Table 4.

Safety data from baseline to 48 weeks

	Total (n=225)	Rituximab (n=108)	Tocilizumab (n=117)	Percentage difference (95% CI)
Serious adverse events	20 (9%)	8 (7%)	12 (10%)	3% (−5 to 10)
Serious adverse events related to study drug	12 (5%)	4 (4%)	8 (7%)	3% (−3 to 9)
Abdominal pain	1 (<1%)	1 (1%)	0	NA
Chest pain*	1 (<1%)	0	1 (1%)	NA
Chronic obstructive pulmonary disease exacerbation	1 (<1%)	1 (1%)	0	NA
Corneal melt*	1 (<1%)	0	1 (1%)	NA
Cytokine release syndrome†	1 (<1%)	1 (1%)	0	NA
Dental cyst	1 (<1%)	0	1 (1%)	NA
Diarrhoea	1 (<1%)	1 (1%)	0	NA
Lower respiratory tract infection	1 (<1%)	0	1 (1%)	NA
Leg pain	1 (<1%)	0	1 (1%)	NA
Pilonidal sinus	1 (<1%)	0	1 (1%)	NA
Pneumonia	1 (<1%)	0	1 (1%)	NA
Urinary tract infection	1 (<1%)	0	1 (1%)	NA
Serious adverse events unrelated to study drug	14 (6%)	4 (4%)	10 (9%)	5% (−1 to 11)
Chest pain	2 (1%)	1 (1%)	1 (1%)	0% (−3 to 2)
Chest pain (cardiac)	1 (<1%)	0	1 (1%)	NA
Coronary angiogram	1 (<1%)	0	1 (1%)	NA
Drainage of pilonidal abscess	1 (<1%)	1 (1%)	0	NA
Hallux valgus	1 (<1%)	0	1 (1%)	NA
Parathyroid adenoma	1 (<1%)	0	1 (1%)	NA
Pleural effusion†	1 (<1%)	0	1 (1%)	NA
Seizure	1 (<1%)	0	1 (1%)	NA
Suicide†	1 (<1%)	1 (1%)	0	NA
Toe amputation	1 (<1%)	0	1 (1%)	NA
Total knee replacement	1 (<1%)	1 (1%)	0	NA
Urinoma	1 (<1%)	0	1 (1%)	NA
Serious adverse events resulting in study drug discontinuation	5 (2%)	2 (3%)	3 (3%)	1% (−3 to 5)
Any non-serious adverse event	170 (76%)	76 (70%)	94 (80%)	10% (−1 to 21)

Data are n (%). All events reported after the first prescription of the study drug up to week 48 (+30 days). Some patients had more than one adverse event. Events are classified using the Medical Dictionary for Regulatory Activities system classification, using the lowest level terms grouping. No cancer was observed during the treatment period. However, there was one kidney carcinoma after week 48. NA=not applicable.

^*Event was a suspected unexpected serious adverse reaction.

^†Event led to treatment drug discontinuation.