Достижение минимальной активности болезни при псориатическом артрите в зависимости от времени назначения синтетических базисных противовоспалительных препаратов, сравнительный анализ эффективности пероральной и подкожной форм метотрексата. Данные Общероссийского регистра пациентов с псориатическим артритом

The goal of psoriatic arthritis (PsA) therapy is to achieve remission or minimal disease activity (MDA). According to the EULAR guidelines, synthetic disease-modifying antirheumatic drugs (sDMARDs), methotrexate (MTX) in particular, are first-line therapy for PsA.Objective: to study the rate of MDA achievement after initiation of sDMARD therapy in patients with early- and late-stage PsA and the efficacy of oral and parenteral MTX.Patients and methods. The investigation enrolled 253 patients (93 men and 160 women) diagnosed with PsA who met the appropriate 2006 CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria and were recorded in the All-Russian PsA Registry. The median (Me) age was 47 (Min 20 – Max 82) years. All the patients took sDMARDs: MTX (n=211) that was received orally (as tablets) (n=102) and parenterally (n=109); leflunomide (n=7); sulfasalazine (n=24); apremilast (n=10); and tofacitinib (n=1). According to the disease duration at sDMARD treatment initiation, the patients were divided into two groups. Group 1 included 165 patients with an early PsA duration of less than 2 years and Group 2 consisted of 88 patients with a disease duration of >2 years. The efficiency of oral and parenteral MTX was evaluated in 182 patients (68 men and 114 women). Every 6 months, the patients underwent a standard rheumatology examination that included PsA activity assessment. The efficiency of MTX therapy was evaluated from MDA achievement (5 out of the 7 criteria) in the patients.Results and discussion. After sDMARD prescription, MDA was achieved in 39 (24%) of the 165 patients with early PsA and in 4 (5%) of the 88 long-term patients. The patients who started sDMARD at an early stage of the disease were significantly more likely to achieve MDA than those with late-stage PsA (odds ratio (OR) 6.5; 95% confidence interval (CI) 2.2–18.9). At 11 years after sDMARD therapy initiation, the cumulative MDA achievement rate in the patients with late-stage disease was 5% (p<0.05). MDA was achieved by 16.5% of the 182 patients receiving oral or subcutaneous MTX. MDA was observed in 25 (31%) patients who received parenteral MTX and in only 5 (5%) patients who took oral MTX. The patients who received parenteral MTX were significantly more likely to achieve MDA than those who took oral MTX as tablets (OR 8.8; 95% CI 3.2–24.3). Following 27-month parenteral MTX therapy, the cumulative rate of MDA achievement was 48%, whereas after oral MTX treatment, that was 7% (p<0.05). In the patients who achieved MDA, the mean dose of parenteral MTX was 17 mg/week, and in those who failed, that was 15 mg/week. The mean dose of oral MTX was 15 mg/week, regardless of MDA achievement.Conclusion. The administration of sDMARD at an early stage of PsA lasting less than 2 years allows MDA to be achieved significantly more often and faster than at later stages of the disease. Among sDMARDs, preference is mostly given to the use of MTX in real clinical practice; the treatment with the latter enables 16.5% of patients to achieve MDA. Parenteral MTX significantly enhances the efficiency of therapy and can achieve MDA in almost one third (31%) of patients.