Clinically Isolated Syndrome, Multiple Sclerosis
Conditions
Keywords
ocrelizumab, OCREVUS, breastmilk transfer, breast milk transfer, lactation
Brief summary
This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) \[in line with the locally approved indications\] treated with ocrelizumab, by assessing the concentration of ocrelizumab in mature breastmilk, as well as the corresponding exposure and pharmacodynamic effects (blood B cell levels) in the infants.
Interventions
DRUGOcrelizumab
Women will receive the ocrelizumab dose regimen as per the locally-approved label. The ocrelizumab dose will be administered as an initial split dose of two 300 mg infusions separated by 14 days or a single 600 mg infusion according to the local prescribing information.
Sponsors
PPD Development, LP
Laboratory Corporation of America
Illingworth Research Group
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Woman is between 18 and 40 years of age at screening * Woman is willing to breastfeed for at least 60 days after the first post-partum ocrelizumab infusion (this decision is to be taken prior to and independent from study participation) * Woman is willing to provide breastmilk samples * Woman has a diagnosis of MS or CIS (in line with the locally approved indications) * Woman has delivered a healthy term singleton infant (≥37 weeks gestation) * Infant is between 2-24 weeks of age at the time of the mother's first post-partum dose of ocrelizumab * For women who received commercial ocrelizumab (OCREVUS) before enrolment: documentation that last exposure to ocrelizumab occurred more than 3 months before the last menstrual period (LMP) and was given at the approved dose of 2 x 300 mg or 1 x 600 mg * Woman agrees to use acceptable contraceptive methods during the study
Exclusion criteria
related to the Mother: * Hypersensitivity to ocrelizumab or to any of its excipients * Received last dose of ocrelizumab \<3 months before the LMP or during pregnancy * Active infections (may be included once the infection is treated and is resolved; women with bilateral mastitis infection should not have samples collected until the infection is completely resolved) * Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state * Known active malignancies, or being actively monitored for recurrence of malignancy * History of breast implants, breast augmentation, breast reduction surgery or mastectomy * Prior or current history of chronic alcohol abuse or drug abuse * Positive screening tests for hepatitis B * Treatment with a DMT for CIS or MS during pregnancy and/or first weeks post-partum, with the exception of formulations of interferon-beta, glatiramer acetate or pulsed corticosteroids * Treatment with drugs known to transfer to the breastmilk and with established or potential deleterious effects for the infant * Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the LMP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) Measured at Day 30 After the Mother's First Ocrelizumab Postpartum Infusion | At Day 30 | Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). The percentage of infants with B cell levels below LLN are reported with the two-sided Clopper Pearson 95% confidence interval (CI). B-cell reference ranges by week of life (absolute and percentage counts) are defined by Borriello et al. 2022. |
| Estimated Average Oral Daily Infant Dosage (ADID) | Up to Day 60 | ADID was calculated as the arithmetic mean of the mother's daily ocrelizumab milk concentration (micrograms/milliliters \[µg/mL\]) over 60 days post-ocrelizumab infusion 1 multiplied by an estimated infant milk intake of 150 milliliters/kilograms/day (mL/kg/day) and based on the weight \[kilograms (kg)\] recorded at the Day 30 visit. Ocrelizumab concentrations reported as below the lower limit of quantification \[LLQ=160 nanograms/millilitres (ng/mL)\] are imputed to zero for the calculation ADID. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk | One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1 | — |
| Average Concentration of Ocrelizumab in Breastmilk (Cmean) | One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1 | — |
| Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk | One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1 | — |
| Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk | One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1 | — |
| Estimated Maximum Oral Daily Infant Dosage (MDID) | Up to Day 60 | MDID was calculated at the subject level as the peak ocrelizumab milk concentration (μg/mL) multiplied by an estimated infant milk intake of 150 mL/kg/day measured over 60 days after the mother's first postpartum ocrelizumab infusion. |
| Average Relative Infant Dose (RID) | Up to Day 60 | Average RID over 60 days was calculated as the ADID (mg/kg/day) divided by the maternal dosage (mg/kg/day) over 60 days multiplied by 100. |
| Serum Concentration of Ocrelizumab in the Infant at Day 30 | At Day 30 | Serum concentration of ocrelizumab in the infant measured at Day 30 after the mother's first ocrelizumab postpartum infusion. Concentrations reported as below the lower limit of quantification (LLQ=156 ng/mL) are set to zero for calculation of summary statistics. |
| Percentage of Mothers With Adverse Events (AEs) | Up to approximately 73.3 weeks after first ocrelizumab dose | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. |
| Percentage of Infants With AEs | Up to approximately 73.3 weeks after first ocrelizumab dose administered to mother | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. |
| Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to Measles, Mumps, and Rubella (MMR) Vaccination | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. mIU/mL=milli-international units per milliliter. |
