Guidelines for the Assessment of Disease Activity and Functional Status in Patients With Ankylosing Spondylitis in Clinical Practice

Dubinina, Tatiana V.; Гайдукова, И. З.; Годзенко, А. А.; Lapshina, S.; Ребров, А. П.; Румянцева, О. А.; Бадокин, В. В.; Бочкова, А. Г.; Бугрова, О. В.; Дубиков, А. И.; Иванова, О. Н.; Korotaeva, T.; Несмеянова, О. Б.; Nikishina, Irina; Оттева, Э. Н.; Раскина, Т. А.; Смирнов, А. В.; Ситало, А. В.; Эрдес, Ш. Ф.

doi:10.14412/1995-4484-2017-344-350

Cited by 27 publications

(14 citation statements)

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“…Для оценки интенсивности боли использовалась числовая рейтинговая шкала (ЧРШ 0-10; где 0 -отсутствие боли, 10 -невыносимая боль). В соответствии с рекомендациями ASAS для оценки функции сустава измеряли при помощи сантиметровой ленты максимальное растояние между медиальными лодыжками [10]. Всем пациентам были выполнены обзорная рентгенография костей таза, МРТ и УЗИ ТБС.…”

Section: материал и методыunclassified

Instrumental diagnosis of coxitis in ankylosing spondylitis in real clinical practice

Agafonova¹,

Dubinina²,

Дёмина³

et al. 2019

Naučno-praktičeskaâ revmatologiâ

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Coxitis is one of the most common extra-axial manifestations of ankylosing spondylitis (AS). Most Russian studies consider hip joint (HJ) involvement in AS patients as a major factor of poor prognosis in this disease. All detected hip joint changes are characterized by one term «coxitis». Until recently, there has been no clarity on inflammation of which structures of HJ leads to its destruction. This problem can be solved by prospective studies. A start was made by the V.A. Nasonova Research Institute of Rheumatology on the study of the evolution of coxitis in AS in 2013. This communication is devoted to the results initially identified by various imaging techniques for detecting HJ changes.Objective:to study the characteristics of HJ injury in AS, which have been detected by different imaging techniques.Subjects and methods.The investigation enrolled 125 AS patients, including 84 men (a male/female ratio of 2:1). The mean age of the patients was 31.4±9.1 years; the mean age at disease onset – 24.6±4.4 years; the median duration of AS at the time of examination – 96 (12–444) months. The HLA-B27 antigen was present in the majority of patients (94%). AS activity defined by ASDAS-CRP and BASDAI was high; BASFI scores averaged 3.4±2.1. All the patients underwent the following instrumental examinations: plain pelvis radiography, HJ ultrasound and magnetic resonance imaging (MRI).Results and discussion.The clinical, ultrasound, and MRI signs of coxitis were found in 82, 75, and 88% of cases, respectively; coxitis was radiologically confirmed only in 50% of patients. This disease was diagnosed by several techniques in the vast majority of cases. The diagnosis of coxitis was based only on clinical signs in only three (2%) patients. In approximately every sixth (16%) patients with AS, who had clinical signs of coxitis, the latter was verified only by one of the instrumental techniques (ultrasonography, radiography, or MRI). Our findings demonstrated that more than half of patients had high coxitis activity, and more prolonged coxitis was responsible for higher X-ray HJ changes and functional limitations.Conclusion.Our study has showed that the instrumental techniques used to diagnose coxitis are not equivalent in evaluating HJ injury. To decide which of them is more effective in screening and predicting the course of coxitis, there is a need for further prospective investigations.

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Section: материал и методыunclassified

Instrumental diagnosis of coxitis in ankylosing spondylitis in real clinical practice

Agafonova¹,

Dubinina²,

Дёмина³

et al. 2019

Naučno-praktičeskaâ revmatologiâ

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“…Оценка клинической активности и функционального статуса выполнялась согласно общепринятым рекомендациям с использованием индексов ASAS [24]. Для определения активности заболевания применяли индексы BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) [25] и ASDAS-CРБ (Ankylosing Spondylitis Disease Activity Score) [25]. Функциональный статус оценивался по индексу BASFI (Bath Ankylosing Spondylitis Functional Index) [25].…”

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“…Для определения активности заболевания применяли индексы BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) [25] и ASDAS-CРБ (Ankylosing Spondylitis Disease Activity Score) [25]. Функциональный статус оценивался по индексу BASFI (Bath Ankylosing Spondylitis Functional Index) [25]. При подсчете болезненных энтезисов использовался индекс MASES (Maastricht Ankylosing Spondylitis Enthesitis Score) [25].…”

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“…Функциональный статус оценивался по индексу BASFI (Bath Ankylosing Spondylitis Functional Index) [25]. При подсчете болезненных энтезисов использовался индекс MASES (Maastricht Ankylosing Spondylitis Enthesitis Score) [25]. Помимо клинического обследования и стандартных лабораторных исследований (общий анализ крови, биохимический анализ крови, исследование уровня СРБ) у всех пациентов определяли наличие HLA-B27, а также проводили обзорную рентгенографию костей таза и поясничного отдела позвоночника (ПОП) с захватом двух последних грудных позвонков (в боковой проекции).…”

Section: материал и методыunclassified

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Comparative Analysis of Main Clinical Manifestations in Males and Females With Early Axial Spondyloarthritis

