Trial Outcomes & Findings for Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease (NCT NCT02559713)

Last Updated: 2021-01-08

Results Overview

Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by enzyme-linked immunosorbent assay (ELISA). Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Day 1 (60 minutes prior to the start of infusion)

Results posted on

2021-01-08

Participant Flow

Participants took part in the study at 4 investigative sites in the United States from 29 November 2017 to 22 February 2019.

Lactating women with a diagnosis of active ulcerative colitis (UC) or Crohn's disease (CD) being treated with vedolizumab were enrolled to receive a single vedolizumab 300 milligrams (mg) dose intravenous (IV).

Participant milestones

Participant milestones
Measure	Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Overall Study STARTED	11
Overall Study Safety Set	11
Overall Study Pharmacokinetic Set	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Overall Study Pretreatment Event/ Adverse Event	1

Baseline Characteristics

Only participants who answered yes to the leading question of 'breastfed in the past' were analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vedolizumab 300 mg n=11 Participants Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Age, Continuous	31.8 years STANDARD_DEVIATION 3.71 • n=11 Participants
Sex: Female, Male Female	11 Participants n=11 Participants
Sex: Female, Male Male	0 Participants n=11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants
Race (NIH/OMB) Asian	1 Participants n=11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	1 Participants n=11 Participants
Race (NIH/OMB) White	9 Participants n=11 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Region of Enrollment United States	11 Participants n=11 Participants
Height	158.9 centimeter (cm) STANDARD_DEVIATION 7.12 • n=11 Participants
Weight	62.72 kilograms (kg) STANDARD_DEVIATION 15.924 • n=11 Participants
Body Mass Index (BMI)	24.78 kg/m^2 STANDARD_DEVIATION 5.534 • n=11 Participants
Smoking Status Never Smoked	11 Participants n=11 Participants
Alcohol Status Has Never Drunk	5 Participants n=11 Participants
Alcohol Status Current Drinker	4 Participants n=11 Participants
Alcohol Status Ex-drinker	2 Participants n=11 Participants
Female Reproductive Status Surgically Sterile	1 Participants n=11 Participants
Female Reproductive Status Female of Childbearing Potential	10 Participants n=11 Participants
Breastfed in the Past Yes	6 Participants n=11 Participants
Breastfed in the Past No	5 Participants n=11 Participants
Problems with Producing Breast Milk for Previously Breastfed Infants No	6 Participants n=6 Participants • Only participants who answered yes to the leading question of 'breastfed in the past' were analyzed.
Fail to Thrive for Previously Breastfed Infants No	6 Participants n=6 Participants • Only participants who answered yes to the leading question of 'breastfed in the past' were analyzed.

PRIMARY outcome

Timeframe: Day 1 (60 minutes prior to the start of infusion)

Population: Pharmacokinetic Set (PK) included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg n=11 Participants Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Concentration of Vedolizumab in Breast Milk at Predose on Day 1 Q4W	0.1350 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk at Predose on Day 1 Q6W	0 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk at Predose on Day 1 Q8W	0.03161 ug/mL Standard Deviation 0.024327

PRIMARY outcome

Timeframe: Day 1 (approximately 60 minutes after the end of infusion)

Population: PK Set included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration at the given timepoint. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.

Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg n=10 Participants Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1 Q8W	0.03756 ug/mL Standard Deviation 0.025572
Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1 Q4W	0.1490 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1 Q6W	0 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.

PRIMARY outcome

Timeframe: Day 4

Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg n=10 Participants Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Concentration of Vedolizumab in Breast Milk on Day 4 Q4W	0.3050 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk on Day 4 Q6W	0.1650 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk on Day 4 Q8W	0.2634 ug/mL Standard Deviation 0.14840

PRIMARY outcome

Timeframe: Day 8

Population: PK Set included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.

Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg n=11 Participants Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Concentration of Vedolizumab in Breast Milk on Day 8 Q4W	0.3050 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk on Day 8 Q6W	0.1410 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk on Day 8 Q8W	0.2113 ug/mL Standard Deviation 0.10299

PRIMARY outcome

Timeframe: Day 15

Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg n=11 Participants Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Concentration of Vedolizumab in Breast Milk on Day 15 Q4W	0.2280 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk on Day 15 Q6W	0.1270 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk on Day 15 Q8W	0.1708 ug/mL Standard Deviation 0.069017

PRIMARY outcome

Timeframe: Day 29

Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg n=11 Participants Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Concentration of Vedolizumab in Breast Milk on Day 29 Q4W	0.1560 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk on Day 29 Q6W	0.06860 ug/mL Standard Deviation NA Standard deviation was not estimable for one participant.
Concentration of Vedolizumab in Breast Milk on Day 29 Q8W	0.1039 ug/mL Standard Deviation 0.040445

PRIMARY outcome

Timeframe: Day 57

Population: Participants from PK Set, included all participants who were enrolled and received 1 dose of vedolizumab in study and had at least 1 measurable milk concentration, who received vedolizumab Q8W regimen prior to Day 1 with data available for this outcome measure were analyzed.

Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk in participants with analysis of vedolizumab concentration from the pooled milk sample was done by ELISA.

Outcome measures

Outcome measures
Measure	Vedolizumab 300 mg n=7 Participants Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Concentration of Vedolizumab in Breast Milk on Day 57	0.04673 ug/mL Standard Deviation 0.020966

Adverse Events

Vedolizumab 300 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vedolizumab 300 mg n=11 participants at risk Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Gastrointestinal disorders Colitis ulcerative	9.1% 1/11 • First dose of study drug in this study to study exit (Up to Day 57)

Other adverse events

Other adverse events
Measure	Vedolizumab 300 mg n=11 participants at risk Vedolizumab 300 mg, IV infusion over 30-minutes, single dose on Day 1.
Gastrointestinal disorders Crohn's disease	9.1% 1/11 • First dose of study drug in this study to study exit (Up to Day 57)
Gastrointestinal disorders Gastrointestinal motility disorder	9.1% 1/11 • First dose of study drug in this study to study exit (Up to Day 57)
Infections and infestations Paronychia	9.1% 1/11 • First dose of study drug in this study to study exit (Up to Day 57)
Infections and infestations Viral infection	9.1% 1/11 • First dose of study drug in this study to study exit (Up to Day 57)

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER