Table 3

Adverse events (AEs) and pregnancy outcomes during the study

Events, n (%)Telitacicept 240 mg
(N=62)
Telitacicept 160 mg
(N=63)
Telitacicept 80 mg
(N=62)
Placebo
(N=62)
Any AE58 (93.5)58 (92.1)56 (90.3)51 (82.3)
Serious AE8 (12.9)10 (15.9)8 (12.9)10 (16.1)
AE resulted in dose reduction or interruption39 (62.9)24 (38.1)25 (40.3)27 (43.5)
AE resulted in discontinuation of study treatment7 (11.3)8 (12.7)7 (11.3)8 (12.9)
AE resulted in death1 (1.6)000
AE at injection site6 (9.7)12 (19.0)7 (11.3)4 (6.5)
AEs of special interest
 Infections and infectious diseases*47 (75.8)46 (73.0)43 (69.4)40 (64.5)
 Upper respiratory tract infection35 (56.5)34 (54.0)30 (48.4)32 (51.6)
 Urinary tract infection8 (12.9)11 (17.5)7 (11.3)4 (6.5)
 Herpes zoster5 (8.1)3 (4.8)8 (12.9)4 (6.5)
 Bronchitis5 (8.1)2 (3.2)4 (6.5)4 (6.5)
 Gastroenteritis1 (1.6)3 (4.8)3 (4.8)2 (3.2)
 Vaginal infection1 (1.6)1 (1.6)2 (3.2)4 (6.5)
 Conjunctivitis2 (3.2)4 (6.3)1 (1.6)0
 Lung infection2 (3.2)1 (1.6)01 (1.6)
 Pulmonary tuberculosis1 (1.6)02 (3.2)1 (1.6)
 Periodontitis4 (6.5)000
 Pharyngitis03 (4.8)1 (1.6)0
 Herpes viral infection1 (1.6)2 (3.2)00
General disorders and administration site conditions6 (9.7)12 (19.0)7 (11.3)4 (6.5)
 Reaction at the injection site5 (8.1)9 (14.3)5 (8.1)3 (4.8)
 Rash at the injection site1 (1.6)2 (3.2)1 (1.6)1 (1.6)
 Pain at the injection site02 (3.2)2 (3.2)0
Immune system disorders2 (3.2)000
 Hypersensitivity reaction1 (1.6)000
 Drug hypersensitivity1 (1.6)000
Pregnancy-related outcomes
 Number of pregnant patients4340
 Pregnancy outcome
 Voluntary termination, n (%)4 (100.0)3 (100.0)3 (75.0)0
 Live birth, n (%)001 (25.0)0
  • *AEs in at least two patients in either treatment group were listed.