Румянцева¹,

Дубинина²,

Demina³

et al. 2019

Naučno-praktičeskaâ revmatologiâ

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Currently, there have been a small number of works on differences between males and females with axial spondyloarthritis (axSpA) and there have been no studies estimating a gender difference in radiographic sacroiliitis progression in axSpA.Objective: to compare the main clinical manifestations of sacroiliitis and its radiological progression in axSpA in men and women over time during a 2-year follow-up period.Subjects and methods. The investigation was conducted using the Moscow cohort from the early SpondyloArthritis (CoRSAr) study, which currently consisted of 175 patients. The analysis included 68 patients followed up for ≥2 years. Their mean age at the time of inclusion in the cohort was 28.5±5.8 years; the mean disease duration was 24.1±15.4 months. 92.6% of patients were HLA-B27-positive.Results and discussion. Among the 68 patients followed up over 2 years, there were 33 (48.5%) men and 35 (51.5%) women. At baseline, the females were older than the males (p<0.01), while the disease duration was the same and averaged about 2 years. Among the males, there were more patients with ankylosing spondylitis (AS) than those among the females (75.5 and 42.8%, respectively; p<0.05), and the men had a higher total score of radiological sacroiliitis (tsrSI) than the women. The level of C-reactive protein (CRP) was also higher in the men than in the women (12.8 and 4.3 mg/l, respectively; p<0.05). Two years later, AS was present in 90.9% of the males and in 60.0% of the females (p<0.05).Conclusion. Women fall ill with axSpA later than men, and the latter are more frequently observed to have HLA-B27, higher tsrSI and elevated CRP levels. Progression from non-radiological axSpa to AS was more common in men.

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“…Анкилозирующий спондилит (АС) представляет собой тяжелое хроническое иммуновоспалительное заболевание, кото-рое относится к группе спондилоартритов и характеризуется обязательным вовлече-нием в патологический процесс позвоноч-ника и/или крестцово-подвздошных суста-вов с потенциальным развитием анкилоза и частым поражением энтезисов и перифе-рических суставов [1,2]. АС является од-ним из наиболее распространенных ревма-тических заболеваний, преимущественно поражает мужчин молодого возраста и от-личается высокой степенью инвалидиза-ции [3,4].…”

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Comparative Evaluation of the Long-Term Efficacy and Safety of the Infliximab Biosimilar BCD-055 and Reference Infliximab in Patients With Ankylosing Spondylitis: Results of the International Multicenter Randomized Double-Blind Phase Iii Clinical Study Asart-2

Лила¹,

Мазуров²,

Зонова³

et al. 2018

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The paper gives data on the clinical efficiency and safety profile of long-term use of the infliximab (INF) biosimilar BCD-055 versus the reference drug Remicade® (REM) in a population of patients with active ankylosing spondylitis (AS).Subjects and methods. An international multicenter randomized double-blind Phase III clinical trial was conducted in 199 patients who were randomized into two groups in a 2:1 ratio and who received BCD-055 or REM at a dose of 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Efficiency assessment was made at 14, 30 and 54 weeks in patients who received at least one dose of INF [intent-to-treat (ITT)], as well as at 54 weeks in those who completed the study according to the Protocol (PP) (per protocol). The efficiency endpoints were the proportion of patients who had achieved ASAS20/ASAS40 responses; changes in BASDAI, BASMI, BASFI, MASES, and SF-36 scores. Immunogenicity was assessed by the proportion of patients in each group with identified binding and neutralizing antibodies (BAbs and NAbs) against INF. The safety analysis included the overall rate of adverse events (AEs), including those that met the respective criteria for serous AEs (SAEs), and grade 3–4 toxicity, as well as the number of cases of early termination of the study because of AEs and SAEs.Results and discussion. The ITT population included 199 patients and the PP one consisted of 161 people. The groups were not statistically different in the rate of and reasons for patient withdrawal from the study. A comparable number of patients achieved ASAS20/ASAS40 responses at 14, 30, 54 weeks (р ≥ 0.05). At 54 week, the proportion of patients who received BCD-055 and REM therapy and achieved an ASAS20 response was 67.42 and 52.24% in the ITT population (p = 0.053) and 80.91 and 68.63% in the PP population (p = 0.128). The BCD-055 and drug comparison groups achieved an ASAS40 response in 53.03 and 38.81% in the ITT population (p = 0.081) and in 63.64 and 50.98% in the PP one (p = 0.177). The proportion of persons with identified BAbs and NAbs was comparable: 21.26 and 3.15% in the BCD-055 group (p = 0.920) and 20.63 and 6.35% in the group REM (p = 0.443), respectively. It was found that the presence of NAbs did not affect the therapeutic response. Both groups did not differ in the detection rate and profile of AEs and SAEs or in the rate of patient withdrawal due to AEs. Most identified AEs were mild to moderate.Conclusion. The efficacy of the INF biosimilar BCD-055 used long in patients with AS did not significantly differ from that of the original drug REM; the safety profile of both drugs was comparable.

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Guidelines for the Assessment of Disease Activity and Functional Status in Patients With Ankylosing Spondylitis in Clinical Practice

Abstract: The paper gives the recommendations for the assessment of disease activity and functional status in patients with ankylosing spondylitis in clinical practice, which have been developed by experts, by taking into account international and Russian experience in managing these patients.

Cited by 27 publications

References 3 publications

Instrumental diagnosis of coxitis in ankylosing spondylitis in real clinical practice

Instrumental diagnosis of coxitis in ankylosing spondylitis in real clinical practice

Comparative Analysis of Main Clinical Manifestations in Males and Females With Early Axial Spondyloarthritis

Comparative Evaluation of the Long-Term Efficacy and Safety of the Infliximab Biosimilar BCD-055 and Reference Infliximab in Patients With Ankylosing Spondylitis: Results of the International Multicenter Randomized Double-Blind Phase Iii Clinical Study Asart-2

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