Точка зрения на применение анифролумаба у больных системной красной волчанкой с недостаточной эффективностью стандартной терапии в реальной клинической практике. Комментарии российских экспертов

   Системная красная волчанка (СКВ) – гетерогенное аутоиммунное заболевание, характеризующееся непредсказуемыми обострениями и исходом. Многие пациенты с СКВ, получающие стандартную терапию (СТ), не могут достичь рекомендуемой цели лечения – ремиссии или низкой активности заболевания (Lupus Low Disease Activity State, LLDAS). В настоящее времени сохраняется высокий уровень неудовлетворенности СТ СКВ, особенно длительным лечением глюкокортикоидами и иммунодепрессантами. Недавно одобренный препарат, антагонист рецептора интерферона I типа, анифролумаб (АФМ), может стать перспективным у пациентов с СКВ с недостаточным ответом на СТ. Исследования эффективности АФМ III фазы продемонстрировали более высокую частоту достижения ремиссии и низкой активности LLDAS у пациентов, получавших АФМ по сравнению с плацебо. В настоящей публикации представлены комментарии российских экспертов к статье Ю. Танака «Точка зрения на применение анифролумаба у пациентов с системной красной волчанкой с недостаточной эффективностью стандартной терапии в реальной клинической практике» («Viewpoint on anifrolumab in patients with systemic lupus erythematosus and a high unmet need in clinical practice»).

1. Tanaka Y. Viewpoint on anifrolumab in patients with systemic lupus erythematosus and a high unmet need in clinical practice. RMD Open. 2023 Aug;9(3):e003270. doi: 10.1136/rmdopen-2023-003270.

2. Piga M, Arnaud L. The main challenges in systemic lupus erythematosus: where do we stand? J Clin Med. 2021 Jan 11;10(2):243. doi: 10.3390/jcm10020243.

3. Lupus Foundation of America. Lupus facts and statistics. 2016. https://www.lupus.org/resources/lupus-facts-and-statistics

4. Kaul A, Gordon C, Crow MK, et al. Systemic lupus erythematosus. Nat Rev Dis Primers. 2016 Jun 16:2:16039. doi: 10.1038/nrdp.2016.39.

5. Chambers SA, Allen E, Rahman A, et al. Damage and mortality in a group of British patients with systemic lupus erythematosus followed up for over 10 years. Rheumatology (Oxford). 2009 Jun;48(6):673-5. doi: 10.1093/rheumatology/kep062. Epub 2009 Apr 9.

6. Segura BT, Bernstein BS, McDonnell T, et al. Damage accrual and mortality over long-term follow-up in 300 patients with systemic lupus erythematosus in a multi-ethnic British cohort. Rheumatology (Oxford). 2020 Mar 1; 59(3):524-533. doi: 10.1093/rheumatology/kez292.

7. Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2019 Jun;78(6): 736-745. doi: 10.1136/annrheumdis-2019-215089. Epub 2019 Mar 29.

8. Асеева ЕА. Гетерогенность клинических проявлений, течения, исходов и качества жизни, связанного со здоровьем у пациентов с системной красной волчанкой. Дисc. докт. мед. наук. Москва; 2023. 243 с.

9. Ugarte A, Danza A, Ruiz-Irastorza G. Glucocorticoids and antimalarials in systemic lupus erythematosus: an update and future directions. Curr Opin Rheumatol. 2018 Sep;30(5): 482-489. doi: 10.1097/BOR.0000000000000527.

10. Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024 Jan 2;83(1): 15-29. doi: 10.1136/ard-2023-224762.

11. Luijten R, Fritsch-Stork RD, Bijlsma JWJ, et al. The use of glucocorticoids in systemic lupus erythematosus. After 60 years still more an art than science. Autoimmun Rev. 2013 Mar; 12(5):617-28. doi: 10.1016/j.autrev.2012.12.001. Epub 2012 Dec 8.

12. Arnaud L, Tektonidou MG. Long-term outcomes in systemic lupus erythematosus: trends over time and major contributors. Rheumatology (Oxford). 2020 Dec 5;59(Suppl5): v29-v38. doi: 10.1093/rheumatology/keaa382.

