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Background: The use of hydroxychloroquine (HCQ) has long been established in Systemic Lupus Erythematosus (SLE) and especially as applicable drug during pregnancy. Recently, beneficial effects and safety of HCQ have been re-discussed in the light of a change in the summary of product characteristics in some countries. More current studies are required to provide patients with evidence-based advice regarding this essential drug when counselling for pregnancy.
Objectives: To examine the impact of HCQ on pregnancy outcomes of SLE women.
Methods: Pregnancies of women with SLE from an outpatient pregnancy clinic were prospectively evaluated before and throughout gestation. Maternal and fetal outcomes in women without HCQ therapy (group A) were compared to pregnancies under HCQ treatment from 1 st trimester on (group B). A multiple logistic regression was performed with adjustment for confounding factors.
Results: We enrolled 184 live births from singleton pregnancies in 145 women (n=77 with HCQ and n=107 w/o HCQ). One neonatal death (group B) occurred after severe preeclampsia at 24 weeks of gestation (w/g) linked to noncompliance in a woman with high-risk aPL profile. One child (group B) was born with mycophenolate mofetil embryopathy.
Women in the HCQ group had a significantly lower rate of preterm births [aOR 0.31 (95%-CI: 0.15-0.64), p = 0.026]. Regarding preeclampsia, we found a tendency towards less incidence with the use of HCQ [aOR 0.49 (95%-CI: 0.23-1.03), p = 0.24]. These improved outcomes are opposed by a higher frequency of risk factors in group B (lupus nephritis, high-risk aPL profile, slightly more hypertension) and a tendency towards more severe SLE (expressed in terms of increased use of Azathioprine) (
Patient characteristics
| All pregnancies (n=184 ) | No HCQ in pregnancy (n=107 ) | HCQ during pregnancy (n=77 ) | ||
|---|---|---|---|---|
| Age (years), median (IQR) | 31.0 (28.0-34.0) | 31.0 (29.0-34.0) | 30.0 (27.0-33.0) | |
| Hypertension, n (%) | 29 (15.8%) | 16 (15.0%) | 13 (16.9%) | |
| Preconception counselling, n (%) | 122 (66.3%) | 69 (64.5%) | 53 (68.8%) | |
| SLE disease & therapy characteristics | Disease duration (years), median (IQR) | 6.7 (2.9-10.3) | 7.0 (3.0-10.0) | 6.7 (2.1-11.0) |
| Lupus nephritis *1 , n (%) | 51 (27.7%) | 25 (23.4%) | 26 (33.8%) | |
| High-risk aPL profile *2 , n (%) | 39 (21.3%) | 21 (19.8%) | 18 (23.4%) | |
| SLEDAI *1 , median (IQR) | 2.0 (0-4.0) | 2.0 (0.0-4.0) | 2.0 (2.0-4.0) | |
| Anti-dsDNA, n (%) | 102 (55.7%) | 47 (44.3%) | 55 (71.4%) | |
| Anti-SSA/Ro and/or Anti-SSB/La, n (%) | 91 (49.7%) | 55 (51.9%) | 36 (46.8%) | |
| Azathioprine *1 , n (%) | 38 (20.7%) | 18 (16.8%) | 20 (26.0%) | |
| Low dose Aspirin *3 , n (%) | 74 (41.1%) | 34 (32.7%) | 40 (52.6%) | |
| Obstetrical history | Nulliparous, n (%) | 113 (61.4%) | 63 (58.9%) | 50 (64.9%) |
| Previous fetal loss, n (%) | 39 (21.2%) | 22 (20.6%) | 17 (22.1%) | |
| Previous (pre-)eclampsia or HELLP, n (%) | 14 (7.6%) | 8 (7.5%) | 6 (7.8%) | |
| Previous congenital heart block, n (%) | 1 (0.54%) | - | 1 (1.3%) | |
| Pregnancy outcome | (mild-moderate) flare *4 , n (%) | 44 (29.5%) | 30 (34.9%) | 14 (22.2%) |
| Preterm birth *5 , n (%) | 46 (25%) | 30 (28.0%) | 16 (20.8%) | |
| Preeclampsia, n (%) | 24 (13%) | 15 (14.0%) | 9 (11.7%) | |
| Intrauterine growth restriction, n (%) | 3 (1.7%) | 1 (1.0%) | 2 (2.6%) | |
| Congenital heart block, n (%) | 1 (0.54%) | - | 1 (1.3%) |
*1 last visit before pregnancy, * 2 according to the 2019 EULAR recommendations, *3 until 16 w/g, *4 increase in SLEPDAI ≥ 4 or increase in prednisolone ≥ 5mg/d, *5 < 37 w/g
Conclusion: In our cohort, SLE women with additional risk factors achieved a favourable pregnancy outcome. This encouraging result is in part attributable to pregnancy counselling with the advice to continue HCQ throughout gestation.
Disclosure of Interests: Isabell Haase Grant/research support from: Abbvie, Medac, Hexal, Pfizer, Ralph Brinks: None declared, Matthias Schneider Grant/research support from: GSK, UCB, Abbvie, Consultant of: Abbvie, Alexion, Astra Zeneca, BMS, Boehringer Ingelheim, Gilead, Lilly, Sanofi, UCB, Speakers bureau: Abbvie, Astra Zeneca, BMS, Chugai, GSK, Lilly, Pfizer, Sanofi, Rebecca Fischer-Betz Consultant of: UCB, Speakers bureau: Abbvie, Amgen, Biogen, BMS, Celgene, Chugai, GSK, Janssen, Lilly, Medac, MSD, Novartis, Roche, UCB, Pfizer.