Ocrevus Shows Promise for Cognitive Function in Relapsing MS
One thing we’ve 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, it appears that Ocrevus slows the disease’s progression, reduces the rate of cognitive decline, and in some patients, even improves cognition.
The American Academy of Neurology’s 2018 Annual Meeting included the latest presentations from Genentech’s publication, Roche, on Ocrevus. Data were presented on how this treatment works for relapsing-remitting forms of MS (RRMS) and its ability to improve cognition. I had the opportunity recently to speak Dr. Hideki Garren, Ph.D., who is group medical director for neuroscience at Genentech, about this latest news.
A common problem
Cognitive impairment is estimated to affect up to 65 percent of people with MS. This can lead to difficulties in effectively expressing ourselves with words, combining ideas with actions, and decision-making. The degree to which we have cognitive problems can vary, depending on our levels of fatigue, outside distractions such as sound, and environmental conditions like temperature changes.
Cognitive problems also can have a noticeable effect on our families and our economic situation. Cognitive problems are one of the most cited reasons for leaving full-time work.
Original clinical trial data
Garren explained that “this is data from the original studies and is a post-hoc analysis,” meaning it uses information from the original trials to look for other outcomes that may be statistically significant. The Phase 3 clinical trials OPERA I (NCT01247324) and OPERA II (NCT01412333), which were used to demonstrate the effectiveness of Ocrevus in reducing relapses, and compared Ocrevus to Rebif (interferon beta-1a), led to its approval by the Food and Drug Administration (FDA).
The information gathered from the trials’ participants informed the latest news that Ocrevus also demonstrates a positive effect on cognition, both in slowing decline and in improving functions.
Two cognitive notes
The two presentations on Ocrevus and cognition looked at different outcomes in people with RRMS. “Ocrevus does both things,” Garren said. “It reduces the rate of cognitive decline, and in some patients, it improves cognition. One analysis showed it slows cognitive decline and the other demonstrates improvement.”
The cognitive functions were measured using the Symbol Digit Modalities Test (SDMT).
“We saw an increase in cognition with Ocrevus in a certain population of patients and we are excited about these results,” Garren said. Of additional interest, he noted a “poster presentation showed patients worse off with cognitive scores improved better compared to patients with less cognitive problems.” Asked what this might mean, he said that although researchers aren’t yet certain, “we will continue to look and dig for this answer because we know this is important information for patients. Overall, in patients there was an improvement in cognitive scores.”
Additionally, Garren said they “continue to follow 3,700 patients from the clinical trial studies through open-label extensions” and are gathering more data to further look at the effects of Ocrevus on cognition and other symptom areas.
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Progressive MS outcomes
Ocrevus is the first DMT approved for use by people with progressive forms of MS. This post-hoc analysis does not include this different group. “Data we have shown is for RRMS. We are also looking at it in-depth for PPMS and will report on that data at future conferences,” Garren said.
The studies
Although the information is brief, if you want to read more, you can find both presentations at the links below.
In the poster presentation titled “Impact of Ocrelizumab on Cognition in Patients at Increased Risk of Progressive Disease,” researchers state that “patients treated with Ocrevus were more likely to achieve clinically meaningful improvements on the SDMT over 96 weeks vs IFN β-1a.”
In the presentation, “Time to Cognitive Worsening in Patients With Relapsing Multiple Sclerosis in Ocrelizumab Phase III Trials,” researchers offered this conclusion: “Compared with IFN β-1a, ocrelizumab significantly lowered the risk of 12- and 24-week confirmed SDMT worsening in patients with RMS. These results provide initial evidence to support a potential delay in cognitive decline with ocrelizumab treatment.”
On a personal note
I’ve been writing about ocrelizumab well before it was presented to the FDA for approval. I have followed its development and studies through conference presentations and interviews with scientists, and it is the disease-modifying therapy I am now on for my MS. I recently wrote about my changes with the nine-hole peg test and SDMT before these presentations were given at AAN, and I appreciated this chance to engage with Dr. Garren and learn more about the science that links with my personal experience.
“Although we are new to this therapeutic area, Roche and Genentech [the makers of Ocrevus] are very much committed to MS and are looking at new potential compounds and new technologies to help with managing the disease and its symptoms,” Garren said. “We are very excited to be in this field.”
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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, Bionews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.
Jason
HSCT offers cognitive replacement; why no article for that?
Senator
Ocrevus also seems to be helping calm my hand jitters, so much that I`m able to write out notes or checks easier and quicker without mistakes.
Jason
Why not get HSCT?
Jason
Here are some of the insurers that are offering this.
