The FDA has approved Ocrevus tonight for primary progressive and relapsing forms of multiple sclerosis. The approval is a major breakthrough since no treatments have previously been approved for primary progressive multiple sclerosis. This monoclonal antibody treatment works by depleted B cells, a type of immune cell. Ocrevus is given intravenously with half given the first day and a second half given 2 weeks later, followed by a single infusion every 6 months.
In 2 relapsing multiple sclerosis trials (OPERA I and II), patients treated with Ocrevus had 46 to 47% less relapses than Rebif. In addition, patients treated with Ocrevus were 40% less likely to progress in disability compared to Rebif treated patients. On MRI scans, the average number of active contrast-enhancing lesions were 94-95% less with Ocrevus treatment than Rebif. In a primary progressive trial (ORATORIO) of 732 patients, treatment with Ocrevus reduced risk of disability progression by 24% compared to placebo treatment. A 29% benefit was also seen on the time to walk 25 feet.
The most common side effects in clinical trials were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Although PML (progressive multifocal leukoencephalopathy) did not occur in Ocrevus clinical trials, this brain infection, which is potentially fatal, has occurred rarely with another B-cell depleting treatment. Other serious infections including reactivation of a Hepatitis B infection are risks. A higher rate of malignancies was seen on ocrelizumab than placebo or Rebif so possible risk of treatment with Ocrevus.
Zinbryta is an antibody therapy that binds onto a receptor (interleukin-2) on the surface of T immune cells. The SELECT trial studied 621 relapsing-remitting multiple sclerosis patients randomized to placebo and Zinbryta 150 mg [daclizumab high-yield process (HYP)] injected under skin every 4 weeks for 1 year. Relapses were reduced 54% for patients on Zinbryta compared to placebo. Zinbryta treatment was associated with 57% less disability progression compared to placebo.
In the DECIDE study of 1841 relapsing-remitting multiple sclerosis patients, Zinbryta under skin every 4 weeks was directly compared to Avonex weekly injections into muscle over 96 to 144 weeks of treatment. Patients on Zinbryta had 45% less relapses than Avonex. Less MRI activity was seen in people treated with Zinbryta (54% reduction on new or newly enlarging T2 lesions and 60% reduction on contrast-enhancing lesions).
Zinbryta can cause severe liver injury including liver failure and autoimmune hepatitis. Liver blood tests are required monthly and up to 6 months after last dose. Other immune-mediated disorders can occur including skin reactions, enlarge lymph nodes, and colon inflammation (colitis). These conditions may require treatment with steroids or immunosuppressive medication.
Most common side effects from Zinbryta (compared to Avonex) included upper respiratory infections, rash (37% of patients) and enlarged lymph nodes. Before starting Zinbryta, testing should be performed for viral hepatitis B and C as well as tuberculosis. Because of its safety profile, Zinbryta should generally be reserved for patients who have had inadequate response to 2 or more MS treatments.
READ ABOUT OTHER TREATMENT OPTIONS
Curing MS and repairing disease damage requires innovative, groundbreaking research. Funding for research is critical. That’s why we need YOU!
Support the National Multiple Sclerosis Society by joining or donating to Team MoBap. STAFF, PATIENTS, FRIENDS and FAMILY ARE INVITED on our team.
Walk MS is Sunday April 17 2016 at Forest Park Upper Muny Lot. Registration 1 PM, Start 2 PM.
REGISTER OR DONATE HERE!
GATEWAYWALKMS.ORG | 1-800-344-4867
Ocrelizumab becomes the FIRST therapy to show positive results in a Phase III clinical trial in PRIMARY PROGRESSIVE multiple sclerosis after numerous other failed trials with other medications.
In the ORATORIA study, ocrelizumab infusions in the vein reduced the risk of clinical disability progression compared to placebo in patients with primary progressive multiple sclerosis. The most common side effect was mild-to-moderate infusion-related reaction. The incidence of serious side effects (adverse events), including serious infections, was similar to placebo.
ORATORIO is a Phase III, randomized, double blind trial comparing ocrelizumab infusions to placebo in 732 primary progressive multiple sclerosis. The primary endpoint of the study was the time to onset of confirmed disability progression, sustained for at least 12 weeks. Ocrelizumab was given in the vein every 6 months as two 300 mg infusions two weeks apart.
Ocrelizumab targets specifically B-cells, a type of white blood cell lymphocyte. Another B-cell therapy, rituximab had failed in a previous primary progressive multiple sclerosis trial. Full abstract results coming next week at ECTRIMS in Barcelona.
Join us for The MS Center for Innovation in Care’s annual program focused on the latest updates in multiple sclerosis. The meeting takes place right after the largest global MS meeting called ECTRIMS in Barcelona, Spain in October. Over 8000 people focused on curing and treating MS will attend including Dr. Barry Singer and Dr. Mark Tullman. New therapies including some expected to be FDA-approved in 2016 will be discussed. The first MS treatment to work in primary progressive multiple sclerosis trials with be reviewed. Progress on myelin repair strategies will be highlighted including research at our center. Options for improving MS symptoms and quality of life will be addressed. A question and answer session will follow. Speakers include Barry Singer MD, Mark Tullman MD and Heather Popham, NP-C.
The FREE program is sponsored by Missouri Baptist Medical Center and will be held Thursday October 29, 2015 at the St. Louis Frontenac Hilton at 6:30 PM. Light refreshments will be served.
