April 1, 2020 News by Marisa Wexler, MS Biosimilar Truxima Works as Well as Rituximab Originator in MS, Study Finds Truxima, aĀ biosimilar of rituximab, is comparable to the originator therapy in terms of effectiveness and safety for treatingĀ multiple sclerosis (MS), a new study suggests. Rituximab āĀ marketed asĀ RituxanĀ in the United States ā isĀ an antibody-based therapy thatĀ works by killing B-cells, which are immune cells…
January 16, 2020 News by Marisa Wexler, MS Scottish Medicines Consortium Approves Ocrevus for Treating PPMS Ocrevus (ocrelizumab) has been approved in Scotland as a treatment for early, inflammatory primary progressive multiple sclerosis (PPMS). The Scottish Medicines Consortium (SMC) has advised that OcrevusĀ can be prescribed by the National Health Service (NHS) forĀ people with PPMS who have had symptoms for less than 15…
October 11, 2019 News by Ana Pena PhD Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports Prescriptions of two multiple sclerosisĀ (MS) treatments ā Ā Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) ā have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…
September 19, 2019 News by Ana Pena PhD #ECTRIMS2019 – Ocrevus Living Up to ‘Game-changing’ Moniker, Genentech’s Hideki Garren Says in Interview Two years after the approval of Ocrevus (ocrelizumab), the latest data continue to support the benefits of the so-called “game-changing” therapy in multiple sclerosis (MS), while new insights highlight its neuronal protective effects and safety. Multiple Sclerosis News Today had the opportunity to speak with Hideki Garren,…
September 17, 2019 News by Ana Pena PhD #ECTRIMS2019 – Early Ocrevus Use Slows Disability in PPMS, Including Risk of Wheelchair Reliance Early and continuous treatment with Ocrevus (ocrelizumab) leads to a greater and more durable slowing of disability progression ā seen for up to 6.5 years ā in people with primary progressive multiple sclerosis (PPMS), according to long-term data on its use in PPMS patients in a Phase 3…
September 16, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – Newer DMTs More Effective Than Older Injectables in Pediatric MS, Study Says Using newer disease-modifying therapies (DMTs) as an initial treatment for children and adolescents with multiple sclerosis (MS) or clinically isolated syndrome (CIS) is associated with fewer relapses and brain lesions compared to the use of older and injectable DMTs, according to a real-world study in the U.S.
September 12, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – No Retinal Thinning with Ocrevus in Relapsing MS Patients, Phase 3 Trials Show Treating relapsing multiple sclerosis (MS) patients with Ocrevus (ocrelizumab) is not associated with retinal thinning ā unlike treatment with Rebif (interferon beta-1a), according to two Phase 3 trials. The findings also showed a link between retinal thinning and brain volume loss. The study, ā…
September 12, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – 6 Years of Ocrevus Use Tied to Low Rates of Serious Infections Treatment for more than six years with OcrevusĀ (ocrelizumab) is linked to lower levels of blood antibodies among people withĀ primary progressive multiple sclerosis (PPMS) and relapsing MS, but rates of serious infections also remain low, an analysis of data from three Phase 3 trials show. Dropping below a certain…
August 23, 2019 News by Ana Pena PhD Rituximab Leads to ‘Dramatic’ Recovery in Boy with Aggressive RRMS, Case Study Reports Treatment with rituximabĀ ā sold as RituxanĀ in the U.S. by RocheĀ and Biogen, and asĀ MabThera byĀ Roche in Europe ā reversed disease course in a “dramatic fashion,” leading to complete remission in a 12-year-old boy with aggressiveĀ relapse-remitting multiple sclerosis (RRMS), a case report states. The report, “…
August 21, 2019 News by Joana Carvalho, PhD Immune System Molecule IL-17A Likely Inflammatory Agent in RRMS, Study Says Interleukin-17A (IL-17A), a molecule that mediates immune and inflammatory responses, likely promotes inflammation and tissue damage in relapsing-remitting multiple sclerosis (RRMS) and should be considered a potential target for treating the disease, a study reports. The findings of the study, “IL-17A is associated with the breakdown of the…
August 21, 2019 News by Ana Pena PhD Gilenya, Aubagio, Tysabri, Tecfidera Dominate MS Therapy Switches in Europe, Spherix Survey Finds Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘sĀ Aubagio (teriflunomide), andĀ BiogenāsĀ TysabriĀ (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…
July 19, 2019 News by Marisa Wexler, MS Convelo Therapeutics and Genentech Join Forces to Develop Remyelination Therapies Convelo Therapeutics has announced a collaboration with Genentech, a member of the Roche Group, to work toward the development of new remyelination therapies for multiple sclerosis (MS) and other myelin disorders. āWe are excited to be working with Genentech to…