State of Illinois approved 2013
State of Illinois approved 2013
BCBS Federal Program approved 2013
Care First BCBS approved 2013
Cigna approved 2013
Humana Military approved 2013
BCBS Regence approved 2013
Anthem BCBS approved 2013
BCBS of Illinois approved 2013
State of Texas overturned BCBS of Texas denial 2013
PHCS United Health Group denial was overturned by independent review 2013
Blue Cross Blue Shield Federal Employee Plan approved 2013
BCBS of Oregon approved 2013
Aetna approved 2013
Blue Cross & Blue Shield of Kansas City approved 2013
Medicare/Medical Mutual of Ohio approved 2013
HealthAlliance (state of Illinois plan) approved 2013
Humana approved 2014
United Healthcare approved 2014
Tricare Standard North Region (Health Net Federal) approved 2014
Blue Cross & Blue Shield of Alabama approved 2014
Cigna approved 2014
Keystone
Blue Cross & Blue Shield of Michigan (PPO) thru the ‘Obamacare’ exchange – Silver Multi-state plans approved 2014
NGS Cofinity (contract with Optum) approved 2014
United Healthcare - PPO approved 2014
Aetna approved 2014
Aetna approved 2014
Cigna approved 2014
Blue Cross & Blue Shield of Michigan approved 2014
Cigna approved 2014
HealthLink (state of Illinois employees) approved 2014
Harvard Pilgrim PPO approved 2014
Cigna approved 2014
SelectHealth approved 2014
Aetna approved 2014
BlueShield of CA - High Option PPO approved 2014
United Healthcare approved 2014
Blue Cross & Blue Shield of Michigan approved 2014
United Healthcare Choice approved 2014
Select Health Care plus approved 2014
Blue Cross & Blue Shield of Michigan approved 2015
Community Care Oklahoma – PPO Select approved 2015
CareFirst Blue ShieldBlue Cross Blue Shield ”Blue Preferred” approved 2015
Only a few are listed.
Dave
And a big however, Does it offer anything for Spms,? Well after a year on Ocrevus, nothing, I am starting to believe Ocrevus is just something that could replace Rituximab since it's patent was running out. See the FDA could now just keep making money. I just pray they would help the people with MS whom have to try to carry this dreadful illness around. GODspeed, Dave? Adios
Jason
"#AAN2018 – Blood Stem Cell Transplant Superior to DMDs in Highly Active RRMS, MIST Trial Shows"
Why are we still using drugs?
Natella
I already had my second infusion of ocrevus, does not really work for me.I actually got worse. Harder to walk, my left side is much weaker now, then it was with tysarbi.
Kathy
The same is true for me after my second infusion. My cognitive function is worse and it ismuch harder to walk my entire right side is affected and previously I was on copaxone
David
Ocrevus shows some interesting results - such a shame about the side effects. The reduction in vaccine efficacy alone is cause for significant concern. Think of the impact of a reduction in flu vaccine efficacy by 50%, and the likely increased mortality among a population of immune suppressed and fragile MS patients, who thought they were protected by getting a flu shot.
It mat be worth the risk for some folks nevertheless: but it would be nice to see some honest discussion of this from the Genentech marketing machine
Karen G.
I have PPMS and would love to hear some feedback from others taking Ocrevus for PPMS. Did you experience any reactions or benefits? Thank you for sharing.
Sal
Just had my 2nd half infusion dose yesterday. I was diagnosed RRMS and showed progressive after MRIs in Feb. A year on Gilenya and I got worse. Today I feel better and have a lot more energy. Brain fog is better, walking better, and balance MUCH better. Pain is much less too. I have hope again...
Jason
Here's what works, not sitting on HSCT since 2009:
http://indianexpress.com/article/lifestyle/health/stem-cell-transplants-show-promise-for-multiple-sclerosis/
Laura
Thank you Jason for your information. I also believe that one of the most important things you can do is find a good doctor. I went to four different neurologists before I found one who was not only exceptional with her knowledge but treated me like a person and took the time to listen to me and members of my family!
Nikee Clausen
Today is 1/15/2019 and I began ocrevus on 8/11/2017 for treatment of my "RRMS" after taking tecfidera for nearly 2 years after my diagnosis, with worsening migraines on that med. I could tell within 24 hours of my first 1/2 that my heat intolerance had decreased-- actually I realized it when sitting on my porch in Iowa humidity-- my hands weren't going completely numb, I didn't feel like my skin was heavier n made of iron, and I wasn't getting the body fatigue that usually comes with it. Fast forward almost 18 months and I've come to understand how my body acts once the ocrevus infusion wears off (around 17 weeks for me) and I'm wondering:
Why don't our neurologists schedule our infusions based on the patient and when those B cells regenerate?! I'm pretty sure the answer is financially motivated due to the cost of ocrevus. Anyone out there feeling the same way? Given the opportunity to feel better some months of the year IS better than none, I know, but why are we made to suffer when a blood test could determine whether it's time for another infusion with more accuracy than the 6 month schedule? I hope they get on this because we ALL deserve to live our lives without this unnecessary pain and fatigue running the show! One love y'all.