Целью терапии псориатического артрита (ПсА) является достижение ремиссии или минимальной активности болезни (МАБ). В соответствии с рекомендациями EULAR синтетические базисные противовоспалительные препараты (сБПВП), в частности метотрексат (МТ), являются первой линией терапии (ПсА).Цель исследования – изучение частоты достижения МАБ после инициации терапии сБПВП у больных с ранней и поздней стадиями ПсА и эффективности перорального и парентерального применения МТ.Пациенты и методы. В исследование включено 253 пациента (93 мужчины и 160 женщин) с диагнозом ПсА, соответствующим критериям CASPAR (2006), наблюдающихся в Общероссийском регистре пациентов с ПсА. Медиана (Me) возраста составила 47 (Min 20 – Max 82) лет. Все пациенты получали сБПВП: МТ – 211 пациентов, из них 102 в таблетированной форме и 109 парентерально; лефлуномид – 7, сульфасалазин – 24, апремиласт – 10, тофацитиниб – 1. В зависимости от длительности болезни в момент инициации терапии cБПВП пациенты были разделены на две группы. В 1-ю группу вошли 165 больных ранним ПсА с длительностью болезни ≤2 года, во 2-ю группу – 88 пациентов с длительностью болезни >2 лет. У 182 пациентов (68 мужчин и 114 женщин) была оценена эффективность таблетированной и парентеральной форм МТ. Каждые 6 мес больным проводилось стандартное ревматологическое обследование, включавшее оценку активности ПсА. Эффективность терапии МТ оценивалась по достижению больными МАБ (5 критериев из 7).Результаты и обсуждение. МАБ после назначения сБПВП достигли 39 (24%) из 165 больных ранним ПсА и 4 (5%) из 88 длительно болеющих пациентов. Пациенты, начавшие принимать сБПВП на ранней стадии болезни, значимо чаще достигали MAБ, чем пациенты с поздней стадией ПсА (отношение шансов, OШ 6,5; 95% доверительный интервал, ДИ 2,2–18,9). Через 11 лет после начала терапии сБПВП у пациентов с поздней стадией заболевания кумулятивная частота достижения MAБ составила 5% (p<0,05). Из 182 больных, получавших МТ в пероральной или подкожной форме, 16,5% достигли МАБ. На фоне парентерального введения МТ МАБ отмечена у 25 (31%) пациентов, тогда как при пероральном применении МТ – только у 5 (5%). Пациенты, получавшие МТ парентерально, значимо чаще достигали МАБ, чем получавшие МТ в таблетированной форме (ОШ 8,8; 95% ДИ 3,2–24,3). За 27 мес терапии парентеральным МТ кумулятивная частота достижения МАБ составила 48%, тогда как при пероральном приеме – 7% (p<0,05). У пациентов, достигших МАБ, средняя доза парентерального МТ составила 17 мг/нед, а у не достигших МАБ – 15 мг/нед. Средняя доза пероральной формы МТ равнялась 15 мг/нед независимо от достижения МАБ.Заключение. Назначение сБПВП при раннем ПсА, длительностью ≤2 года, позволяет достигать МАБ значимо чаще и быстрее, чем на более поздних стадиях заболевания. В реальной клинической практике из сБПВП в большинстве случаев назначается МТ, на фоне лечения которым 16,5% больных достигают МАБ. Применение парентеральной формы МТ значимо повышает эффективность терапии и позволяет достичь МАБ практически у трети (31%) больных

