Table 3 Safety outcomes

From: Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials

TEAEs, n (%)

PRIME

PRIME2

Placebo n = 75

Dupilumab n = 75

Placebo n = 82

Dupilumab n = 77

Patients with ≥1 TEAE

42 (56.0)

49 (65.3)

38 (46.3)

42 (54.5)

Patients with any severe adverse eventa

5 (6.7)

3 (4.0)

1 (1.2)

2 (2.6)

Patients with any treatment-emergent SAE

6 (8.0)

5 (6.7)

2 (2.4)

2 (2.6)

Deaths

0

0

0

0

Patients with TEAE leading to treatment discontinuationb

2 (2.7)

0

1 (1.2)

0

TEAEs reported in ≥5% of patients in any treatment group (MedDRA PT), n (%)

 Nasopharyngitis

3 (4.0)

4 (5.3)

0

2 (2.6)

 Headache

4 (5.3)

4 (5.3)

5 (6.1)

4 (5.2)

 COVID-19

4 (5.3)

0

1 (1.2)

1 (1.3)

 Neurodermatitis

6 (8.0)

1 (1.3)

3 (3.7)

2 (2.6)

TEAE groups of interest, n (%)

 Herpes viral infections (HLT)c

0

0

0

4 (5.2)

 Skin infections (excluding herpetic infections)d

7 (9.3)

2 (2.7)

5 (6.1)

4 (5.2)

 Conjunctivitis (narrow)e

2 (2.7)

2 (2.7)

0

3 (3.9)

 Coronavirus infections (HLT)f

4 (5.3)

1 (1.3)

3 (3.7)

1 (1.3)

 COVID-19

4 (5.3)

0

1 (1.2)

1 (1.3)

 Asymptomatic COVID-19

0

0

2 (2.4)

 

 COVID-19 pneumonia

0

1 (1.3)

0

0

  1. Included in the analysis were all patients in the safety analysis set, which included all randomized patients who received ≥1 dose of dupilumab or placebo. Patients are listed according to the study drug they received, which may differ from the randomized group. Results are reported for the 24 weeks of treatment.
  2. aConsidered unrelated to the study intervention except for two events of sepsis and mesenteritis, experienced by one placebo-treated patient in PRIME.
  3. bIn PRIME, one event each of Hodgkin’s disease and neurodermatitis (MedDRA PTs), considered unrelated to the study drug. In PRIME2, one event of urticaria.
  4. cHerpes viral infections (HLT) includes MedDRA PTs oral herpes, herpes zoster, ophthalmic herpes zoster and genital herpes simplex. None of these TEAEs was severe, and all patients recovered with corrective treatment while continuing dupilumab.
  5. dSkin infection TEAEs (excluding herpetic infections) were identified based on blinded medical review of all reported TEAEs identified as possible skin infections using CMQ30067. This search included MedDRA PTs under HLGT Skin and subcutaneous tissue infections and infestations, all MedDRA PTs under HLT Skin structures and soft tissue infections, all MedDRA PTs of ‘wound infection’ and MedDRA PTs of chalazion, hordeolum and skin papilloma.
  6. eConjunctivitis (narrow term) includes MedDRA PTs conjunctivitis, conjunctivitis bacterial, conjunctivitis viral, conjunctivitis adenoviral, conjunctivitis allergic and atopic keratoconjunctivitis.
  7. fCoronavirus infections (HLT) include MedDRA PTs COVID-19, asymptomatic COVID-19 and COVID-19 pneumonia.
  8. COVID-19, Coronavirus Disease 2019; HLGT, MedDRA High-Level Group Term; HLT, MedDRA High-Level Term; MedDRA, Medical Dictionary for Regulatory Activities; PT, MedDRA Preferred Term.
Back to article page