13. Van Vollenhoven RF, Bertsias G, Doria A, et al. 2021 DORIS definition of remission in SLE: final recommendations from an international task force. Lupus Sci Med. 2021 Nov; 8(1):e000538. doi: 10.1136/lupus-2021-000538.

14. Franklyn K, Lau CS, Navarra SV, et al. Definition and initial validation of a Lupus Low Disease Activity State (LLDAS). Ann Rheum Dis. 2016 Sep;75(9):1615-21. doi: 10.1136/annrheumdis-2015-207726. Epub 2015 Oct 12.

15. Kandane-Rathnayake R, Golder V, Louthrenoo W, et al. Lupus low disease activity state and remission and risk of mortality in patients with systemic lupus erythematosus: a prospective, multinational, longitudinal cohort study. Lancet Rheumatol. 2022 Dec;4(12): e822-e830. doi: 10.1016/S2665-9913(22)00304-6. Epub 2022 Oct 22.

16. Golder V, Kandane-Rathnayake R, Hoi AYB, et al. Association of the lupus low disease activity state (LLDAS) with health-related quality of life in a multinational prospective study. Arthritis Res Ther. 2017 Mar 20;19(1): 62. doi: 10.1186/s13075-017-1256-6.

17. Kandane-Rathnayake R, Louthrenoo W, Hoi A, et al. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus – a multinational observational cohort study. Arthritis Res Ther. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3.

18. Crow MK. Advances in understanding the role of type I Interferons in systemic lupus erythematosus. Curr Opin Rheumatol. 2014 Sep;26(5):467-74. doi: 10.1097/BOR.0000000000000087.

19. Решетняк ТМ, Асеева ЕА, Шумилова АА и др. Портрет пациента с системной красной волчанкой для назначения ингибитора интерферона типа I анифролумаба. Современная ревматология. 2023;17(6):14-21. doi: 10.14412/1996-7012-2023-6-14-21

20. Решетняк ТМ, Асеева ЕА, Шумилова АА, Лила АМ. Ингибитор рецепторов интерферона 1 типа (анифролумаб – «Сафнело») в лечении пациентов с СКВ (описание клинических наблюдений). Поликлиника. 2023;(3-2):20-26.

21. Morand EF, Furie R, Tanaka Y, et al. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020 Jan 16;382(3): 211-221. doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18.

22. Furie RA, Morand EF, Bruce IN, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019 Dec;1(4):e208-e219. doi: 10.1016/S2665-9913(19)30076-1. Epub 2019 Nov 11.

23. Furie R, Khamashta M, Merrill JT, et al. Anifrolumab, an anti-interferon-α receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol. 2017 Feb;69(2):376-386. doi: 10.1002/art.39962.

24. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo controlled phase III extension trial of the long term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. 2023 Feb;75(2):253-265. doi: 10.1002/art.42392. Epub 2022 Nov 11.

25. Morand EF, van Vollenhoven R, Furie R, et al. Lupus low disease activity state attainment in the phase 3 placebo-controlled TULIP long-term extension trial of anifrolumab. Ann Rheum Dis. 2023;82(Suppl. 1):33-4. doi: 10.1136/annrheumdis-2023-eular.1568

26. AstraZeneca. Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus. 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/saphnelo-approved-in-the-us-for-sle.html

27. Pons-Estel GJ, Ugarte-Gil MF, Alarcon GS. Epidemiology of systemic lupus erythematosus. Expert Rev Clin Immunol. 2017 Aug;13(8):799-814. doi: 10.1080/1744666X.2017.1327352. Epub 2017 May 16.

28. Langham J, Barut V, Samnaliev M, et al. Disease severity, flares and treatment patterns in adults with systemic lupus erythematosus in the UK: a real-world observational retrospective cohort analysis. Rheumatol Adv Pract. 2021 Aug 27;5(3):rkab061. doi: 10.1093/rap/rkab061. eCollection 2021.

29. Parikh SV, Almaani S, Brodsky S, et al. Update on lupus nephritis: core curriculum 2020. Am J Kidney Dis. 2020 Aug;76(2):265-281. doi: 10.1053/j.ajkd.2019.10.017. Epub 2020 Mar 24.

