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.

12 comments

    • 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.

    • 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.

  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.

  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.

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