Favorable Efficacy and Similar Safety with Ocrevus in Relapsing MS, Study Finds

Favorable Efficacy and Similar Safety with Ocrevus in Relapsing MS, Study Finds

Treatment with Ocrevus (ocrelizumab) has superior or comparable effectiveness and a similar safety profile to other available disease-modifying treatments (DMTs) for treating relapsing multiple sclerosis (MS), according to a new review study.

The research, “Systematic review and network meta-analysis comparing ocrelizumab with other treatments for relapsing multiple sclerosis,” was published in the journal Multiple Sclerosis and Related Disorders.

Current treatment options for relapsing MS aim to slow disability progression, lessen the number and severity of relapses, and reduce MS’ effects on health-related quality of life. Although therapies with higher effectiveness (efficacy) usually are reserved for later stages in disease course due to safety concerns, recent evidence has suggested that early use of high-efficacy medications may improve disease control.

Network meta-analyses (NMAs) — statistical studies that combine the results of various studies — can inform on the efficacy and safety of different therapies by comparing them directly within clinical trials and indirectly based on a common comparator, often a placebo. Prior NMAs in relapsing MS, however, have used variable methodology, and have not assessed all available data.

Ocrevus (marketed by Genentech, a member of the Roche group) is approved in the U.S. and Europe for people with relapsing MS and those with primary progressive MS.

Now, researchers conducted a systematic literature review and NMA to compare Ocrevus’ efficacy and safety to that of all other approved DMTs in patients with relapsing MS. Roche funded this study.

The team searched relevant data on online databases, clinical trial registries, conference websites, and health technology assessment agencies’ websites. In total, 33 randomized clinical trials were included in the study, and all had a minimum duration of 12 weeks and had more than 75% of patients with relapsing MS as participants.

The key efficacy outcomes analyzed in the NMA were 12-week confirmed disability worsening, and the annualized relapse rate (ARR) (the number of confirmed relapses per year), which was the primary outcome of the OPERA I and OPERA II Phase 3 trials of Ocrevus (NCT01247324 and NCT01412333), the team noted.

In turn, the main safety outcomes assessed were serious adverse events (SAEs, aka side effects), and discontinuation of treatment due to an AE.

To assess each treatment’s efficacy and safety, researchers also determined a parameter called “surface under the cumulative ranking curve” (SUCRA), in which a value of 0% stood for “the treatment is certainly ranked last,” and 100% meant “the treatment is certainly ranked first.”

In total, 17 treatments were analyzed, including placebo and Ocrevus. The others were: Aubagio (teriflunomide, 7 and 14 mg, marketed by Sanofi Genzyme), Avonex (interferon beta-1a, by Biogen), Betaseron/Betaferon (interferon beta-1b, by Bayer HealthCare), Gilenya (fingolimod, by Novartis), glatiramer acetate (marketed as Copaxone (by Teva Pharmaceuticals) and Glatopa (by Sandoz), Lemtrada (alemtuzumab, by Sanofi Genzyme), Mavenclad (cladribine, 3.5 and 5.25  mg/kg, by EMD Serono), Plegridy (pegylated interferon beta-1a, by Biogen), Rebif (interferon beta-1a, by EMD Serono), Tecfidera (dimethyl fumarate, by Biogen), Tysabri (natalizumab, by Biogen), and Zinbryta (daclizumab, by Biogen and AbbVie).

Results showed that Ocrevus had superior efficacy to 10 other DMT treatments in reducing the risk of 12-week confirmed disability progression, and to 12 other therapies in reducing ARR, both including placebo.

Interestingly, no DMT seemed to have higher efficacy than Ocrevus in either outcome measure.

Regarding safety, Ocrevus showed a similar risk of SAE and rate of treatment discontinuation due to AEs compared to other treatments (including placebo).

When analyzing efficacy and safety in parallel with SUCRA values, researchers found that Ocrevus had a consistently high probability of being ranked as the most effective or tolerable treatment.