| Mean Titers of Mumps, IgG Antibody in Response to MMR Vaccination | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. RU/mL=relative units per milliliter. |
| Absolute CD19+ B Cell Count in the Infant | At Day 30 | Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). |
| Percentage of Infants With Positive Humoral Response to MMR Vaccination | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for MMR vaccine are as follows: Anti-Measles Vir IgG(-70)CL: ≥ 120 mIU/mL; Anti-MumpsAT Vir iGG(-70)CL: ≥ 17 RU/mL; Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 IU/mL. |
| Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccine | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. |
| Mean Titers of Bordetella Pertussis, IgG Antibody in Response to DTP Vaccine | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows: * COI \< 0.95: Negative * COI 0.95-1.04: Equivocal * COI \> 1.04: Positive The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (\>1.04). |
| Mean Titers of Tetanus Toxoid, IgG Antibody in Response to DTP Vaccine | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. |
| Percentage of Infants With Positive Humoral Response to DTP Vaccine | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows: * COI \< 0.95: Negative * COI 0.95-1.04: Equivocal * COI \> 1.04: Positive The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (\>1.04). |
| Mean Titers of Haemophilus Influenzae Type B (Hib), IgG Antibody in Response to Hib Vaccine | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to Hib vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. |
| Percentage of Infants With Positive Humoral Response to Hib Vaccine | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for Hib vaccine are as follows: Hib, IgG: ≥ 0.15 µg/mL. |
| Mean Titers of Anti-Hepatitis B Surface Antibody in Response to Hepatitis B Virus (HBV) Vaccine | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to HBV vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. |
| Percentage of Infants With Positive Humoral Response to HBV Vaccine | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for HBV vaccine are as follows: Anti-HBs: ≥ 10 mIU/mL. |
| Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to PCV-13 vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. |
| Percentage of Infants With Positive Humoral Response to PCV-13 | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for PCV-13 vaccine are as follows: 13 Valent anti-pneumococcal antibody panel: ≥ 0.35 µg/ml. |
| Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination | Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13) | The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. IU/mL=international units per milliliter. |
| Percentage of CD19+ B Cell in the Infant | At Day 30 | Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). |
Countries
Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 13 mother-infant pairs took part in the study across 7 sites in the United States, Spain, and the United Kingdom from 16 September 2021 to 13 January 2025.
Pre-assignment details
Lactating mothers with clinically isolated syndrome (CIS) or multiple sclerosis (MS) who, in consultation with their treating physician, chose to continue or start postpartum treatment with commercial ocrelizumab were enrolled in this study. This study included a 60-day treatment and sampling period followed by an 11-month vaccination period.
Participants by arm
| Arm | Count |
|---|---|
| Mothers Lactating mothers initiating ocrelizumab received two doses of 300 mg, as an IV infusion on Day 1 and Day 14, and mothers resuming ocrelizumab received a single dose of 600 mg, as an IV infusion on Day 1 at the discretion of the physicians, in accordance with local prescribing information. | 13 |
| Infants Infants of mothers who received commercial IV ocrelizumab at the discretion of the physicians, in accordance with local prescribing information were observed until the last visit which was at 1 month (+ 30 days) after the first dose of MMR vaccine (if first dose is administered at 11 months of age or later) or 1 month (+ 30 days) after second dose of MMR vaccine (if first dose is administered before 11 months of age), or at Month 13 of chronological age (+ 30 days) if MMR vaccine is not planned to be administered. | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment and Sampling Period (60 Days) | Withdrawal by Subject | 1 | 1 |
| Vaccination Period (11 Months) | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Infants | Mothers | Total |
|---|---|---|---|
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adults (18-64 years) | 0 Participants | 13 Participants | 13 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65-84 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 5 Participants | 0 Participants | 5 Participants |
| Age, Customized Newborns (0-27 days) | 8 Participants | 0 Participants | 8 Participants |
| Age, Customized Preterm newborn infants (gestational age <37 weeks) | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not reported | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 19 Participants |
| Sex: Female, Male Male | 7 Participants | 0 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 10 / 13 | 12 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Estimated Average Oral Daily Infant Dosage (ADID)
ADID was calculated as the arithmetic mean of the mother's daily ocrelizumab milk concentration (micrograms/milliliters \[µg/mL\]) over 60 days post-ocrelizumab infusion 1 multiplied by an estimated infant milk intake of 150 milliliters/kilograms/day (mL/kg/day) and based on the weight \[kilograms (kg)\] recorded at the Day 30 visit. Ocrelizumab concentrations reported as below the lower limit of quantification \[LLQ=160 nanograms/millilitres (ng/mL)\] are imputed to zero for the calculation ADID.
