McDonald Criteria 2017 Boost MS Diagnoses by 25%

Damian McNamara

October 23, 2018

BERLIN — In a series of remarkably similar presentations, researchers from three European countries showed that use of the 2017 McDonald criteria resulted in the diagnosis of about 25% more cases of multiple sclerosis (MS) in adults compared to the 2010 criteria.

The updated criteria also facilitated diagnosis of more children with MS — even as young as 5 years of age — according to a fourth study presented here during the same session at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2018.

Importantly, the newer criteria resulted in earlier diagnosis without sacrificing accuracy — another theme that emerged across studies comparing the sensitivity and specificity of the 2017 criteria with those of the 2010 criteria in clinical settings.

"We continue to refine our criteria, with the goal to identify more people with multiple sclerosis and to initiate treatment earlier," session comoderator Ruth Ann Marrie, MD, PhD, director of the Multiple Sclerosis Clinic and professor in the Department of Internal Medicine (Neurology) at the University of Manitoba in Canada, told Medscape Medical News. "It's also important to test new criteria in a range of populations."

The consistent message from across the studies presented here is that the 2017 McDonald criteria allow earlier treatment without a substantial risk for misdiagnosis, Marrie added.

Spanish Series

In one report, researchers compared the 2017 and 2010 McDonald criteria at time of diagnosis of a clinically isolated syndrome (CIS) among 566 people. One aim was to assess the 132 people who meet the full 2017 criteria and who experienced a second attack over a mean of 7 years and whether or not the 2010 criteria would identify them at follow-up.

Using the complete 2017 McDonald criteria at baseline, 51% of patients (23% more than would have been diagnosed using 2010 criteria) were diagnosed with MS, Georgina Arrambide, MD, PhD, a neurologist at the Center of Multiple Sclerosis of Catalonia in Barcelona, Spain, reported at ECTRIMS.

Of the entire cohort, 66% were women; the patients' mean age was 32 years. For 77% of the patients, findings on brain MRI were abnormal, and about half were found to have spinal cord involvement on imaging.

The time to progression to MS was "more or less the same, but shorter with the new criteria," Arrambide added.

The dissemination in space of lesions criterion was met by 58.8% using the 2017 criteria, compared with 54.5% using the 2010 criteria. About 32.5% of participants met the dissemination in time component on either version of the criteria.

For 59% of patients, cerebral spinal fluid samples tested positive for oligoclonal bands (OCBs). OCBs are a new component of the 2017 criteria.

After a median follow-up of 6.9 years (range, 2.7 - 10.6), 86 of the 132 patients (65%) initiated disease-modifying treatments. During that time, 68 patients (52%) had a second attack.

In addition, 97 participants (74%) fulfilled the 2010 McDonald criteria during follow-up.

News From the Netherlands

In a second study of a group of 229 participants with CIS, researchers found that 113 had experienced a second attack during a mean follow-up of 5.4 years.

This finding set the stage for comparing the 2017 revised McDonald criteria with the 2010 version by investigators in the Netherlands.

All patients had undergone baseline brain MRI scanning within 3 months of CIS diagnosis, and "patients with missing data were not excluded," Roos M. van der Vuurst de Vries, MD, Erasmus University Medical Center, Rotterdam, said at ECTRIMS. "We want to show how the criteria perform in clinical practice."

As previously reported by Medscape Medical News, the prospective, multicenter PROUD study showed that the updated 2017 McDonald criteria provide higher sensitivity, lower specificity, and about the same degree of diagnostic accuracy as the 2010 iteration.

The lower specificity without loss of accuracy suggests that, "maybe with more follow-up time, more patients will have a second attack," she added.

Compared to the 2010 criteria, use of the 2017 McDonald criteria led to 51 additional MS diagnoses, or about 28% more — "about the same amount the previous speaker mentioned," she said. The primary factor behind the additional diagnoses was presence of OCBs.

Better, According to the British

In a third analysis designed to assess performance of the 2017 McDonald criteria compared with the 2010 criteria in adults with CIS, Wallace J. Brownlee, MBChB, PhD, of the Institute of Neurology, University College London, United Kingdom, and colleagues tracked progression among 154 people entered prospectively in a database.

After a mean follow-up of almost 15 years after disease onset, 94 of the 154 patients (61%) developed clinically definitive MS.

Applying the 2017 and 2010 McDonald criteria, the investigators found that the new criteria were more sensitive for the dissemination in space for lesions, at 88%, vs 85% for the 2010 version. Specificity was the same at 73%.

With regard to dissemination in time, the revised criteria likewise demonstrated greater sensitivity, at 94%, compared to 87% with the 2010 criteria. The specificity, however, was slightly lower for the 2017 version, at 72% vs 73%. The 2017 criteria accuracy was slightly higher, at 85% vs 82% with the 2010 criteria.

Taken together, the dissemination in space and dissemination in time criteria were more sensitive with the updated criteria, at 89%, compared to 81% with the 2010 version. They also were more accurate, at 83% vs 79%. Again, the specificity was lower with the 2017 criteria, at 73% vs 75%.

The results demonstrate that 57% of patients who develop clinically definitive MS could be diagnosed at time of presentation with CIS using the McDonald 2017 criteria, vs 44% with the 2010 criteria, Brownlee said. He said the 2017 criteria "will allow for an earlier, more streamlined diagnosis of MS."

Diagnosing More Kids in the UK

The 2017 McDonald criteria again emerged superior to the 2010 version on a number of factors in a separate study of 156 children.

In this study, 94 children were diagnosed with MS during follow-up, and another 62 were diagnosed with non-MS demyelinating syndromes, reported Yael Hacohen, MBBS, DPhil, of the University College London Great Ormond Street Institute of Child Health.

A new brain lesion was found on MRI for 100% of those who developed MS, compared with 7% in the non-MS cohort.

"Another interesting finding in this cohort is that for patients with MS, irrespective of age, time to first relapse was 6 months," Hacohen said. "This is much faster than what we see in adults."

The 2017 McDonald criteria allow presence of OCBs to fulfill the dissemination in time requirement. Because of this, an additional 35 patients were diagnosed with MS using the new criteria vs the 2010 version.

Compared to the 2010 criteria, the revised criteria were associated with greater accuracy, at 94% vs 66%; higher specificity, at 79% vs 54%; and similar sensitivity, at about 94% for both.

"In general, an alternative diagnosis should be looked for in children who at CIS onset do not have evidence of intrathecal OCBs," the researchers note. "By putting together the evidence provided by previous studies carried out in adults, our finding suggests that the same criteria could be applied routinely to children at any age."

The caveat with the 2017 McDonald criteria is that the criteria should be applied to the right patients, Marrie added. They should only be used in patients "who present with typical symptoms of clinically isolated syndrome," she said.

The UK adult study was funded by the United Kingdom MS Society, the Neurological Foundation of New Zealand, and the National Institute for Health Research University College London Hospitals Biomedical Research Center. Dr Marrie, Dr van der Vuurst de Vries, Dr Brownlee, and Dr Hacohen have disclosed no relevant financial relationships. Dr Arrambide receives compensation for consulting services from Biogen-Idec; research support from Novartis; travel expenses for scientific meetings from Novartis, Roche, and Stendhal; and speaking honoraria from Sanofi-Aventis and Stendhal.

34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2018. Abstracts 139-142, presented October 11, 2018.

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