Crohn's Disease, Ulcerative Colitis
Conditions
Brief summary
This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.
Detailed description
This was a phase 2, multiple-dose, open-label study of vedolizumab administered intravenously (IV) every 8 weeks. The study population included treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants, as well as 38 UC participants who had tolerated vedolizumab well during Study C13002 (NCT01177228). In the original study protocol, all participants were randomized to receive vedolizumab at doses of either 6 mg/kg or 10 mg/kg. With the implementation of Amendment 1, the assigned doses of vedolizumab were decreased to 2.0 mg/kg and 6.0 mg/kg. To implement the dose changes, instead of randomizing all participants across both doses, those who rolled over from Study C13002 were reassigned to receive the 2.0 mg/kg dose and all participants who entered C13004 naïve to treatment were to receive the 6.0 mg/kg dose, starting on the next scheduled dosing day. Also, if participants assigned to the 2 mg/kg dose experienced flare, they were to receive the higher 6 mg/kg dose. In the results analyses for this study, participants are grouped according to the lowest dose received, i.e., 2.0 mg/kg or 6.0 mg/kg vedolizumab.
Interventions
DRUGvedolizumab
Vedolizumab for intravenous (IV) infusion
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed and active ulcerative colitis (UC) or Crohn's Disease (CD) * Crohn's Disease Activity Index (CDAI) Score of 220 - 450 for participants with CD * Partial Mayo score of 2 - 7 for participants with UC * Patient should be appropriate candidate for biologic therapy per guidelines * Up-to-date on cancer screening * No severe systemic disease * Patients with evidence of abscess * Agree to comply with study procedures including contraception
Exclusion criteria
* Low lymphocyte counts * History of imaging abnormalities, multiple sclerosis (MS), brain tumor or other neurological illness * Active or recent serious infections * Recent treatment with biologic (i.e., Remicade) or investigational drug * Impending surgery * Any participants with vedolizumab human anti-human antibody (HAHA) titers ≥1:125 or with a previous immediate hypersensitivity reaction during or shortly after vedolizumab infusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From Day 1 to Day 637 | An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities. |
| Number of Participants With Clinically Significant Laboratory Findings | through Day 637 | Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood. |
| Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML) | through Day 637 | At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist. |
| Number of Participants With Human Anti-human Antibodies (HAHA) | Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Days 43, 99, 155 and 267, predose | The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the ACT-1 binding interference assay. ACT-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling. |
| Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Days 43, 99, 155 and 267, predose | The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal address in cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay at time points where at least 50% of participants in the analysis set had non-missing results. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling. |
| Serum Concentration of Vedolizumab Before Dosing | Days 43, 99, 155 and 267, predose | Vedolizumab serum concentrations were measured from serum samples collected for pharmacokinetic (PK) analysis within 2 hours prior to dosing. The original protocol specified that PK parameters, including but not limited to minimum plasma concentration (Cmin), were to be estimated; however, due to intrapatient dose modification with Amendment 1, it was no longer feasible to perform a full PK parameter estimation. The summaries of pre-infusion data (i.e., trough levels) are presented at time points where at least 50% of participants had quantifiable vedolizumab concentrations, using a value of 0 for results below a measurable range. This provides information on the pharmacokinetic behavior of vedolizumab when administered as long-term therapy. |
Countries
Canada
Participant flow
Recruitment details
Participants took part in the study at 14 investigative sites in Canada and Russia, between 07 December 2007 and 31 March 2010.
Pre-assignment details
Treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants were assigned to receive 6.0 mg/kg vedolizumab. Participants who rolled over from Study C13002 (NCT01177228) were assigned to receive 2.0 mg/kg vedolizumab.
