Практикующие ревматологи и клинические исследовате-ли ежедневно сталкиваются с необходимостью определения воспалительной активности и динамики заболевания, а также эффективности лечения. Клиническая оценка чрезвычайно важна для характеристики состояния пациента, страдающего ревматическим заболеванием. Разработаны различные мето-ды оценки активности процесса, которые необходимы как для наблюдения за течением болезни, так и для выбора такти-ки лечения. Ревматические заболевания характеризуются раз-нообразием течения, что затрудняет создание единого индек-са или метода оценки для каждой из нозологий. За последние годы проведено несколько международных конференций, по-священных определению степени активности ревматических заболеваний, итогом которых явилась разработка комбини-рованных индексов, отражающих воспалительную актив-ность, выраженность отдельных параметров заболевания, функциональное состояние пациентов. Для расчета индексов используются визуально-аналоговые шкалы (ВАШ), опрос-ники для пациентов, данные физикальной оценки пациента врачом. Необходимость применения таких шкал и индексов очевидна при спондилоартритах, при которых лабораторные показатели (СОЭ, СРБ) обладают низкой чувствительностью для оценки воспаления и в меньшей степени, чем выражен-ность боли и скованность, а также данные объективного об-следования, отражают состояние пациента [1]. Оценка клинических проявленийанкилозирующего спондилита В настоящее время степень воспалительной активности и функциональных нарушений при анкилозирующем спон-дилите (АС) определяют по ВАШ для оценки боли и ско-ванности, а также по ряду суммарных показателей, характе-ризующих те или иные параметры заболевания.Для оценки боли в позвоночнике используют среднее арифметическое двух показателей по ВАШ или числовой рейтинговой шкале (ЧРШ) за последнюю неделю: боль в ночное время и боль в течение суток. ВАШ и ЧРШ оценки боли: Ночная больБоль в течение суток При помощи этих же шкал определяют такие показате-ли, как утренняя скованность в позвоночнике и общая оценка активности болезни пациентом.
П р о г р е с с в р е в м а т о л о г и и в X X I в е к е ФГБНУ Научноисследовательский институт ревматологии им. В.А. Насоновой,
Н е п р е р ы в н о е п о с л е д и п л о м н о е о б р а з о в а н и е в р а ч е й Псориатический артрит (ПсА)-хроническое воспалительное заболевание суставов, позвоночника и энтезисов из группы спонди-лоартритов (СпА), которое обычно развивается у больных с псориазом (Пс). ПсА, по современным представлениям, является ком-ФГБНУ «Научноисследовательский институт ревматологии им. В.А. Насоновой»,
Objective. To compare clinical features in psoriatic arthritis (PsA) patients with and without axial involvement. Subjects and methods. 385 PsA patients (172 males and 213 females) from National PsA Register were examined, their diagnosis verified according to CASPAR criteria. Patients’ median age was 45 [35; 54] years, median disease duration – 5,1 [0; 8] years. Pelvis X-ray and HLA-B27 levels in addition to physical examinations were obtained in all patients. Sacroiliitis (SI) was established based on radiographic findings (rSI) including bilateral changes corresponding to at least stage II, or unilateral – corresponding to at least stage III of Kellgren-Lawrence radiographic grading scale. Patients’ radiographs were evaluated by an independent radiologist. Disease activity was assessed using the DAS28 (Disease activity score 28), DAS (Disease activity in psoriatic arthritis) and BASDAI (Bath ankylosing spondylitis disease activity index) scales. 100 mm visual analog scale (VAS) was used for assessment of pain intensity (PI) and the Patient’s Global Assessment of Disease Activity (PtGA). Patients were distributed into two groups: Group 1 included rSI(+) patients, Group 2 – patients without radiologically confirmed SI – rSI (-). Results. Group 1 included 214 (55,6%) patients with axial involvement, 106 males and 108 females, Group 2 rSI (-) – 171 (44,4%) patients, 66 males and 105 females Proportion of men was significantly higher in RSi(+) group – 49,5% vs 38,6% in rSi(-) group (Odds Ratio, OR – 1,56, 95% CI 1,6-2,4; р = 0,0324). Patient’s median age was 45 [35; 54] and 46 [34; 56] years, respectively (p=0,911). Higher rates of HLA-В27 positivity were found in group rSI(+) patients, than in rSI(-), respectively in 62 out of 126 and in 26 out of 78 patients (OR 1,9, 95% CI 1,1-3,5). Patients from RSI(+) group had more severe erosive peripheral arthritis. Median tender joint counts (TJC) were 9 [14; 18] and 6 [3; 12] (р=0,02), while radiographic feet bone erosions