“SUCRA values consistently ranked ocrelizumab [Ocrevus] among the most effective or tolerable treatments across all outcomes,” researchers wrote.

As for other efficacy and safety outcomes, Ocrevus revealed superior efficacy in reducing the risk of 24-week confirmed disability progression compared to placebo, Rebif, or Aubagio (7 mg), and to enable relapse-free periods compared to 14 other medications.

Also, Ocrevus was associated with a reduced likelihood of all-cause treatment discontinuation, compared to Rebif or Plegridy, but higher than Tysabri or Lemtrada.

Overall, the “results suggest that ocrelizumab [Ocrevus] has an efficacy superior to or comparable with all other currently approved DMTs across all endpoints [goals] analyzed, and a similar safety profile,” the researchers concluded.

The team also noted that the results can “be used to inform reimbursement and treatment decisions,” they added.

Of note, two of the study’s authors are employees of Roche, while another received consulting fees from the company.

José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has studied Biochemistry also at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario, in London, Ontario. His work ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
José is a science news writer with a PhD in Neuroscience from Universidade of Porto, in Portugal. He has studied Biochemistry also at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario, in London, Ontario. His work ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.
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    • David Flannery says:

      I am on Ocrevus – just had my third dose last week. Prior to that, I was on Rituximab – which is essentially the same profile (what made them create Ocrevus) for about two years. Diagnosed in 2001, I was averaging 1-3 relapses every year. I’ve received more Solumedrol than I care to mention to tamp down the flare-ups. I always felt great and returned to baseline (which is quite good still), but always trended up to toward flare. Until Rituxan/Ocrevus. I’ve been relapse free for 3+ years now. Also – the cost you noted – still ridiculous, but not $123K (I believe Lemtrada is in that zone) is about half in real terms – what the insurers pay. I thought the cost would be up there, but they released it at a cost comparable to the older drugs – I’ve been on Copaxone, Avonex, Rebif, Rebif+Mycophenolate (did sort of ok on that), and the worst for me was Tecfidera. I relapses like I wasn’t on anything when on Tecfidera. The drug copay assistance is pretty good with Ocrevus by the way. I do not work for or benefit from Ocrevus, other than to tell you I am doing exceptionally well with this treatment and so is everyone I’ve heard that is on it. This article seems to provide faint praise – out of fairness to all the other drugs and companies, but I think we’re going to have to admit at some point that some are simply better than others.

        • Dion Shaw says:

          Had a autologous stem cell transplant in Oct 2015 in Freeport. Felt great for 10 to 12 weeks and slowly returned to baseline.

          Dr Burt at Northwestern tester me twice for HSCT. Rejected by insurance the first time and by Dr Burt the second time. Burt wants patients he knows he can fix, not like long term patients like me, 25 years+.

          • Carmela says:

            I also have MS for the past 25 years.
            What medication are you on now? How are you feeling?

      • Dion Shaw says:

        Amen to the hospital stays for solumedrol.

        I’m still on Rebif. Tried Gilenya but had heart trouble. Tried Aubagio – it made me feel worse. Tried Techfideria and did ok. New neurologist said too many cases of PML on Tech, so back to Rebif.

        Waiting for Shingrix to bring my varicella titer up to acceptable levels so I can go on Lemtrada. Been over a year; ironically since my last solumedrol trip.

        I feel your pain.

        Best wishes to you.

    • My husband has been on Ocrevus for two years. It has slowed down his progression and we only go twice a year for the infusions. It is expensive but between insurance and the drug company helping out, it is more reasonable. Can you really put a price on a person’s ability to be like you were before this disease? This is only my and my husband’s opinion.

    • Alan Seattle says:

      Patients do not pay for medication, except for copays, so cost (to the insurance company) is irreverent to the patient.

  1. ALAN Seattle says:

    Doesn’t anyone understand that firstly, drugs are not expensive…to patients. It’s like living at home and complaining about property taxes. * We don’t pay the costs *. You don’t pay, so stop complaining.

