Table 1.
Clinical trials that investigated the effects of biological therapies in pSS.
| Therapy | References Year |
Study Characteristics | Outcome | ||
|---|---|---|---|---|---|
| Type/Phase | Cohort Size (n =) | Follow-Up Period (w) | |||
| Rituximab | Carubbi et al., 2013 [91] | RCT | 41 | 120 | ↓ ESSDAI activity, ↓ glandular infiltrate, ↓ ectopic GC |
| Devauchelle- Pensec et al., 2014 [94] | RCT | 120 | 24 | Fatigue alleviation | |
| Cornec et al., 2016 [47] | Open label | 45 | 24 | Mild glandular B-cell depletion | |
| Bowman et al., 2017 [95] | RCT/III | 133 | 26 | No clinical efficacy | |
| Fisher et al., 2018 [96] | RCT/III | 52 | 48 | Improvement in ultrasound score | |
| Belimumab | Mariette et al., 2013 [97] | Open label/II | 30 | 28 | Reduction in parotid swelling, Mild ↓ of B cell activation |
| de Vita et al., 2015 [98] | Open label/II | 30 | 52 | Improvement in ESSDAI score | |
| Quartuccio et al., 2016 [99] | Open label/II | 13 | 52 | No significant changes in type II IFN scores | |
| Belimumab/Rituximab | Mariette et al., 2022 [100] | RCT/II | 86 | 68 | B cell depletion in salivary gland |
| Abatacept | Adler et al., 2013 [101] | Open label | 11 | 24 | ↓ glandular inflammation, ↑ saliva production |
| Haacke et al., 2017 [102] | Pilot RCT | 15 | 24 | Inhibition of local formation of memory B-cells | |
| Verstappen et al., 2017 [103] | Open label | 15 | 48 | ↓ cTfh-cells and expression levels of the activation marker ICOS on T-cells | |
| Baer et al., 2020 [104] | RCT/III | 187 | 24 | No significant clinical efficacy | |
| de Wolff et al., 2022 [105] | RCT/III | 40 | 48 | Improvement in ESSDAI activity and eyes dryness. | |
| Tocilizumab | Felten et al., 2020 [106] | RCT | 110 | 44 | No significant clinical efficacy |
| Ianalumab (VAY736) | Bowman et al., 2022 [107] | RCT/IIb | 190 | 24 | ↓ ESSDAI activity |
| Diekhoff et al., 2022 [108] | RCT | 27 | 24 | Improvement in salivary gland ultrasound score | |
| LD-IL-2 | He et al., 2022 [109] | RCT/II | 60 | 12 | Restore the balance of T and B cell subsets |
Abbreviations: RCT, randomized control trial; ↓, low; ↑, high; ESSDAI, EULAR Sjögren’s syndrome disease activity index; GC, germinal centers; IFN, interferon; cTfh cells, circulating T follicular helper cells; ICOS, inducible costimulator; LD-IL-2, low-dose-interleukin-2.