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New MS Criteria Aim to Simplify Diagnosis 8 MULTIPLE SCLEROSIS MAY 2011 • CLINICAL NEUROLOGY NEWS Oral Laquinimod Reduced MS New MS Criteria Relapses by 23% in Phase III Study Aim to Simplify Diagnosis BY SHERRY BOSCHERT of experimental neurology at the had MS for an average of 9 years. Scientific Institute and University of Patients underwent clinical evalua- BY KERRI WACHTER FROM THE ANNUAL MEETING OF THE Vita-Salute San Raffaele, Milan. tions every 3 months and yearly MRI AMERICAN ACADEMY OF NEUROLOGY FROM ANNALS OF NEUROLOGY Most importantly, he said in an in- exams. By the end of the study, the HONOLULU – Two years of taking terview, the laquinimod group mean number of gadolinium-en- n international panel has revised the the investigational oral drug laquin- showed 33% less brain atrophy over hanced lesions on MRI was 37% low- McDonald criteria for the diagnosis of imod reduced multiple sclerosis re- the course of the study. “That’s in- er in the laquinimod group and the Amultiple sclerosis to simplify the use of lapses and slowed progression to- teresting because most drugs fail to mean number of new T2 lesions was imaging in determining the dissemination of ward disability and brain atrophy, have an effect on this,” he said. 30% lower, compared with placebo. central nervous system lesions both in space and compared with These multi- The mean number of new T1 le- time, while preserving sensitivity and specificity. placebo, in a A parallel trial is ple benefits sions, which are characterized by The new revisions also address the applica- phase III study underway to may be tied to more severe tissue damage, was 27% bility of the criteria in non-Western Caucasian of 1,106 pa- confirm the laquinimod’s lower with the drug, compared with populations – specifically Asian and Latin Amer- tients with re- findings, and novel mecha- placebo. ican populations – and children and adolescents. lapsing-remit- results from the nism of action, Laquinimod appeared to be well The changes update the 2005 version of the ting multiple trial are expected which address- tolerated. Seventy-nine percent of criteria based on new evidence and consensus, sclerosis. in the fall of 2011. es both the dis- patients who were randomized to which “pointed to the need for their simplifica- The annual- ease’s acute in- laquinimod and 77% of patients who tion to improve their comprehension and utili- ized relapse DR. COMI flammatory were randomized to placebo finished ty and for evaluating their appropriateness in rate declined activity and the the double-blind study. populations that differ from the largely Western by 23% among patients who took accumulation of irreversible tissue Elevations of liver enzymes were Caucasian adult population from which the cri- laquinimod 0.6 mg daily in the ran- damage, he said. more common in the laquinimod teria were derived,” wrote lead author Dr. Chris domized trial, which involved 139 The results suggest that laquini- group (7%) than in the placebo group H. Polman and his coauthors (Ann. Neurol. centers in 24 countries, Dr. Giancar- mod is a “very promising” treatment, (3%), but these were transient and re- 2011;69:292-302). lo Comi and his associates reported Dr. Comi said. “In the end, what versible and did not lead to signs of In an accompanying editorial, Dr. Richard A. at the meeting. The annualized re- matters is how much damage there liver problems, Dr. Comi said. Liver Rudick agreed (Ann. Neurol. 2011;69:234-6). lapse rates were 0.304 on laquini- is to the patient and how much the enzyme elevations greater than three “The McDonald criteria were not just for clini- mod and 0.395 on placebo. drug was able to prevent that.” times the upper limit of normal oc- cal trials, but for neurologists in practice. How- The laquinimod group also Baseline characteristics of the two curred in 2% of the placebo group ever, some neurologists found the McDonald cri- showed a 36% reduction in disability groups were similar, including de- and 5% of the laquinimod group. teria complex and difficult to use in the clinic, progression, which “is quite a big mographics, clinical factors and MRI The overall rates of adverse events and even experienced MS specialists were un- thing, more than what has been re- findings. At the start of the study, were low (22% on laquinimod and certain about some aspects of the criteria.” Dr. ported” in previous drug studies, said 46% of the laquinimod group and 16% on placebo) and did not differ Rudick is the director of the Mellen Center for Dr. Comi, director of the depart- 40% of the placebo group had active significantly between the drug and Multiple Sclerosis Treatment and Research at the ment of neurology and the institute disease. Patients in both groups had placebo groups. Two patients on Cleveland Clinic. placebo