30. FDA. Benlysta, prescribing information. 2011. URL: www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf

31. Jayne D, Rovin B, Mysler EF, et al. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022 Apr;81(4): 496-506. doi: 10.1136/annrheumdis-2021-221478. Epub 2022 Feb 10.

32. Vital EM, Merrill JT, Morand EF, et al. Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials. Ann Rheum Dis. 2022 Jul;81(7):951-961. doi: 10.1136/annrheumdis-2021-221425. Epub 2022 Mar 25.

33. Bruce IN, van Vollenhoven RF, Morand EF, et al. Sustained glucocorticoid tapering in the phase 3 trials of anifrolumab: a post-hoc analysis of the TULIP-1 and TULIP-2 trials. Rheumatology (Oxford). 2023 Apr 3;62(4): 1526-1534. doi: 10.1093/rheumatology/keac491.

34. Morand EF, Abreu G, Furie RA, et al. Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus. Ann Rheum Dis. 2023 May;82(5):639-645. doi: 10.1136/ard-2022-222748. Epub 2023 Jan 23.

35. Kikuchi J, Hanaoka H, Saito S, et al. Lupus low disease activity state within 12 months is associated with favorable outcomes in severely active systemic lupus erythematosus. Rheumatology (Oxford). 2022 Aug 30;61(9): 3777-3791. doi: 10.1093/rheumatology/keac002.

36. Morand EF, Trasieva T, Berglind A, et al. Lupus low disease activity state (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the phase IIb MUSE trial of anifrolumab. Ann Rheum Dis. 2019 Nov;78(11):e122. doi: 10.1136/annrheumdis-2018-214487. Epub 2018 Oct 29.

37. Adamichou C, Bertsias G. Flares in systemic lupus erythematosus: diagnosis, risk factors and preventive strategies. Mediterr J Rheumatol. 2017 Mar 28;28(1):4-12. doi: 10.31138/mjr.28.1.4. eCollection 2017 Mar

38. Furie R, Morand EF, Askanase AD, et al. Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus. Lupus. 2021 Jul;30(8):1254-1263. doi: 10.1177/09612033211014267. Epub 2021 May 12.

39. Flouda S, Sampatakaki E, Moysidou GS, et al. Anifrolumab for refractory skin disease in systemic lupus erythematosus (SLE): a single center case series. Ann Rheum Dis. 2023;82(Suppl 1):1468. doi: 10.1136/annrheumdis-2023-eular.6077

40. Khan MA, Khan FH, Khan HB, et al. Role of anifrolumab in refractory cutaneous manifestations of lupus erythematosus: a case series and literature review. Cureus. 2023 May 27;15(5):e39553. doi: 10.7759/cureus.39553. eCollection 2023 May.

41. Plüβ M, Piantoni S, Wincup C, et al. Rapid response of refractory systemic lupus erythematosus skin manifestations to anifrolumab – a case-based review of clinical trial data suggesting a domain-based therapeutic approach. J Clin Med. 2022 Jun 15;11(12):3449. doi: 10.3390/jcm11123449.

42. Gatto M, Saccon F, Zen M, et al. Early disease and low baseline damage as predictors of response to belimumab in patients with systemic lupus erythematosus in a real-life setting. Arthritis Rheumatol. 2020 Aug;72(8): 1314-1324. doi: 10.1002/art.41253. Epub 2020 Jun 12.

43. Gerosa M, Beretta L, Ramirez GA, et al. Long-term clinical outcome in systemic lupus erythematosus patients followed for more than 20 years: the Milan systemic lupus erythematosus consortium (SMiLE) cohort. J Clin Med. 2022 Jun 22;11(13):3587. doi: 10.3390/jcm11133587.

44. Ruiz-Irastorza G, Bertsias G. Treating systemic lupus erythematosus in the 21^st century: new drugs and new perspectives on old drugs. Rheumatology (Oxford). 2020 Dec 5; 59(Suppl5):v69-v81. doi: 10.1093/rheumatology/keaa403.

45. Bruce IN, van Vollenhoven RF, Psachoulia K, et al. Time to onset of clinical response to anifrolumab in patients with SLE: pooled data from the phase III TULIP-1 and TULIP-2 trials. Lupus Sci Med. 2023 Jan; 10(1):e000761. doi: 10.1136/lupus-2022-000761.