    Secondly, the only reason we have any drugs, is exactly because they are a goldmine for the companies who develop them. No one would otherwise develop meds for such a small group of people.

    So be happy they are so expensive and that the rest of the country is forced to pay for our treatment and that research continues.

    • Stephen says:

      The problem, of course, is that US citizens are paying more than citizens of other countries. Much more. Roughly 50% of all Pharma income comes from just the US. In effect, we are paying extra through higher taxes and higher insurance premiums so that other countries can pay less. I’m not so sure about you, but US citizens subsidizing European drug prices doesn’t sound very patriotic to me.

  2. Treva says:

    My son began Ocrevus in the Opera clinical trials and has been relapse free ever since. His foot drop disappeared and only shows in high heat or heavy physical exertion. His mood swings and sleep improved dramatically too. I began Ocrevus in Dec. 2017, receiving my second full dose in Dec. 2018, and have been doing great. I feel better, move better,etc., and have had no relapses. My neuro says that my left hand/arm are back to full strength and we are monitoring left foot/leg for improvement. Neither my son nor I have any side effects from the Ocrevus at all. It has been a tremendous blessing for us. The co-pay program helps immensely with the cost.

  3. Daryl J. Melancon says:

    I have started taking Ocrevus and Taking my 2nd dose this Friday before that I was on Tysabri for 12 years I’m not saying that it didn’t work but, I had it in my mind that it wasn’t working anymore so no matter the cost because they are all very expensive you have to feel like it is working in your mind I do feel better so far Knock on wood.

  4. sean fitzpatrick says:

    I’ve been on Ocrevus for three treatments coming up on my 4th next week. I was on copaxone for 2.5 years and saw very little results with often pain at injection sites. I found my strength and ability to focus at my job much better. My mother has Ms and at 72 she has been taken over by MS. I wish my mom had a chance to be on Ocrevus because i think things would have been different for her. I work hard at eating well and staying in shape. (800 push ups a week and many miles on my bike) Which i also think is important so never stop even on some less than great days. This change of drug for me is game changing in many ways. I look forward to my future once again. Thank you modern medical technology and Ocrevus. I hope other people have a chance for hope on this drug. MS will never beat me with my will and help from Ocrevus. And no I dont work for Them. Just happy to have it enter my life.

  5. Regina says:

    Is anyone concerned about the potential malignancies with long term use of Ocrevus? My neurologist suggested that I consider starting treatment with Ocrevus. However, I can’t help but think that although there have been numerous trials, that the “real” trial is happening as we speak. As more and more MS patients are being pushed into this treatment. I feel that in a couple of years, we may see not so favorable outcomes. Is it paranoia? Something about it scares me.

    • Fermi says:

      Regina, I feel exactly like you do (i.e. that the “real” trial is going on now and that in a few years we may see many adverse consequences because of this drug). My neuro is recommending the dmt too; I have been on Rebif then Plegridy for 5 years. The beta-interferons have been around for years with a trusted record. And they worked in regards to the relapses and progression, it was the side effects/quality of life that eventually caused me to stop taking the injections (horrible headaches, flu-like symptoms, worsened fatigue, and depression). Some of those symptoms very well may have just been the MS, not the drug, though. However, like you, I am afraid of Ocrevus. I just don’t think the clinical trials were large enough – or long enough – to say that it is safe. I’m struggling between starting this or going back on Plegridy. The side effects (and the MS itself) are, in my opinion, a smaller price to pay versus cancer/malignancies. We already have enough problems as it is. I feel like we are guiney pigs due to the huge influx of “new” dmts that have flooded the market in a relatively short time – with no long term studies to back them. Big pharma sells hope; and those who are seeking it, don’t question the consequences much. Doctors get kickbacks from them for promoting/pushing their product. And those who claim to be so much better on the new ones (like Ocrevus), are they? Or, is it a psychological reaction that they are in fact better? You are not alone in your thoughts/fears. I am right there with you. I’m at an impasse as to what to do while my neuro sits there tapping his fingers and treating me like a disobedient child.

