Table 2.
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.
No AEs were reported for cohorts 1 (0.0003 mg/kg, n = 1) and 2 (0.0015 mg/kg, n = 1).
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.
Related to skin biopsy site.