Up to week 16 | After week 16 | |||||
Filgotinib 200 mg (n=5) | Lanraplenib 30 mg (n=4) | Filgotinib 200 mg (n=3) | Lanraplenib 30 mg (n=0) | Filgotinib 200 mg/lanraplenib 30 mg (n=1) | Lanraplenib 30 mg/filgotinib 200 mg (n=1) | |
Subjects with any TEAE, n (%) | 3 (60.0) | 4 (100.00) | 1 (33.3) | – | 1 (100.0) | 1 (100.0) |
Neutropenia | 2 (40.0) | 0 (0.0) | 0 (0.0) | – | 1 (100.0) | 0 (0.0) |
Peripheral oedema | 0 (0.0) | 1 (25.0) | 1 (33.0) | – | 0 (0.0) | 0 (0.0) |
Bronchitis | 0 (0.0) | 2 (50.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Furuncle | 1 (20.0) | 0 (0.0) | 0 (0.0) | – | 1 (100.0) | 0 (0.0) |
Arthralgia | 0 (0.0) | 0 (0.0) | 1 (33.0) | – | 1 (100.0) | 0 (0.0) |
Anaemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | – | 1 (100.0) | 0 (0.0) |
Leucopenia | 1 (20.0) | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Amaurosis fugax | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Vitreous floaters | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Dyspepsia | 1 (20.0) | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Food poisoning | 0 (0.0) | 0 (0.0) | 1 (33.0) | – | 0 (0.0) | 0 (0.0) |
Nausea | 1 (20.0) | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Fatigue | 1 (20.0) | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | – | 1 (100.0) | 0 (0.0) |
Nasopharyngitis | 0 (0.0) | 0 (0.0) | 1 (33.0) | – | 0 (0.0) | 0 (0.0) |
Sinusitis | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
URI | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Contusion | 0 (0.0) | 0 (0.0) | 1 (33.0) | – | 0 (0.0) | 0 (0.0) |
Fall | 0 (0.0) | 0 (0.0) | 1 (33.0) | – | 0 (0.0) | 0 (0.0) |
Lymphocytes decreased | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Hyper-cholesterolaemia | 1 (20.0) | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Hypo-albuminaemia | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Muscle spasms | 0 (0.0) | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 1 (100.0) |
MSK pain | 0 (0.0) | 0 (0.0) | 1 (33.0) | – | 0 (0.0) | 0 (0.0) |
Lupus | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Headache | 1 (20.0) | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Anxiety | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Acute kidney injury | 0 (0.0) | 1 (25.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Pollakiuria | 1 (20.0) | 0 (0.0) | 0 (0.0) | – | 0 (0.0) | 0 (0.0) |
Rash | 0 (0.0) | 0 (0.0) | 0 (0.0) | – | 1 (100.0) | 0 (0.0) |
Safety analysis set includes subjects who received at least one dose of study drug. Treatment-emergent events began on or after the study drug start date up to 30 days after permanent discontinuation of study drug or led to premature study drug discontinuation.
MSK, musculoskeletal; TEAE, treatment-emergent adverse event; URI, upper respiratory tract infection.