This is the extension study of ocrelizumab when people who had taken beta interferon were switched onto ocrelizumab and compared to ocrelizumab. You can read what the medical writer, drafted for the authors, I mean drafted in response to the input from the authors:-).
You can have a read, but the important point is this the brain volume lost in the 2 years of being put on beta interferon compared to ocrelizumab was still there after 3 years of every one being on ocrelizumab. So what’s lost is lost. Time is brain and so make sure you get on an effective treatment as quickly as possible after disease onset. Therefore, I am not sure we should be celebrating those people accredited with the trial design, so I hought I would give their names a miss., to test their new drug against agents that they know will not work well for the people volunteering for the trials.
I am sure they work well for some people
Medical writer et al. Five-years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension [published online ahead of print, 2020 Jul 20]. Neurology. 2020;10.1212/WNL.0000000000010376.
Objective: To assess over 3 years of follow-up, the effects of maintaining or switching to ocrelizumab (OCR) therapy on clinical and MRI outcomes and safety measures in the open-label extension (OLE) phase of the pooled OPERA studies in relapsing multiple sclerosis.
Methods: After 2 years of double-blind, controlled treatment, patients continued OCR (600 mg infusions every 24 weeks) or switched from interferon (IFN) β-1a (44 μg 3 times weekly) to OCR when entering the OLE phase (3 years). Adjusted annualized relapse rate, time to onset of 24-week confirmed disability progression/improvement (CDP/CDI), brain MRI activity (gadolinium-enhanced and new/enlarging T2 lesions), and percentage brain volume change were analyzed.
Results: Of patients entering the OLE phase, 88.6% completed Year 5. The cumulative proportion with 24-week CDP was lower in patients who initiated OCR earlier, vs patients initially receiving IFN β-1a (16.1% vs 21.3% at Year 5; p=0.014). Patients continuing OCR maintained, and those switching from IFN β-1a to OCR attained near complete and sustained suppression of new brain MRI lesion activity from Year 3 to 5. Over the OLE phase, patients continuing OCR exhibited less whole brain volume loss from double-blind study baseline vs those switching from IFN β-1a (-1.87% vs -2.15% at Year 5; p<0.01). Adverse events were consistent with past reports and no new safety signals emerged with prolonged treatment.
Conclusion: Compared with patients switching from IFN β-1a, earlier and continuous OCR treatment up to 5 years provided sustained benefit on clinical and MRI measures of disease progression.
Classification of evidence: This study provides Class III evidence that earlier and continuous treatment with ocrelizumab provided sustained benefit on clinical and MRI outcomes of disease activity and progression compared with patients switching from IFN β-1a. The study is rated Class III because of the initial treatment randomization disclosure that occurred after inclusion in OLE.
Clinical trial identifier numbers: NCT01247324/NCT01412333.