Results of a non-interventional multicenter study of management of patients with non-radiological axial spondyloarthritis in real-life clinical practice in the Russian Federation (NiSpAR)

NiSpAR is a non-interventional, multicenter study whose aim was to describe a cohort of patients with non-radiological axial spondyloarthritis (nr-axSpA) and approaches to its diagnosis in the Russian Federation.

Material and methods. The study involved 20 research centers in different regions of the Russian Federation. The work consisted of two phases: retrospective data collection 12 months before enrolment in the study and prospective observation of patients in whom the diagnosis of nr-axSpA was confirmed (104 weeks).

The study included 272 patients who met the inclusion and exclusion criteria (Full Analysis Set, FAS). The mean age of the FAS-population was 38.7±11.0 years. The diagnosis of nr-axSpA was confirmed in 159 (58.5 %) of the 272 patients. Of the remaining 113 (41.5%) participants, 57 (50.4%) did not have the information required to confirm the diagnosis, 34 (30.1%) did not have pelvic radiographs, and 22 (19.5%) did not fulfil the ASAS criteria for nr-axSpA.

Results and discussion. The mean age of patients with nr-axSpA was 37.6±10.4 years, more than half of them (52.8%) were women. The median disease duration was 36 [12; 80] months. In half of the patients the disease duration was more than 2 years, in more than one third – less than 2 years. The median CRP and ESR values were 5.0 [2.0; 12.0] mg/l and 11.0 [5.0; 18.0] mm/h, respectively. The BASDAI averaged 3.5±2.0 and was >4 in more than half of the cases (64.2%). The mean ASDAS-CRP value reached 2.6±1.1. Only 1 in 5 participants (20.8%) had low axSpA activity, while in 61.1% it was high (44.7%) or very high (16.4%). An inactive state was found in a small number of patients (9.4%). Twenty two (13.8%) patients had treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) in anamnesis, and 21 (13.2%) patients were still taking them.

Conclusion. The results of the retrospective phase of the study show that in real-life clinical practice in the Russian Federation there is a continued positive trend towards improving the diagnosis of nr-axSpA. The median duration of the disease at the time of enrolment in the study was 3 years. The frequency of use of magnetic resonance imaging has increased by more than 1.8 times. At the same time, practitioners still have difficulties in establishing the diagnosis of nr-axSpA and a shortage of bDMARDs for treatment of these patients.

1. Erdes ShF, Badokin VV, Bochkova AG, et al. On the terminology of spondyloarthritis. Nauchno-prakticheskaya revmatologiya. 2015;53(6):657-60. (In Russ.)].

2. Rudwaleit M, van der Heijde D, Landewe R,et al. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.

3. Baraliakos X, Hermann KG, Braun J. Imaging in axial spondyloarthritis: diagnostic problems and pitfalls. Rheum Dis Clin North Am. 2012 Aug;38(3):513-22. doi: 10.1016/j.rdc.2012.08.011. Epub 2012 Sep 25.

4. Kleinert S, Schuch F, Rapp P, et al. Radiographic and non-radiographic axial spondyloarthritis are not routinely distinguished in everyday clinical care: an analysis of real-world data from rheumatology practices. Rheumatol Int. 2024 Apr;44(4):653-661. doi: 10.1007/s00296-023-05463-7. Epub 2023 Oct 8.

5. Akkoc N, Khan MA. Is Axial Spondyloarthritis More Common Than Rheumatoid Arthritis? Curr Rheumatol Rep. 2020 Jul 25;22(9): 54. doi: 10.1007/s11926-020-00934-3

6. Hocevar A, Potocnik Pucelj N, Jese R, et al. The incidence of spondyloarthritis in Slovenia. Medicine (Baltimore). 2019 Jun; 98(26):e16177. doi: 10.1097/MD.0000000000016177

7. Lila AM, Dreval RO, Shipitsyn VV. Assessment of organization of medical care and drug provision for patients with rheumatic diseases, and the socioeconomic burden of these diseases in the Russian Federation. Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2018;12(3):112-119. (In Russ.)]. doi: 10.14412/1996-7012-2018-3-112-11.

