Roche (Malaysia) Sdn. Bhd. recently announced the availability of OCREVUS® in Malaysia, a twice-yearly convenient dosing option for the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Multiple sclerosis (MS) is a neurological condition that affects the brain and spinal cord (the central nervous system) which control all bodily functions. MS damages the coating that protects the nerves or known as myelin. This loss of myelin or demyelination disrupts the ability of the nerves to conduct electrical impulses to and from the brain¹
As a result, people with MS can experience a varying range of symptoms. Rarely are two patients’ symptoms alike and symptoms can range from mild to debilitating. Symptoms can include blurred vision, dizziness, fatigue, numbness and tingling, muscle spasm, stiffness and limb weakness, mobility issues, speech difficulties, vertigo, pain,bowel or bladder problems and difficulty in swallowing¹.
As of 2020, MS affects 2.8 million people worldwide². This equates to 1 in 3,000 people in the world living with MS¹. A higher prevalence is recorded in North America, Europe, and parts of Australia with as many as 1 in every 300 people having MS¹.
Although the prevalence of MS is lower in Asia¹, symptoms suffered by patients are no less severe than those in the West. In Malaysia, it is listed as a rare disease³ with an estimated prevalence of 6 per 100,000 population⁴.
OCREVUS® - Slowing Progression and Suppressing Relapses
Administered by intravenous infusion every six months, OCREVUS® has shown sustained high-efficacy to slow disease progression, thus positively impacting the quality of life of MS patients.⁵
Data shows that 8 out of 10 RMS patients are progression-free of their condition after 10 years.⁶
Speaking at the OCREVUS® launch, Deepti Saraf, General Manager of Roche (Malaysia) Sdn. Bhd., said, “MS may be a rare disease but there is an urgent unmet need to improve the diagnosis, treatment and management of MS. Women account for 83% of the MS incidence in Malaysia⁷. It is our hope that women will not have to go through this debilitating condition which undoubtedly impacts their future as well as their roles in society.
“Therefore, it was crucial for Roche to deploy a highly efficacious & efficient treatment early in the disease course, aiming to halt progression, while offering the added benefit of dosing convenience of only twice yearly.
“Furthermore, our Roche Patient Assistance Program helps alleviate the financial burden for patients, ensuring patients can access the necessary treatments and medications they need, ultimately empowering them to prioritize their health and well-being,” continued Deepti.
Understanding MS
According to Dr Low Soon Chai, a Consultant Neurologist, “Multiple sclerosis is a life-long incurable condition. It is five times more common in women than in men⁸.”
“The disease is highly unpredictable. For some, it means going through phases of getting better (remission) and then experiencing setbacks (relapse), while for others, it follows a continuous worsening over time. Nonetheless, people with all forms of MS experience disease activity such as inflammation in the nervous system and permanent loss of nerve cells in the brain, even when their clinical symptoms aren’t apparent or don’t appear to be getting worse.”
“The important goal when treating MS is to reduce disease activity as soon as possible to slow down the disability progression. If not well managed, individuals with severe multiple sclerosis may develop irreversible or complete disability,” Dr Low added.
Explaining the different types of MS, Dr Chey Shin Yee, a Consultant Neurologist, said, “MS includes individuals with relapsing-remitting MS (RRMS), which is the most common type. People with RRMS experience episodes of relapses of neurological symptoms, followed by periods of improvement or remission. An episode can last for days or weeks and recovery could take weeks or months, depending on the symptoms, with some patients never recovering fully from their symptoms.”
“Over time, some individuals with RRMS may transition to secondary progressive MS (SPMS), where there is a gradual worsening of neurological function and disability accumulation, even without relapses. This transition typically occurs after many years of living with RRMS.”
“Primary progressive multiple sclerosis (PPMS) is a rarer form of MS. Unlike relapsing-remitting MS (RRMS), where individuals experience episodes of worsening symptoms followed by periods of remission, PPMS is characterized by a steady worsening of symptoms from the beginning, without distinct relapses or remissions. People with advanced MS may have to rely on mobility aids or become wheelchair bound, and are unable to work and need carers to look after them sooner,” Dr. Chey added.
Dr Low and Dr Chey emphasized the importance to consult neurologists when experiencing symptoms suggestive of MS for an accurate diagnosis and to rule out other neurological conditions that may mimic MS.
En. Rizal Aminuddin, President of Multiple Sclerosis Society of Malaysia (MSSM) and a caregiver, said, “We are indeed pleased that Roche is collaborating with us to enhance national awareness for early intervention, treatment and management to avoid progression of this debilitating disease.”
“MSSM believes in a holistic and innovative approach to MS treatment. We continually advocate for new medicines to be made available to patients and for general practitioners to be trained on MS so they can also help detect MS early and channel patients to the right specialists for follow-up treatment.”
