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. 2020 Nov 24;109(5):1293–1303. doi: 10.1002/cpt.2091

Table 2.

Summary of adverse events (MedDRA preferred term) occurring in ≥ 2 participants per cohort in healthy participants (part A) or patients with psoriasis (part B)

Part A: Healthy participants (N = 40) a Placebo (n = 14) GSK2831781

0.0075 mg/kg

(ADA‐ve)

(n = 6)

0.04 mg/kg

(ADA‐ve)

(n = 6)

0.15 mg/kg

(ADA‐ve)

(n = 6)

0.15 mg/kg

(ADA + ve)

(n = 6)

0.15 mg/kg

(combined)

(n = 12)

Total (n = 24)
Any event, n (%) 8 (57) 5 (83) 6 (100) 3 (50) 3 (50) 6 (50) 17 (65)
Headache, n (%) 2 (14) 1 (17) 3 (50) 0 1 (17) 1 (8) 5 (19)
Back pain, n (%) 2 (14) 1 (17) 0 0 2 (33) 2 (17) 3 (12)
Nasopharyngitis, n (%) 2 (14) 0 2 (33) 1 (17) 0 1 (8) 3 (12)
Abdominal pain, n (%) 0 3 (50) 0 0 0 0 3 (12)
Oropharyngeal pain, n (%) 0 2 (33) 0 0 1 (17) 1 (8) 3 (12)
Part B: Patients with psoriasis (N = 27) Placebo (n = 9) GSK2831781
0.5 mg/kg (n = 6) 1.5 mg/kg (n = 6) 5 mg/kg (n = 6) Total (n = 18)
Any event, n (%) 9 (100) 4 (67) 6 (100) 6 (100) 16 (89)
Headache, n (%) 4 (44) 1 (17) 3 (50) 2 (33) 6 (33)
Nasopharyngitis, n (%) 3 (33) 2 (33) 2 (33) 2 (33) 6 (33)
Back pain, n (%) 0 2 (33) 1 (17) 3 (50) 6 (33)
Oral herpes, b n (%) 1 (11) 2 (33) 0 1 (17) 3 (17)
Diarrhea, n (%) 1 (11) 2 (33) 0 0 2 (11)
Oropharyngeal pain, n (%) 0 0 2 (33) 0 2 (11)
Post‐procedural inflammation, c n (%) 0 0 0 2 (33) 2 (11)

ADA, anti‐drug antibodies; ADA‐ve, ADA negative; ADA + ve, ADA positive; AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities.

a

No AEs were reported for cohorts 1 (0.0003 mg/kg, n = 1) and 2 (0.0015 mg/kg, n = 1).

b

Three of 18 (17%) patients receiving GSK2831781 reported oral herpes infection, and 3 of 9 (33%) placebo‐treated patients reported AEs of oral herpes, herpes zoster, and ophthalmic herpes zoster.

c

Related to skin biopsy site.