For Patients and Caregivers

Click here for study design information

Quick Links:

Superior relapse rate reductions vs Rebif
Significant impact on disability
Superior reductions in T1 Gd+ lesions
Superior reductions in T2 lesion activity
NEDA by Week 96

SUPERIOR RELAPSE REDUCTIONS vs REBIF AT YEAR 21

OCREVUS reduced relapse rate by nearly half1

SUPERIOR RELAPSE REDUCTIONS vs REBIF AT YEAR 2 (CONTROLLED PERIOD)1

Annualized relapse rate with OCREVUS® (ocrelizumab) vs Rebif
  • 83%/82% of patients treated with OCREVUS were relapse free at the end of the 2-year controlled period vs 71%/72% with Rebif (OPERA I/OPERA II)1

The efficacy and safety of OCREVUS in RMS were studied vs Rebif in 2 double-blind, double-dummy trials evaluating over 1600 patients for 2 years.1,2

ARR THROUGH 10+ YEARS (CONTROLLED AND OPEN-LABEL EXTENSION [OLE] PERIODS)3

Annualized relapse rates compared to those observed in the controlled period

Relapses were defined as new or worsening neurologic symptoms that were attributable to multiple sclerosis, persisted for over 24 hours, were immediately preceded by a stable or improving neurological state for at least 30 days, and were accompanied by objective neurological worsening as defined in the study protocols. Measurements performed at intermediate timepoints were not prespecified in the statistical testing hierarchy and reflect numerical trends only2,4

Limitations of the open-label, uncontrolled study period

Patients in the OLE period successfully completed the controlled period and are subject to continued dropout; they may represent an enriched population. The endpoints measured were not prespecified or powered to conclude statistical significance; they only convey numerical trends. Conclusions regarding the treatment effect of OCREVUS cannot be drawn on the basis of OLE data. Measurements performed at intermediate timepoints were not prespecified in the statistical testing hierarchy and reflect numerical trends only.1,5

Select Important Safety Information

Contraindications
Treatment with ocrelizumab is contraindicated in patients with active hepatitis B virus infection and in patients with a history of life-threatening administration reactions to ocrelizumab. OCREVUS ZUNOVO is also contraindicated in patients with a history of hypersensitivity to ocrelizumab, hyaluronidase, or any component of OCREVUS ZUNOVO.

Only OCREVUS significantly impacted disability in 3 endpoints across 2 identical RMS trials vs an active comparator1,2

SUPERIOR REDUCTION IN RISK OF CDP vs REBIF (CONTROLLED PERIOD)

  • OPERA I and II (RMS): 2 identical, active comparator-controlled clinical trials 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. The primary outcome of both studies was annualized relapse rate (ARR) 

Limitations

  • Patients in the OLE period successfully completed the controlled period and are subject to continued dropout; they may represent an enriched population. The endpoints measured were not prespecified or powered to conclude statistical significance; they only convey numerical trends. Conclusions regarding the treatment effect of OCREVUS cannot be drawn on the basis of OLE data.

DISABILITY DATA THROUGH 10+ YEARS1,3,8

In the controlled period, fewer OCREVUS patients had experienced disability progression than those who started on Rebif3,8

TIME TO ONSET OF 24-WEEK CDP (CONTROLLED AND OLE PERIODS)3,8

During the controlled period, fewer OCREVUS® (ocrelizumab) patients had experienced disability progression than those who started on Rebif
  • Conclusions regarding the treatment effect of OCREVUS cannot be drawn on the basis of OLE data.
  • All patients in the OLE period have been treated with OCREVUS.3

>90% of patients treated with OCREVUS showed no 12-week or 24-week confirmed disability progression in the controlled period1,2

SIGNIFICANT DIFFERENCE IN CDI vs REBIF (CONTROLLED PERIOD)2

  • >20% OF OCREVUS-TREATED PATIENTS SHOWED CONFIRMED DISABILITY IMPROVEMENT (CDI)2

Confirmed disability progression (CDP) was defined as patients with EDSS ≤5.5 who experienced an EDSS increase of ≥1.0. For patients with EDSS >5.5, progression was an EDSS increase of ≥0.5. Disability progression was categorized as confirmed if it was present at 12 or 24 weeks over the treatment period.2

Confirmed disability improvement (CDI) was defined as a reduction from the baseline EDSS score of at least 1.0 point (or 0.5 points if the baseline EDSS score was >5.5) that was sustained for at least 12 weeks in patients with a baseline EDSS score of at least 2.0.2

See the latest data

Explore the latest OCREVUS safety data, including open-label extension data.