Time frame: Up to Day 60
Population: Pharmacokinetic Analysis Set Mothers (PASM) included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Infants | Estimated Average Oral Daily Infant Dosage (ADID) | 64.50 micrograms (µg) |
Primary
Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) Measured at Day 30 After the Mother's First Ocrelizumab Postpartum Infusion
Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose). The percentage of infants with B cell levels below LLN are reported with the two-sided Clopper Pearson 95% confidence interval (CI). B-cell reference ranges by week of life (absolute and percentage counts) are defined by Borriello et al. 2022.
Time frame: At Day 30
Population: Full Analysis Set Infants (FASI) included all the infants of women in the FASM population. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infants | Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN) Measured at Day 30 After the Mother's First Ocrelizumab Postpartum Infusion | 0 percentage of participants |
Secondary
Absolute CD19+ B Cell Count in the Infant
Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose).
Time frame: At Day 30
Population: FASI included all the infants of women in the FASM population. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infants | Absolute CD19+ B Cell Count in the Infant | 1431.50 cells per microliter (cells/µL) |
Secondary
Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk
Time frame: One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1
Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Area Under the Milk Concentration-Time Curve (AUC) of Ocrelizumab in Mature Breastmilk | 3.98 micrograms/millilitres*day (μg/mL*day) | Standard Deviation 4.93 |
Secondary
Average Concentration of Ocrelizumab in Breastmilk (Cmean)
Time frame: One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1
Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Average Concentration of Ocrelizumab in Breastmilk (Cmean) | 0.074 μg/mL | Standard Deviation 0.077 |
Secondary
Average Relative Infant Dose (RID)
Average RID over 60 days was calculated as the ADID (mg/kg/day) divided by the maternal dosage (mg/kg/day) over 60 days multiplied by 100.
Time frame: Up to Day 60
Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Average Relative Infant Dose (RID) | 0.50 percentage | Standard Deviation 0.58 |
Secondary
Estimated Maximum Oral Daily Infant Dosage (MDID)
MDID was calculated at the subject level as the peak ocrelizumab milk concentration (μg/mL) multiplied by an estimated infant milk intake of 150 mL/kg/day measured over 60 days after the mother's first postpartum ocrelizumab infusion.
Time frame: Up to Day 60
Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Estimated Maximum Oral Daily Infant Dosage (MDID) | 153.20 µg | Standard Deviation 137.15 |
Secondary
Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk
Time frame: One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1
Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Maximum Concentration (Cmax) of Ocrelizumab in Breastmilk | 0.18 μg/mL | Standard Deviation 0.15 |
Secondary
Mean Titers of Anti-Hepatitis B Surface Antibody in Response to Hepatitis B Virus (HBV) Vaccine
The immune response to HBV vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Mean Titers of Anti-Hepatitis B Surface Antibody in Response to Hepatitis B Virus (HBV) Vaccine | 1158.01 mIU/mL | Standard Deviation 1263.32 |
Secondary
Mean Titers of Bordetella Pertussis, IgG Antibody in Response to DTP Vaccine
The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows: * COI \< 0.95: Negative * COI 0.95-1.04: Equivocal * COI \> 1.04: Positive The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (\>1.04).
