Long-Term Reductions in MS Disability Progression After Ocrelizumab Treatment

Neurology Advisor Contributing Writer
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In the transition from RRMS to SPMS, inflammation that occurs early in the disease process slowly decreases over time, but a gradual worsening of symptoms occurs. The challenge for clinicians is to determine whether worsening symptoms are from the last relapse, or whether the patient has progressed to SPMS. A careful history of changes in a patient’s symptoms, neurologic examination, and MRI can help determine whether the transition has occurred. Interferon beta (Avonex, Betaseron, Extavia and Rebif), Aubagio (teriflunomide), Gilenya (fingolimod), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab) are approved by the FDA for use in relapsing forms of MS, including SPMS. Many of those who progress to SPMS continue using these medications unless they are no longer adequately controlling disease activity. In this case, patients may transition to Novantrone (mitoxantrone), the only medication approved by the FDA specifically for SPMS, as well as worsening relapsing MS.

In the transition from RRMS to SPMS, inflammation that occurs early in the disease process slowly decreases over time, but a gradual worsening of symptoms occurs. The challenge for clinicians is to determine whether worsening symptoms are from the last relapse, or whether the patient has progressed to SPMS. A careful history of changes in a patient’s symptoms, neurologic examination, and MRI can help determine whether the transition has occurred.

Interferon beta (Avonex, Betaseron, Extavia and Rebif), Aubagio (teriflunomide), Gilenya (fingolimod), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab) are approved by the FDA for use in relapsing forms of MS, including SPMS. Many of those who progress to SPMS continue using these medications unless they are no longer adequately controlling disease activity. In this case, patients may transition to Novantrone (mitoxantrone), the only medication approved by the FDA specifically for SPMS, as well as worsening relapsing MS.

Study evaluates the benefits of ocrelizumab on 48-week confirmed disability progression in MS observed in pooled OPERA I and OPERA II, as well as a 3 year ocrelizumab treatment in an open-label extension.

The following article is part of conference coverage from the 2019 Annual Meeting of the Consortium of Multiple Sclerosis Centers , in Seattle, Washington. Neurology Advisor‘s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from CMSC 2019.

SEATTLE — The benefits of ocrelizumab on 48-week confirmed disability progression (CDP) in multiple sclerosis observed in the 2-year double-blind period of the pooled OPERA I and OPERA II trials (trial registration: NCT01247324, NCT01412333) were greater than those observed in the 12- and 24-week CDP, and the benefits were maintained after 3 years of ocrelizumab treatment in the open-label extension (OLE), according to research presented at the 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers, held May 28 through June 1, 2019, in Seattle, Washington.

Study investigators assessed the efficacy of maintaining or switching to ocrelizumab therapy on 48-week CDP (CDP48) in the OLE of the pooled OPERA I and OPERA II phase 3 trials in relapsing multiple sclerosis. At the beginning of the OLE, patients either continued ocrelizumab or were switched from interferon beta 1-alpha to ocrelizumab (interferon-OCR). Time to onset of CDP48 was analyzed for the 2-year double-blind period and over 3 years of the OLE.

Eighty percent of patients from the pooled OPERA I and OPERA II trials entered the OLE, of which 89% completed through year 3. In the double-blind period, the risk for CDP48 was reduced by 57% (P <.001) compared with interferon beta 1-alpha. A lower proportion of patients with CDP48 was observed with continuous ocrelizumab vs interferon-OCR at OLE years 1, 2, and 3 (6.5% vs 11.7%, Δ=5.2% [P <.001]; 9.4% vs 14.1%, Δ=4.7% [P =.007]; and 10.4% vs 15.7%, Δ=5.4% [P =.004], respectively).

Study investigators conclude, “The benefits of ocrelizumab on CDP48 observed in the 2-year double-blind period were greater than for 12- and 24-week CDP, potentially due to a higher specificity for permanent disability accumulation. The benefit was maintained after 3 years’ ocrelizumab treatment in the OLE. After 5 years of follow up, the CDP48 benefits accrued in those initiating ocrelizumab 2 years earlier were maintained vs those switching from interferon beta 1-alpha to ocrelizumab at OLE baseline.”

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Study investigators report financial connections to GlaxoSmithKline, Brainstorm, Neurona Therapeutics, Symbiotix, Annexon, Bionure, Alector, Molecular Stethoscope, Actelion, Alkermes, Almirall, Bayer, Biogen, Celgene/Receptos, df-mp, EXCEMED, GeNeuro, Genzyme, Japan Tobacco, Merck, Minoryx, Mitsubishi Pharma, Novartis, F. Hoffman-La Roche Ltd, Sanofi-Aventis, Santhera, Teva, Vianex, GW Pharma, MedDay Pharmaceuticals, Alkermes, Acorda Therapeutics, and EMD Serono.

Visit Neurology Advisor‘s conference section for continuous coverage from CMSC 2019.

Reference

Hauser SL, Kappos L, Montalban X, et al. Long-term reduction in 48-week confirmed disability progression after 5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis. Presented at: The 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers; May 28-June 1, 2019; Seattle, WA. Abstract NDM02.

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