, pp. 1413–1432, 2011.
[15]
National Clinical Advisory Board of the National Multiple Sclerosis Society, Recommendations Regarding Corticosteroids in the Management of Multiple Sclerosis, National Multiple Sclerosis Society, New York, NY, USA, 2008.
[16]
T. Patzold, M. Schwengelbeck, L. M. Ossege, J. P. Malin, and E. Sindern, “Changes of the MS functional composite and EDSS during and after treatment of relapses with methylprednisolone in patients with multiple sclerosis,” Acta Neurologica Scandinavica, vol. 105, no. 3, pp. 164–168, 2002.
[17]
B. C. Healy, I. R. Degano, A. Schreck, et al., “The impact of a recent relapse on patient-reported outcomes in subjects with multiple sclerosis,” Quality of Life Research, vol. 21, no. 10, pp. 1677–1684, 2012.
