For Patients and Caregivers

The first and only DMT with 2 positive Phase III clinical trials for PPMS-ORATORIO and ORATORIO-HAND (OHAND)1-3

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OHAND evaluated preservation of function in patients with PPMS who were older and had more advanced disease compared to those studied in ORATORIO, with a focus on upper extremity (UE) function2

MS SPECIALIST VIDEO

OHAND results: 
MS specialist presentation

Neurologist and MS specialist Dr Barry Singer summarizes top-line results of the OHAND study for PPMS

STUDY DESIGN

Ocrelizumab is approved in patients with PPMS based on the Phase III ORATORIO pivotal trial1,3

Both ORATORIO (N=732) and OHAND (N=1013) were sizable trials

Baseline characteristics

OHAND: Included patients with PPMS up to age 65 and with an EDSS up to 8.02

‡In ORATORIO, defined as treatment-naive for B-cell therapies and no other immunosuppressive medications in the prior two years. In OHAND, defined as treatment-naive for B-cell therapies; immunosuppressive medications were allowed but required appropriate washout.1

OHAND measured the impact of ocrelizumab using composite confirmed disability progression (cCDP), a novel and more comprehensive disability measure2,4

To overcome the limitations of using EDSS alone, cCDP also includes the 9-hole peg test (9HPT), which specifically measures UE function and has been shown to be predictive of increases in disability progression4-6

OHAND cCDP§ =

First occurrence of either event||

A disability event was defined as the first occurrence of either4:

  • 9HPT: ≥20% change in 9HPT time from baseline that was sustained on subsequent visits for at least 12 weeks

OR

  • EDSS: ≥1.0-point increase from a baseline EDSS score of ≤5.5 that was sustained on subsequent visits for at least 12 weeks or ≥0.5-point increase from a baseline EDSS score of >5.5 that was sustained on subsequent visits for at least 12 weeks
OHAND primary endpoint: time to onset of 12-week composite CDP

§The components of cCDP may vary from study to study.
||Confirmed at 12 weeks after the event.2

PPMS EFFICACY
ORATORIO efficacy OHAND efficacy

ORATORIO established ocrelizumab as the first and only DMT proven 
to significantly slow disability progression in PPMS3,7

Significant reduction in the risk of confirmed disability progression (CDP) vs placebo on
2 endpoints (12- and 24-week CDP)1

In exploratory subgroup analyses of ORATORIO, the proportion of female patients with disability progression confirmed at 12 weeks after onset was similar in OCREVUS [IV] (ocrelizumab)-treated patients and placebo-treated patients (approximately 36% in each group). In male patients, the proportion of patients with disability progression confirmed at 12 weeks after onset was approximately 30% in OCREVUS [IV]-treated patients and 43% in placebo-treated patients. Clinical and MRI endpoints that generally favored OCREVUS [IV] numerically in the overall population, and that showed similar trends in both male and female patients, included annualized relapse rate, change in T2 lesion volume, and number of new or enlarging T2 lesions. ORATORIO was not powered to detect differences among these subgroups.

Ocrelizumab significantly reduced the risk of disability progression as measured by cCDP, including UE function in 9HPT and EDSS1,2

OHAND studied a population that had more advanced disease (higher median EDSS) and higher median age than those in ORATORIO

Proportion of patients with 12-week cCDP defined as the first occurrence of either4:

  • 9HPT: ≥20% change in 9HPT time from baseline that was sustained on subsequent visits for at least 12 weeks

OR

  • EDSS: ≥1.0-point increase from a baseline EDSS score of ≤5.5 that was sustained on subsequent visits for at least 12 weeks or ≥0.5-point increase from a baseline EDSS score of >5.5 that was sustained on subsequent visits for at least 12 weeks

Both components—9HPT and EDSS—reinforce the significance of the overall cCDP result2*

*The data presented are not inclusive of all endpoints in the OHAND study.