View RMS Safety Data

Request information

Speak to an OCREVUS Representative to learn more about OCREVUS.

Contact a Rep

Select Important Safety Information

The warnings and precautions for ocrelizumab are infusion reactions (OCREVUS) or injection reactions (OCREVUS ZUNOVO) and infections, which include respiratory tract infections, herpes, hepatitis B virus (HBV) reactivation, and a warning for progressive multifocal leukoencephalopathy (PML). Additional warnings are possible increased risk of immunosuppressant effects with other immunosuppressants, reduction in immunoglobulins, malignancies, and immune-mediated colitis.

OCREVUS demonstrated superior reductions in mean number of T1 Gd+ lesions over 2 years1

NEAR-COMPLETE SUPPRESSION of T1 Gd+ LESIONS1*

Mean number of T1 Gd+ lesions with OCREVUS® (ocrelizumab) vs Rebif

T1 GD+ LESIONS (CONTROLLED AND OLE PERIODS)3†

Mean number of T1 Gd+ lesions observed in the OLE period were consistent with the controlled period.

Conclusions regarding the treatment effect of OCREVUS (ocrelizumab) cannot be drawn on the basis of OLE data.

*The precise mechanism by which OCREVUS exerts its therapeutic effects in MS is unknown.1
†Relative reductions vs Rebif in T1 Gd+ lesions were observed in the controlled period at each of the intermediate timepoints, Weeks 24, 48, and 96. The measurements performed at these intermediate timepoints were not prespecified in the statistical testing hierarchy and reflect numerical trends only.2,4

Unadjusted controlled and OLE data include the ITT population; clinical cutoff date: November 2022. Number of T1 Gd+ lesions at each timepoint for all patients in the treatment group divided by the total number of brain MRI scans at that timepoint.3,8

Select Important Safety Information

OCREVUS: Infusion Reactions
Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue OCREVUS if a life-threatening or disabling infusion reaction occurs.

OCREVUS ZUNOVO: Injection Reactions
Management recommendations for injection reactions depend on the type and severity of the reaction. Permanently discontinue OCREVUS ZUNOVO if a life-threatening or disabling injection reaction occurs.

OCREVUS demonstrated superior reductions in mean number of T2 lesions over 2 years1

SUPERIOR REDUCTIONS IN MEAN NUMBER OF NEW OR ENLARGING T2 LESIONS1

NEW OR ENLARGING T2 LESIONS (CONTROLLED AND OLE PERIODS)3

Conclusions regarding the treatment effect of OCREVUS (ocrelizumab) cannot be drawn on the basis of OLE data.

‡Relative reductions in T2 lesions were observed in the controlled period at each of the intermediate timepoints, Weeks 24, 48, and 96. The measurements performed at these intermediate timepoints were not prespecified in the statistical testing hierarchy and reflect numerical trends only.2,4

Unadjusted controlled and OLE data include the ITT population; clinical cutoff date: November 2022. Number of new or enlarging T2 lesions relative to preceding scan for all patients in the treatment group at each timepoint for all patients in the treatment group divided by the total number of brain MRI scans at that timepoint.3,8

Select Important Safety Information

Infections
Serious, including life-threatening or fatal, bacterial, viral, parasitic and fungal infections have occurred with ocrelizumab. An increased risk of serious infections has been observed in patients who have received anti-CD20 B-cell depleting therapies. Delay administration of ocrelizumab in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with ocrelizumab-containing products and after discontinuation, until B-cell repletion

NEDA BY WEEK 96 (POST HOC ANALYSIS)2

No evidence of disease activity (NEDA) in the controlled period including re-baselined analysis

Assessment and limitations of NEDA in OPERA I and II

  • The predefined secondary endpoint was not statistically significant, and it was considered nonconfirmatory because it fell below the break in the statistical hierarchy at change in Multiple Sclerosis Functional Composite Scale (MSFCS) score from baseline to Week 962,4
  • Exploratory result based on modified ITT population2,4

