Sjögren's disease & overlap diseases

Pregnancy outcomes in women with primary Sjögren's syndrome: an analysis of data from the multicentre, prospective, GR2 study

Lancet RheumatolPublished Prospective cohort study

Main finding · Adverse pregnancy outcomes, matched controlled studyResult — go to the resultOdds ratio 1.31 95% CI 0.53–2.98

Authors' conclusion

Pregnancies in women with primary Sjögren's syndrome had very good prognoses for mothers and fetuses, with no overall increase in adverse pregnancy outcome risk compared with the general population.

Study context

Population
Women with pSS (ACR/EULAR 2016 criteria) who conceived before March 2021 with an ongoing pregnancy at 12 weeks of gestation, GR2 registry, France106 pregnancies in 96 women with pSS
Participants
105 vs 420
Exposure
Pregnancies in women with pSS vs matched general-population controls
  • pSSn = 105
  • Matched controlsn = 420reference
Outcome
Adverse pregnancy outcomes:
  • Fetal or neonatal death
  • Placental insufficiency leading to preterm delivery [<37 weeks]
  • Small-for-gestational-age birthweight
Methodological detailsmulticentre, matched controlled comparison with general population
  • Multicentre
  • Matched controlled comparison with general population

Main finding

As reported in the abstract

Adverse pregnancy outcomes, matched controlled study

Odds ratio

1.31

95% CI 0.53–2.98

P = 0.52

Events by group

pSSvs Matched controls
OR 1.31 (95% CI 0.53–2.98); P = 0.52

Observational data: associations, not effects.

Further findings

OutcomeP value
aPL positivity, pregnancies with vs without adverse outcomes (n=55 with aPL data)P = 0.023
pSS flare (≥3-point increase in ESSDAI), pregnancies included at week 18 or earlier
13% · 12
  • pSS flare (≥3-point increase in ESSDAI), pregnancies included at week 18 or earlier: 93 pregnancies included at week 18 of gestation or earlier
  • aPL positivity, pregnancies with vs without adverse outcomes (n=55 with aPL data): With adverse outcomes 50%
  • aPL positivity, pregnancies with vs without adverse outcomes (n=55 with aPL data): Without adverse outcomes 4%

pSS flare (≥3-point increase in ESSDAI), pregnancies included at week 18 or earlier

No baseline parameters were associated with pSS flare

Adverse pregnancy outcomes in the GR2 cohort (twin pregnancies and medical termination excluded)

Adverse pregnancy outcomes among the remaining 88 pregnancies
six (7%)
  • Four twin pregnancies and one medical termination excluded

aPL positivity, pregnancies with vs without adverse outcomes (n=55 with aPL data)

Anti-RNP antibody positivity more frequent among pregnancies with adverse outcomes, not statistically significant

Original publication

Pregnancy outcomes in women with primary Sjögren's syndrome: an analysis of data from the multicentre, prospective, GR2 study. Lancet Rheumatol. Published 8 May 2023. doi:10.1016/s2665-9913(23)00099-1

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