Trial Outcomes & Findings for Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) (NCT NCT03196427)

A total of 59 participants with ulcerative colitis (UC) or Crohn's disease (CD) took part in the study across 34 investigative sites in Belgium, United States, France, Hungary, Israel, Poland, Ukraine, and United Kingdom from 30 July 2018 to 17 July 2025.

Pediatric participants who had completed MLN0002-2003 (NCT03138655), and at Week 22, had achieved clinical response were enrolled to receive vedolizumab at the same dosage per body weight (\>= 30 kg and \< 30 kg). As per planned analysis, participants with disease worsening based on Pediatric Ulcerative Colitis Activity Index (PUCAI) or Pediatric Crohn's Disease Activity Index (PCDAI) scores escalated to vedolizumab IV from low to high doses (150 to 300 mg or 100 to 200 mg) at Week 40.

Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

AE defined as any untoward medical occurrence in clinical investigation participants administered drug; it does not necessarily have to have causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it was considered related to the drug. TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug, or an already-present AE that worsened in intensity or frequency following the treatment start, occurring from the first dose of study drug to the day of last dose of study drug.

Clinical response was defined as a continued reduction in complete Mayo score of \>=3 points and \>=30 percent (%) from baseline (at initiation of MLN0002-2003) and continued decrease in rectal bleeding subscore of \>=1 point from baseline, or absolute rectal bleeding subscore of less than or equal to (\<=1) point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings on endoscopy and physician rating of disease activity, each graded from 0 to 3 where 0 indicated normal and 3 indicated more severe disease. These scores were summed to give a total score range of 0 to 12; where higher scores indicated more severe disease.

Maintenance of clinical response based on SES-CD and CDAI was defined as a 50% reduction in SES-CD score on endoscopy compared to the baseline endoscopy \[at initiation of MLN0002-2003 (NCT03138655)\]; and continued reduction in CDAI that is a \>= 70 point decrease from the baseline CDAI score at the initiation of MLN0002-2003 (NCT03138655). CDAI was a research tool used to quantify the symptoms of participants with Crohn's disease. SES-CD consisted of 3 variables: ulcer size, ulcerated and affected surfaces and presence of narrowing each graded from 0 to 3 with score of 0 means no colonic lesions or mucosal healing, and SES-CD greater than (\>) 1 indicated the presence of mucosal lesions.

Time to major IBD-related events was defined as time from study treatment start to first major IBD-related hospitalization, surgery, or procedure due to UC and CD.

The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III used a 5-point Likert scale ranging from 1 to 5 for all answers. The total score was obtained by summing individual domain scores. The total score ranged from 35 to 175, with higher scores suggesting better quality of life.

The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The Bowel Symptoms domain consisted of 7 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The bowel symptoms domain score ranged from 7 to 35, with higher scores suggesting a better quality of life.

The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The systemic symptoms domain consisted of 3 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The systemic symptoms domain score ranged from 3 to 15, with higher scores suggesting a better quality of life.

The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The social functioning domain consisted of 12 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The social functioning domain score ranged from 12 to 60, with higher scores suggesting a better quality of life.

The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The body image domain consisted of 3 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The body image domain score ranged from 3 to 15, with higher scores suggesting a better quality of life.

The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The treatment/interventions domain consisted of 3 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The treatment/interventions domain score ranged from 3 to 15, with higher scores suggesting a better quality of life.

The IMPACT-III questionnaire was a self-reported measure with 35 closed questions encompassing 6 domains. The emotional functioning domain consisted of 7 items. Each item was scored using a 5-point Likert scale ranging from 1 to 5. The emotional functioning domain score ranged from 7 to 35, with higher scores suggesting a better quality of life.

Height velocity (centimeter per year \[cm/year\]) was calculated as the change in height divided by the duration \[time between the two height measures\].

Change from baseline in height was reported.

Change from baseline in weight was reported.

BMI was calculated as Weight (in kilograms)/height (in meters square).

Tanner Stage Evaluation was a scale used to evaluate growth parameters standardized for age, sex, and pubertal development. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Tanner stage was assessed at or before age 16 years for females or 17 years for males.