Ocrelizumab demonstrated reduction in the risk of disability progression as measured by a comprehensive assessment inclusive of UE function2,4

PPMS SAFETY

OHAND provided additional safety data consistent with the known profile for ocrelizumab2

The safety data in OHAND were comparable to ORATORIO

OHAND was conducted during the COVID-19 pandemic, which may have influenced the incidence of AEs, serious AEs, and infections. The OHAND study enrolled older patients with higher levels of disability compared to those studied in ORATORIO. To contextualize these findings for OHAND, rates are presented both including and excluding COVID-19–related events.2

Ocrelizumab has a well-established safety profile with 10+ years of clinical trial data8

Explore OLE safety data

Rethink what is possible for impacting disability progression in MS2

Download the OHAND PPMS Brochure

9HPT=9-hole peg test; AE=adverse event; cCDP=composite confirmed disability progression; CDP=confirmed disability progression; DMT=disease-modifying treatment; EDSS=Expanded Disability Status Scale; FSS=functional systems score; HR=hazard ratio; IRR=infusion-related reaction; IV=intravenous; MS=multiple sclerosis; PPMS=primary progressive multiple sclerosis; PRMS=progressive-relapsing multiple sclerosis; RMS=relapsing multiple sclerosis; SPMS=secondary progressive multiple sclerosis; T1 Gd+=T1 gadolinium-enhancing; T2=transverse relaxation time; UE=upper extremity.

NEXT: OCREVUS [IV] Safety

 

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.

OCREVUS is indicated for the treatment of:

  • Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more.
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, all adult and pediatric patients who were treated with OCREVUS received premedication with methylprednisolone (or an equivalent steroid), and may have also received an antihistamine (all pediatric patients) and/or an analgesic/antipyretic to reduce the risk of infusion reactions prior to each infusion. In adults, the incidence of infusion reactions in patients treated with OCREVUS was 34% to 40%. There were no fatal infusion reactions, but 0.3% of patients with MS who were treated with OCREVUS experienced infusion reactions that were serious, some requiring hospitalization.

In pediatric patients, the incidence of infusion reactions in patients treated with OCREVUS was 48%, compared with an incidence of 24% in patients who received placebo infusion (fingolimod-treated patients). There were no fatal infusion reactions, but one pediatric patient (1.1%) treated with OCREVUS experienced an infusion reaction that was serious because it required 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. These reactions are more commonly reported with the first infusion.

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 adult patients treated with OCREVUS experienced infections compared to patients taking REBIF or placebo. In RMS trials in adults, 58% of patients treated with OCREVUS experienced one or more infections compared to 52% of patients treated with REBIF. In the PPMS trial, 70% of patients treated with OCREVUS experienced one or more infections compared to 68% of patients on placebo. Ocrelizumab increases the risk for upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes-related infections.

In the pediatric study, infections occurred in 73% of patients treated with OCREVUS (1.5 infections per patient year) and 59% of patients treated with fingolimod (1.2 infections per patient year). Upper respiratory tract infections, nasopharyngitis, and influenza, all of which were mild to moderate, were more frequently reported in patients treated with OCREVUS compared to patients treated with fingolimod.

Delay administration of ocrelizumab in patients with an active infection until the infection has resolved.

Respiratory Tract Infections

A higher proportion of adult patients treated with OCREVUS experienced respiratory tract infections compared to patients taking REBIF or placebo. In RMS trials in adults, 40% of patients treated with OCREVUS experienced upper respiratory tract infections compared to 33% of patients treated with REBIF, and 8% of patients treated with OCREVUS experienced lower respiratory tract infections compared to 5% of patients treated with REBIF. In the PPMS trial, 49% of patients treated with OCREVUS experienced upper respiratory tract infections compared to 43% of patients on placebo and 10% of patients treated with OCREVUS 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 in adults, herpes infections were reported more frequently in patients treated with OCREVUS than in patients treated with REBIF, 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 patients treated with OCREVUS 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 age-appropriate 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. If indicated, non-live vaccines may be administered prior to recovery from B-cell depletion, but assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered 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) in adults 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 patients treated with OCREVUS. Breast cancer in adults 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.