“I also speak from experience as a MS caregiver when I share that the journey a patient goes through can be quite traumatic if they are not channeled to the right treatment and medical support early,” he added.
En. Rizal, whose wife has been an MS patient since 2011, expressed his appreciation to Roche Malaysia for supporting patients by providing a patient assistance programme that enables patients to gain access to treatments that provide better outcomes.
“Patient assistance programmes help ease the financial burden of the patient and their families, ensuring the patients can access the necessary care with ease of mind,” said En. Rizal.
Deepti also shared that the collaboration with MSSM is in line with Roche’s purpose of ‘Doing now what patients need next’. “By fostering inclusivity and breaking down barriers, we aim to empower every individual affected by MS to receive the support and resources they need on their journey towards better health,” Deepti concluded.
Clinical Data Support Efficacy of OCREVUS®
Clinical data indicates that OCREVUS® is effective at slowing disability progression (RMS) and treating patients with PPMS⁵.
The efficacy of OCREVUS® for the treatment of RMS was shown in two clinical trials, OPERA I AND OPERA II, in 1,656 participants treated for 96 weeks. In both, the patients receiving OCREVUS® had reduced relapses by nearly half (46%).
It also proved effective at slowing down progression with participants on OCREVUS® being less likely to have disability progression (40%)⁵ while a small percentage had disability progression (9.8%). More people (33%) also showed disability improvement after 3 months with OCREVUS®. The drug was also proven to reduce brain lesions⁵.
Both studies showed a significant reduction in MRI lesions, with a rate of 94% and 95% respectively. In the ORATORIO study of PPMS in 732 participants treated for at least 120 weeks, OCREVUS® was seen to delay disability progression with participants on OCREVUS® being less likely to have disability progression (24%)⁹.
OCREVUS® was approved by the US FDA in March 2017 for adults with RMS and PPMS¹⁰. It is now approved in Malaysia, in November 2023 for both RMS and PPMS.
OCREVUS® has been included in Roche’s Patient Assistance Program (RPAP) which helps eligible patients access their prescribed Roche medicines under a subsidized scheme to support their overall treatment cost. For further information about MS, OCREVUS® and Roche’s RPAP, please contact your neurologist or treating physician.
References
Available at Atlas of MS 3rd edition. https://www.msif.org/wp-content/uploads/2020/10/Atlas-3rd-Edition-Epidemiology-report-EN-updated-30-9-20.pdf. Last accessed 2 February 2024.
Walton, C., King, R., Rechtman, L., et al. (2020). “Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition.” Multiple Sclerosis Journal, 26(14), 1816-1821. https://journals.sagepub.com/doi/10.1177/1352458520970841. Last accessed 2 February 2024.
Available at the Ministry of Health Malaysia (MOH). https://pharmacy.moh.gov.my/sites/default/files/document-upload/malaysian-orphan-medicines-guideline-2020_0.pdf. Last accessed 2 February 2024.
Available at Atlas of MS. https://www.atlasofms.org/map/malaysia/epidemiology/number-of-people-with-ms. Last accessed 2 February 2024.
Hauser, S.L., Amit, B.-O., Giancarlo, C., et al. (2017). “Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis.” N Engl J Med, 376, 221-234. https://www.nejm.org/doi/full/10.1056/NEJMoa1601277. Last accessed 2 February 2024.
Weber, M. S., Kappos, L., Hauser, S. L., Nicholas, J. A., Scheneble, H.-M., Wang, Q., Giovannoni, G., Filippi, M. (2023). "The Patient Impact of 10 Years of Ocrelizumab Treatment in Multiple Sclerosis: Long-term Data from the Phase III OPERA and ORATORIO Studies." Paper presented at: 9th Joint ECTRIMS-ACTRIMS Meeting; October 11-13, 2023; Milan, Italy.
Available at Atlas of MS. https://www.atlasofms.org/chart/malaysia/epidemiology/female-to-male-ratio-of-people-with-ms. Last accessed 2 February 2024.
Viswanathan, S., Wah, L.M. (2019). “A nationwide epidemiological study on the prevalence of multiple sclerosis and neuromyelitis optica spectrum disorder with important multi-ethnic differences in Malaysia.” Multiple Sclerosis Journal, 25(11), 1452-1461. https://journals.sagepub.com/doi/10.1177/1352458518792430. Last accessed 2 February 2024.
Montalban, X., Hauser, S.L., Kappos, L., et al. (2017). “Ocrelizumab versus placebo in primary progressive multiple sclerosis.” N Engl J Med, 376, 209-220. https://www.nejm.org/doi/full/10.1056/nejmoa1606468. Last accessed 2 February 2024.
Lin, M., Zhang, J., Zhang, Y., Luo, J., Shi, S. (2022). “ Ocrelizumab for multiple sclerosis.” Cochrane Database Syst Rev, 5(5). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9115862/. Last accessed 2 February 2024.
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