|
| 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) |
|