Participants by arm
| Arm | Count |
|---|---|
| Vedolizumab 2 mg/kg Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks | 37 |
| Vedolizumab 6 mg/kg Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks | 35 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 7 |
| Overall Study | Lack of Efficacy | 0 | 11 |
| Overall Study | Rolled over to Study C13008 (NCT00790933 | 22 | 15 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Vedolizumab 2 mg/kg | Vedolizumab 6 mg/kg | Total |
|---|---|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 11.06 | 42.1 years STANDARD_DEVIATION 15.79 | 42.1 years STANDARD_DEVIATION 13.47 |
| Body Mass Index (BMI) | 27.04 kg/m^2 STANDARD_DEVIATION 6.045 | 24.86 kg/m^2 STANDARD_DEVIATION 5.286 | 25.98 kg/m^2 STANDARD_DEVIATION 5.754 |
| Body Surface Area (BSA) | 1.89 m^2 STANDARD_DEVIATION 0.233 | 1.81 m^2 STANDARD_DEVIATION 0.27 | 1.85 m^2 STANDARD_DEVIATION 0.253 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 34 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Height | 168.9 cm STANDARD_DEVIATION 8.83 | 168.4 cm STANDARD_DEVIATION 11.49 | 168.7 cm STANDARD_DEVIATION 10.14 |
| Inflammatory Bowel Disease Type Crohn's Disease | 0 participants | 19 participants | 19 participants |
| Inflammatory Bowel Disease Type Ulcerative Colitis | 37 participants | 16 participants | 53 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 37 participants | 34 participants | 71 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 29 Participants |
| Weight | 77.03 kg STANDARD_DEVIATION 17.62 | 70.81 kg STANDARD_DEVIATION 17.82 | 74.01 kg STANDARD_DEVIATION 17.868 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 37 | 27 / 35 |
| serious Total, serious adverse events | 3 / 37 | 7 / 35 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity. The intensity for each AE was defined according to the following criteria: Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities.
Time frame: From Day 1 to Day 637
Population: Safety analysis set, defined as all enrolled participants who received at least 1 dose of study drug. Analysis was based on the lowest dose received, rather than dose at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vedolizumab 2 mg/kg | Number of Participants With Adverse Events (AEs) | Any Adverse Event | 21 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Adverse Events (AEs) | Severe Adverse Event | 2 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Adverse Events (AEs) | Drug-related Adverse Event | 5 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Adverse Events (AEs) | Adverse Event Resulting in Discontinuation | 0 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Adverse Events (AEs) | Serious Adverse Event | 3 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Adverse Events (AEs) | Drug-related Serious Adverse Event | 1 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Adverse Events (AEs) | Serious Adverse Event Resulting in Discontinuation | 0 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Adverse Events (AEs) | On-study Deaths | 0 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Adverse Events (AEs) | On-study Deaths | 0 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Adverse Events (AEs) | Any Adverse Event | 35 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Adverse Events (AEs) | Serious Adverse Event | 7 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Adverse Events (AEs) | Severe Adverse Event | 9 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Adverse Events (AEs) | Serious Adverse Event Resulting in Discontinuation | 5 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Adverse Events (AEs) | Drug-related Adverse Event | 21 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Adverse Events (AEs) | Drug-related Serious Adverse Event | 4 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Adverse Events (AEs) | Adverse Event Resulting in Discontinuation | 7 participants |
Primary
Number of Participants With Clinically Significant Laboratory Findings
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood.
Time frame: through Day 637
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vedolizumab 2 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | Anemia | 3 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | White Blood Cells Increased | 0 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | White Blood Cells Decreased | 0 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | C-reactive Protein Increased | 1 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | Hypokalemia | 0 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | Hypomagnesemia | 0 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | Hepatic enzyme increased | 0 participants |
| Vedolizumab 2 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | ALT and AST Increased | 0 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | ALT and AST Increased | 1 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | Anemia | 0 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | Hypokalemia | 2 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | White Blood Cells Increased | 1 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | Hepatic enzyme increased | 1 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | White Blood Cells Decreased | 1 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | Hypomagnesemia | 1 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Clinically Significant Laboratory Findings | C-reactive Protein Increased | 0 participants |
Primary
Number of Participants With Human Anti-human Antibodies (HAHA)
Time frame: Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vedolizumab 2 mg/kg | Number of Participants With Human Anti-human Antibodies (HAHA) | 2 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Human Anti-human Antibodies (HAHA) | 1 participants |
Primary
Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML)
At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist.
Time frame: through Day 637
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vedolizumab 2 mg/kg | Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML) | 0 participants |
| Vedolizumab 6 mg/kg | Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML) | 0 participants |
Secondary
Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay
The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the ACT-1 binding interference assay. ACT-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.
