Table 8.
B cell targeted drugs in pSS part 3: drugs targeting other B cells survival and function pathways.
| 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 | ||||||||
|
LOU064
BTK inhibitor |
NCT04035668 Phase II LOUISSe [350] |
2016 ACR/EULAR criteria SSa and/or SSb+ ESSDAI ≥ 6 UWS >0 mL/min |
252 | ? | ? | ? | ΔESSDAI at 24w | Estimated Study Completion on January 2023 |
Secondary endpoint | Secondary endpoint | Secondary endpoint | |
|
Tirabrutinib
(GS-4059) BTK inhibitor |
NCT03100942 Phase II [342] |
AECG criteria SSa and/or SSb+ ESSDAI ≥ 4 |
38 | 37 | 55.8 ± 10.06 |
? | 10.4 ± 5.36 |
Protocol-Specified Response Criteria at 12w |
not met | ESSPRI = | ESSPRI = | ESSDAI = |
|
BMS-986142
BTK inhibitor |
NCT02843659 Phase II [351] |
2016 ACR/EULAR criteria SSa and/or SSb+ ESSDAI ≥ 6 UWS >0 mL/min |
5+6 | 7 | 51.2 ± 11.41 |
? | ? | ΔESSDAI at 12w | Not published |
Secondary endpoint | Secondary endpoint | Secondary endpoint |
|
Branebrutinib
BTK inhibitor |
NCT04186871 Phase II [352] |
2016 ACR/EULAR criteria Moderate to severe pSS |
? | ? | ? | ? | ? | Protocol-Specified Response Criteria at 24w | Estimated Study Completion on June 2022 |
na | na | Primary endpoint |
|
Baminercept
LT β -R fusion protein |
NCT01552681 Phase II [353] |
2016 ACR/EULAR criteria UWS >0.1 mL/min ≥ 1 non-life-threatening systemic manifestation(s) |
33 | 19 | 52.0 ± 11.0 |
? | 3.1 ± 3.4 |
ΔSWS at 24w | not met | D-VAS = Schirmer ⇧ UWS = |
F-VAS = | ESSDAI = |
|
Parsaclisib (INCB050465)
PI3Kδ inhibitor |
NCT03627065 Phase II [354] |
AECG criteria SGUS score > 2 SSa and/or SSb+ ESSDAI ≥ 6 Oral dryness score ≥ 5. |
10 | ? | ? | ? | ΔSGUS score at 12w | Not published | na | na | na | |
|
Seletalisib
(UCB5857) PI3Kδ inhibitor |
NCT02610543 Phase II [355] |
AECG criteria FAN ≥ 1:160 SSa and/or SSb+ ESSDAI ≥ 6 |
13 | 14 | ? | ? | ? | ΔESSDAI at 12w | not met | ESSPRI = SWSF = Schirmer = |
na | ESSDAI = |
|
Leniolisib
(CDZ173) PI3Kδ inhibitor |
NCT02775916 Phase II [356] |
pSS diagnosis SSa and/or SSb+ ESSDAI ≥ 6, ESSPRI ≥ 5 SWS > 0.1 mL/min |
20 | 10 | 47.3 ± 13.07 |
? | ? | ΔESSDAI at 12w SAEs at 12w |
not met | ESSPRI = | SF-36 = MFI = |
na |