8. McGonagle D, Ramonda R, Scagnellato L, Scriffignano S, Weddell J, Lubrano E. A strategy towards disentangling treatment refractory from misdiagnosed axial Spondyloarthritis. Autoimmun Rev. 2023 Aug 3:103405. doi: 10.1016/j.autrev.2023.103405. Epub ahead of print.

9. Hermann J, Giessauf H, Schaffler G, et al.Early spondyloarthritis: usefulness of clinical screening. Rheumatology (Oxford). 2009 Jul; 48(7):812-6. doi: 10.1093/rheumatology/ kep119

10. Mauro D, Forte G, Poddubnyy D, Ciccia F.The Role of Early Treatment in the Management of Axial Spondyloarthritis: Challenges and Opportunities. Rheumatol Ther. 2024 Feb; 11(1):19-34. doi: 10.1007/s40744-023-00627-0. Epub 2023 Dec 18.

11. Smirnov AV, Erdes ShF. Optimization of X-ray diagnosis of ankylosing spondylitis in clinical practice: Importance of a plain X-ray film of the pelvis. Nauchno-prakticheskaya revmatologiya. 2015;53(2):175-181. (In Russ.)].

12. Tyukhova EYu. Magnetic resonance imaging of the spine and sacroiliac joints in patients with spondyloarthritis. Nauchno-prakticheskaya revmatologiya. 2012;50(2):106-111. (In Russ.)].

13. Feldtkeller E, Bruckel J, Khan MA. Scientific contributions of ankylosing spondylitis patient advocacy groups. Curr Opin Rheumatol. 2000 Jul;12(4):239-47. doi: 10.1097/00002281-200007000-00002;

14. Dubinina TV, Erdes ShF. Reasons for late diagnosis of ankylosing spondylitis in clinical practice. Nauchno-prakticheskaya revmatologiya. 2010;48(2):43-48. (In Russ.)].

15. Redeker I, Callhoff J, Hoffmann F, et al. Determinants of diagnostic delay in axial spondyloarthritis: an analysis based on linked claims and patient-reported survey data. Rheumatology (Oxford). 2019 Sep 1;58(9): 1634-1638. doi: 10.1093/rheumatology/kez090

16. Navarro-Compan V, Benavent D, Capelusnik D, et al. ASAS consensus definition of early axial spondyloarthritis. Ann Rheum Dis. 2023 Jun 15:ard-2023-224232. doi: 10.1136/ard-2023-224232. Online ahead of print.

17. Lapshina SA, Myasoutova LI, Mukhina RG, Salikhov IG. Effectiveness of educational programs on early diagnosis of ankylosing spondylitis for primary care physicians in Kazan. Nauchno-prakticheskaya revmatologiya. 2014; 52(2):183-186. (In Russ.)].

18. Magrey M, Schwartzman S, de Peyrecave N, et al. Nonradiographic axial spondyloarthritis: expanding the spectrum of an old disease: A narrative review. Medicine (Baltimore). 2022 Apr 15;101(15):e29063. doi: 10.1097/MD.0000000000029063

19. Robinson PC, van der Linden S, Khan MA,Taylor WJ. Axial spondyloarthritis: concept, construct, classification and implications for therapy. Nat Rev Rheumatol. 2021 Feb;17(2): 109-118. doi: 10.1038/s41584-020-00552-4. Epub 2020 Dec 23.

20. Ez-Zaitouni Z, Bakker PAC, van Lunteren M, et al. Presence of multiple spondyloarthritis (SpA) features is important but not sufficient for a diagnosis of axial spondyloarthritis: data from the SPondyloArthritis Caught Early (SPACE) cohort. Ann Rheum Dis. 2017 Jun;76(6):1086-1092. doi: 10.1136/annrheumdis-2016-210119. Epub 2017 Jan 6.

21. Rumyantseva DG, Erdes ShF. Axial spondyloarthritis: a current look at the concept and evolution of the disease. Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2019;13(4):4-10. (In Russ.)]. doi: 10/14412/1996-7012-2019-4-4-10.

22. Rumyantseva DG, Dubinina TV, Demina AB, et al. Ankylosing spondylitis and non-radiographic axial spondyloarthritis: two stages of a disease? Terapevticheskii arkhiv. 2017;89(5): 33-7. (In Russ.)].

23. Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1): 19-34. doi: 10.1136/ard-2022-223296. Epub 2022 Oct 21.