Post hoc analysis: re-baselined NEDA data9

Assessment and limitations of re-baselined NEDA in OPERA I and II9

  • During Weeks 48 to 96, the lower frequency of MRI scans compared with other time periods may have influenced the proportions of patients maintaining NEDA
  • Moving into the clinical practice setting, the optimal timing of re-baselining should reflect the anticipated timing for reaching complete DMT efficacy, to give a more reliable indication of subsequent drug failure
  • Conclusions from cross-trial comparisons are limited because of differences including comparators, patient populations, MRI techniques, frequency of assessments, analysis methods, and definitions of NEDA

Generation O in OPERA I and II

Select baseline characteristics of patients in OCREVUS trials for RMS1,10-13

Only aCD20 for MS with 10+ years of clinical trial experience1,3

OPERA I and OPERA II were identical head-to-head clinical trials of OCREVUS vs Rebif® (interferon β-1a) in RMS2

OPERA I AND OPERA II POOLED ANALYSIS2,3,5

  • Patients who received Rebif during the controlled period continued to receive Rebif during the open-label extension (OLE) screening period until their first infusion of OCREVUS2
  • In the OLE phase, the first 600-mg dose of OCREVUS was administered as two 300-mg infusions given 2 weeks apart3

KEY INCLUSION CRITERIA2

  • ≥2 relapses within last 2 years
  • ≥1 relapse in last year
  • EDSS score from 0.0 to 5.5

CONTROLLED AND OLE STUDY ENDPOINTS2

  • Annualized relapse rate (primary endpoint)
  • 12-week and 24-week confirmed disability progression (CDP) in the controlled period and 24-week and 48-week CDP in the OLE period
  • Confirmed disability improvement (CDI) at 12 weeks through 96 weeks
  • Mean number of T1 Gd+ lesions and new or enlarging T2 hyperintense lesions per MRI at Week 96
  • Exploratory composite endpoint: proportion of patients with No Evidence of Disease Activity (NEDA) in the controlled period
  • Safety

Limitations of the open-label, uncontrolled study period

Patients in the OLE period successfully completed the controlled period and are subject to continued dropout; they may represent an enriched population. The endpoints measured were not prespecified or powered to conclude statistical significance; they only convey numerical trends. Conclusions regarding the treatment effect of OCREVUS cannot be drawn on the basis of OLE data.1,5

*OCREVUS: OPERA I, n=410; OPERA II, n=417. Rebif: OPERA I, n=411; OPERA II, n=418.2
†OCREVUS arm: 600-mg intravenous (IV) dose every 24 weeks (first dose: two 300-mg IV infusions 2 weeks apart) or placebo as subcutaneous (SC) injections 3 times/week; Rebif arm: 44-μg SC 3 times/week or placebo IV infusions every 24 weeks.2

Request information

Speak to an OCREVUS Representative to learn more about OCREVUS.

Contact a Rep

 

aCD20=anti-CD20; ARR=annualized relapse rate; DMT=disease modifying therapy; EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; ITT=intent-to-treat; MRI=magnetic resonance imaging; MS=multiple sclerosis; OLE=open-label extension; RMS=relapsing multiple sclerosis.

Important Safety Information & Indications

Indications

OCREVUS and OCREVUS ZUNOVO are indicated for the treatment of:

  • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
  • Primary progressive MS, in adults.
Contraindications

Treatment with ocrelizumab is contraindicated in patients with active hepatitis B virus infection and in patients with a history of life-threatening administration reactions to ocrelizumab. OCREVUS ZUNOVO is also contraindicated in patients with a history of hypersensitivity to ocrelizumab, hyaluronidase, or any component of OCREVUS ZUNOVO.

Warnings and Precautions
Injection Reactions (OCREVUS ZUNOVO) OR Infusion Reactions (OCREVUS)

OCREVUS ZUNOVO can cause injection reactions, which can be local or systemic. Common symptoms of local injection reactions reported by patients treated with OCREVUS ZUNOVO in multiple sclerosis (MS) clinical trials included erythema, pain, swelling, and pruritus. Common symptoms of systemic injection reactions reported by patients included headache and nausea. In an open-label, active-controlled trial, injection reactions were more frequently reported with the first injection; 49% of patients experienced an injection reaction with the first injection.

