New Ocrevus Data, Post-FDA Approval, Supports Range of Benefits, Genentech’s Hideki Garren Says

New Ocrevus Data, Post-FDA Approval, Supports Range of Benefits, Genentech’s Hideki Garren Says

Ocrevus (ocrelizumab), Genentech’s humanized anti-CD20 monoclonal antibody, continues to show clear evidence that it helps to slow disease progression and enable better function — including in the hands and limbs — of relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS), latest data reveals.

The first FDA-approved therapy — in March 2017 —  tackling both MS forms, Ocrevus was quickly considered a “game-changing MS treatment.”  Last week, Multiple Sclerosis News Today interviewed Dr. Hideki Garren, Genentech’s Group Medical Director of Product Development Neuroscience, about current views and the data collected to date on the therapy’s effectiveness.

“We have been very pleased by the overwhelmingly positive reception that Ocrevus has had from the MS community and regulatory bodies across the world. As of the end of 2017, over 30,000 people have been treated with Ocrevus, and it has been approved for use in 50 countries globally,” Garren said.

“Ongoing data for Ocrevus support the need for the medicine and reinforce why we have seen such positive uptake in the U.S. … and the recent approvals across the globe, such as the recent EU approval,” he added.

At the ACTRIMS 2018 Forum that took place Feb. 1–3, Genentech presented several posters with new data, results that “expand on prior presentations by showing the impact of Ocrevus on functions that are important for the day-to-day activities of people with MS, such as hand/arm function and visual acuity,” said Garren.

In one presentation, researchers assessed the proportion of relapsing MS patients who achieved NEPAD in the Phase 3 OPERA trials (NCT01247324 and NCT01412333), a new endpoint that stands for “no evidence of progression or active disease.” NEPAD includes hand/arm function and walking assessments, two new parameters that “are highly relevant for people with MS because it is these abilities that allow them to maintain their independence and quality of life,” Garren said.

NEPAD is also a more comprehensive measure of disability progression, and is considered a clinically meaningful measurement of overall disease activity and disability progression in people with both relapsing MS and PPMS, Garren emphasized.

The analysis showed that, compared to Rebif (interferon beta-1a), treatment with Ocrevus increased the proportion of patients reaching NEPAD at week 96 post-treatment by 82 percent. These results are in agreement with previous Ocrevus data that had NEDA (no evidence of disease activity) as its endpoint — treatment for the same period led to 75 percent of patients achieving NEDA compared with Rebif.

“The results here show that an even higher proportion of people with MS maintain no signs of disease progression on a more comprehensive measure, NEPAD,” Garren said.

“Maintaining NEPAD is important because it signifies that a patient has no relapses, no confirmed disability progression measured by the Expanded Disability Status Scale (EDSS), no progression equal to or above 20 percent on the timed 25-foot walk (T25-FW [assessing exercise capacity]) and the nine-hole peg test (9-HPT [assessing finger dexterity]), no gadolinium-enhancing T1 MRI lesions and no new or enlarging T2 MRI lesions,” Garren said.

Treatment also lowered the risk of severe progression of upper extremity impairments for both hands (dominant and non-dominant) in PPMS patients compared to placebo controls, a new analysis of the ORATORIO trial (NCT01194570) showed.

These findings represent a key step in treating PPMS patients, those at higher risk of losing hand and arm function compared to relapsing MS patients, Garren said.

“Ocrevus reduced the risk of more severe upper extremity disability progression in patients with PPMS compared with placebo in an exploratory analysis of the ORATORIO study,” he said. “Slowing disability progression in the hands or arms — also known as upper extremity function — is important to help maintain independence and quality of life.”

Visual impairment is also a common and often irreversible clinical manifestation of the disease. Patients can experience “reduced low-contrast vision, which can significantly impact the ability to perform key tasks of daily functioning (e.g., driving, reading),” Garren said. About half of MS patients progress to optic neuritis — inflammation of the optic nerve in the eye.

Compared to Rebif, treatment with Ocrevus led to significant visual improvements in a specific subgroup of relapsing MS patients with visual impairment — a 54 percent improvement in the seven-letter change between the two groups, a parameter considered clinically meaningful, said Garren.

Ocrevus-treated patients showed a better ability to read low-contrast letters over the course of the two OPERA trials, while Rebif-treated patients did not.

