Table 3.

Open label and randomized controlled trials performed in AAV.

References	Design/anti-TNF-α therapy	Number of patients	Main objectives	Follow-up	Main results	Side effects
Stone et al. [40]	Open label trial ETN	20 GPA	BVAS at 6 months adverse events during 6 months	6 months	3 points Decrease of BVAS (P < 0,05)	Injection site reaction in 25% 95% of patients still taking ETN
WGET research group [41]	Randomized controlled trial ETN versus placebo	180 GPA (89 ETN, 91 placebo)	Sustained remission at 27 months (BVAS = 0)	27 months	69,7% for ETN versus 75,3% for placebo (NS)	56,2% for ETN versus 57,1% for placebo had a life threatening event (NS)
Morgan et al. [45]	Open label trial IFX	33 (22 GPA, 11 MPA) (16 IFX, 17 standard treatment)	Time to clinical remission (BVAS ≤ 1)	12 months	No difference between the two groups	Infections in 8 patients for IFX and 7 for standard treatment (NS)
De Menthon et al. [44]	Randomized controlled trial IFX versus rituximab	17 GPA (9 IFX, 8 RTX)	CR/PR at month 12	12 months	IFX: 2 CR, 1 PR RTX: 4 CR, 1 PR	One death in both groups (invasive Aspergillosis for IFX and sudden death for RTX)
Laurino et al. [46]	Phase 2 open label trial ADA	14 (9 GPA, 5 MPA)	(i) Induction of remission within the first 14 weeks (ii) time to remission	17 months	(i) 78,5% achieved remission (ii) Time to remission 12 weeks	Infections in 3 patients (1 mild and 2 severe including 1 death)

NS: Nonsignificant; RTX: rituximab; CP: complete remission; PR: partial remission.