died from unrelated causes, The 2010 revisions to the McDonald criteria with no deaths in the laquinimod are intended to allow a more rapid diagnosis of Drug Will Easily Find a Niche group. The laquinimod group re- MS in some instances, with equivalent or im- ported higher rates of abdominal proved specificity or sensitivity, and will clarify he results were very positive tion, so it may fit in early MS pain (5%) and back pain (16%), com- and simplify the diagnostic process with fewer Ton disease and on relapse where it may show its greater ef- pared with placebo (3% and 9%, re- required MRI examinations, according to Dr. rate reduction. These were both ficacy. spectively). Polman of the neurology department at the Free very good signs. In addition, What we’ve learned in the last In 2010, the oral medication fin- University in Amsterdam, and his coauthors. laquinimod was a relatively or 10 years – and most important of golimod (Gilenya) was approved as The International Panel on Diagnosis of MS maybe very safe medication for all – is not which drug to use, but adjunctive therapy for relapsing-re- reviewed published research related to the diag- people to take. when to treat, and to treat early, mitting MS. Concerns about in- nosis of MS and to the original and revised Mc- In contrast, some of the new- because treating early seems to creased risks for cardiac problems, Donald criteria, gathered from literature search- er agents are having difficulty be where we can see the best and immune suppression, and cancer with es of English-language publications. going through the phase III test- most effect. fingolimod were not a problem in the The panel stressed that the updated criteria ing for approval. For example, Laquinimod has a different laquinimod study, Dr. Comi said. should be applied only to patients who present one of the other agents has been mechanism of action. It seems One patient in the placebo group with a typical clinically isolated syndrome (CIS) VIEW ON THE NEWS held up in the Food and Drug to involve the signaling path- developed pericarditis. There was no suggestive of MS or symptoms consistent with Administration review because ways that are in the innate im- evidence of decreased immune func- a central nervous system (CNS) inflammatory of safety concerns. mune system. We’re learning tion on laquinimod. For example, demyelinating disease, because the development Another one that was just ap- about that now. There is going 17% on placebo on 20% on laquini- and validation of the criteria have been limited proved has risks for immune sup- to be much more to be learned mod developed herpes infection. to patients with such presentations. It also re- pression. Laquinimod does not about this drug after it’s ap- There were six cases of cancer in the mains imperative that alternative diagnoses be appear to have a risk for immune proved in terms of its mecha- placebo group and eight in the considered and excluded. suppression, yet it has efficacy in nisms of action. laquinimod group, for rates of 1.1% relapsing-remitting MS. and 1.5%, respectively. Neuromyelitis Optica and Spectrum Disorders Many patients who will toler- SCOTT S. ZAMVIL, M.D., is A parallel trial is underway to con- The panel focused on the differential diagnosis ate one drug will not tolerate an- professor of neurology at the firm the findings, and results from for MS of neuromyelitis optica (NMO) and other drug, so it will be very University of California, San that trial are expected in the fall of NMO spectrum disorders, because “there is in- easy to find a niche for this par- Francisco. He was not associated 2011, he said. creasing evidence of relapsing CNS demyeli- ticular drug. with the laquinimod study. He has Teva Pharmaceuticals, which is de- nating disease characterized by involvement of Most patients don’t want an in- been a consultant for Teva veloping laquinimod, funded the optic nerves (unilateral or bilateral optic neuri- jectable therapy. On the other Pharmaceuticals, Biogen Idec, and study. Dr. Comi has received com- tis), often severe myelopathy with MRI evidence hand, we have to recognize that Serono. In addition, Dr. Zamvil pensation from Teva, Novartis, Sanofi- of longitudinally extensive spinal cord lesions, even an oral medication can pose has received grant support or Aventis, Merck Serono, and Bayer often normal brain MRI (or with abnormalities some risks. Laquinimod does not served on data safety monitoring Schering Pharma. Some of his asso- atypical for MS), and serum aquaporin-4 (AQP4) seem to have any of those risks, boards for multiple drug ciates in the study reported relation- autoantibodies.” but it causes immune modula- companies. ships with Teva and other companies The panel agreed that this phenotype should manufacturing drugs for MS.
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