June 10, 2019 Columns by Ed Tobias MS News That Caught My Eye Last Week: Ozanimod for RRMS, MS Monitoring App, Video Series FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS Another disease-modifying therapy (DMT) is a step closer to gaining approval for use both in the U.S. and in Europe. And that’s good news. The discouraging news, however, is that once again, the approval is being…
June 6, 2019 News by Marisa Wexler, MS Roche, Sutter Health Testing Floodlight Mobile App That Monitors Patients’ MS Sutter Health, a California-based healthcare group, has partnered with the biotechnology company Roche to test a new mobile app that aims to improve monitoring of symptoms in people who have multiple sclerosis (MS). The app, called Floodlight, “may give neurologists access to meaningful, actionable patient data to…
May 13, 2019 News by Joana Carvalho, PhD Ocrevus Approved in UK as First NHS Treatment for PPMS After firstĀ rejecting it due to cost-effectiveness concerns, the National Institute for Health and Care Excellence (NICE) has now approved the use of Ocrevus (ocrelizumab) for people in the U.K. with early, inflammatory primary progressive multiple sclerosis (PPMS). This means that PPMS patients living in the…
May 9, 2019 News by Jose Marques Lopes, PhD #AANAM – Greater Exposure to Ocrevus Means Less Risk of Disability Progression in MS Patients, Study Contends Higher exposure to Ocrevus (ocrelizumab) is associated with greater immune B-cell depletion in the blood, and lessened risk of disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive disease (PPMS), according to new research. The study supporting that finding, āPharmacokinetics, Pharmacodynamics and…
February 11, 2019 News by Jonathan Grinstein Petition Urges NHS England to Make Ocrevus Available for PPMS Patients More than 21,000 people have signed a petition calling for Ocrevus (ocrelizumab) to be made available by the National Health Service (NHS) in England for people with primary progressive multiple sclerosis (PPMS). According to anĀ MS Trust press release, the…
November 15, 2018 News by Jose Marques Lopes, PhD Ocrevus Helps Preserve Hand and Arm Function in PPMS Patients, Trial Data Show TreatingĀ primary progressive multiple sclerosis (PPMS) patients with Ocrevus (ocrelizumab) can help to preserve strength and function in their hands and the arms, analysis of data from a Phase 3 trial found. The research, āOcrelizumab reduces progression of upper extremity impairment in patients with primary progressive…
November 7, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Better MS Monitoring and Disease Understanding Among Goals of FLOODLIGHT Open, Genentech Director Says The ability to track multiple sclerosis (MS) at any time, gain a more complete picture of each patientās disease course and a better understanding of MS are among the possible benefits of the FLOODLIGHT app, according to Laura Julian, PhD, principal medical science director at Genentech. The company…
October 4, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Genentech to Present Ocrevus-related MS Studies at Conference Treatment with Ocrevus (ocrelizumab) over five years lessened upper limb disability progression in primary progressive multiple sclerosis (PPMS) patients, reduced relapses and brain disease activity in patients with relapsing MS, and helped achieveĀ no evidence of disease progression (NEDA) in a greater proportion of African-descent patients, compared to treatment…
September 13, 2018 News by Jose Marques Lopes, PhD Ocrevus Increases Proportion of PPMS Patients with No Disease Progression or Activity, Phase 3 Trial Shows TreatingĀ primary progressive multiple sclerosisĀ patients with OcrevusĀ (ocrelizumab)Ā led to a three-fold increase in the proportion of those showing no evidence of disease progression and no signs of inflammatory disease activity over more than two years of treatment, results of a Phase 3 trial show, and support new measures that might better capture disability in PPMS patients. The research, āEvaluation of No Evidence of Progression or Active Disease (NEPAD) in Patients With Primary Progressive Multiple Sclerosis in the ORATORIO Trial,ā was published in the journal Annals of Neurology. Measuring disease progression in clinical trials and clinical practice requires reliable and comprehensible measures. Although widely used, the Expanded Disability Status Scale (EDSS, range 0-10) cannot fully capture changes in walking speed and hand or arm function, which are key determinants of overall disability in progressive forms of MS. No evidence of progression (NEP) is a newer measure that reflects the absence of disability progression, including upper