Efficacy and safety of tenoxicam (Texared®) in ankylosing spondylitis: results of the prospective single-centre controlled study «ASTERIA»

The aim of the study – to evaluate the safety and influence of tenoxicam (Texared®) on the duration and severity of morning stiffness, spinal pain at night, activity and function in patients with ankylosing spondylitis (AS)
Materials and methods. The study included 30 patients (aged 18 to 60) with AS who sequentially sought medical care at the V.A. Nasonova Research Institute of Rheumatology and voluntarily signed an informed consent form to participate in the study. Most patients (66.7%) were male. The average age of patients was 37.6±9.5 years, and the average duration of the disease was 134.5±92.3 months. HLA-B27 antigen positivity was detected in 76.7% of cases. All patients who voluntarily agreed to participate in the study and signed an informed consent form at the initial visit were prescribed tenoxicam (Texared®) at a daily dose of mg. At week 0, 14 days and 90 days (3 months) after the start of therapy, standard clinical and laboratory examinations were performed.
Results and discussion. On the background of regular tenoxicam administration, most patients with AS achieved a reduction in clinical parameters of disease activity compared to baseline and its dynamics after 90 days: a decrease in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) indices to 3.8 (p<0.016) and ASDAS (Ankylosing Spondylitis Disease Activity Score) to 2.8±1.3 (p<0.011) was noted; the severity and duration of morning stiffness to 3.9±2.5 and 3.0±2.7 (p<0.01 in both cases), respectively; patient assessment of disease activity to 4.1±2.2 (p<0.00); night-time back pain – to 3.0±2.6 (p<0.00). After 14 days of treatment, one third of patients achieved a 20% improvement according to ASAS (Assessment of SpondyloArthritis International Society) criteria. After 90 days, the number of responders was 70.3%. Tolerability of therapy was good in 44.4% of cases. No serious adverse events were recorded during the study.
Conclusion. In patients with high and very high AS activity, tenoxicam (Texared®) therapy has been shown to have a positive effect on disease activity, including the severity of night-time back pain and the severity and duration of morning stiffness. The drug is well tolerated and has a favourable safety profile.

1. Baraliakos X, Kiltz U, Peters S, Appel H, Dybowski F, Igelmann M, et al. Efficiency of treatment with non-steroidal antiinflammatory drugs according to current recommendations in patients with radiographic and non-radiographic axial spondyloarthritis. Rheumatology (Oxford). 2017;56(1):95-102. doi: 10.1093/rheumatology/kew367

2. Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023;82(1):19-34. doi: 10.1136/ard-2022-223296

3. Wang R, Dasgupta A, Ward MM. Comparative efficacy of nonsteroidal anti-inflammatory drugs in ankylosing spondylitis: A Bayesian network meta-analysis of clinical trials. Ann Rheum Dis. 2016;75(6):1152-1160. doi: 10.1136/annrheumdis-2015-207677

4. Fragoulis GE, Siebert S. Treatment strategies in axial spondyloarthritis: What, when and how? Rheumatology (Oxford). 2020;59(Suppl 4):iv79-iv89. doi: 10.1093/rheumatology/keaa435

5. Ward MM, Deodhar A, Gensler LS, Dubreuil M, Yu D, Khan MA, et al. 2019 update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Care Res (Hoboken). 2019;71(10):1285-1299. doi: 10.1002/acr.24025

6. Van der Linden S, Valkenburg HA, Cats A. Modified New York criteria 1984 (Evaluation of diagnostic criteria for ankylosing spondylitis: A proposal for modification of the New York criteria). Arthritis Rheum. 1984;27:361-368.

7. Dubinina TV, Gaidukova IZ, Godzenko AA, Lapshina SA, Rebrov AP, Rumyantseva OA, et al. Guidelines for the assessment of disease activity and functional status in patients with ankylosing spondylitis in clinical practice. Nauchno-Prakticheskaya Revmatologia = Rheumatology Science and Practice. 2017;55(4):344-350 (In Russ.). doi: 10.14412/1995-4484-2017-344-350

8. Stone MA, Inman RD, Wright JG, Maetzel A. Validation exercise of the Ankylosing Spondylitis Assessment Study (ASAS) group response criteria in ankylosing spondylitis patients treated with biologics. Arthritis Rheum. 2004;51:316-320. doi: 10.1002/art.20414

9. Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4

10. Karateev AE, Lila AM, Mazurov VI, Nasonov EL, Dipkina OM, Alekseeva LI, et al.; Expert consensus 2024: Rational use of non-steroidal anti-inflammatory drugs. Modern Rheumatology Journal. 2025;19(S1):1-40 (In Russ.). doi: 10.14412/1996-7012-2025-1S-1-40

11. Gaydukova IZ, Aparkina AV, Khondkaryan EV, Rebrov AP. Effectiveness of the tenoxicam in patients with ankylosing spondylitis. S.S. Korsakov Journal of Neurology and Psychiatry. 2018;118(2):35-39 (In Russ.). doi: 10.17116/jnevro20181182135-39

12. Tsai WC, Ou TT, Yen JH, Wu CC, Tung YC. Long-term frequent use of non-steroidal anti-inflammatory drugs might protect patients with ankylosing spondylitis from cardiovascular diseases: A nationwide case-control study. PLoS One. 2015;10(5):e0126347. doi: 10.1371/journal.pone.0126347

13. Braun J, Baraliakos X, Westhoff T. Nonsteroidal anti-inflammatory drugs and cardiovascular risk – A matter of indication. Semin Arthritis Rheum. 2020;50(2):285-288. doi: 10.1016/j.semarthrit.2019.07.012

14. Gaidukova IZ, Rebrov AP, Lapshina SA, Otteva EN, Dubinina TV, Badokin VV, et al. Use of nonsteroidal anti-inflammatory drugs and biological agents for the treatment of axial spondyloarthritides. Recommendations of the Spondyloarthritis Study Group of Experts, All-Russian Public Organization «The Association of Rheumatology of Russia». Nauchno-Prakticheskaya Revmatologia = Rheumatology Science and Practice. 2017;55(5):474-484 (In Russ.). doi: 10.14412/1995-4484-2017-474-484