Assessment of the prevalence of systemic lupus erythematosus in women with reproductive health problems in the Russian Federation. Results of the multicenter pilot PRISMA study

Objective: to assess the prevalence of systemic lupus erythematosus (SLE) in the Russian population of patients with reproductive health problems (RHP).

Material and methods. Patients were enrolled in 2023–2024 at 15 clinical centers in 5 federal districts of the Russian Federation. Women referred by a gynecologist, reproductive specialist, or general practitioner to a rheumatologist to rule out a systemic autoimmune rheumatic disease (SARD) were included. The study comprised two visits: the first screening visit and the second (final, 2–6 weeks later) visit, during which SARD verification was performed. Descriptive statistics methods were used for data analysis. The frequency of features in two independent study groups was compared using χ2 (Pearson’s test), odds ratios with 95% confidence intervals. The association between antibody levels and clinical manifestations was assessed by constructing a regression model.

Results and discussion. Of 631 women examined, 612 (97.0%) met the inclusion criteria; 19 women were excluded because they did not have RHP (infertility or pregnancy loss) and/or signs of SARD. Antinuclear factor (ANF) was determined in 590 of 612 women. ANF positivity was detected in 238 (40.3%) of 590 patients. Of these 238 women, antinuclear antibodies were detected in 71, and decreased complement component levels were found in 55 (C3 in 28 and C4 in 27). SARD was diagnosed in 71 (11.6%) cases: SLE in 27 (4.4%) (definite in 23 and probable/incomplete in 4), mixed connective tissue disease was newly diagnosed in 36 (5.9%), Sjцgren’s disease in 4 (0.7%), and systemic sclerosis in 4 (0.7%). Among ANF-positive patients with RHP, 167 (70.2%) of 238 had no SARD.

Conclusion. In this multicenter pilot study, the frequency of SLE in the Russian population among women with RHP was 4.4% (27 of 612 women), and the overall frequency of SARD was 11.6% (71 of 612). ANF positivity occurred more than three times (40.3%) more often than newly diagnosed SARD cases, indicating the need for further studies to clarify the reasons for ANF occurrence in women of childbearing age with RHP and for their longitudinal follow-up.

1. Reshetnyak TM, Kosheleva NM, Nasonov EL. Systemic lupus erythematosus and pregnancy: Before gestation, during and after childbirth. Nauchno-Prakticheskaya Revmatologia. 2023;61(3):292-297 (In Russ.).

2. Amirbekova Zh, Gagloeva G, Zhienbaeva A, et al. Pregnancy in systemic lupus erythematosus: review of literature. Reproduktivnaya meditsina (Tsentral'naya Aziya). 2023;(1): 116-125. (In Russ.).

3. Vlasova GA, Perminova SG, Kosheleva NM, Nazarenko TA. Reproductive function in women with immuno-inflammatory rheumatic diseases. Akusherstvo i ginekologiya. 2019; (10):51-9. (In Russ.).

4. Vlasova GA, Perminova SG, Kosheleva NM, Veyukova MA. The impact of therapy for immune-inflammatory rheumatic diseases on reproductive function. Akusherstvo i ginekologiya. 2021;(7):53-60. (In Russ.).

5. Lila AM, Trofimov EA, Lila VA. Systemic lupus erythematosus: Specific features of its course and therapy options. Modern Rheumatology Journal. 2015;9(3):43-47. (In Russ.). doi: 10.14412/1996-7012-2015-3-43-47.

6. Kosheleva NM, Matyanova EV, Fedorova EV, Klimenchenko NI. Pregnancy outcomes in patients with rheumatoid arthritis and systemic lupus erythematosus. Part I. Maternal outcomes. Nauchno-Prakticheskaya Revmatologiya. 2019;57(2):180-185. (In Russ.).

7. Petri M, Orbai AM, Alarcon GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8): 2677-86. doi: 10.1002/art.34473.

8. Hochberg MC. Updating the American college of rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum. 1997 Sep;40(9): 1725. doi: 10.1002/art.1780400928.

9. Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006 Feb;4(2):295-306. doi: 10.1111/j.1538-7836.2006.01753.x.

10. Female Infertility. Clinical Guidelines. Akusherstvo i ginekologiya. (In Russ.). 2025;10 (Supplement).

11. Diffuse connective tissue diseases and other systemic inflammatory connective tissue diseases. In: Nasonova VA, Bunchuk NV, editors. A guide to internal medicine. Rheumatic diseases. Moscow; 1997. P. 160-218.

12. Reshetnyak TM. Antiphospholipid syndrome: Diagnosis and clinical manifestations (a lecture). Nauchno-Prakticheskaya Revmatologia. 2014;52(1):56-71. (In Russ.).

13. Panafidina TA, Popkova TV, Lila AM, Nasonov EL. Incomplete systemic lupus erythematosus. Own observation and literature review. Nauchno-Prakticheskaya Revmatologia. 2023;61(6):678-688. (In Russ.).

