Mavenclad quickly reduces MRI lesions in early MS

A demyelinating event occurs when myelin — the protective coating around nerve fibers — experiences damage; this status is also known as clinically isolated syndrome (CIS). According to the study, Mavenclad given at early stages of disease development might delay or even prevent progression to MS.

The study, “Early MRI Outcomes in Participants With a First Clinical Demyelinating Event at Risk of Multiple Sclerosis in the ORACLE-MS Study,” was published in Multiple Sclerosis Journal – Experimental, Translational and Clinical.

Mavenclad, a disease-modifying oral tablet developed by EMD Serono (Merck KGaA outside of the U.S. and Canada), is approved to treat relapsing forms of MS. Its efficacy has been demonstrated in several clinical trials.

One such trial, a Phase 3 study called ORACLE-MS (NCT00725985), showed that taking Mavenclad after a first clinical demyelinating event lowered the risk of conversion to clinically definite MS, meaning it delayed MS onset.

To be eligible for the study, patients had to have at least two clinically silent lesions on MRI at screening. Additional MRI scans were taken about every three months thereafter. The study lasted 96 weeks (almost two years).

“ORACLE-MS therefore provided an opportunity to evaluate temporal changes in MRI activity and onset of treatment effects on brain lesions,” the researchers wrote.

Data analysis after ORACLE-MS was completed showed that Mavenclad tablets at the approved dose of 3.5 mg/kg reduced the number of T1 lesions highlighted using gadolinium (a contrast agent) by 85.3%, and that of T2 lesions by 78.4%, compared with a placebo. (T1 and T2 refer to different methods used to generate images on MRI; T1 lesions represent areas of active, ongoing inflammation, while T2 lesions are areas where inflammation has caused damage, regardless of whether there is ongoing inflammation at the time of the scan.)

Mavenclad (at 3.5 mg/kg; one of two trial doses) also reduced the number of combined unique active lesions (lesions detected on T1 or T2, or both, avoiding double counting) by 82.2% compared with the placebo.

The reduction in lesion number was observed starting at 13 weeks after the initiation of Mavenclad (3.5 mg/kg) treatment, and low lesion counts were maintained throughout the 96-week study period.

Lesion volume was also lower in patients treated with Mavenclad (3.5 mg/kg) compared with those on a placebo. Again, the reduction in lesion volume was observed within 13 weeks after treatment initiation, and the effect was maintained throughout the entire study.

Similar results were obtained with Mavenclad tablets at the 5.25 mg/kg trial dose.

“The findings from ORACLE-MS generally provide support for the benefits of treatment intervention during early MS disease, as cladribine tablets treatment delayed or prevented MS,” the researchers wrote.

“Further study would be needed to evaluate an additional benefit of institution of therapy at presentation with [a first clinical demyelinating event], … as there was a delay between [the] presentation and the start of the treatment,” the team added.

In the ORACLE-MS study, the time between a first clinical demyelinating event and screening was up to 75 days.

Margarida Maia

Fact Checked By:
Patricia Silva PhD

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

Article published by multiplesclerosisnewstoday.com.

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Andrew Cushen

Trustee

Andrew is an independent corporate affairs and strategy consultant, working and living in Auckland. He has previously held senior positions in a number of corporate and not-for-profit entities in New Zealand.

Across his career, Andrew has worked as a funder of research projects (albeit in different areas than medicine and health), served in a number of not-for-profit governance roles, and been successful in developing and implementing collaborative funding models to extend investment in research and community programmes.

Andrew’s interest in Multiple Sclerosis stems from his father’s diagnosis with progressive MS in the early 2000s, and he is keenly interested in research, treatment and management approaches that may lessen the impact of MS on those diagnosed and their families.

Julia Howell

Trustee

Julia is a qualified nurse and midwife, with a varied career including specialising in eating disorders, primary healthcare, and management.    

Julia, in partnership with a GP, set up an outpatient clinical trials unit (Southern Clinical Trials). Under her leadership this grew into a network of 6 sites across NZ. This network merged with another one in 2021 to form PCRN, NZ’s largest clinical trials network. Julia is currently working as joint COO for PCRN.

Julia’s daughter was diagnosed with MS aged 14 and she has been intimately involved with her management over the years.

 

Jan Campbell

Trustee

Born in Ōtautahi Jan trained as a nurse in Christchurch, as a midwife in Winchester, UK and has a degree in philosophy with particular interest in healthcare and business ethics.

After working in the public health system in the UK and NZ, Jan joined Roche Pharmaceuticals based in Auckland in 1999. As a respected senior leader and Medical Director, she established a medical division over the ensuing 20 years responsible for significant investment in clinical trials in NZ, developing a top-class global medicine information service, compassionate medicine supply for kiwis in need, pharmacovigilance oversight and a team working closely with patients, specialists, MEDSAFE and PHARMAC to support the safe and appropriate use of Roche medicines.