Another ACTRIMS presentation focused on Ocrevus’ safety and long-term benefit-risk profile. Clinical trial results showed infusion-related reactions (IRR) to be the most common overall adverse events in Ocrevus-treated patients compared to those given Rebif or placebo.

However, according to Garren, these reactions are manageable and can be minimized.

“IRRs are most often seen during the first infusion, generally mild-to-moderate in severity,” he said. “Pre-medication with methylprednisolone and an antihistamine must be administered to reduce IRRs. In addition, slowing or stopping infusions, where needed, can help manage IRRs.”

Real-world clinical data, also presented at the meeting, supported this tendency — 12.9 percent of patients receiving Ocrevus had an IRR during one of the first two infusions — in contrast to data from the clinical trials, where the percentage was higher (34.3 and 39.9 percent).

But this data, being collected by the Cleveland Clinic Mellen Center for Multiple Sclerosis, is still preliminary, and Garren noted that “initial findings from the three-month follow-up are too early to compare to clinical trial results.”

The goal is to assess Ocrevus’ efficacy, safety, and tolerability in clinical practice, and “real-world data in conjunction with clinical trial data may further help to inform treatment decisions and improve patient outcomes,” Garren added.

Overall, “data presented at ACTRIMS continue to reinforce a favourable benefit-risk profile and effect of Ocrevus in reducing disease activity and disability progression in patients with [relapsing] MS and PPMS, including MS-related symptoms like hand/arm function and vision acuity that can have a substantial impact on the day-to-day lives of people with MS,” he said.

“Given the large number of over 30,000 people with MS already taking Ocrevus, we are committed to continuing to provide data to help better understand how Ocrevus may benefit people with MS,” Garren concluded.

 

46 comments

    • Kym says:

      Hi. It’s not approved for secondary progressive. But, my Dr. is putting me on it anyway. He said if it helps RR and PP, why wouldn’t it help SP. Good luck to you!

    • Debra says:

      My question exactly. My doctor doesn’t say, but I’m just like all the stuff I read about secondary progressive.

      I’m taking Ocrevus too.

  1. Joseph Gendusa says:

    Has there been any deaths from using ocrevus?
    Or has there been any deaths not caused buy ocrevus but the patient was using ocrevus?

    • Jean says:

      I was told by my neurologist that the same cells that Orcevus targets are the ones that protect your body from breast cancer. I’ve not seen any related data. It makes me think they are purposely NOT studying that.

  2. Tina Orille says:

    It is really a big help for MS?
    Is there any Doctor who lives in Canada to introduce the new medicine can help MS people

  3. Senator says:

    I used to take Solumedrol (5x1000mg) every 3 months. Ocrevus has replaced it, and I could not be happier. It not only saves me from taking a steroid, it also saves me and my caregiver time. We now save over a full day every year ! Great side benefit !

  4. Steven A Talboys says:

    Husband had his first infusion in January. Within the first hour of starting the infusion he had a reaction; cold, sweats, uncontrollable shaking & vomiting. He was given Demerol (for shaking & help to relax) & zofran for nausea. He calmed down & med was restarted an hour later at a slower rate. He completed first half of the first dose, no problems. Drove 4 1/2 hours home & within 48 hours he ended up in the hospital for four days, with mini seizures & then a grand mall seizure. He is now unable to drive due to being put on seizure medicine & his gait is worse then before he had the infusion. He also now has to wear a first alert necklace, use a cane/walker & support bars are being installed in home. He’s decided the side effects out weigh the benefits. SEIZURES WERE NEVER LISTED AS A SIDE EFFECT.

    • Debbie says:

      I had my first split dose in Sept/Oct…can’t say I saw a huge improvement, but no worse either. Had a seizure on Feb 14th at work. Now I’m afraid I’ll have more. Nothing showed on MRI or EEG. Neurologist has not put me on anti seizure med yet since only had one seizure but not driving anyway.

    • Dawn says:

      Thanks for the info … do you know about pml risks too ? I am tired of these high dollar drug companies using people as research study … wondering about how many reactions and how many deaths too ? Tysarbi was not as good for some either and yet it was pushed as the Best thing going

    • Tammy says:

      Oh my. I am so sorry to hear this. I am set up for my initial infusion next month, but I’m backing out. I have other immunity and white blood cell problems, and I believe I would have a mix of odd effects like your husband. I hope his condition improves.

  5. Dania Magee says:

    I was taking Gylenia.As soon as Ocrevus came out I inmediatedly switched. I have never had the energy that I have now.My life has change.