14. Etchegaray-Morales I, Mendoza-Pinto C, Arellano-Avendaсo FJ, et al. Epidemiology of systemic lupus erythematosus in Latin America. Reumatol Clin (Engl Ed). 2024 Dec; 20(10):560-566. doi: 10.1016/j.reumae.2024.11.003.

15. Shaduro DV, Beloglazov VA, Petrov AV, Aliev KA. Modern clinical epidemiological characteristic of lupus erythematosus based on the data of regional registry. Klinicheskaya meditsina. 2017;(2):140-147. (In Russ.).

16. Niehues T, von Hardenberg S, Velleuer E. Rapid identification of primary atopic disorders (PAD) by a clinical landmark-guided, upfront use of genomic sequencing. Allergol Select. 2024 Oct 2:8:304-323. doi: 10.5414/ALX02520E.

17. Fousteri G, Dave Jhatakia A. Viral Infections and Autoimmune Disease: Roles of LCMV in Delineating Mechanisms of Immune Tolerance. Viruses. 2019 Sep 21; 11(10):885. doi: 10.3390/v11100885.

18. Olivares-Hernandez A, Figuero-Perez L, Miramontes-Gonzalez JP, et al. Immune System Disorders, Cancer and Viral Infections: A New Treatment Opportunity for the Immune Checkpoint Inhibitors. Life (Basel). 2021 Dec 15;11(12):1400. doi: 10.3390/life11121400.

19. Greenhalgh T, Sivan M, Perlowski A, Nikolich JЋ. Long COVID: a clinical update. Lancet. 2024 Aug 17;404(10453):707-724. doi: 10.1016/S0140-6736(24)01136-X.

20. Blanco LP, Salmeri N, Temkin SM, et al. Endometriosis and autoimmunity. Autoimmun Rev. 2025 Mar 26;24(4):103752. doi: 10.1016/j.autrev.2025.103752.

21. Lukac S, Schmid M, Pfister K, et al. Extragenital Endometriosis in the Differential Diagnosis of Non-Gynecological Diseases. Dtsch Arztebl Int. 2022 May 20;119(20): 361-367. doi: 10.3238/arztebl.m2022.0176.

22. Moyer A, Edens C. Impact of Systemic Lupus Erythematosus on Conception: Insights into infertility, fertility preservation, assisted reproductive technology and pregnancy outcomes. Semin Reprod Med. 2024 Sep; 42(3):209-227. doi: 10.1055/s-0044-1793827.

23. He WR, Wei H. Maternal and fetal complications associated with systemic lupus erythematosus: An updated meta-analysis of the most recent studies (2017-2019). Medicine (Baltimore). 2020 Apr;99(16):e19797. doi: 10.1097/MD.0000000000019797.

24. Trofimov EA. Antiphospholipid syndrome: features of the course in pregnant women and treatment principles. Vestnik NovGU. 2016; 6(97):63-67. (In Russ.).

25. Vinet E, Clarke AE, Gordon C, et al. Decreased live births in women with systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2011 Jul;63(7):1068-72. doi: 10.1002/acr.20466.

26. Krasselt M, Baerwald C. Sex, symptom severity and quality of life in rheumatology. Clin Rev Allergy Immunol. 2019 Jun;56(3): 346-361. doi: 10.1007/s12016-017-8631-6.

27. Xia XY, Liu ST, Song ZC, et al. Current investigation of the high prevalence of sexual dysfunction in female patients with systemic lupus erythematosus: a cross-sectional study. Rheumatol Int. 2024 Oct;44(10):2147-2157. doi: 10.1007/s00296-024-05690-6.

28. Carson SA, Kallen AN. Diagnosis and management of infertility: a review. JAMA. 2021 Jul 6;326(1):65-76. doi: 10.1001/jama.2021.4788.

29. Pashnina IA, Krivolapova IM, Fedotkina TV, et al. Antinuclear autoantibodies in health: autoimmunity is not a synonym of autoimmune disease. Antibodies (Basel). 2021 Feb 25;10(1):9. doi: 10.3390/antib10010009.

30. Reshetnyak TM, Shumilova AA, Kosheleva NM. Lechebnoe delo. 2021;(4):96-103. (In Russ.).

31. Cavalcante MB, Cavalcante CTMB, Sarno M, et al. Antinuclear antibodies and recurrent miscarriage: systematic review and meta-analysis. Am J Reprod Immunol. 2020 Mar;83(3):e13215. doi: 10.1111/aji.13215.

32. Deroux A, Dumestre-Perard C, DunandFaure C, et al. Female infertility and serum auto-antibodies: a systematic review. Clin Rev Allergy Immunol. 2017 Aug;53(1):78-86. doi: 10.1007/s12016-016-8586-z.

33. Desinova OV, Starovoytova MN, Guseva IA, et al. Features of systemic sclerosis-rheumatoid arthritis overlap syndrome (SS-RA overlap syndrome). Nauchno-prakticheskaya revmatologiya. 2007;45(4):18-23. (In Russ.).

34. Barber MRW, Drenkard C, Falasinnu T, et al. Global epidemiology of systemic lupus erythematosus. Nat Rev Rheumatol. 2021 Sep; 17(9):515-532. doi: 10.1038/s41584-021-00668-1.