February 24, 2022 News by Marisa Wexler, MS #ACTRIMS2022 ā Machine Learning Helps Predict Treatment Response in PPMS Machine learning ā using computer algorithms ā can be used to identify people with primary progressive multiple sclerosis (PPMS) who are more likely to respond to treatment, a new study shows. The ability to predict treatment response could allow clinical trials to be designed more efficiently, researchers said. Jean-Pierre…
April 27, 2021 News by Marisa Wexler, MS #AANAM – Early Ocrevus Treatment Helps to Protect Nervous System Editorās note: TheĀ Multiple Sclerosis News TodayĀ team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17ā22. GoĀ hereĀ to read the latest stories from the conference. TreatingĀ multiple sclerosis (MS) in its earlier stages with Ocrevus (ocrelizumab) can substantially lower disease activity and lessen damage…
March 19, 2021 News by Margarida Maia, PhD Ocrevus May Delay by 7 Years PPMS Patients’ Need for Wheelchair Ocrevus (ocrelizumab) treatment may delay the need for a wheelchair by seven years in patients with primary progressive multiple sclerosisĀ (PPMS), a study reports. This delay, drawn from clinical trial data on treatment- versus placebo-group patients and supported by real-world findings, likely translates to long-term benefits for PPMS patients,…
April 29, 2020 News by Marisa Wexler, MS Ocrevus’ Early Use May Lower Need for Walking Aid by 49% Over 6 Years StartingĀ treatment with OcrevusĀ early can lower almost by half the need for a walking aid inĀ peopleĀ with relapsing forms ofĀ multiple sclerosis (MS) over six years, new analyses of Phase 3 trial data that compared immediate initiation with a two-year delay show. A separate analysis also found…
April 3, 2020 News by Joana Carvalho, PhD Ocrevus Lowers Progression Risk in More Disabled MS Patients, Study Suggests For multiple sclerosis (MS) patients with considerable disability, Ocrevus (ocrelizumab) appears to lower the risk of continued progression in both relapsing and primary progressiveĀ forms of the disease, data from an exploratory and post-hoc analysis of three Phase 3 trials report. These findings were in the study, ā…
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 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…
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…
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.
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…
March 28, 2017 News by Patricia Silva, PhD Ocrevus’ Journey from Defiant Idea to Game-Changing Treatment Twenty years ago, the idea that B-cell depletion could treat multiple sclerosisĀ would have been greeted with a hearty laughĀ byĀ any well-respected neurologist or MS researcher ā or perhapsĀ a scoff. But times change and research advances. Today, a medicine that gets rid of certain B-cells may beĀ the most powerful drug yetĀ developed against…
February 28, 2017 News by Patricia Silva, PhD ‘Ocrevus Has the Potential to Change How MS Is Treated,’ Genentech’s Peter Chin Says in Interview March 28, at the latest, may be a historic date for the multiple sclerosis (MS) community ā patients, families, caregivers, researchers, and physicians alike. The U.S. Food and Drug Administration (FDA) will have its say about the marketing approval forĀ Ocrevus (ocrelizumab). The drugĀ willĀ be the first to offerĀ benefit to…
February 28, 2017 News by Patricia Silva, PhD Full Transcript of Interview with Genentech’s Medical Director, Peter Chin, on Ocrevus BelowĀ is a transcript of theĀ Multiple Sclerosis News TodayĀ interview with Dr. Peter Chin ā principal medical director at Genentech ā about the importance of the pending U.S. Food and Drug Administration (FDA) approval of a Biologics Licensing Application (BLA) for Ocrevus (ocrelizumab). An an indepth article on this interview,Ā lookingĀ Ocrevus…
February 24, 2017 News by Patricia Silva, PhD #ACTRIMS2017 – 3 Trials Show MS Patients Receiving Ocrevus Had No Elevated Infection Risk A detailed analysis ofĀ relapsing and primary progressive multiple sclerosis (MS) patients in the three Phase 3 trials of Ocrevus (ocrelizumab) showed that the treatment did not significantly increase their risk of infections ā serious or otherwise. Certain infections, including common colds and influenza, were numerically more common among Ocrevus-treated patients,…
February 23, 2017 News by Patricia Silva, PhD #ACTRIMS2017 – No Evidence of Progression More Likely Among PPMS Patients on Ocrevus Genentechās Ocrevus (ocrelizumab) increased the proportion of patients with no evidence of progression (NEP) in the recently concluded ORATORIO Phase 3 clinical trial in patients with primary progressive multiple sclerosis (PPMS). The evaluation of NEPĀ ā a combined measure of three disability assessments ā was a secondary exploratory endpoint of…
January 3, 2017 News by Patricia Silva, PhD Ocrevus Seen in Phase 3 Trials to Benefit Both Primary Progressive and Relapsing MS Patients Recently published data from three Phase 3 trials of Ocrevus (ocrelizumab) show that the investigational drug does what no other therapy has achieved so far ā working to prevent disease in both relapsing and primary progressive (PP) forms of multiple sclerosis (MS). Publications in the New England Journal…