As a retiree Jan has volunteered for Mercy Hospice in Auckland and the WBoP Museum in Katikati. Now living in Ōtepoti, Jan sits on both the MS Research Trust and MSNZ executive committees with a keen interest to ensure people with MS get a fair go in NZ.

Dr Elza Cloete

Trustee

Elza is a Neonatal Paediatrician at Christchurch Women’s Hospital. Originally from South Africa, she moved to New Zealand in 2006 and completed her specialist training in Auckland.

Subsequent to that she embarked on doctoral studies at the University of Auckland’s Liggins Institute and obtained a PhD investigating congenital heart disease in new-born babies.

Elza received the Vice-Chancellor’s award for best doctoral thesis for her research and is the author of several research publications. She moved to Christchurch in 2020 for a work opportunity in clinical practice.

Elza was diagnosed with MS in 2012 and brings a consumer perspective and research experience to the Trust.

Dr Ernie Willoughby

Trustee

Dr Willoughby has been a consultant neurologist at Auckland City Hospital (1979 to 2021 – now retired, emeritus) and clinical associate professor at Auckland University School of Medicine.

He directed the MS clinic at Auckland Hospital, has had a long association with the Auckland and NZ MS Societies, and is a member of the International Medical and Scientific Board of the MS International Federation.

Dr Brian Linehan

Independent Trustee

Dr Brian Linehan is a retired pathologist who was previously Managing Director of Medlab Hamilton.

He is currently Chairman of the Tranmere group of investment companies and a Director of a number of other private companies. In 2014, he retired after 12 years on the Council of the University of Waikato where he was Pro-Chancellor.

He is a past Chairman of the New Zealand Medical Association, past Chairman of NZMA Ethics Committee, past President and Chairman of CMAAO (Combined Medical Associations of Asia and Oceania) and past Chairman of IANZ (International Accreditation NZ).

Brian was diagnosed with MS in 2007 but is still active and mobile.

Peter Wood - JP, BCom, AGNZ, ACIS, FNZTA

Treasurer

Peter gained his commerce degree at Victoria University of Wellington and has been practising as a Chartered Accountant initially in Wellington and then in Tauranga.

Peter was a respected and trusted advisor to many businesspeople.
He is now resident in Auckland and consultants to a limited number business clients.

He has also served his community through involvement with Jaycees, Lions and Rotary clubs and a number of charitable trusts.

Peter is currently the Treasurer of Multiple Sclerosis Auckland and a trustee of the Multiple Sclerosis Auckland Trust. Peter is a Justice of the Peace and a member Governance New Zealand and is a Fellow of the NZ Trustees’ Association.

Neil Woodhams

Trustee

Neil is an independent health management consultant who has had an extensive career in health management as a senior manager or consultant to government, DHBs, primary care and community providers. 

Neil is President of MS New Zealand and a trustee of the MS Auckland Region Trust. Neil was also President of MS Auckland until he stepped down from this role mid-2020 to concentrate on his national roles.

Neil’s wife was diagnosed with MS in 1994. One of his four sons was also diagnosed in 2010.

Neil strongly believes in the objectives of the NZ Multiple Sclerosis Research Trust and has advocated for the establishment of the Trust for over 10 years.

Sir William Gallagher

Trustee

Sir William is renowned as a motivational, pragmatic and hands-on businessman in and outside of New Zealand and has a reputation both as a dynamic leader and one of NZ’s most astute businessmen.

Still very involved in the daily operation, he maintains regular contact with customers in the 130 countries in which Gallagher products are sold spending up to 150 days a year on the road representing the company and its philosophies and emphasising the ethics and integrity of his professional and personal dealings.

His achievements have been officially recognised by a string of awards, the latest to mark his commitment to enterprise and leadership skills being his Knighthood in the 2010 New Year’s Honours List. He was also the 1996 winner of the prestigious Excellence in Communication Leadership award, the first time in its history that it had been awarded outside of North America. He also received an MBE in 1987 followed by a Companion of the New Zealand Order of Merit (CNZM) in 1998.

Sir William Gallagher - KNZM, MBE. HonD

Patron

Sir William is renowned as a motivational, pragmatic and hands-on businessman in and outside of New Zealand and has a reputation both as a dynamic leader and one of NZ’s most astute businessmen.

Still very involved in the daily operation, he maintains regular contact with customers in the 130 countries in which Gallagher products are sold spending up to 150 days a year on the road representing the company and its philosophies and emphasising the ethics and integrity of his professional and personal dealings.

His achievements have been officially recognised by a string of awards, the latest to mark his commitment to enterprise and leadership skills being his Knighthood in the 2010 New Year’s Honours List. He was also the 1996 winner of the prestigious Excellence in Communication Leadership award, the first time in its history that it had been awarded outside of North America. He also received an MBE in 1987 followed by a Companion of the New Zealand Order of Merit (CNZM) in 1998.