Table 3 Safety events with ustekinumab treatment during the follow up

Any adverse events

48 (19.6)

Most common adverse events^a

Diarrhea

7 (2.8)

New perianal fistula

3 (1.2)

Cutaneous rash or allergic skin reaction

9 (3.7)

Anemia

6 (2.4)

Psychological distress symptoms

4 (1.6)

Arthralgia

2 (0.8)

Headache

3 (1.2)

No serious infections

12 (4.9)

 Erysipelas

1 (0.4)

 Peristomal cutaneous infection

3 (1.2)

 Gastrointestinal infection (including Clostridioides difficile infection)

6 (2.4)

 Upper respiratory tract

2 (0.8)

 Lower urinary tract infection

1 (0.4)

Severe adverse events

8 (3.3)

 Perianal abscess

2 (0.8)

 Bowel perforation

3 (1.2)

 Small bowel obstruction

1 (0.4)

 Serious infection

2 (0.8)

  Gastrointestinal infection

1 (0.4)

  Hepatic abscess

1 (0.4)