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

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

BY JOSE MARQUES LOPES, PHD

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.

Source:https://multiplesclerosisnewstoday.com

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