In OCREVUS MS clinical trials, the incidence of infusion reactions in patients [who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions prior to infusion] was 34% to 40%, with the highest incidence with the first infusion. There were no fatal infusion reactions, but 0.3% of intravenous ocrelizumab-treated MS patients experienced infusion reactions that were serious, some requiring hospitalization. Symptoms of infusion reactions can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis.

Monitor OCREVUS ZUNOVO patients during and after injections. Observe patients treated with OCREVUS for infusion reactions during the infusion and for at least one hour after completion of the infusion. Inform patients that administration reactions can occur during or within 24 hours of treatment.

Reducing the Risk and Managing Injection or Infusion Reactions

For OCREVUS ZUNOVO, administer oral pre-medication (e.g., dexamethasone or an equivalent corticosteroid, and an antihistamine) at least 30 minutes prior to each OCREVUS ZUNOVO injection to reduce the risk of injection reactions. The addition of an antipyretic (e.g., acetaminophen) may also be considered.

For OCREVUS, administer pre-medication (e.g., methylprednisolone or an equivalent corticosteroid, and an antihistamine) to reduce the frequency and severity of infusion reactions. The addition of an antipyretic (e.g., acetaminophen) may also be considered.

Management recommendations depend on the type and severity of the reaction. For life-threatening reactions, immediately and permanently stop OCREVUS ZUNOVO or OCREVUS and administer appropriate supportive treatment. For less severe OCREVUS ZUNOVO injection reactions, the injection should be interrupted immediately, and the patient should receive symptomatic treatment. The injection should be completed at the healthcare provider’s discretion and only after all symptoms have resolved. For less severe OCREVUS infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections

Serious, including life-threatening or fatal, bacterial, viral, parasitic and fungal infections have been reported in patients receiving ocrelizumab. An increased risk of infections (including serious and fatal bacterial, fungal, and new or reactivated viral infections) has been observed in patients during and following completion of treatment with anti-CD20 B-cell depleting therapies.

A higher proportion of OCREVUS-treated patients experienced infections compared to patients taking REBIF or placebo. In RMS trials, 58% of OCREVUS-treated patients experienced one or more infections compared to 52% of REBIF-treated patients. In the PPMS trial, 70% of OCREVUS -treated patients experienced one or more infections compared to 68% of patients on placebo. OCREVUS was not associated with an increased risk of serious infections in MS patients in controlled trials.

Ocrelizumab increases the risk for upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes-related infections. Delay administration of ocrelizumab in patients with an active infection until the infection has resolved.

Respiratory Tract Infections

A higher proportion of OCREVUS-treated patients experienced respiratory tract infections compared to patients taking REBIF or placebo. In RMS trials, 40% of OCREVUS-treated patients experienced upper respiratory tract infections compared to 33% of REBIF-treated patients, and 8% of OCREVUS-treated patients experienced lower respiratory tract infections compared to 5% of REBIF-treated patients. In the PPMS trial, 49% of OCREVUS-treated patients experienced upper respiratory tract infections compared to 43% of patients on placebo and 10% of OCREVUS-treated patients experienced lower respiratory tract infections compared to 9% of patients on placebo. The infections were predominantly mild to moderate and consisted mostly of upper respiratory tract infections and bronchitis.

Herpes

In active-controlled (RMS) clinical trials, herpes infections were reported more frequently in OCREVUS-treated patients than in REBIF-treated patients, including herpes zoster (2.1% vs. 1.0%), herpes simplex (0.7% vs. 0.1%), oral herpes (3.0% vs. 2.2%), genital herpes (0.1% vs. 0%), and herpes virus infection (0.1% vs. 0%). Infections were predominantly mild to moderate in severity. In the placebo-controlled (PPMS) clinical trial, oral herpes was reported more frequently in the OCREVUS-treated patients than in the patients on placebo (2.7% vs 0.8%).

Serious cases of infections caused by herpes simplex virus and varicella zoster virus, including central nervous system infections (encephalitis and meningitis), intraocular infections, and disseminated skin and soft tissue infections, have been reported in the postmarketing setting in multiple sclerosis patients receiving ocrelizumab. Serious herpes virus infections may occur at any time during treatment with ocrelizumab. Some cases were life-threatening.

