Results of a non-interventional observational multicenter study of the management of patients with axial psoriatic arthritis in real-life clinical practice (NiSaXPA)

Psoriatic arthritis (PsA) is a chronic immunoinflammatory disease of the joints, spine and entheses from the group of spondyloarthritis, which is usually observed in patients with psoriasis. In recent years, the axial form of PsA (axPsA) has been actively researched. However, there is insufficient data on approaches to the diagnosis and treatment of patients with axPsA in real-life clinical practice. This article presents the results of an interim analysis of data from a non-interventional multicenter observational study on the treatment of patients with axPsA in real-life clinical practice (NiSaXPA) in Russian centers.Objective: to identify patients with axPsA, their characteristics and describe treatment tactics in real-life clinical practice.Material and methods. Patients with PsA who met the inclusion criteria were prospectively followed up during routine visits to a rheumatologist. Participants' axial radiographs were uploaded to a database in order for it to be confirmed the presence or absence of axPsA by two independent experts, a rheumatologist and a radiologist. Patients with a confirmed axPsA diagnosis participated in a further data collection phase (Visit 2, week 24).Results and discussion. Six hundred patients were enrolled into the study. At the time of analysis, 386 (64.3%) of them (209 men and 177 women) were screened for axPsA. The diagnosis of axPsA was confirmed in 241 (62.4%) cases; these patients formed the Per Protocol (PP) population. The mean age of patients with axPsA in the PP population was 46.30±12.6 years and the body mass index (BMI) was 27.4±5.2 kg/m2 . In 14.9% of patients, the duration of psoriasis was less than 1–5 years, in 21.5% – 5–10 years and in 63.6% – more than 10 years. The duration of PsA symptoms was less than 1–5 years in 31.2 % of patients, 5–10 years in 31.6 % and more than 10 years in 37.2 %. Low disease activity (BASDAI ˂ 4) was achieved in 33.3 % of patients with axPsA at visit 1 and in 64.3 % at visit 2; the BASDAI index declined on average from 4.67±1.95 to 3.31±1.89 points.In real-life clinical practice, patients were most frequently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) – 88.7% and 71.7% (visits 1 and 2, respectively), and synthetic disease-modifying antirheumatic drugs (sDMARDs) –79.1% and 70.7%, respectively; therapy with biologic disease-modifying antirheumatic drugs (bDMARDs) was initiated in 40.2% and 60.6% of patients, respectively.Conclusion. The results of the interim analysis of this observational study showed that in 87.2% of patients who met the CASPAR criteria for PsA there was a suspicion of axial manifestations of PsA on the primary care level. However, only 62.4% of them had a confirmed diagnosis of axPsA on centralized expert assessment, which may indicate a possible overdiagnosis of axial lesions in real-life practice and emphasizes the importance of collaboration between a rheumatologist and a radiologist when analyzing the results of imaging studies. 33.3% of patients with axPsA had low disease activity according to BASDAI at baseline and 64.3% after 24 weeks, meaning that the disease was only adequately controlled in one third of cases despite therapy; the number of these patients doubled after a change in therapy. In real-world clinical practice, patients with axPsA are most commonly prescribed drugs from the NSAID and sDMARD groups; the frequency of use of biologic drugs varied between 40.2 and 60.6% by the end of the observation period

Results of a non-interventional multicenter observational study on the diagnosis and treatment of patients with axial psoriatic arthritis in rea-world clinical practice in the Russian Federation (NiSaXPA)

