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  • O8 Hydroxychloroquine blood levels at first trimester of pregnancy, and materno-fetal outcomes: a prospective study of 174 patients with systemic lupus erythematosus (GR2 study)

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O8 Hydroxychloroquine blood levels at first trimester of pregnancy, and materno-fetal outcomes: a prospective study of 174 patients with systemic lupus erythematosus (GR2 study)
  1. Gelsomina Alle1,2,
  2. Gaëlle Guettrot-Imbert1,
  3. Estibaliz Lazaro3,
  4. Anna Molto1,4,
  5. Maddalena Larosa5,
  6. Anne Murarasu1,
  7. Christophe Richez6,
  8. Nathalie Morel1,
  9. Pauline Orquevaux7,
  10. Laurent Sailler8,
  11. Viviane Queyrel9,
  12. Benoit Blanchet10,
  13. Emmanuelle Pannier11,
  14. Luc Mouthon1,12,
  15. Véronique Le Guern1,
  16. Nathalie Costedoat-Chalumeau1,12,
  17. on behalf of the GR2 Study Group
  1. 1Service de Médecine Interne, Centre de référence des maladies auto-immunes et systémiques rares d’Ile-de-France, AP-HP Hôpital Cochin, Paris, France
  2. 2Rheumatology Section, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
  3. 3Service de Médecine Interne, Hôpital du Haut-Lévêque, Centre Hospitalier Universitaire de Bordeaux, France
  4. 4Service de Rhumatologie, AP-HP Hôpital Cochin, Paris, France
  5. 5Unit of Rheumatology, Dept. of Medical Specialties, Ospedale La Colletta, ASL3, Genoa, Italy
  6. 6Service de Rhumatologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
  7. 7Service de Médecine Interne, Hôpital Robert Debré, Centre Hospitalier Universitaire de Reims, Reims, France
  8. 8Service de Médecine Interne, Centre Hospitalier Universitaire de Toulouse, Toulouse, France
  9. 9Service de Rhumatologie, Centre Hospitalier Universitaire de Nice, Nice, France
  10. 10Biologie du médicament – Toxicologie, AP-HP Hôpital Cochin, Paris, France
  11. 11Service de Maternité Gynécologie Obstétrique Port-Royal, Hôpital Cochin, Paris, France
  12. 12Université de Paris Cité, Paris, France

Abstract

Introduction Pregnancies in patients with systemic lupus erythematosus (SLE) are associated with an increased risk of adverse maternal (including flares) and fetal outcomes. Hydroxychloroquine (HCQ) decreases disease activity and the occurrence of flares, but little is known about the usefulness of monitoring HCQ blood levels during pregnancy. The aim of this study was to evaluate the correlation between HCQ blood levels in the first trimester of pregnancy, and the maternal and fetal outcomes in these patients.

Methods We included pregnant SLE patients enrolled in the French prospective ‘Groupe de recherche sur la Grossesse et les Maladies Rares’ (GR2) study, with at least one available first-trimester whole-blood HCQ level. We evaluated several cut-offs: 500 ng/ml, 750, and 1000 ng/ml, as a therapeutic target, and a threshold of 200 ng/ml for assessing severe non-adherence. The primary outcomes were maternal flares (mild/moderate or severe, identified by SLEDAI Flare Index) during the 2nd and 3rd trimesters of pregnancy, and any adverse pregnancy outcomes (APOs), which included fetal/neonatal death, placental insufficiency resulting in preterm delivery, and/or small-for-gestational-age neonates.

Results We included 174 patients (median age 32.1 years -IQR 28.8–35.2-). Thirty (17.2%) patients had flares, 4 (2.3%) of these were severe. APOs occurred in 28 patients (16.1%). There were no significant differences in APOs according to HCQ levels, neither between those with infra-therapeutic HCQ levels ≤500 ng/ml vs >500 ng/ml (23.5% vs 14.3%, p=0.19), nor between those with non-adherent HCQ levels ≤200 ng/ml vs >200 ng/ml (20.0% vs 15.7%, p=0.67). There were no significant differences in maternal flares based on varying HCQ cut-offs. However, there was a significant increase in severe flares among patients with infra-therapeutic (HCQ ≤500 ng/ml) (8.8% vs 0.7%, p=0.005), and non-adherent (≤ 200 ng/ml) HCQ levels (13.3% vs 1.3%, p=0.003).

Conclusion First-trimester HCQ blood levels did not predict APOs, but infra-therapeutic (≤500 ng/ml) and non-adherent HCQ levels (≤200 ng/ml) were associated with severe maternal flares during pregnancy. Therefore, this study supports the assessment of HCQ blood level monitoring in pregnant women with SLE, as an indicator of severe non-adherence, and a predictor of severe maternal disease activity during pregnancy.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/lupus-2024-el.18

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