Клинический статус и трудоспособность пациентов, включенных в Общероссийский регистр пациентов с псориатическим артритом

Objective: to study the clinical characteristics of PsA and working capacity in patients included in the All-Russian PsA Registry.Patients and methods. The investigation enrolled 614 patients aged 19–84 years with psoriasis from 39 subjects the Russian Federation, who were followed up in the All-Russian PsA Registry. On the basis of the assessment of demographic data, the spectrum of comorbidities, the degree of activity of the underlying disease according to Disease Activity Index for PsA (DAPSA) and Disease Activity in 28 joints (DAS28), clinical, functional, and social indicators were analyzed in the patients. The investigators studied information on the patients employment, working capacity, and disability, by assessing the group of the latter. The health status and the presence and severity of functional impairment in the patients were analyzed using the Health Assessment Questionnaire (HAQ), while their working efficiency was estimated according to the Workers Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP questionnaire), by calculating the following parameters: absenteeism, presenteeism, an overall decrease in labor productivity, and impairment in daily functional activity.Results and discussion. The analysis of the All-Russian PsA Registry showed that most of them were of working age (30 to 59 years); 48.4% had concomitant diseases. Data on DAPSA changes were obtained in 349 patients, who were recorded to have mainly moderate (34.7%) or high (42.7%) disease activity, multiple dactylitides and enthesitides, and limited joint function. The registry reflects information on the social status of 521 patients: employed (61.2%) and unemployed (22.1%) persons, pensioners (15.2%), and students (1.5%). More than one third (37.1%) of patients with PsA had disability, mainly of Group III. The changes in the HAQ disability index were assessed in 326 patients; mild, moderate, and severe functional impairments were observed in 36, 26.4, and 3.7%, respectively. Absenteeism was detected in less than one third of patients with PsA, presenteeism was found in about half; there was an overall decrease in labor productivity in more than 60% and daily activity impairment in 68.8%. Statistically significant direct moderate correlations were established between the indicators of PsA activity (DAPSA and DAS28) and the level of productivity impairment in the patients; this was mostly related to an overall decline in labor productivity and to a decrease in daily activity.Conclusion. The data obtained from real clinical practice suggest that half of the PsA patients had high disease activity and a third had severe functional impairment, which led to a lower quality of life and to disability. The overall decrease in labor productivity and daily activity, which was detected in more than half of the patients, was associated with high PsA activity. The follow-up in the All-Russian PsA Registry, regular anti-inflammatory therapy with disease-modifying antirheumatic drugs and biological agents can improve the clinical and functional status and, consequently, working capacity in patients with PsA.Цель исследования – изучить клинические характеристики ПсА и трудоспособность пациентов, включенных в Общероссийский регистр ПсА.Пациенты и методы. В исследование вошли 614 пациентов с ПсА в возрасте 19–84 лет из 39 субъектов Российской Федерации, наблюдающихся в Общероссийском регистре ПсА. На основании оценки демографических данных, спектра коморбидных заболеваний, степени активности основного заболевания по индексам DAPSA и DAS28 у пациентов проанализированы клинические, функциональные и социальные показатели. Изучены сведения о занятости и трудоспособности, наличии инвалидности с оценкой ее группы. Состояние здоровья пациентов, наличие и выраженность функциональных нарушений анализировали с помощью опросника HAQ, производительность труда – с помощью опросника WPAI-SHP с расчетом следующих параметров: абсентеизма, презентеизма, общего снижения производительности труда и нарушений повседневной функциональной активности.Результаты и обсуждение. Как показал анализ Общероссийского регистра пациентов с ПсА, большинство из них были трудоспособного возраста (от 30 до 59 лет), 48,4% имели сопутствующие заболевания. Данные о динамике индекса DAPSA получены у 349 пациентов, у которых зарегистрированы в основном умеренная (34,7%) или высокая (42,7%) активность заболевания, множественные дактилиты и энтезиты, ограничения функции суставов. В регистре отражены сведения о социальном статусе 521 пациента: 61,2% работали, 22,1% не работали, 15,2% были пенсионерами и 1,5% – учащимися. Более трети (37,1%) больных ПсА имели инвалидность, преимущественно III группы. Динамика индекса HAQ оценена у 326 больных: минимальные функциональные нарушения отмечались в 36% случаев, умеренные – в 26,4%, выраженные – в 3,7%. Абсентеизм определялся менее чем у трети больных ПсА, презентеизм – примерно у половины, общее снижение производительности труда – более чем у 60%, а нарушения повседневной активности – у 68,8%. Установлено наличие статистически значимых прямых корреляций умеренной силы между показателями активности ПсА (DAPSA и DAS28) и уровнем нарушения трудоспособности пациентов, в большей степени это касалось общего снижения производительности труда и снижения повседневной активности.Заключение. Полученные данные реальной клинической практики свидетельствуют о том, что у половины больных ПсА имелась высокая активность болезни, а у трети – серьезные функциональные нарушения, которые привели к снижению качества жизни и инвалидизации. Общее снижение производительности труда и повседневной активности, выявленное более чем у половины больных, ассоциировалось с высокой активностью ПсА. Динамическое наблюдение в Общероссийском регистре пациентов с ПсА, регулярная противовоспалительная терапия базисными противовоспалительными препаратами и генно-инженерными биологическими препаратами позволяют улучшить клинический и функциональный статус, а следовательно, и трудоспособность больных ПсА

