Table 4

Summary of the outcomes evaluated in RCTs including primary-2002 patients with Sjögren syndrome

Author (year)PatientsWeeksDrug, doseOutcomes
Global/
composite
DrynessPainFatigueHRQoLSalivary flowsOcular testsESSDAI
Mariette et al12 (2004)10322Infliximab, 5 mg/kgVASVASVASVASSFRSchir
Sankar et al (2004)672812Etanercept, 25 mgVASVASSFRLiss, Schir
Dass et al13 (2008)1724RTX, 1 g/15 daysVASSF-36*
Meijer et al10 (2010)3048RTX, 1 g/15 daysVAS*MFISF-36SWSLiss, BUT, Schir
Norheim et al14 (2012)264Anakinra, 100 mg/dayVASBDI
Devauchelle-Pensec et al15 (2014)12224RTX, 1 g/15 daysVASVASVASVASSF-36SFRSchirMean improvement
Bowman et al19 (2017)13348RTX, 1 g/15 dysVASVAS oralVASESSPRI, SF-36UWS*Lachr flowLog-transf
St Clair et al18 (2018)5224Baminercept, 100 mg weeklyVASVASVASUWS, SWSLiss, Schir*Mean score
  • Grey cells=primary outcome.

  • *Statistically significant.

  • BDI, Beck Depression Inventory; ESSDAI, EULAR Sjögren's syndrome disease activity index; ESSPRI, EULAR Sjogren's Syndrome Patient Reported Index; HRQoL, health-related quality of life; MFI, Multidimensional Fatigue Inventory; RCT, randomised controlled trial; RTX, rituximab; Schir, schirmer; SF-36, Short Form-36 Health Survey; SFR, salivary flow rate; SFR, salivary flow rate; UWS, unstimulated whole saliva; VAS, visual analogue scale.