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Mean Titers of Bordetella Pertussis, IgG Antibody in Response to DTP Vaccine | 1.12 COI | Standard Deviation 0.82 |
Secondary
Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccine
The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Mean Titers of Corynebacterium Diphtheriae, IgG Antibody in Response to Diphtheria-Tetanus-Pertussis (DTP) Vaccine | 1.94 IU/mL | Standard Deviation 3.13 |
Secondary
Mean Titers of Haemophilus Influenzae Type B (Hib), IgG Antibody in Response to Hib Vaccine
The immune response to Hib vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Mean Titers of Haemophilus Influenzae Type B (Hib), IgG Antibody in Response to Hib Vaccine | 3.45 micrograms per milliliter (ug/mL) | Standard Deviation 4.21 |
Secondary
Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to Measles, Mumps, and Rubella (MMR) Vaccination
The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. mIU/mL=milli-international units per milliliter.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: Antibody Immune Response Analysis Set of Infants (AIRI) included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Mean Titers of Measles, Immunoglobin G (IgG) Antibody in Response to Measles, Mumps, and Rubella (MMR) Vaccination | 2590.91 mIU/mL | Standard Deviation 2210.74 |
Secondary
Mean Titers of Mumps, IgG Antibody in Response to MMR Vaccination
The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. RU/mL=relative units per milliliter.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Mean Titers of Mumps, IgG Antibody in Response to MMR Vaccination | 54.19 RU/mL | Standard Deviation 34.72 |
Secondary
Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13)
The immune response to PCV-13 vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 23F, IgG | 10.50 ug/mL | Standard Deviation 13.17 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 1, IgG | 4.80 ug/mL | Standard Deviation 6.38 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 3, IgG | 2.56 ug/mL | Standard Deviation 3.16 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 4, IgG | 8.28 ug/mL | Standard Deviation 9.18 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 5, IgG | 9.98 ug/mL | Standard Deviation 15.72 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 6A, IgG | 27.28 ug/mL | Standard Deviation 34.5 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 6B, IgG | 27.02 ug/mL | Standard Deviation 70.85 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 7F, IgG | 9.44 ug/mL | Standard Deviation 14.11 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 9V, IgG | 4.21 ug/mL | Standard Deviation 3.66 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 14, IgG | 14.93 ug/mL | Standard Deviation 14.49 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 18C, IgG | 9.62 ug/mL | Standard Deviation 11.47 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 19A, IgG | 1.70 ug/mL | Standard Deviation 1.41 |
| Infants | Mean Titers of Pneumococcal Capsular Polysaccharide, Serotypes, IgG Antibody in Response to 13-valent Pneumococcal Conjugate Vaccine (PCV-13) | Pneumococcal Capsular Polysaccharide, Serotype 19F, IgG | 45.83 ug/mL | Standard Deviation 80.11 |
Secondary
Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination
The immune response to MMR vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines. IU/mL=international units per milliliter.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Mean Titers of Rubella, IgG Antibody in Response to MMR Vaccination | 94.21 IU/mL | Standard Deviation 51.39 |
Secondary
Mean Titers of Tetanus Toxoid, IgG Antibody in Response to DTP Vaccine
The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. This was to evaluate whether infants can mount humoral immune responses to clinically relevant vaccines.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants | Mean Titers of Tetanus Toxoid, IgG Antibody in Response to DTP Vaccine | 1.23 IU/mL | Standard Deviation 0.43 |
Secondary
Percentage of CD19+ B Cell in the Infant
Infant blood samples were collected at Day 30 after the mothers received their first postpartum ocrelizumab infusion (regardless of whether women receive a 600 mg or a 2x300 mg dose).
Time frame: At Day 30
Population: FASI included all the infants of women in the FASM population. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infants | Percentage of CD19+ B Cell in the Infant | 21.80 percentage of cells |
Secondary
Percentage of Infants With AEs
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Time frame: Up to approximately 73.3 weeks after first ocrelizumab dose administered to mother
Population: Safety Analysis Set Infants (SAFI) included all the infants of women in the FASM population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infants | Percentage of Infants With AEs | 92.3 percentage of infants |
Secondary
Percentage of Infants With Positive Humoral Response to DTP Vaccine
The immune response to DTP vaccine was assessed 1 month after the first dose of MMR vaccine (if the first dose is administered at 11 months of age or later) or 1 month after the second dose of MMR vaccine (if the first dose is administered before 11 months of age), or at Month 13 of chronological age if MMR vaccine was not planned to be administered. Cut-off Index (COI) = unitless ratio calculated as the signal intensity of the sample divided by the signal of the assay's cut-off calibrator. It is interpreted as follows: * COI \< 0.95: Negative * COI 0.95-1.04: Equivocal * COI \> 1.04: Positive The assay used has not been standardized against WHO International Units (IU/mL) for Bordetella pertussis IgG and therefore, cannot be converted to IU/mL. Higher COI values = a stronger antibody signal, but are not directly correlated with clinical protection. Positivity was defined using the manufacturer's COI cut-off (\>1.04).