Influence of the duration of psoriatic arthritis on the achievement of remission and minimal disease activity during therapy with genetically engineered biologic drugs. Data from the all-russian register of patients with psoriatic arthritis

Aim. To study the frequency and timing of the onset of remission and minimal disease activity after the administration of genetically engineered biologic drugs (GEBD) in patients with early and long-term psoriatic arthritis observed within the framework of the All-Russian register of patients with psoriatic arthritis.Material and methods. The study included 140 patients with psoriatic arthritis (77 men, 63 women) who met the CASPAR criteria, who took part in the All-Russian register and were followed up every 6 months. Previously, patients did not receive GEBD. The median age of the patients was 42 [19-73] years. All patients were divided into two groups depending on the duration of psoriatic arthritis before the appointment of GEBD: early psoriatic arthritis - ≤2 years (67 patients) and long-standing psoriatic arthritis - more than 2 years (73 patients). All patients were prescribed GEBD (37 - adalimumab, 26 - infliximab, 20 - etanercept, 19 - golimumab, 1 - certolizumab pegol, 33 - ustekinumab, 4 - secukinumab) in combination with or without methotrexate. All patients were assessed for the activity and efficacy of psoriatic arthritis therapy according to DAPSA and the criteria for minimal disease activity (number of painful joints - ≤1, number of swollen joints - ≤1, PASI - ≤1 or BSA - ≤3, pain score - ≤15, overall assessment of activity disease by the patient - ≤20 mm on a visual analogue scale, HAQ - ≤0.5, enthesitis -≤1) at the beginning of the study and every 6 months. The number of patients who achieved remission (DAPSA ≤4) or minimal disease activity (5 criteria out of 7) at least 1 time during therapy with GEBD was determined. The cumulative frequency and timing of achieving remission after the appointment of GEBD were calculated.Results. After the initiation of treatment with GEBD, DAPSA remission was achieved at least once in 24 out of 67 (36%) patients with early psoriatic arthritis and in 19 out of 73 (26%) patients with long-standing psoriatic arthritis. The minimum disease activity was achieved, respectively, in 33 of 67 (49%) and 23 of 73 (32%) patients. The time interval to achieve remission in early psoriatic arthritis was significantly less than in long-standing one. Its median was 48 months (95% CI: 11.75-84.25) and 139 months (95% CI not determined) (p<0.05), respectively. The time until the minimum activity of the disease was reached in patients with early psoriatic arthritis was significantly less than in patients with long-standing psoriatic arthritis. Its median was 21 months (95% CI: 13.1-28.9) and 58 months (95% CI: 0-118.1), respectively (p<0.05).Conclusion. In real clinical practice, after prescribing GEBD, patients with an early stage of psoriatic arthritis (no more than 2 years of illness) achieve remission and minimal disease activity significantly more often and faster than patients with long-term illness

The clinical status and working capacity in patients included in the All-Russian Psoriatic Arthritis Registry