were found in 58 (27,1%) and 29 (17%) patients, respectively (OR 1,8, 95% CI 1,1-3,0). Disease activity was higher in rSI(+) group. Median DAS28 score was 4,3 [3,3; 5,6] and 4,05 [3,03; 4,88] (р=0,02), DAPSA – 28,40 [15,65; 43,65] and 20,0 [12,45; 30,0], (р < 0,01), BASDAI – 1,6 [0; 5,1] and 0 [0; 4,5] (р < 0,01), C-reactive protein (CRP) – 0,9 [0,4; 2,2] mg/dl and 0,8 [0,3; 1,3] mg/dl, respectively (р=0,029). PtGA VAS values were 56,5 [42,3; 70,0] mm and 50,0 [30,0; 60,0] mm (р < 0,01); physicians global assessment (PGA) – 54,0 [40,0; 69,5] mm and 40,0 [25,5; 50,0] mm (р < 0,01); PI VAS values were 50,0 [40,0; 70,0] mm and 50,0 [20,5; 58,8] mm, respectively (р < 0,01). Higher rates of entheses involvement based on the Leeds Enthesitis Index (LEI) and dactylitis were documented in rSI(+) group. Median LEI score was 0 [0; 2] and 0 [0; 1] (p=0,02), while dactylitis was established in 71 (31,2%) and 32 (18,7%) patients, respectively (OR 2,2, 95% CI 1,3-3,5). More severe cutaneous involvement was also found in rSI(+) patients as compared to rSI (-). BSA (Body Surface Area) > 3% involvement was established in 94 (43,9%) and 57 (33,3%) patients, respectively (OR 1,7, 95% CI 1,03-2,4). Axial involvement was associated with more pronounced functional impairment. Median HAQ was 1,0 [0,6; 1,5] and 0 [0-2,2] (р=0,02). Conclusion. Axial involvement in PsA patients is associated with more severe articular damage, higher enthesitis and dactylitis rates, more severe psoriasis, which should be considered when planning treatment.
Objective: to evaluate the clinical efficacy and safety of the targeted synthetic disease-modifying anti-rheumatic drug (DMARD) tofacitinib (TOFA; Yakvinus®) in patients with active psoriatic arthritis (PsA) at 12 and 24 weeks after starting treatment. To define the place of TOFA in the therapy of PsA patients. Subjects and methods. Examinations were made in 41 patients (17 men and 24 women) with active PsA and an insufficient response to previous treatment with synthetic DMARDs and/or biological agents (BA). Before starting therapy, the median disease activity for psoriatic arthritis (DAPSA) and disease activity score (DAS28) were 44.2 [37.8; 55.3] and 5.5 [4.7; 6.1], respectively. TOFA tablets were prescribed at a dose of 5 mg twice daily for 24 weeks with possible dose escalation to 10 mg twice daily after 12 weeks. At the beginning of the investigation, at 12 and 24 weeks, the investigators assessed disease activity and TOFA therapy efficiency of according to DAPSA, DAS28 and minimal disease activity (MDA) criteria: tender joint count ≤1, swollen joint count ≤1, a psoriasis area severity index (PASI) ≤1 or body surface area (BSA) ≤3%, pain intensity ≤15 mm, patient global assessment ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, and enthesitis ≤1. They also determined the number of patients who had achieved remission (DAPSA ≤4, DAS28 score <2.6), low disease activity (DAPSA 5-14, ≤2.6, DAS28 <3.2) or MDA (5 out of the 7 criteria) during TOFA therapy at 24-week follow-up. The safety of therapy was evaluated by analyzing the drug-induced adverse events (AE): the frequency, severity and time of their occurrence were studied. Results and discussion. At 24 weeks after initiation of TOFA therapy, there was a significant decrease of median DAPSA and DAS28 values as compared to baseline, to 11 [4.3; 17.3] and 2.6 [1.7; 3.4] respectively. The median Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) also significantly decreased from 6 [4.2; 7] and 3.8 [2.8; 4.4] to 1.4 [0.6; 3.2] and 1.5 [1; 2.1] respectively. The median BSA was significantly reduced from 3 [1; 5] to 0.5 [0.1; 2]. At 24 weeks after initiation of TOFA therapy, DAPSA and DAS28 low disease activity/remission were achieved by 38.5/23.1% and 17.9/53.9% of patients, respectively. Fifteen (38.5%) patients achieved MDA. 38 (92.7%) of the 41 patients completed a full TOFA therapy cycle. Two patients dropped out of the investigation due to ineffective therapy and one due to AE (diarrhea occurring up to 10 times daily, headache, elevated blood pressure, and lacrimation). At 24 weeks, 14 (34.2%) patients reported to have AE. The most common AE noted in 7 (17.1%) patients were infections: acute respiratory viral infection (n=3), fever (n=2), and folliculitis (n=2). In addition, two patients had diarrhea and two had headache. Conclusion. TOFA is an effective drug for the treatment of PsA patients with moderate or high inflammatory activity, has a significant effect on all clinical manifestations of PsA and has a satisfactory safety profile.