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis. Number analyzed refers to infants with data available for the specified IgG antibody titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants | Percentage of Infants With Positive Humoral Response to DTP Vaccine | Corynebacterium Diphtheriae, IgG | 100 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to DTP Vaccine | Bordetella Pertussis, IgG | 50 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to DTP Vaccine | Tetanus Toxoid, IgG | 100 percentage of infants |
Secondary
Percentage of Infants With Positive Humoral Response to HBV Vaccine
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for HBV vaccine are as follows: Anti-HBs: ≥ 10 mIU/mL.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infants | Percentage of Infants With Positive Humoral Response to HBV Vaccine | 100 percentage of infants |
Secondary
Percentage of Infants With Positive Humoral Response to Hib Vaccine
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for the IgG antibody titer. Seroprotective titer based on vaccine tests for Hib vaccine are as follows: Hib, IgG: ≥ 0.15 µg/mL.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infants | Percentage of Infants With Positive Humoral Response to Hib Vaccine | 88.9 percentage of infants |
Secondary
Percentage of Infants With Positive Humoral Response to MMR Vaccination
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for MMR vaccine are as follows: Anti-Measles Vir IgG(-70)CL: ≥ 120 mIU/mL; Anti-MumpsAT Vir iGG(-70)CL: ≥ 17 RU/mL; Anti-Rub Vir IgG(-70)RUOCL: ≥ 10 IU/mL.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Number analyzed refers to infants with data available for the specified IgG antibody titer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants | Percentage of Infants With Positive Humoral Response to MMR Vaccination | Measles, IgG | 100 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to MMR Vaccination | Mumps, IgG | 77.8 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to MMR Vaccination | Rubella, IgG | 100 percentage of infants |
Secondary
Percentage of Infants With Positive Humoral Response to PCV-13
Percentage of infants with positive humoral response (seroprotective titers as defined for the individual vaccine) was presented for each IgG antibody titer. Seroprotective titer based on vaccine tests for PCV-13 vaccine are as follows: 13 Valent anti-pneumococcal antibody panel: ≥ 0.35 µg/ml.
Time frame: Up to 1 month after the first or second dose of MMR vaccine (at approximately Month 13)
Population: AIRI included all infants in the SAFI for whom any serum titers of antibody immune response to vaccinations were available. Overall number analyzed are the number of infants with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 19F, IgG | 100 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 23F, IgG | 80 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 1, IgG | 80 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 3, IgG | 70 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 4, IgG | 80 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 5, IgG | 90 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 6A, IgG | 100 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 6B, IgG | 80 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 7F, IgG | 100 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 9V, IgG | 90 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 14, IgG | 100 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 18C, IgG | 80 percentage of infants |
| Infants | Percentage of Infants With Positive Humoral Response to PCV-13 | Pneumococcal Capsular Polysaccharide, Serotype 19A, IgG | 60 percentage of infants |
Secondary
Percentage of Mothers With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Time frame: Up to approximately 73.3 weeks after first ocrelizumab dose
Population: Safety Analysis Set Mothers (SAFM) included all mothers who met the eligibility criteria and received any post-partum dose of ocrelizumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infants | Percentage of Mothers With Adverse Events (AEs) | 76.9 percentage of participants |
Secondary
Serum Concentration of Ocrelizumab in the Infant at Day 30
Serum concentration of ocrelizumab in the infant measured at Day 30 after the mother's first ocrelizumab postpartum infusion. Concentrations reported as below the lower limit of quantification (LLQ=156 ng/mL) are set to zero for calculation of summary statistics.
Time frame: At Day 30
Population: Pharmacokinetic Analysis Set Infants (PASI) included all infants in the FASI with a serum sample to allow measurement of ocrelizumab concentration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Infants | Serum Concentration of Ocrelizumab in the Infant at Day 30 | NA µg/mL |
Secondary
Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk
Time frame: One 600 mg infusion: before infusion and at 24 hours (Day 1), Days 7, 30 and 60 post-infusion; Two 300 mg infusions: before infusion 1 and at 24 hours (Day 1), Days 7, 14, 15 (24 hours after infusion 2), 21, 30 and 60 post-infusion 1
Population: PASM included all mothers in the FASM with a breastmilk sample to allow measurement of ocrelizumab concentration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infants | Time of Maximum Concentration (Tmax) of Ocrelizumab in Breastmilk | 3.97 days |