  6. Izzy says:

    I started my treatment last Friday and noticed improvement upon waking up the next morning. I was truly amazed. After the treatment I was feeling out of it but that could have been the long day. My blood pressure was 120 over 78-80 for the first 5 hours. Then the steroids kicked in (they start with a steroid and then administer the Ocrevus). My BP shot up to 170 and my sitting pulse was at 110 (usually around 68-70). I gradually mellowed but did feel out of it.

    The next morning however,I got up out of bed with no difficulty, walked across my apartment with no difficulty and felt pretty good overall. Much more energy. Yes, I know some of this could be psychosomatic but the constant cramping in my left hand has really improved, my IT band has definitely limproved allowing me to walk almost naturally and I feel really good.

  7. Eugene C Smith says:

    I was not told that I had MS until I was 60 and at that time the doctor called it chronic progressive which is really PPMS. Does the age restriction prevent me from obtaining ocrevus?

    • Clara says:

      I am 75 and very interested in Ocrevus but my doctor says it has not been tested enough on older people. Is there additional information on the age question?

      • Wayne White says:

        Call the “Mind Clinic” in Farmington Hills. They have 5 years I’d data on ocrevus having participated in both clinical trials. I’m 64 and starting on ocrevus as soon as insurance is lined up. No age limitation that I have heard of.

    • Margarita Alfonso says:

      I’m started beginning of November 1 doze 2nd doze two weeks later My Birthday was on December 18 turned 73 years I had hope for this medicine I would like to tell you My han were closed I can open them up put on the table open hands also I’m moving my big toe I have not walked for 10 plus years no less move my Toe. I’m a lucky person had no side effects had a headache but nothing bad

  8. Tonia Furr says:

    My husband is 63. He has PPR MS. His first treatment started working the next day! He was so tired everyday. His spasms were so bad too.He seems to be doing great. More ENERGY!!!

  9. Tonia Furr says:

    Sorry, it should have been PPMS. I really thought my husband would be in a wheelchair fulltime soon. I’m happy that this has turned out well for so many people!

  10. Genevive says:

    I’ve just been diagnosed with RMS, I’m 54, female and this is my first choice in treatment care. I start in 3 weeks and I’m feeling good about this. I will be updating.

  11. Roberta Sloniker says:

    I had my first infusion in Nov. 2017. No reaction. I’m just starting to notice a substantial change in stamina. I am able to do almost twice as much on my feet than before the Nov. treatment. Very pleased.

  12. Mary says:

    My 43 y/o son has had PP for ten years. Ocrevus was offered to him and we were so happy something was developed that was specifically aimed at something other than RR. He was in the process of preparing for his first treatment and he tested JC+. Treatment now not recommended = devastated!

    • Stacy says:

      I am Jc+ have ppms and I’m 45. It’s amazing… You should really push for it. Without it I would still be stuttering walking with assistance brain fog couldn’t drive vision problems and all of that now that I had one full dose has cleared dramatically.

  13. Betty says:

    I heard about this and was very excited, but after reading most of the comments, I guess it is the same as all the other MS drugs. There can be horrific side effects–some worse than the original MS. The cost of it is just way too much. I will never try it. I will stick to my Low Dose Naltrexone. It has been working for me for years.

    • Audra says:

      This is what I am doing as well. Do you mind me asking how many milligrams you are using? I’m at 4. I was told by my pharmacist that several MS patients use this and swear by it, but I have never talked with someone really walking through it. Would love to chat!

  14. DoRhonda Myles says:

    I will be receiving my first infusion tomorrow and I am so anxious to see and feel the difference. I am exhausted and weak all of the time that I know my symptoms can only get better from here. I’ll definitely give an update.

  15. Karen says:

    I had my first split dose two weeks ago and the second two days ago. I had a slight IRR on the first one – scratchy throat. They adjusted the pre-meds for my second dose and I didn’t have any reaction at all. I woke up yesterday and today feeling much more energetic and able to walk easier. I wasn’t sure if I was imagining it or not. I have PPMS and my doctor told me that I could probably only expect that it wouldn’t progress, and not much more. Obviously, not a cure. After reading these comments, maybe I’m not imagining it. Maybe I am actually feeling better! As long as I don’t progress, I will be happy though. My condition progressed way more than I liked over the last year, so I went with Ocrevus for the hope of stopping it. I’m excited for the boost in energy over these past couple of days. I haven’t felt this good for a long time.

