TWO-YEAR EXPERIENCE OF INFLIXIMAB BIOSIMILAR TREATMENT IN PATIENTS WITH ANKYLOSING SPONDILITIS AND SUSTAINABLE STRUCTURAL AND FUNCTIONAL CHANGES OF THE SPINE
Protsenko G.O., Pasternak M.L.
Summary. Aim. To assess the clinical and laboratory effectiveness of the biosimilar infliximab (BI) within two years of use in patients with stable structural and functional changes in the spine with ankylosing spondylitis. Materials and methods. We examined 36 patients with a reliable diagnosis of AS (according to the modified New York criteria). All participants in the study were divided into 2 groups: group № 1 — with the central form of AS; group № 2 — with combined lesions of the axial skeleton and peripheral joints. During the first 52 weeks, the BI infusion was carried out according to the standard scheme. During 53 to 105 weeks of observation, subgroups were identified in each group, taking into account the frequency of BI administration: every 8 weeks (subgroup A) and every 10 weeks (subgroup B). To assess the effectiveness of treatment, the following were determined: C-reactive protein (CRP), activity indices were calculated — Ankylosing Spondylitis Disease Activity Score taking into account CRP (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Metrology Index (BASMI) and the presence of active inflammation on MRI. Results. According to the results of the study, BI is equally effective in patients of both groups during the first 52 weeks of observation, where the interval between infusions was 8 weeks. Patients with AS with lesions of the peripheral joints demonstrated stable remission within 105 weeks of follow-up on the ASDAS-CRP, BASDAI, and BASMI scales, provided that BI was administered every 8 weeks. An extension of the intervals between BI doses up to 10 weeks (group № 2B) was associated with an increase in symptoms and manifestations of active AS according to the above scales. Conclusion. Clinical experience shows that the use of tumor necrosis factor alpha inhibitor (BI) in AS can effectively reduce the severity of symptoms on the ASDAS-CRP, BASDAI, BASMI scales and allows better control of disease activity not only in the early stages, but also to achieve long-term clinical laboratory remission in patients with persistent structural changes in the spine and improve their functional activity.
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