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Table 3 Infections in the open-label period

From: Long-term safety of brazikumab in the open-label period of a randomized phase 2a study of patients with Crohn’s disease

AE, count

Brazikumab/ Brazikumab (n = 52)

Placebo/ Brazikumab (n = 52)

Total (N = 104)

Total infectionsa

42

58

100

 Urinary tract infection

4

5

9

 Vulvovaginal mycotic infection

1

6

7

 Sinusitis

1

6

7

 Bronchitis

2

4

6

 Upper respiratory tract infection

2

4

6

 Tonsilitis

2

3

5

 Tooth infection

3

2

5

 Subcutaneous abscess

4

0

4

Clostridium difficile colitis

3

0

3

 Pharyngitis streptococcal

1

2

3

 Anal abscess

2

0

2

 Anal candidiasis

0

2

2

 Ear infection

0

2

2

 Groin abscess

1

1

2

 Influenza

1

1

2

 Nasopharyngitis

1

1

2

 Pharyngitis

2

0

2

 Pyelonephritis

1

1

2

 Tooth abscess

0

2

2

  1. Infections occurring in 1 patient each for the brazikumab/brazikumab group included abdominal abscess, Campylobacter infection, cholecystitis, external ear inflammation, gingivitis, mastoiditis, esophageal candidiasis, pilonidal cyst, postprocedural infection, rhinitis, and viral infection
  2. Infections occurring in 1 patient each for the placebo/brazikumab group included amoebiasis, Cryptosporidiosis infection, diarrhea, folliculitis, gastroenteritis, herpes zoster, infected dermal cyst, pelvic abscess, peritonitis, pneumonia, pyrexia, respiratory tract infection, respiratory tract infection (viral), sialadenitis, tracheobronchitis, and vomiting
  3. aInfections were defined as any events involving a suspected viral, bacterial, fungal, or other infectious agent, including viral reactivation events and opportunistic infections, meeting ≥ 1 of the following criteria: events that are serious, grade 3 or higher, involve treatment with oral or parenteral antibiotics/antivirals/antifungals, or involve study discontinuation
  4. AE, adverse event