REGISTER at 314-996-LIFE. Love to see you there!
Ocrelizumab is an anti-CD20 antibody therapy given as an infusion every 6 months. Ocrelizumab temporarily knocks out B cells, an important immune cell involved in causing damage in multiple sclerosis. Two Phase 3 clinical trials (OPERA I and II) were conducted to evaluate ocrelizumab in relapsing multiple sclerosis. In both trials, patients were randomized to Rebif or ocrelizumab 600 mg intravenously every 24 weeks. Only the first dose of ocrelizumab was divided into 300 mg on Day 1 and Day 15. OPERA I and II randomized 821 and 835 patients, respectively.
Treatment with ocrelizumab significantly reduced the number of relapses per year (annualized relapse rate), the risk of disability progression and reduced the number of brain lesions compared to Rebif treatment. Results were just announced in a press release. Exact difference will be presented at a future scientific meeting.
The most common side effects of ocrelizumab were mild-to-moderate infusion-related reactions. The incidence of serious infections on ocrelizumab was similar to Rebif.
The MS Center for Innovations in Care was a site for the OPERA clinical program.
FDA approved Lemtrada (alemtuzumab) today for relapsing forms of multiple sclerosis. Because of its safety profile, Lemtrada should generally be reserved for patients who have had inadequate response to two or more other MS medications. Lemtrada is an antibody treatment that is given in the vein over 5 days the first year and 3 days the second year. Eighty percent of patients do not require treatment in the 3rd year. Lemtrada removes certain immune cells from the body for months (approximately 6 months for B lymphocytes and 1 year for T lymphocytes).
In the CARE-MS I Trial, 581 early, active relapsing-remitting patients, who had received no prior MS therapy, were randomized to Rebif or Lemtrada treatment. Compared to those MS patients on Rebif, those individuals on Lemtrada had 55% less relapses. A low percentage of patients had worsening disability on both treatments without a significant difference between Rebif and Lemtrada (11% and 8% respectively worsened). In the CARE-MS II Trial, Lemtrada IV treatment dropped new relapses by half (49%) compared to Rebif in a 2 year trial. People with MS treated with Lemtrada also were 42% less likely to progress in disability than on Rebif and have less MRI activity.
Autoimmune disease is a risk of Lemtrada including 34% thyroid disease (including 1% orbital involvement), 2% incidence of low platelets which can lead to serious bleeding complications (thrombocyopenia), and 0.3% serious renal disease (glomerular nephropathies). Other risks include serious infections (including fungal and herpetic) and serious infusion reactions including anaphylaxis. Lemtrada may cause an increase risk of malignancy include thyroid cancer, melanoma and lymphoproliferative disorders.
Safety monitoring includes baseline and monthly complete blood count with differential, serum creatinine and urinalysis with cell counts monthly for 4 years. At baseline and every 3 months, blood thyroid function testing (such as TSH) should be checked. In addition, patients need baseline and yearly skin exams to screen for melanoma.
Your Invited! Come to our program on the latest MS treatments along with strategies to reduce MS symptoms and improve quality of life. Groundbreaking research from the world’s largest annual international MS conference will be presented. Hear about potential future preventative therapies and treatments to repair myelin in attempt to restore function in individuals living with MS. A question and answer session will follow the presentation. FREE. Refreshments will be served. Presenters: Barry Singer, MD; Mark Tullman, MD and Heather Popham, NP. Sponsored by Missouri Baptist Medical Center.
Thursday, Oct 30, 2014. 6:30 PM to 8:30 PM. St. Louis Frontenac Hilton. 1355 South Lindbergh.
CALL 314-996-LIFE to REGISTER.
Treatment adherence (taking your multiple sclerosis medication regularly) can have a direct impact on how well you live with MS. Not taking medication regularly has been associated with more relapses. Many obstacles prevent medications from being taken regularly. People with MS sometimes minimize the severity of the disease, forget to take doses, have needle phobia and/or experience treatment side effects. Out-of-pocket costs and insurance issues can lead to a lapse in treatment. Partner with your healthcare provider(s) to find solutions to help you stay on path.
Specialty pharmacies are actually collecting data on whether you are refilling your medication regularly. If you refill on time because your taking your medication as directed, you will have a high medication possession ratio. As expected, low medication possession ratios on Copaxone and interferons have been associated with more MS relapses.
Educating yourself about MS and keeping long-term goals in mind will help you stick with your treatment plan. If having side effects or injection site issues, talk to your doctor about ways to potential minimize these issues. Alternative treatment options can be explored if desired. Pharmaceutical companies that make the various MS meds can help with co-pay assistance and often provide free medication to uninsured or underinsured individuals if not on Medicare or Medicaid. Patient assistance programs are available to help with costs for people on government insurance plans.
Tired of daily Copaxone 20 mg injections for multiple sclerosis? A new option is now available. FDA just approved 40 mg dose three times a week.
The GALA trial studied Copaxone 40 mg (double dose) three times a week vs. placebo in 1404 patients. Copaxone 40 mg three times a week reduced new relapses 34% and reduced MRI activity with contrast 45%. Safety of Copaxone 40 mg appears comparable to 20 mg dose. In fact, a lower amount of immediate post-injection reactions were seen in the GALA 40 mg trial. Previous studies had demonstrated a 29% reduction of relapses with Copaxone 20 mg daily.
If interested in switching to 40 mg three times a week, discuss with your healthcare provider.