Liver Injury

Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including ocrelizumab. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with ocrelizumab found to have an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with ocrelizumab, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue ocrelizumab.

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

Females of reproductive 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.

Pediatric Use

Use of OCREVUS for this indication is supported by evidence from one randomized, double blind clinical study in 187 pediatric patients (93 of whom received OCREVUS) and additional pharmacokinetic data in pediatric patients.

The overall safety profile in pediatric patients 10 years of age and older receiving OCREVUS was generally consistent with that observed in adult patients.

Safety and effectiveness of OCREVUS have not been established in pediatric patients less than 10 years of age or who weigh less than 25 kg.

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
  • RRMS in pediatric patients 10 years of age and older: The most common adverse reactions were consistent with those observed in adults with RMS

The most common adverse reaction observed with OCREVUS ZUNOVO in adult 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.

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      Montalban X, Hauser SL, Kappos L, et al; ORATORIO Clinical Investigators. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med. 2017;376(3):209-220. doi:10.1056/NEJMoa1606468

    • Giovannoni G, Airas L, Bove R, et al. Efficacy and safety of ocrelizumab vs placebo in primary progressive MS: results of the phase IIIb ORATORIO-HAND study. Poster presented at: 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 24-26, 2025; Barcelona, Spain. Abstract O128.

      Giovannoni G, Airas L, Bove R, et al. Efficacy and safety of ocrelizumab vs placebo in primary progressive MS: results of the phase IIIb ORATORIO-HAND study. Poster presented at: 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 24-26, 2025; Barcelona, Spain. Abstract O128.

    • OCREVUS [prescribing information]. South San Francisco, CA: Genentech, Inc. 2025.

      OCREVUS [prescribing information]. South San Francisco, CA: Genentech, Inc. 2025.

    • Kappos L, Yiu S, Dahlke F, et al. Composite confirmed disability worsening/progression is a useful clinical endpoint for multiple sclerosis clinical trials. Neurology. 2025;104(10):e213558. doi:10.1212/WNL.0000000000213558

      Kappos L, Yiu S, Dahlke F, et al. Composite confirmed disability worsening/progression is a useful clinical endpoint for multiple sclerosis clinical trials. Neurology. 2025;104(10):e213558. doi:10.1212/WNL.0000000000213558

    • Feys P, Lamers I, Francis G, et al. The nine-hole peg test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017;23(5):711-720. doi:10.1177/1352458517690824

      Feys P, Lamers I, Francis G, et al. The nine-hole peg test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017;23(5):711-720. doi:10.1177/1352458517690824

    • Fox EJ, Markowitz C, Applebee A, et al. Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial. Mult Scler. 2018;24(14):1862-1870. doi:10.1177/1352458518808189

      Fox EJ, Markowitz C, Applebee A, et al. Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial. Mult Scler. 2018;24(14):1862-1870. doi:10.1177/1352458518808189

    • Weber MS, Kappos L, Hauser SL, et al. 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: 9th Joint ECTRIMS-ACTRIMS Meeting; October 11-13, 2023; Milan, Italy. Poster P302.

      Weber MS, Kappos L, Hauser SL, et al. 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: 9th Joint ECTRIMS-ACTRIMS Meeting; October 11-13, 2023; Milan, Italy. Poster P302.

    • Hauser SL, Kappos L, Montalban X, et al. Safety of ocrelizumab in multiple sclerosis: up to 11 years of updated analysis in patients with relapsing and progressive multiple sclerosis. Poster presented at: 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 18-20, 2024. Poster P300.

      Hauser SL, Kappos L, Montalban X, et al. Safety of ocrelizumab in multiple sclerosis: up to 11 years of updated analysis in patients with relapsing and progressive multiple sclerosis. Poster presented at: 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 18-20, 2024. Poster P300.

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