  16. Eryn says:

    Has this been compared to Tysabri? I have been doing ok on this, but since it has been so long my Dr is suggesting I switch and this is the only medication he’s recommendedthat doesn’t seem like taking two steps back.

  17. Anita smith says:

    I started infusions in October. I feel as if I’ve gone downhill since. I’ve since become more dizzy and unsteady. Still hoping for positive results, my next infusion. Is in may I’m really hoping for improvement so that I can rerun to work
    Re

    • Paulette says:

      I’ve been on since end of sept. Tysabri before that since 2006. My neuro clearly said it’s a long term treatment and not to judge anything until after I was on it a year. They don’t consider it to be fully effective, if it’s going to be , until after a full year. I go for my 6 months in a couple weeks.

    • Tasha brown says:

      I started in Jan and have had dizziness/vertigo ever since first infusion. Also just had MRI and developed two new lesions. Very annoyed and disappointed

    • Cheryl Bibbee says:

      I too felt even worse after the first two half doses last August. I took my second one last February and after the first one I did feel like I was getting worse but when i had my second one i felt bad first two days then suddenly i felt great. Mind you I still have most of my symptoms but a reduction in the time and severity have been greatly reduced. But my energy is way off the chart compared to before I had any treatments. I know it will not ever cure me but will make life livable. Can’t wait for my next infusion hoping I feel even better. Good luck my friend.

  18. Frank Yakupcak jr. says:

    I started my Ocrevus last August. It is an amazing medication, it makes for a long day, but goodbye injections, and Tec Fidera(di-methyl fumate). My thoughts are, its bad enough our minds are deteriorating, lets try to ease our livers a little 🙂

  19. Mardi Niles says:

    So happy to hear the positive results happening with Ocrevus. I had my first split dose in September and October. I was hoping for a miracle. Well, as one contributor here said, was it all “in my Head”. I believe it worked and I was walking much better and loving it. On New Years Eve I fell, not a bad fall, but a fall. After a few days of a swollen ankle with no pain, returning symptoms started popping up. More allover pain/spasms and slower walking. I am still very optimistic that the Ovrevus will work and for a longer period. I am scheduled to receive my next infusion/full in April. I will be 65 in June and perhaps it is going to take a bit longer. MS has been my “best” friend for years. It never leaves my side, always there reminding me of our relationship. I laugh at that at times. I have had months at a time without too many symptoms. I have one new symptom that makes me curious. This is for women who nursed their babies. I feel like milk is coming into my breast. I know crazy, but it happens quite often. Has anyone else had this happen. It is totally different from the MS hug feeling, but today the milk coming in feeling was followed by a hug, this was one of my first. Any ideas?

  20. Pat Dunkin says:

    Hi had both my 1/2 dose in Feb.2018. Waiting on my first full dose in Aug/Sept time frame! Did great then March 2, 2018, Baganda to have severe inside pain, turns out I have had shingles, very bad case, it is now March 27th and for the first time on Friday I was able to function! They told me that the shingles had nothing to do with the Ocravius! It was just bad timing on the the shingles part! It will take me longer to get over this but I can still feel my feet and legs that I could not over the last 18 months!! But I’m getting there and no side effects from the new med!! Thank Pat Dunkin

  21. Mary Ellen Pastor says:

    Can anyone give me info re: the deaths? My friend started the drug, did 2 rounds -she refused the 3rd when she learned of the deaths Were deaths due to the drug itself or to pre-existing patient conditions. She has been declining for years with PP and RR Was working for her. She is bedbound. Where can I find this information re deaths? It seemed to stop her decline and she felt better.

  22. Abby says:

    I am currently on lemtrada does anyone know if there is a difference in the reaction. I am JC + and afraid to keep trying meds that don’t really help

  23. Elaine Ashare says:

    Can Ocrevus be administered 3 times a year instead of 2 times? I had the 600 mg( 3rd treatment) and I felt GREAT for a couple of months, but now it seems to have worn off. Just wondering if I can have it every 4 months?

  24. S Walters says:

    I started Ocrevus in August 2017 felt great right off the bat and then in 5 months the numbness and tingling came back. Had my second infusion in February 2018 and as of today nothing has come back
    I am back working over 40 hours per week in sales…there are some changes to my bathroom issues but we are working on those. The cost of the medication jumps after your split infusion so don’t be scared off

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