Axial involvement in psoriatic arthritis is quite common. There is no data on the use of tofacitinib, an oral Janus kinase inhibitor, in psoriatic arthritis patients with axial involvement, nor is there any data on its effect on active MRI sacroiliitis.The aim of the study was to assess the effect of tofacitinib therapy on the dynamics of active MRI sacroiliitis in psoriatic arthritis patients.Materials and methods. 41 patients with active psoriatic arthritis fulfilling the CASPAR criteria were included. Median age was 41.0 [34; 50] years old, median disease duration was 6.0 [3; 10] years. Apart from a standard clinical examination, 40 patients underwent sacroiliac joint MRI on scanner Siemens General Electric 1.5 TESLA. Bone marrow edema on MRI (STIR) with one lesion on two consecutive slices or at least two lesions on a single slice, was considered active MRI sacroiliitis. Tofacitinib was given in 5 mg tablets twice a day with a possible dose increase up to 10 mg twice a day after 12 weeks of therapy. At the end of study, over a period of 24 weeks, sacroiliac joint MRI examination was repeated in 35 patients.Results. Prior to tofacitinib therapy, active MRI sacroiliitis was detected in 14 of 40 (35%) patients: bilateral – in 9 patients, unilateral – in 5 patients. At the end of 24 weeks therapy, active MRI sacroiliitis was detected in 4 of 35 (11.4%) patients observed: in 1 patient with baseline bilateral MRI sacroiliitis and in 2 patients with unilateral MRI sacroiliitis. 1 patient showed negative dynamics, that is, development of active MRI sacroiliitis (absent at baseline). The decrease in number of active MRI sacroiliitis patients is statistically significant (p=0.017). At baseline, inflammatory changes were detected in 23 of 80 (28.8%) sacroiliac joints, after 24 weeks of therapy they were found in 5 of 70 (7.1%; p=0.001) sacroiliac joints observed. During the treatment period, there was a significant decrease in the initially high activity of spondylitis. After 24 weeks of treatment, median BASDAI decreased from 6.0 [4.2; 7.0] to 1.4 [0.6; 3.2], median ASDAS-CRP from 3.8 [2.8; 4.4] to 1.5 [1.0; 2.1] (p=0.001 for both comparisons). Prior to tofacitinib therapy, high activity according to BASDAI was observed in 90.2% of patients, low activity – in 9.8%; at the end of study – in 13.5% and 86.5% of patients, respectively (p=0.001). At baseline, very high activity by ASDAS-CRP was detected in 61% of patients, high activity – in 29.2%, low activity – in 9.8% of patients. At the end of study there weren’t any patients with very high activity by ASDAS-CRP (p=0.001), high activity remained in 23.1%, moderate and low activity – in 30.7% and 46.2% of patients, respectively (p=0.001 for both comparisons). Significant differences between baseline symptoms in patients with MRI sacroiliitis and without it were defined by number of digits with dactylitis – 2 [0; 4] and 0 [0; 2] (p=0.04) and by ESR values – 47 [26; 76] and 20 [6; 37] mm/h (p=0.02). These parameters were higher in MRI sacroiliitis subgroup. By the end of study, these differences leveled out: the number of digits with dactylitis decreased to 0 [0; 0] and 0 [0; 0] (р=0.48), ESR – to 12 [6; 16] and 8 [6; 16] mm/h, respectively (p=0.78).Conclusion. Tofacitinib therapy shows high efficacy in reducing active MRI sacroiliitis and decreasing activity of axial involvement in psoriatic arthritis patients. The use of tofacitinib in patients with active MRI sacroiliitis as well as dactylitis and increased ESR levels demonstrated its high efficacy.
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