Using the MS Clinical Course Descriptions in Clinical Practice

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1 Using the MS Clinical Course Descriptions in Clinical Practice Mark J. Tullman, MD Director of Clinical Research The MS Center for Innovations in Care Missouri Baptist Medical Center Disclosures Consultant/speaking fees: Acorda Therapeutics, Allergan, Bayer Healthcare, Biogen, Genzyme, Novartis, Questcor Teva, Research support: Acorda Therapeutics, Genzyme, Novartis, Roche

2 Consensus Points: At least annual assessment of clinical and MRI disease activity for relapsing MS At least annual clinical assessments for progressive forms of MS No consensus on optimal imaging frequency that would be beneficial for progressive MS Lublin FD et al. Neurology 2014;83: Case 1 A 32-year-old female awoke with mild blurred vision in her left eye accompanied by eye pain that was worse with eye movement She was evaluated by an ophthalmologist, diagnosed with optic neuritis, and referred to a neurologist

3 Case 1 2 years prior - tingling traveling down her spine and into her legs with neck flexion and numbness and tingling in her hands and feet x 2 weeks No other significant past medical history Exam: VA 20/80 OS, APD, and mild decreased vibratory sensation if her toes Blood work, including NMO IgG was negative Case 1

4 Case 1 LP: 1 WBC, protein 40 mg/dl, elevated IgG index and OCBs Diagnosed with RRMS. Treated with a 3-day course of intravenous methylprednisolone and her symptoms resolved Treated with glatiramer acetate Doing well one year later with no new/worsening symptoms. Exam normal with the exception of mild temporal pallor OS and decreased vibratory sensation in her feet Brain MRI - no new, enlarging, or enhancing lesions Case 1 She was still doing well 1 year later Tolerating glatiramer acetate nicely and reported rarely missing a dose No new/worsening symptoms Exam unchanged

5 Case MS Clinical Description Subtypes 2013 MS Disease Modifiers Phenotypes With full recovery from relapses Clinically Isolated Syndrome (CIS) Not active* Active* Relapsing Remitting Disease (RRMS) With sequelae / residual deficit after incomplete recovery Relapsing-Remitting Disease (RRMS) Not active* Active* *Activity : clinical relapses and/or MRI (Gd-enhancing MRI lesions; new/enlarging T2 lesions Lublin, et al. Neurology. 2014;83(3):

6 Baseline Brain MRI Lesion Number: 20-Year Clinical Status EDSS >3 EDSS lesions Patients, % Patients, % No. of Brain Lesions 0 EDSS 6 EDSS 3 Fisniku LK et al. Brain. 2008;131: Brex PA et al. N Eng J Med. 2002;346:

7 Change in Brain MRI T2 Lesion Volume Correlates with the Development of SPMS Median T2 Lesion Volume, cm Clinically isolated syndrome RRMS SPMS Time, years Fisniku LK et al. Brain. 2008;131:

8 POST HOC ANALYSIS ARR BG-12 BID 0.22, GA 0.29, P=0.10 P=0.007 BG-12 BID vs. GA for T2 lesions P value BG-12 BID vs. GA for Gd+ lesions not published Fox RJ et al. N Eng J Med 2012;367:

9 MRI Outcomes in DEFINE and ENDOSRSE Mean # of new/enlarging T2 lesions Mean # of gadoliniumenhancing lesions GA DMF GA DMF Year Year Arnold DL et al. Poster P059. Presented at the Joint ACTRIMS-ECTRIMS Meeting 2014, Boston, MA. At present, there are no evidence-based guidelines for using activity assessment for management decisions in clinical practice. Lublin FD et al. Neurology 2014;83:

10 Clinical and MRI Activity-Free: A Realistic Goal? % without disease activity in AFFIRM Placebo Natalizumab % without disease activity in CARE-MS II IFN beta-1a Alemtuzumab Hardova E et al. Lancet Neurol 2009;8: Hartung HP et al. P Presented at the AAN Annual Meeting 2013, San Diego, CA. Case 2 61-year-old male diagnosed with MS in 1991 was referred by his sister 1 st symptoms: diplopia and impaired balance x 3 weeks in 1985 Right hemiparesis in MRI and LP. Diagnosed with MS Relapsing-remitting course with incomplete recovery over the next 7 years. Symptoms included blurred vision, vertigo, and weakness

11 Case 2 Late 1990s, developed gradually progressive paraparesis and gait imbalance. Started using a walker in Treated with IFN beta-1b from Last relapse 1990s Hasn t had an MRI or seen a neurologist in > 10 years Stable for 5 years Case 2 Medications include baclofen, gabapentin, dalfampridine, and oxybutynin Examination findings include an INO on right lateral gaze, appendicular ataxia, and a spastic paraparesis Impression: SPMS. Clinically stable for 5 years. MRI activity indeterminate

12 Case MS Clinical Description Subtypes 2013 MS Disease Modifiers Phenotypes PP accumulation of disability from onset with or without temporary plateaus, minor remissions and improvements accumulation of disability from onset (PP) Active* and with progression# Disease SP PR accumulation of disability after initial relapsing course, with or without occasional relapses and minor remissions accumulation of disability from onset but clear acute clinical attacks with or without full recovery Disease (SP) accumulation of disability after initial relapsing course Active but without progression Not active but with progression Not active and without progression (stable disease) *Activity : clinical relapses and/or MRI (Gd-enhancing MRI lesions; new/enlarging T2 lesions) # progression measured by clinical evaluation at least annually Lublin, et al. Neurology. 2014;83(3):

13 Case 3 42-year-old male with PPMS referred for a 2 nd opinion regarding possible treatment with disease-modifying therapy 7-year history of gradually progressive weakness in his extremities, gait imbalance, and slurred speech More difficulty using a paint brush over the past year Started using a cane 2 years ago Walker for the past 10 months He has never had an exacerbation Treated with glatiramer acetate for 2 years followed by IFN beta-1a 44 mcg for about 2 years. IFN beta-1a was discontinued 18 months ago due to apparent lack of efficacy Case 3 Afraid to discontinue LDN in case it might be helping No prior response to dalfampridine several years ago Recently complete PT/OT Exam findings include cerebellar speech, quadriparesis, ataxic, spastic, and paretic gait MRIs 2 years ago revealed multiple non-enhancing brain and spinal cord lesions. MRIs of the brain & cervical spine were obtained

14 Case MS Clinical Description Subtypes 2013 MS Disease Modifiers Phenotypes PP accumulation of disability from onset with or without temporary plateaus, minor remissions and improvements accumulation of disability from onset (PP) Active* and with progression# Disease SP PR accumulation of disability after initial relapsing course, with or without occasional relapses and minor remissions accumulation of disability from onset but clear acute clinical attacks with or without full recovery Disease (SP) accumulation of disability after initial relapsing course Active but without progression Not active but with progression Not active and without progression (stable disease) *Activity : clinical relapses and/or MRI (Gd-enhancing MRI lesions; new/enlarging T2 lesions) # progression measured by clinical evaluation at least annually Lublin, et al. Neurology. 2014;83(3):

15 Rituximab in Primary MS Hawker K et al. Ann Neurol 2009;66: Conclusions The 2013 revisions: Provide guidance for routine clinical and MRI assessments Help to better characterize the disease course Might influence treatment decisions Properly designed studies are needed to help determine the adequacy of treatment and when therapy should be changed or discontinued

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