Table 10.
T-cell targeted drugs in pSS: therapies preventing autoantigen presentation.
| DRUG | TRIAL (Reference) |
Inclusion Criteria | Number of Subjects | Age (Years) |
Disease Duration (Years) | Mean ESSDAI | Primary Outcome | Results | Effects (Statistically Significant) | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drg | Ctrl | Sicca Syndrome | Fibro-Like | Systemic | ||||||||
|
Petesicatib
RO5459072 Cathepsin S Inhibitor |
NCT02701985 Phase IIa [364] |
AECG criteria SSa and/or SSb+ ESSDAI ≥ 5 ESSPRI ≥ 5 USW > 0.0 mL/min Oral D-VAS ≥ 5/10 |
38 | 37 | 52.2 ± 12.5 |
? | ? | ΔESSDAI ≥ 3 at 12w | Not met | ESSPRI = | ESSPRI = SF36 = |
ESSDAI = |
|
Efalizumab
Anti-LFA-1 |
NCT00344448 Phase II [365] |
AECG criteria SSa and/or SSb+ |
6 | 3 | 53 ± 11.2 |
? | ? | Protocol-specified composite score at 12w | Early termination due to serious side effect in other trial | |||