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)
Authors: Dubinina T. V. , Lila A. M. , Kvasova E. V. , Agafonova E. M. , Andrianova I. A. , Ivanova L. V. , Yurk D. V. , Garaeva N.  A. , Akulinushkina E. Y. , Vedekhina A. N. , Bashkova I. B. , Lapshina S. A. , Grabovetskaya Y. Y. , Semenova N. F. , Valkova M. I. , Krechikova D. G. , Mazhaeva O. S. , Vinogradova I. B. , Bugrova O. V. , Voloshenko S. M. , Enikeeva G. R. , Immis E. S. , Timasheva L. F. , Biserova E. E. , Shaimukhametova L. Z. , Patrikeeva I. M. , Barakat A. A. , Shesternya P. A. , Nikitina N. M. , Yupatova M. I. , Anoshenkova O. N. , Korolev M. A. , Ubshaeva Y. B. , Vasilenko E. A. , Zonova E. V. , Nesmeyanova O. B. , Bogdanova E. A. , Mazurov V. I. , Samigullina R. R. , Marusenko I. M. 
Published: April 2024

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.