First ANZ guidelines launched in multiple sclerosis

The first consensus statement for managing multiple sclerosis (MS) in Australia and New Zealand has been released, offering healthcare professionals critical guidance in an increasingly complex treatment landscape shaped by a surge in innovative therapies.

Led by Monash University, the consensus recommendations (part 1, part 2) address the unique challenges faced by 39,000 people living with this chronic neurological condition. While there is no cure, disease-modifying therapies (DMTs) have the potential to reduce relapses and slow disability progression.

Senior author Associate Professor Mastura Monif, neurologist and researcher from the Monash University School of Translational Medicine and head of Alfred Health’s Neuroimmunology Service, highlighted the need for updated, locally relevant guidance.

“New disease-modifying therapies are more effective and better tolerated,” Associate Professor Monif said. “But it’s a much more complex treatment landscape than it was 20 years ago, and there is new evidence being generated all the time on many aspects of the disease. It is really important that the approach used is focused on both the effectiveness and safety for the individual so they can get the best possible outcome.”

Although the Therapeutic Goods Administration (TGA) adopted an international MS guideline in 2009, last updated in 2015, the newly developed consensus statement provides recommendations tailored to local practices and available therapies.

The consensus recommendations outline the 14 DMTs currently available through the Pharmaceutical Benefits Scheme (PBS) and the eight listed on the New Zealand Pharmaceutical Schedule, detailing the efficacy, safety, and monitoring considerations of each therapy.

For relapsing-remitting MS (RRMS), which affects 85% of people with the disease, high-efficacy therapies such as Biogen’s Tysabri (natalizumab), Roche’s Ocrevus (ocrelizumab), Novartis’ Kesimpta (ofatumumab), and Merck’s Mavenclad (cladribine) are generally favoured as first-line treatments.

A recent Cochrane review reinforced the efficacy of certain DMTs, concluding with ‘high’ confidence that “two‐year treatment with natalizumab, cladribine, or alemtuzumab decreases relapses more than with other DMTs.”

However, the ANZ consensus recommendations underscores the importance of weighing risks and benefits, particularly with Tysabri (natalizumab). It advises that before initiating and throughout treatment, clinicians should discuss the risk of progressive multifocal leukoencephalopathy (PML) and conduct anti-JCV antibody testing every six months.

Safety considerations extend to sphingosine‐1‐phosphate (S1P) inhibitors, such as BMS’ Zeposia (ozanimod) and Novartis’ Mayzent (siponimod), which may be linked to a higher incidence of cutaneous malignancies, particularly basal cell carcinoma, necessitating at least annual skin checks for patients using these MS therapies.

Additionally, for women on moderate to high-efficacy DMTs who have not tested positive for an oncogenic human papillomavirus (HPV) type, the guidelines recommend cervical cancer screening every three years instead of five.

Co-author Associate Professor Douglas Johnson, Head of General Medicine and Infectious Disease Physician at the Royal Melbourne Hospital, highlighted the need for vigilance in managing infection risks.

“Patients and their specialists should be aware of the potential infectious complications related to MS disease-modifying therapy and the appropriate treatment or referral pathways,” Associate Professor Johnson said.

MS Australia CEO Rohan Greenland welcomed the guidelines, emphasising their value in clinical decision-making.

“The new guidelines will be an invaluable resource, especially for generalist clinicians navigating this rapidly evolving field. They provide a clear and ready reference to best-practice evidence and expert consensus – an important milestone in MS care in Australia.”

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