limb function and walking speed. Maintaining NEP status means stable disease with no worsening in EDSS, in walking ability (assessed by the Timed 25-Foot Walk (T25FW) test, or the time it takes to walk 25 feet as quickly and safely as possible), and in upper limb function (assessed by the 9-Hole Peg Test (9HPT), a test of arm and hand dexterity). Patients with PPMS have less frequent signs of disease activity, which include relapses and brain lesions (assessed though magnetic resonance imaging or MRI). So scientists proposed a new measure ā called āno evidence of progression or active diseaseā (NEPAD) ā to evaluate both NEP and clinical and MRI measures of active disease. The researchers believe that NEPAD may represent a more sensitive and comprehensive measure of disease control in PPMS patients. The randomized, double-blind ORATORIO Phase 3 trial (NCT01194570) analyzed the efficacy and safety of Ocrevus ā developed byĀ Genentech, part of theĀ RocheĀ group ā in 732 PPMS patients (age range 18ā55). Results showed that Ocrevus treatmentĀ delayed the relative risk of disability progression by 25% compared to placebo, while also reducing the volume of chronic brain lesions and total brain volume loss. As a result, Ocrevus became the first therapy approved by the U.S. Food and Drug Administration and the European Commission for both PPMS and relapsing MS. Now, researchers assessed Ocrevusā effect in PPMS patients included in the Roche-funded ORATORIO study using as trial goals changes in NEP and NEPAD. These people received either 600 mg of Ocrevus or placebo by intravenous (IV) infusion every six months for a minimum of 120 weeks (about 2.3 years). The trialās main goal was time to onset of clinical disability progression (CDP) sustained for at least 12 weeks. CDP was defined as a 1.0 point or greater increase in EDSS score from a baseline (study start) score of 5.5 or less, or a 0.5-point increase from a baseline score greater than 5.5. NEP status, analyzed in 230 placebo- and 461 Ocrevus-treated patients, was defined as no evidence of CDP for 12 weeks, no 20% or more change in hand/arm function as measured by the 9HPT for 12 weeks, and no 20% or more change in walking ability as measured by the T25FW test for 12 weeks.Ā "The 20% cut-off for progression on the T25FW test and the 9HPT has previouslyĀ been shown to be a clinically meaningful magnitude of disease progression," the study noted. In turn, NEPAD ā assessed in 234 placebo- and 465 Ocrevus-treated patients ā included NEP, no brain MRI-measured disease activity, and no relapses.Ā Relapses were defined as new or worsening neurological symptoms attributable to MS lasting longer than 24 hours and preceded by neurological stability for a minimum of 30 days. Brain MRI scans were conducted at baseline, and weeks 24, 48, and 120; new or enlarging T2 lesions and/or T1 enhancing lesions were considered evidence of MRI disease activity (T1 MRI imaging offers information about current disease activity by highlighting areas of active inflammation, while a T2 MRI image provides information about disease burden or lesion load). Overall, the majority of the PPMS patients analyzed experienced clinical disease progression or evidence of disease activity. From baseline to week 120, Ocrevus-treated patients who achieved NEP (42.7% of 461 people) or NEPAD (29.9% of 465) Ā ā no disease activity or progression ā were found to have lower T2 brain lesion volume and a lower EDSS score (lesser disability) compared to those with evidence of MS progression. They also had a slightly superior performance on the 9HPT and the T25FW test. Patients who reached NEPAD also showed fewer T1 lesions than patients with progressing or active disease. Compared to placebo treatment, the proportion of Ocrevus-treated PPMS patients maintaining NEP or NEPAD from baseline to week 120 was higher ā for NEP, 42.7% versus 29.1% in the placebo group; for NEPAD, 29.9% versus 9.4% in the placebo group. These results showed that Ocrevus treatment increased theĀ proportion of PPMS patients with NEPAD throughout the 120 weeks of the study by three-fold. āIn conclusion, ocrelizumab (Ocrevus) increased the proportion of patients with PPMS with no evidence of progression and no clinical and subclinical disease activity compared with placebo,ā the team wrote. āAs such, NEPAD may represent a meaningful and comprehensive disease outcome in patients with PPMS.ā However, data from ORATORIO's open-label extension and real-world data are needed to "determine whether NEPAD maintained throughout 120 weeks will translate intoĀ sustained NEPAD and enhanced protection against accrual of disability in patients with PPMS overĀ the long term," the researchers concluded. Of note, five of the studyās 11 authors are employees and/or shareholders of Roche or Genentech.
