LONDON — New guidelines for the treatment of multiple sclerosis (MS) are being drawn up in both Europe and the United States, with initial drafts of both sets of guidelines having been released in the past few days.

The new European guidelines were the subject of a late-breaking news session at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016. The guidelines, which are a joint initiative of ECTRIMS and the European Academy of Neurology (EAN), are still in preparation and are hoped to be published early next year.

A draft copy of the proposed new US guidelines has been made available on the American Academy of Neurology (AAN) website for review, together with an accompanying summary version for lay stakeholders, including patients, families, and caregivers. Both AAN documents are open for feedback, with comments to be submitted by October 8.

Both sets of draft guidelines have been described as rather conservative by some MS experts.

Asked for comment by Medscape Medical News, Jeffrey Cohen, MD, Cleveland Clinic, Ohio, said, "I have not reviewed either the ECTRIMS-EAN or AAN treatment guidelines yet in detail. My initial impressions are: (1) the two guidelines are largely in agreement on key points, (2) both tried to be as evidence-based as possible and to explicitly indicate the 'quality' of the data for each recommendation, (3) both are relatively conservative and many of the recommendations seem like 'old news,' and (4) because they both attempted to be data driven and there are no data to inform many certain key issues encountered frequently, I suspect many clinicians will find them to be less helpful than hoped."

Daniel Kantor, MD, past president of the Florida Society of Neurology, added: "These guidelines are useful in that people have sat down and had discussions. But they are not useful in the sense that they don't help people select one medicine over another. In my view, the European guidelines are more in line with current thinking than the draft US guidelines. I think the US guidelines are somewhat downgrading the treatment of MS. They bring into question the treatment of CIS [clinically isolated syndrome]; they question treatment of MS in general if patients haven't had a relapse in the previous 2 years. Those aren't good reasons not to give medication."

European Guideline Highlights

Presenting an overview of the proposed European guidelines at the ECTRIMS meeting, Susana Otero, MD, MS Center of Catalonia, Spain, highlighted the following recommendations:

  • The entire spectrum of disease-modifying drugs should be prescribed only in centers that have adequate infrastructure for the comprehensive assessment of patients and the ability to detect side effects and promptly address them.

  • For patients with CIS and abnormal MRI findings, consider interferon or glatiramer acetate.

  • Offer early disease-modifying treatment to patients with active relapsing-remitting MS, defined as the presence of relapses or MRI activity.

  • The choice among the wide range of available drugs depends on patient characteristics and comorbidities, disease severity/activity, drug safety profile, and accessibility of the drug.

  • Perform regular MRI and clinical assessment to monitor disease activity, and offer more efficacious drugs to patients who show activity while receiving interferon or glatiramer acetate.

  • If a highly efficacious drug is stopped, consider another highly efficacious drug.

Dr Otero said the writing committee had decided not to make specific recommendations for specific drugs because this would depend on features of each individual patient, and there was not sufficient evidence for the drugs to be prioritized.

On whether to start with a less active or more active drug, she said, "We have left open the possibility to start with an aggressive therapy if the clinical situation justifies this in the minds of the physician."

Elaborating on this to Medscape Medical News, Xavier Montalban, MD, chair of the writing committee, added: "We didn't include any recommendations on induction therapy at this stage as there is very little evidence and these guidelines are evidence based. Our guidelines are based on the traditional escalation approach. Perhaps in second round we will include more consensus opinion in addition to evidence-based recommendations."

In response to comments that the guidelines could be considered too general, Dr Otero said, "We are not necessarily targeting MS specialists with these guidelines. They are probably directed more to the nonexpert general neurologist and in that regard they would probably be very helpful."

US Guideline Highlights

The US document notes that the last AAN guidelines on treatment of MS were issued in 2002 and only included β-interferon and glatiramer acetate. It points out that the treatment landscape has changed considerably over the past 14 years, with more than 16 medications currently approved and widely prescribed for the treatment of MS in the United States, and other agents nearing approval.

The new AAN draft guidelines review evidence from published studies on all disease-modifying treatments used in MS, and presents this for each individual drug in terms of effect on relapses, MRI lesions, disability, and adverse event–related discontinuations.

In terms of practice recommendations, the guidelines make the following points:

  • When starting treatment and selecting a drug therapy, clinicians must take into account patient preference for route of administration, lifestyle, cost, efficacy, and tolerability.

  • Clinicians should evaluate readiness or reluctance to initiate drug therapy and counsel on its importance in patients with MS who are suitable candidates.

  • For CIS, clinicians may offer disease-modifying therapy to patients with two or more brain or spinal cord lesions that have imaging characteristics consistent with MS.

  • For currently untreated patients with CIS or relapsing forms of MS who have not had relapses in 2 or more years and do not have new MRI lesion activity, the benefit of initiating therapy has not been studied. In such patients, side effects and the burden of taking a long-term medication that may not be beneficial might outweigh the potential benefit of reducing relapse rate. Therefore, clinicians may recommend serial imaging and close follow-up rather than initiating treatment in these patients.

  • Patients with relapsing forms of MS with recent clinical relapses or MRI activity should be treated and regularly monitored for adherence, tolerability, and effectiveness.

  • Few recommendations about preference of one agent over another are made. Exceptions to this are a specific recommendation against using mitoxantrone at all for MS because of safety issues and advice to prescribe alemtuzumab, fingolimod, or natalizumab for patients with very active MS. The guidelines also state that natalizumab should not be used in patients positive for JC virus antibodies.

  • MRI disease activity should be monitored periodically during the first 5 years from clinical onset, and switching drugs should be discussed in patients who have experienced one or more relapses, two or more unequivocally new MRI lesions, or increased disability over a 1-year period. Current evidence supports higher efficacy of alemtuzumab, natalizumab, and fingolimod compared with previously approved self-injectable treatments.

  • Patients with secondary progressive MS medication should stop taking drug therapy if they do not have ongoing relapses or MRI activity and have not been ambulatory (Expanded Disability Status Scale score of 7 or greater) for at least 2 years.

  • For patients with CIS who appear stable, there is a knowledge gap, and clinicians should review the risk of continuing therapy vs the risk of stopping.

Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016. Abstract 255. Presented September 17, 2016.

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