Time frame: Days 43, 99, 155 and 267, predose
Population: Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 43 (26, 19) | 0.277 % ACT1 binding | Standard Deviation 0.216 |
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 155 (n=26, 17) | 0.700 % ACT1 binding | Standard Deviation 1.5 |
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 99 (n=26, 17) | 0.596 % ACT1 binding | Standard Deviation 0.69 |
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 267 (n=25, 12) | 0.276 % ACT1 binding | Standard Deviation 0.247 |
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 1 (0, 20) | NA % ACT1 binding | — |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 267 (n=25, 12) | 0.767 % ACT1 binding | Standard Deviation 1.48 |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 1 (0, 20) | 14.6 % ACT1 binding | Standard Deviation 4.46 |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 43 (26, 19) | 0.311 % ACT1 binding | Standard Deviation 0.2 |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 99 (n=26, 17) | 0.288 % ACT1 binding | Standard Deviation 0.271 |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay | Day 155 (n=26, 17) | 1.09 % ACT1 binding | Standard Deviation 3.31 |
Secondary
Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay
The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal address in cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay at time points where at least 50% of participants in the analysis set had non-missing results. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.
Time frame: Days 43, 99, 155 and 267, predose
Population: Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 43 (n=26, 19) | 0.538 percent MADCAM binding | Standard Deviation 0.512 |
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 155 (n=26, 16) | 0.646 percent MADCAM binding | Standard Deviation 0.673 |
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 99 (n=26, 16) | 1.22 percent MADCAM binding | Standard Deviation 1.2 |
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 267 (n=25, 12) | 1.05 percent MADCAM binding | Standard Deviation 1.38 |
| Vedolizumab 2 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 1 (n=0, 20) | NA percent MADCAM binding | — |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 267 (n=25, 12) | 0.975 percent MADCAM binding | Standard Deviation 1.55 |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 1 (n=0, 20) | 18.5 percent MADCAM binding | Standard Deviation 5.95 |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 43 (n=26, 19) | 0.705 percent MADCAM binding | Standard Deviation 1.29 |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 99 (n=26, 16) | 0.838 percent MADCAM binding | Standard Deviation 0.95 |
| Vedolizumab 6 mg/kg | Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay | Day 155 (n=26, 16) | 0.369 percent MADCAM binding | Standard Deviation 0.54 |
Secondary
Serum Concentration of Vedolizumab Before Dosing
Vedolizumab serum concentrations were measured from serum samples collected for pharmacokinetic (PK) analysis within 2 hours prior to dosing. The original protocol specified that PK parameters, including but not limited to minimum plasma concentration (Cmin), were to be estimated; however, due to intrapatient dose modification with Amendment 1, it was no longer feasible to perform a full PK parameter estimation. The summaries of pre-infusion data (i.e., trough levels) are presented at time points where at least 50% of participants had quantifiable vedolizumab concentrations, using a value of 0 for results below a measurable range. This provides information on the pharmacokinetic behavior of vedolizumab when administered as long-term therapy.
Time frame: Days 43, 99, 155 and 267, predose
Population: The PK Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PK parameters. Participants without dose modification and with available serum concentration data at each time point (indicated by n) are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 2 mg/kg | Serum Concentration of Vedolizumab Before Dosing | Day 43 (n=27, 19) | 25.2 μg/mL | Standard Deviation 6.68 |
| Vedolizumab 2 mg/kg | Serum Concentration of Vedolizumab Before Dosing | Day 99 (n=24, 18) | 11.2 μg/mL | Standard Deviation 4.33 |
| Vedolizumab 2 mg/kg | Serum Concentration of Vedolizumab Before Dosing | Day 155 (n=26, 17) | 8.40 μg/mL | Standard Deviation 3.65 |
| Vedolizumab 2 mg/kg | Serum Concentration of Vedolizumab Before Dosing | Day 267 (n=26, 12) | 7.40 μg/mL | Standard Deviation 3.18 |
| Vedolizumab 6 mg/kg | Serum Concentration of Vedolizumab Before Dosing | Day 267 (n=26, 12) | 25.2 μg/mL | Standard Deviation 11.7 |
| Vedolizumab 6 mg/kg | Serum Concentration of Vedolizumab Before Dosing | Day 43 (n=27, 19) | 76.2 μg/mL | Standard Deviation 36.9 |
| Vedolizumab 6 mg/kg | Serum Concentration of Vedolizumab Before Dosing | Day 155 (n=26, 17) | 26.4 μg/mL | Standard Deviation 17.7 |
| Vedolizumab 6 mg/kg | Serum Concentration of Vedolizumab Before Dosing | Day 99 (n=24, 18) | 32.5 μg/mL | Standard Deviation 20.5 |