MS specialist Dr. Gabriel Pardo shares his thoughts on the long-term safety data of OCREVUS.
For complete safety information, please see the full Prescribing Information.
In Phase III trials, the most common adverse events (AEs) were infusion reactions and infections (mainly mild to moderate)1
AEs were classified according to Medical Dictionary for Regulatory Activities (MedDRA) versions 18.0, 18.1, 22.1, and 24.1. Multiple occurrences of the same AE in one patient are counted multiple times, except for malignancies.
*Data as of April–July 2015.
†Includes patients with RMS who received any dose of OCREVUS during the controlled period and associated OLE periods of the Phase II and Phase III studies plus VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, LIBERTO, CHIMES, and OLERO (data as of November 2022).
‡Incudes patients with PPMS who received any dose of OCREVUS during the controlled period and associated OLE periods of OBOE, CONSONANCE, and OLERO (data as of November 2022).
§Includes patients who received any dose of OCREVUS during the controlled period and associated OLE periods of the Phase II and Phase III studies plus VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, LIBERTO, CONSONANCE, CHIMES, and OLERO, including patients originally randomized to comparator (IFN β-1a or placebo) who switched to open-label OCREVUS treatment (data as of November 2022).
||Serious infections are defined using AEs falling into the MedDRA system organ class “Infections and infestations,” and using “Is the event nonserious or serious?” from the AE case report form.
¶Malignancies are identified using AEs falling into the standard MedDRA query “Malignant tumours (narrow).”
#For malignancies, incidence rates are reported and exposure in PY was calculated from first treatment to onset of first malignancy.
OPERA I and II (RMS): Two randomized, double-blind, double-dummy, active comparator–controlled clinical trials of identical design vs Rebif in 1656 patients (OCREVUS; OPERA I [n=410], OPERA II [n=417]; Rebif; OPERA I [n=411], OPERA II [n=418]) with RMS treated for 96 weeks. Both studies included patients who had experienced ≥1 relapse within the prior year, or ≥2 relapses within the prior 2 years, and had an EDSS score between 0 and 5.5.
ORATORIO (PPMS): A randomized, double-blind, placebo-controlled clinical trial in 732 patients (OCREVUS, n=488; placebo, n=244) with PPMS treated for at least 120 weeks. Selection criteria included patients aged 18 to 55 and required a baseline EDSS score of 3.0 to 6.5 and a score of 2.0 or greater for the EDSS pyramidal functional systems score due to lower extremity findings. Patients also had no history of RMS, SPMS (secondary progressive multiple sclerosis), or PRMS (progressive relapsing multiple sclerosis).1,58
**The COVID-19 pandemic resulted in an increased number of cases of infections related to SARS-CoV-2 during the reporting interval. For both RMS and PPMS, serious infections data are presented for the full OCREVUS all-exposure population and a subset of this population without COVID-19 infections (Ex-COVID-19). In the Ex-COVID-19 analysis, patients continued to contribute to the incidence of all other AEs.5
††Includes patients who received any dose of OCREVUS during the controlled period and associated OLE periods of the Phase II and Phase III studies plus VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, LIBERTO, and CONSONANCE, including patients originally randomized to comparator (IFN β-1a or placebo) who switched to open-label OCREVUS treatment (data as of November 2022).5
‡‡The exposure in PY during Year 9 is limited for meaningful interpretation.5
Breast cancer was found in:
The FDA recommends that OCREVUS patients follow standard breast cancer screening guidelines1
The American Cancer Society recommends that patients age <40 with risk factors for breast cancer should ask their HCP whether mammograms are advisable and how often to have them. Patients age 45 to 54 should get mammograms every year.65
“Age-at-enrollment” methodology only captures how old a patient was at the trial baseline, and not when the event occurred. However, as study follow-up continues and patients become older, the “age-at-event onset” methodology, based on the age of the patient at the onset of malignancy, is a more precise method of calculating the standardized incidence rate.5
††Nonmelanoma Skin Cancer (NMSC) is not reported in the Surveillance, Epidemiology, and End Results (SEER) program.5
‡‡Includes patients who received any dose of OCREVUS during the controlled period, extended-controlled period, and associated OLE periods of the Phase II and Phase III studies, including patients originally randomized to comparator (Rebif or placebo) who switched to open-label OCREVUS treatment.63
§§Includes patients described in footnote ‡‡ plus VELOCE, CHORDS, CASTING, and OBOE.63
∥ ∥Includes patients described in footnote §§ plus ENSEMBLE.63
¶¶Includes patients described in footnote ∥ ∥ plus LIBERTO.63
##Includes patients described in footnote ¶¶ plus CONSONANCE.63
***Includes patients who received any dose of OCREVUS during the controlled period, and associated OLE periods of the Phase II and Phase III studies, plus VELOCE, CHORDS, CASTING, OBOE, ENSEMBLE, LIBERTO, and CONSONANCE, including patients originally randomized to comparator (Rebif or placebo) who switched to open-label OCREVUS treatment.63
The SEER Program of the National Cancer Institute (NCI) is an authoritative source of information reporting data on cancer incidence in 48% of the general US (non-MS specific) population. No comparisons should be made due to limitations that have not been fully accounted for, such as variations in patient populations, as well as differences in sample size, temporal changes, and other potential confounding factors.66
Visit the OCREVUS dosing schedule for your patients.
Speak to an OCREVUS Representative to learn more about OCREVUS.
EDSS=Expanded Disability Status Scale; OLE=open-label extension; PY=patient-years; RMS=relapsing multiple sclerosis; SEER=Surveillance, Epidemiology, and End Results.
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