Objective: to study the clinical characteristics of PsA and working capacity in patients included in the All-Russian PsA Registry.Patients and methods. The investigation enrolled 614 patients aged 19–84 years with psoriasis from 39 subjects the Russian Federation, who were followed up in the All-Russian PsA Registry. On the basis of the assessment of demographic data, the spectrum of comorbidities, the degree of activity of the underlying disease according to Disease Activity Index for PsA (DAPSA) and Disease Activity in 28 joints (DAS28), clinical, functional, and social indicators were analyzed in the patients. The investigators studied information on the patients employment, working capacity, and disability, by assessing the group of the latter. The health status and the presence and severity of functional impairment in the patients were analyzed using the Health Assessment Questionnaire (HAQ), while their working efficiency was estimated according to the Workers Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP questionnaire), by calculating the following parameters: absenteeism, presenteeism, an overall decrease in labor productivity, and impairment in daily functional activity.Results and discussion. The analysis of the All-Russian PsA Registry showed that most of them were of working age (30 to 59 years); 48.4% had concomitant diseases. Data on DAPSA changes were obtained in 349 patients, who were recorded to have mainly moderate (34.7%) or high (42.7%) disease activity, multiple dactylitides and enthesitides, and limited joint function. The registry reflects information on the social status of 521 patients: employed (61.2%) and unemployed (22.1%) persons, pensioners (15.2%), and students (1.5%). More than one third (37.1%) of patients with PsA had disability, mainly of Group III. The changes in the HAQ disability index were assessed in 326 patients; mild, moderate, and severe functional impairments were observed in 36, 26.4, and 3.7%, respectively. Absenteeism was detected in less than one third of patients with PsA, presenteeism was found in about half; there was an overall decrease in labor productivity in more than 60% and daily activity impairment in 68.8%. Statistically significant direct moderate correlations were established between the indicators of PsA activity (DAPSA and DAS28) and the level of productivity impairment in the patients; this was mostly related to an overall decline in labor productivity and to a decrease in daily activity.Conclusion. The data obtained from real clinical practice suggest that half of the PsA patients had high disease activity and a third had severe functional impairment, which led to a lower quality of life and to disability. The overall decrease in labor productivity and daily activity, which was detected in more than half of the patients, was associated with high PsA activity. The follow-up in the All-Russian PsA Registry, regular anti-inflammatory therapy with disease-modifying antirheumatic drugs and biological agents can improve the clinical and functional status and, consequently, working capacity in patients with PsA

OPTIMIZING THE DIAGNOSIS, A MONITORING AND TREATMENT SYSTEM FOR PSORIATIC ARTHRITIS IN REAL PRACTICE: GENERAL PRINCIPLES FOR ORGANIZING AN ALL-RUSSIAN REGISTER OF PATIENTS WITH PSORIATIC ARTHRITIS

The paper presents the design, general characteristics of and possibilities of data usage from the All-Russian register of patients with psoriatic arthritis (PsA).The purpose of creating and introducing the register into Russian healthcare practice is to evaluate the effectiveness of the diagnosis and treatment of PsA. The All-Russian register of PsA patients was created for the period 2016–2018 within the framework of the All-Russian register of patients with arthritis «OREL» on the basis of the V.A. Nasonova Research Institute of Rheumatology and with the support of the All-Russian public organization «Association of Rheumatologists of Russia». This system is an all-Russian population-based register that allows for the recording and monitoring of patients with PsA throughout the follow-up period. This enables healthcare specialists and organizers to obtain reliable information on the state of care for this category of patients in the region.The main purpose of the register is to provide necessary information support and automated technology for solving the problems of accounting, controlling, and monitoring of the status of PsA patients and to organize information interaction between specialists. The register is based on existing state regulatory legal acts. While developing and testing of the register, there were a number of tasks to be solved: to evaluate the efficiency of existing standard and promising targeted PsA therapies in real practice; to assess and improve the routing of patients with PsA. The use of the register allows an operational analysis of the following characteristics: demographic and socioeconomic parameters of patients with PsA; anamnestic data of patients with this condition; results of clinical examinations, instrumental and laboratory data.The geography of the register covers 27 regions of the Russian Federation; the register includes information on 460 patients with PsA.Creating a register permits one to track the dynamics of various parameters (social, demographic, and medical ones), to compare treatment options and the clinical and functional characteristics of patients with PsA, and to evaluate their performance, disability and changes in the social and labor status during the treatment performed. Thus, for the first time in the Russian Federation, the demographic, functional, and socioeconomic parameters of patients with PsA were comprehensively analyzed and the level of performance and impaired daily activities in PsA patients were studied using the WPAI questionnaire; moreover, the patients’ functional and psychological status was evaluated for the first time, by applying the PsAID-12, FACIT questionnaires (in the patients of the V.A. Nasonova Research Institute of Rheumatology).An analysis of the information available in the register makes it possible to compare the efficiency of different PsA treatment regimens, by estimating the rates of remission and/or minimal disease activity in real practice