If serious herpes infections occur, treatment with ocrelizumab should be discontinued or withheld until the infection has resolved, and appropriate treatment should be administered.

Hepatitis B Virus Reactivation

Hepatitis B virus (HBV) reactivation has been reported in MS patients treated with ocrelizumab in the postmarketing setting. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with ocrelizumab. Do not administer ocrelizumab to patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.

Possible Increased Risk of Immunosuppressant Effects With Other Immunosuppressants

When initiating treatment with ocrelizumab after an immunosuppressive therapy or initiating an immunosuppressive therapy after ocrelizumab-containing products, consider the potential for increased immunosuppressive effect. Treatment with ocrelizumab has not been studied in combination with other MS therapies.

Vaccinations

Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ocrelizumab treatment for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ocrelizumab treatment for non-live vaccines. Ocrelizumab may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines following treatment with ocrelizumab has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated With Ocrelizumab Products During Pregnancy

In infants of mothers exposed to ocrelizumab during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of B-cell counts as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines.

You may administer non-live vaccines, as indicated, prior to recovery from B-cell depletion, but you should consider assessing vaccine immune responses, including consultation with a qualified specialist, to assess whether a protective immune response was mounted.

Progressive Multifocal Leukoencephalopathy

Cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients with MS treated with ocrelizumab in the postmarketing setting. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically occurs only in patients who are immunocompromised, and that usually leads to death or severe disability. PML has occurred in ocrelizumab-treated patients who had not been treated previously with natalizumab, (which has a known association with PML), were not taking any immunosuppressive or immunomodulatory medications associated with risk of PML prior to or concomitantly with ocrelizumab and did not have any known ongoing systemic medical conditions resulting in compromised immune system function.

JCV infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

At the first sign or symptom suggestive of PML, withhold treatment with ocrelizumab-containing products and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. 

Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms of PML. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. If PML is confirmed, treatment with ocrelizumab should be discontinued.

Reduction in Immunoglobulins

As expected with any B-cell depleting therapy, decreased immunoglobulin levels are observed with ocrelizumab treatment. The pooled data of OCREVUS clinical studies (RMS and PPMS) and their open-label extensions (up to approximately 7 years of exposure) have shown an association between decreased levels of immunoglobulin G (IgG<LLN) and increased rates of serious infections. Monitor the levels of quantitative serum immunoglobulins during treatment with ocrelizumab and after discontinuation of treatment, until B-cell repletion, and especially in the setting of recurrent serious infections. Consider discontinuing treatment with ocrelizumab- in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Malignancies

An increased risk of malignancy with ocrelizumab may exist. In controlled trials, malignancies, including breast cancer, occurred more frequently in OCREVUS-treated patients. Breast cancer occurred in 6 of 781 females treated with OCREVUS and none of 668 females treated with REBIF or placebo. Patients should follow standard breast cancer screening guidelines.

Immune-Mediated Colitis

Immune-mediated colitis, which can present as a severe and acute-onset form of colitis, has been reported in patients receiving ocrelizumab in the postmarketing setting. Some cases of colitis were serious, requiring hospitalization, with a few patients requiring surgical intervention. Systemic corticosteroids were required in many of these patients. The time from treatment initiation to onset of symptoms in these cases ranged from a few weeks to years. Monitor patients for immune-mediated colitis during ocrelizumab treatment and evaluate promptly if signs and symptoms that may indicate immune-mediated colitis, such as new or persistent diarrhea or other gastrointestinal signs and symptoms, occur.

Use in Specific Populations
Pregnancy

There are no adequate data on the developmental risk associated with use of ocrelizumab in pregnant women. There are no data on B-cell levels in human neonates following maternal exposure to ocrelizumab-containing products. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. Ocrelizumab is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.

Lactation

There are no data on the presence of ocrelizumab or hyaluronidase in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Ocrelizumab was excreted in the milk of ocrelizumab-treated monkeys. Human IgG is excreted in human milk, and the potential for absorption of ocrelizumab to lead to B-cell depletion in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ocrelizumab and any potential adverse effects on the breastfed infant from ocrelizumab or from the underlying maternal condition.

Females and Males of Reproductive Potential

Women of childbearing potential should use effective contraception while receiving ocrelizumab and for 6 months after the last dose of ocrelizumab. Instruct patients that if they are pregnant or plan to become pregnant while taking OCREVUS or OCREVUS ZUNOVO, they should inform their healthcare provider.