  6. Stacy says:

    The FDA only did minimal studies there’s no recommendations to doctors because they don’t know yet. And it can cause PML. There have been more deaths that haven’t been released yet.

  7. Kim Hawkins says:

    I am a 61, soon to be 62, year old female. Diagnosed with MS in December. Have been on Copaxone since January. In April I had a relapse. My neurologist is now suggesting Trifecta or Ocrevus. Blood work showed positive for JC Virus. Needless to say, I am scared to death of both these meds. I’m kind of leaning toward Orcevus, but I’m concerned about the bottom line cost to me after insurance and co pay assistance. Can someone tell me what they are paying out of pocket?

    • Michelle says:

      I had pretty bad diarrhea with Tecfidera even after a year. I did all the suggestions to help overcome it. I had to stop at gas stations all the time. I pooped my pants a lot too. Didn’t work for me but I have a friend the ho had milder diarrhea.

    • Jean Visco says:

      I too am 61, will 62 in August and just diagnosed with MS this week. As we are outliers with this disease I’d love to know your first symptoms and how long they lasted and how you are feeling and doing. Mine started with numbness and its been going on for 50 days. Doctor say my case is mild but recommending Ocrevus, about to go for second opinions. What was the thinking behind Copaxone?

  8. kj slay says:

    As the mother of an MS patient, my 35 year old son has fallen so far during the last few years. He decided to stop using the drugs as it was bothering him more than helping. Now he seems to be in a downward spiral that hasn’t let up. He is waiting for his second half of Ocrevus as of this writing. He seems more alert/legs/arms strength is good. He hasn’t walked in 2 years, and relies on us his folks to feed/bath/take to doctor. I am hoping this works for him. What I would like for folks to take away from MY comments, is that the modifying drugs are there for a reason. Son was off of them for 4 years, and is paying the price. Please PLEASE take what ever actions you feel right for yourselves, but remember modifying means curtailing this disease even for a little while. Hugs to all warriors battling this merciless disease.

  9. Ana says:

    I’m not sure where to begin…
    My daughter was diagnosed in 2016, one month prior to her 16th birthday. Her neurologist started her off with Gilenya, which was great for almost 2 years. Then he suggested switching her to Ocrevus but we had to wait until her 18th birthday to come around because it’s not approved for anyone under the age of 18. It was the longest 4 months that we had to wait. Ocrevus has done wonders for her confidence and determination to live a full life and talks about her future plans. I can’t even imagine how she gets through her days, let alone getting through them with the symptoms that she has learned to live with. However, Ocrevus has given her what no one can, the WILL to plan for a future, HER future. She has been switched over to an adult neurologist now that she is 18 but he wants to switch her to Tysabri, a monthly infusion as opposed to an infusion every 6 months and I fail to understand why if Ocrevus has been working just fine… no relapses, no active demyelination, no new lesions, so why switch her….???? Can anyone shed some light on this please.

    • nd says:

      Ask your doctor. Seriously, that’s the answer. Whenever a dr says he wants to change something the first thing out of your mouth should be “why”. Not accept it and go on the internet asking people who have 0 information about you. Ask the person sitting in the room with you. He’s the only one that has the answers, all anyone else can do is speculate.

    • Ilona says:

      I have been using Tysabri for 4 years – none of the worsening really suited me. I’m going to get Ocrevus now because I haven’t been on the same drug for a long time because of the risk of PML

  10. SMAC says:

    Terrible drug!!! Would not recommend it. I know every case is different but for me Ocrevus has been a nightmare. Too many side effects. Will ho back on tecfidera. SERIOUSLY CONSIDER THIS MEDICATION

  11. CB says:

    I’ve been on Tysabri for about 16 years or since the trials started. I had a few relapses before I started and havnt had any relapses since I started Tysavri. I am at the top stage of the JCV positive and have to come off Tysabri. I am very very nervous as to me Tysabri gave me me my life back but the longer on Tysabri the higher the risk of PML is getting higher. Ocrevus has been suggested. Is it as good as Tysabri?

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