Compared with patients who initially received interferon treatment, those given ocrelizumab had superior disability progression after a 6-year follow-up.
Stephen L. Hauser, MD
Patients with relapsing multiple sclerosis (RMS) who initiated ocrelizumab treatment earlier were reported with greater 24-week confirmed disability progression (CDP24) and relapse rate compared with patients who received initial interferon treatment, according to data from a new open-label study report.
After a 4-year study period, the group who continued on ocrelizumab treatment (OCR-OCR) had an annualized relapse rate (ARR) decrease from 0.13 to 0.05, while those who switched to ocrelizumab from interferon ß-1a (IFN-OCR) had a decrease from 0.20 to 0.04. These findings were reported at America’s Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum, February 27-29, 2020, in West Palm Beach, Florida.
Ocrelizumab was previously approved in 2017 for the treatment of relapsing forms of MS, including clinically isolated syndrome, as well as secondary progressive and primary progressive disease. Additionally, the FDA issued updates to the drug label reflecting new information about infusion reactions, vaccinations, and risks in specific patient populations were made in January 2020.
In the double-blind period of the phase 3 trials which were the basis of this open-label assessment—OPERA 1 and OPERA 2 (NCT01247324; NCT01412333)—the therapy was found to be safe and tolerable in RMS over a 96-week period. In this analysis, investigators assessed the efficacy of switching to or maintaining ocrelizumab therapy on disease activity and progression after 4 years of follow-up in the open-label extension (OLE) period of OPERA 1 and OPERA 2.
Patients who completed the double-blind period either continued ocrelizumab (n = 702) or were switched from interferon (IFN) β-1a to ocrelizumab (n = 623) at the start of the OLE period. In total, 62.6% (n = 519) and 69.2% (n = 572) of the IFN and ocrelizumab groups, respectively, completed the open-label study through year 4.
Investigators assessed patients on adjusted ARR, time to onset of CDP24, and change in adjusted mean Expanded Disability Status Scale (EDSS) score from double-blind period baseline.
At the end of year 4, 82.3% of the patients who entered the OLE completed the open-label extension. From pre-switch to years 1, 2, 3, and 4 post-switch, AAR decreased from 0.20 to 0.10, 0.08, 0.07, and 0.04, respectively, among IFN-OCR patients. Compared with OCR-OCR continuers, ARR was maintained at a lower rate at pre-OLE and through the 4 years of the OLE period (0.13, 0.10, 0.08, 0.07, 0.05).
In addition to the lower ARR, ORC-ORC continuers had lower proportions of patients with CDP24 in the year pre switch, and at OLE year 1 and years after when compared to IFN-OCR switchers. In the year pre switch, 7.7% of OCR-OCR continuers had CDP24, compared to 12% of IFN-OCR switchers. The trend continued in OLE year 1 (10.1% vs 15.6%), OLE year 2 (13.9% vs 18.1%), OLE year 3 (16.2% vs 21.3%) and OLE year 4 (19.2% vs 23.7%; P <.05).
Investigators noted a similar safety profile of OCR from what was observed in the double-blind period. Additional data on the lasting measures of permanent disability using a 48-week CDP are expected to be presented at a later date.
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Hauser SL, Kappos L, Giovannoni G, et al. Long-term reduction of relapse rate and confirmed disability progression after 6 years of ocrelizumab treatment in patients with relapsing MS. Presented at 2020 ACTRIMS forum. February 27-29, 2020; West Palm Beach, Florida. Abstract P064.