December 21, 2016 News by Joana Fernandes, PhD FDA Extends Review of Ocrevus as Potential Treatment for Both Forms of MS Until March The U.S. Food and Drug Administration recently extended until the end of March its review of the Biologics License Application (BLA) forĀ Ocrevus (ocrelizumab). The application was submitted by Roche, requesting FDA approval forĀ Ocrevus as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) and ā for a first…
December 21, 2016 News by Patricia Silva, PhD New Phase 3 Trial of Ocrevus to Treat RRMS Begins Enrolling Patients in US Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were notĀ helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society. The trial is an open-label study, meaning…
September 23, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – Primary Progressive MS Patients May Soon Have Ocrevus as Treatment Results from the ORATORIO trial, exploring Ocrevus (ocrelizumab) for the treatment of primary progressive forms of multiple sclerosis (MS), showed that the drug stopped disease progression for more than two years in more patients than a placebo. The findings, a highlight at the European Committee for Treatment and Research…
September 15, 2016 News by Joana Fernandes, PhD #ECTRIMS2016 – New Data Show Ocrevus Effective in Treating Primary and Relapsing MS Positive new dataĀ from Phase 3 clinical trials assessingĀ Ocrevus (ocrelizumab) as a treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) were recently announced by Roche, the company responsible for marketing and developing this investigationalĀ therapy. The results are being presented at the 32nd Congress of the…
June 29, 2016 News by InĆŖs Martins, PhD 1st Potential Therapy for Primary Progressive MS, Ocrelizumab, Under Priority Review by FDA The U.S. Food and Drug Administration (FDA) is givingĀ priority review to a request to approveĀ Ocrevus (ocrelizumab) as a treatment forĀ both forms of multiple sclerosis, the drug’s developer,Ā Genentech, announced. If the company’s Biologics License Application (BLA) is approved,Ā Ocrevus will become the first drug ableĀ to treat patients with either relapsing or…
June 6, 2016 News by Patricia Silva, PhD #CMSC16 – Ocrevus (Ocrelizumab) in PPMS Prevented Disability Progression, Lowered MRI Lesion Volume, Study Shows Data recently presented at the Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual Meeting showed that Roche/Genentechās investigational drugĀ ocrelizumab (Ocrevus) lowered the risk of disability progression in primary progressive multiple sclerosis (PPMS), a condition for which no approved treatments exist. The study was presented during the “…
June 6, 2016 News by InĆŖs Martins, PhD #CMSC16 – Genentech’s Ocrelizumab (Ocrevus) a Promising Therapy for Primary Progressive MS; Interview with Lead Researcher Genentech,Ā a member of the RocheĀ Group, was founded more than 35 years ago and has been focused on a variety of research fields, includingĀ cancer, immunology, neurodegenerative disorders, metabolic diseases, and infectious diseases. Genentech has been committed to discovering and developing new medicines for patients with major diseases of the nervous…
February 18, 2016 News by BioNews Staff FDA Grants ‘Breakthrough Therapy’ Designation to Genentechās Ocrelizumab for PPMS Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment forĀ primary progressive multiple sclerosis (PPMS),Ā Breakthrough Therapy DesignationĀ based on positiveĀ Phase 3 clinical trial results showing thatĀ ocrelizumab significantly reduced disability progression and other disease activity markers compared toĀ placebo. The FDA designation is…
October 9, 2015 News by Patricia Inacio, PhD Ocrelizumab: Could Genentech/Rocheās Experimental Drug Be the First Effective Progressive MS Therapy? Roche announced positive results for three pivotal Phase III studies of experimental MS therapy ocrelizumab in relapsing multiple sclerosis and primary progressive multiple sclerosis (PPMS) patients at this year’s ECTRIMS 2015 conference. The results, particularly for treating PPMS, indicate that the novel therapy may represent…
September 29, 2015 News by Patricia Silva, PhD Could Genentechās Ocrelizumab Become the First Effective Primary Progressive MS Therapy? Genentech, a leading biotechnology company and member of the Roche Group, recently announced promising results on a pivotal Phase III clinical trial (ORATORIO) assessing its investigational therapyĀ ocrelizumab as a treatmentĀ for patients with primary progressive multiple sclerosis (PPMS). Multiple sclerosis (MS) is a chronic, progressive neurodegenerative disorder that results from…
July 1, 2015 News by Patricia Silva, PhD Rocheās Ocrelizumab Found to be Superior to Standard Interferon Therapy in Relapsing Multiple Sclerosis Patients Roche recently announced encouraging results on its investigational medicine ocrelizumab as a therapy for patients with relapsing multiple sclerosis, which includesĀ either RRMS or SPMS with relapses. Ocrelizumab was evaluated in two pivotal studies (OPERA I and OPERA II), where it was compared to interferon (IFN) beta-1a (RebifĀ®), the standard-of-care…