September 12, 2018 News by Diogo Pinto NICE Rules Against Bringing Ocrevus into NHS for Primary Progressive Patients in UK The National Institute for Health and Care Excellence, better known as NICE, issued a final decision against includingĀ Ocrevus (ocrelizumab) as a treatment for primary progressive multiple sclerosis (PPMS) in the subsidized public health system for England and Wales. The agency’s “final appraisal,” which mirrors its draft…
July 9, 2018 News by Jose Marques Lopes, PhD NICE Agrees to Add Ocrevus to NHS for RRMS Patients in England and Wales, But Scotland Will Not Relapsing-remitting multiple sclerosis (RRMS) patients with active disease may now be treated with Ocrevus (ocrelizumab, developed byĀ Genentech) within the National Health Service (NHS) ā the subsidized public health system that covers England and Wales. But those in Scotland will not. The National Institute for Health and…
July 3, 2018 News by Vijaya Iyer, PhD NICE Opposes Ocrevus as PPMS Treatment in UK’s Public-funded Health System The National Institute for Health and Care Excellence, known as NICE, has decided against recommending thatĀ Ocrevus be part of public-funded treatments for adults withĀ primary progressive multiple sclerosis (PPMS). The National Health Service (NHS) is the subsidized, publicly funded healthcare system for England, with similar structures…
June 21, 2018 News by Kara Elam Webinar Focuses on Importance of Maintaining Independence for Progressive MS Patients When a progressively debilitating disease like multiple sclerosis (MS) causes a patient to feel physically āwiped outā after a simple daily activity, such as a shower, it is of utmost importance for these individuals and the people in their support system to understand how they can maintain independence for…
June 18, 2018 News by Vijaya Iyer, PhD First Clinical Trial to Focus on Improving Hand Function in PPMS Patients Announced A new clinical trial will be the first in the world to recognize the importance of retaining hand function for wheelchair-bound patients with primary progressive MS (PPMS), according to a press release from Queen Mary University of London. The international trial, which will be conducted by a…
June 15, 2018 News by Alice MelĆ£o, MSc #EAN2018 – Ocrevus May Delay Progression to Wheelchair by Up to 7 Years, New Analysis of PPMS Patient Data Shows Treatment with Ocrevus (ocrelizumab) slows disability progression in primary progressive multiple sclerosis (PPMS) in ways that may be of considerable importance to patients ā including the possibility of delaying the need for a wheelchair by up to seven years, according to new data from a Phase 3…
May 8, 2018 News by Alice MelĆ£o, MSc Rituximab Seen to Ably and Safely Treat Refractory RRMS Patients in French Study An approved lymphoma treatment,Ā rituximab was found to be effective and safe for relapsing-remitting multiple sclerosis (RRMS) patients whose active disease has failed to respond to immunosuppressive therapies, a retrospective French study reports. Published in the Multiple Sclerosis Journal in an article titled, āEfficacy of…
May 3, 2018 Columns by Laura Kolaczkowski Ocrevus Shows Promise for Cognitive Function in Relapsing MS One thing weāve all hoped for with our disease-modifying therapies (DMT) is a treatment that will improve our multiple sclerosis (MS) and not just keep it from worsening. The latest studies presented on Ocrevus (ocrelizumab) hold promise that this treatment may have finally arrived. According to recent reports,…
April 9, 2018 News by Patricia Silva, PhD MSunderstood CafĆ© in Dublin Gives Customers Glimpse into Life of MS Patients A recent pop-up cafe in Dublin allowed customers to experience what it’s like to live with multiple sclerosis (MS)Ā to highlight the urgent need for improved access to care and treatment for MS patients in Ireland. MSunderstood CafĆ© gave customers a small taste of the challenges and symptoms MS…