Most Common Adverse Reactions

In patients treated with OCREVUS:

  • RMS: The most common adverse reactions (≥10% and >REBIF): upper respiratory tract infections and infusion reactions.
  • PPMS: The most common adverse reactions (≥10% and >placebo): upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections.

The most common adverse reaction observed with OCREVUS ZUNOVO in patients with RMS and PPMS was injection reactions (incidence of 49%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information throughout and click here for full OCREVUS Prescribing Information and Medication Guide. For OCREVUS ZUNOVO, click here for full Prescribing Information and Medication Guide.

    • OCREVUS [prescribing information]. South San Francisco, CA: Genentech, Inc. 2024.

      OCREVUS [prescribing information]. South San Francisco, CA: Genentech, Inc. 2024.

    • Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3): 221​-234.

      Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3): 221​-234.

    • Weber MS, Kappos L, Hauser SL, Nicholas JA, Schneble HM, Wang Q, Giovannoni G, Filippi M. The patient impact of 10 years of ocrelizumab treatment in multiple sclerosis: Long-term data from the Phase III OPERA and ORATORIO studies. Poster presented at: 39th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), October 11-13, 2023.

      Weber MS, Kappos L, Hauser SL, Nicholas JA, Schneble HM, Wang Q, Giovannoni G, Filippi M. The patient impact of 10 years of ocrelizumab treatment in multiple sclerosis: Long-term data from the Phase III OPERA and ORATORIO studies. Poster presented at: 39th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), October 11-13, 2023.

    • Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3)(suppl):S6.

      Hauser SL, Bar-Or A, Comi G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3)(suppl):S6.

    • Hauser SL, Kappos L, Arnold DL, et al. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020;29(13)e1854-e1867.

      Hauser SL, Kappos L, Arnold DL, et al. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020;29(13)e1854-e1867.

    • Data on File. Genentech, Inc. April 2019.

      Data on File. Genentech, Inc. April 2019.

    • 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: 5th Congress of the European Academy of Neurology (EAN); June 29-July 2, 2019; Oslo, Norway.

      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: 5th Congress of the European Academy of Neurology (EAN); June 29-July 2, 2019; Oslo, Norway.

    • Data on file. Genentech, Inc. April 2023.

      Data on file. Genentech, Inc. April 2023.

    • Havrdová E, Arnold DL, Bar-Or A, et al. No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a. Mult Scler J Exp Transl Clin. 2018;4(1): 2055​2173​1876​0642.

      Havrdová E, Arnold DL, Bar-Or A, et al. No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a. Mult Scler J Exp Transl Clin. 2018;4(1): 2055​2173​1876​0642.

    • Turner B, Cree BAC, Kappos L, et al. Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis. J Neurol. 2019;266(5):1182 -1193.

      Turner B, Cree BAC, Kappos L, et al. Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis. J Neurol. 2019;266(5):1182 -1193.

    • Data on file. Genentech, Inc. February 2022.

      Data on file. Genentech, Inc. February 2022.

    • Traboulsee A, Hauser SL, Havrdov E, et al. Efficacy of ocrelizumab on brain MRI outcomes in patients with early relapsing multiple sclerosis: pooled analysis of the OPERA studies. Presented at: 69th American Academy of Neurology (AAN) Annual Meeting; April 22-28, 2017; Boston, MA. Poster 338.

      Traboulsee A, Hauser SL, Havrdov E, et al. Efficacy of ocrelizumab on brain MRI outcomes in patients with early relapsing multiple sclerosis: pooled analysis of the OPERA studies. Presented at: 69th American Academy of Neurology (AAN) Annual Meeting; April 22-28, 2017; Boston, MA. Poster 338.

    • Treaba CA, Balasa R, Podeanu DM, et al. Cerebral lesions of multiple sclerosis: is gadolinium always irreplaceable in assessing lesion activity? Diagn Interv Radiol. 2014;20:178 -184.

      Treaba CA, Balasa R, Podeanu DM, et al. Cerebral lesions of multiple sclerosis: is gadolinium always irreplaceable in assessing lesion activity? Diagn Interv Radiol. 2014;20:178 -184.