Objective: The aim of the NiSaXPA study is to evaluate the quality of diagnosing, socio-demographic characteristics and treatment tactics of patients with axial psoriatic arthritis (axPsA) in real-world clinical practice in the Russian Federation.Material and methods. The study involved 600 patients from 21 clinical centers in the Russian Federation.Results and discussion. The diagnosis of axPsA was confirmed in 357 (59.5%) of 600 patients according to the centralized expert assessment. All 357 patients with axial lesions met criteria of the clinical guidelines for the treatment of patients with PsA. Of these, 201 (69%) patients had radiologically significant sacroiliitis (SI) according to Kellgren and 103 (59.2%) had active SI according to magnetic resonance imaging. The presence of syndesmophytes was confirmed in 119 (43.9%) patients. Inflammatory back pain was observed in approximately 80% of patients, most commonly in the lumbar and cervical spine. "Silent" sacroiliitis were found in 1.1–3.5 % of cases. 26.8% of patients were positive for HLA-B27. In the 6 months prior to the study, high PsA activity was present in 21.6% of patients according to the rheumatologist's assessment, while high activity according to the BASDAI index was found in 71.9 % of patients, and moderate and high activity according to the DAPSA index – in 82.7%. On the 24th week of observation, the number of patients with low activity according to BASDAI doubled and reached 66.3 %, while low activity and remission according to the DAPSA index amounted to 52.5% and 8.1% of patients, respectively. In most cases (about 27%), patients with axial manifestations were prescribed interleukin (IL) 17A inhibitors, about 14% of patients received tumor necrosis factor-α inhibitors, and about 4% received IL23 inhibitors.Conclusion. In 40.5% of patients, axial skeletal involvement in PsA was over-diagnosed due to misinterpretation of clinical and imaging data. The vast majority of patients (77%) were treated with synthetic disease-modifying antirheumatic drugs, mainly methotrexate, which do not affect the activity of spondylitis. Biologic disease-modifying antirheumatic drugs (bDMARDs) were taken by 46.5% of patients. Switching therapy to bDMARDs led to a significant reduction in disease activity.In order to improve the quality of medical care, the Russian clinical guidelines for the treatment of patients with PsA and the algorithms for the diagnosis of axial involvement need to be comprehensively implemented

Результаты неинтервенционного наблюдательного многоцентрового исследования тактики ведения пациентов с аксиальным псориатическим артритом в условиях реальной клинической практики (NiSaXPA)

Psoriatic arthritis (PsA) is a chronic immunoinflammatory disease of the joints, spine and entheses from the group of spondyloarthritis, which is usually observed in patients with psoriasis. In recent years, the axial form of PsA (axPsA) has been actively researched. However, there is insufficient data on approaches to the diagnosis and treatment of patients with axPsA in real-life clinical practice. This article presents the results of an interim analysis of data from a non-interventional multicenter observational study on the treatment of patients with axPsA in real-life clinical practice (NiSaXPA) in Russian centers.Objective: to identify patients with axPsA, their characteristics and describe treatment tactics in real-life clinical practice.Material and methods. Patients with PsA who met the inclusion criteria were prospectively followed up during routine visits to a rheumatologist. Participants' axial radiographs were uploaded to a database in order for it to be confirmed the presence or absence of axPsA by two independent experts, a rheumatologist and a radiologist. Patients with a confirmed axPsA diagnosis participated in a further data collection phase (Visit 2, week 24).Results and discussion. Six hundred patients were enrolled into the study. At the time of analysis, 386 (64.3%) of them (209 men and 177 women) were screened for axPsA. The diagnosis of axPsA was confirmed in 241 (62.4%) cases; these patients formed the Per Protocol (PP) population. The mean age of patients with axPsA in the PP population was 46.30±12.6 years and the body mass index (BMI) was 27.4±5.2 kg/m2 . In 14.9% of patients, the duration of psoriasis was less than 1–5 years, in 21.5% – 5–10 years and in 63.6% – more than 10 years. The duration of PsA symptoms was less than 1–5 years in 31.2 % of patients, 5–10 years in 31.6 % and more than 10 years in 37.2 %. Low disease activity (BASDAI ˂ 4) was achieved in 33.3 % of patients with axPsA at visit 1 and in 64.3 % at visit 2; the BASDAI index declined on average from 4.67±1.95 to 3.31±1.89 points.In real-life clinical practice, patients were most frequently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) – 88.7% and 71.7% (visits 1 and 2, respectively), and synthetic disease-modifying antirheumatic drugs (sDMARDs) –79.1% and 70.7%, respectively; therapy with biologic disease-modifying antirheumatic drugs (bDMARDs) was initiated in 40.2% and 60.6% of patients, respectively.Conclusion. The results of the interim analysis of this observational study showed that in 87.2% of patients who met the CASPAR criteria for PsA there was a suspicion of axial manifestations of PsA on the primary care level. However, only 62.4% of them had a confirmed diagnosis of axPsA on centralized expert assessment, which may indicate a possible overdiagnosis of axial lesions in real-life practice and emphasizes the importance of collaboration between a rheumatologist and a radiologist when analyzing the results of imaging studies. 33.3% of patients with axPsA had low disease activity according to BASDAI at baseline and 64.3% after 24 weeks, meaning that the disease was only adequately controlled in one third of cases despite therapy; the number of these patients doubled after a change in therapy. In real-world clinical practice, patients with axPsA are most commonly prescribed drugs from the NSAID and sDMARD groups; the frequency of use of biologic drugs varied between 40.2 and 60.6% by the end of the observation period.Псориатический артрит (ПсА) – хроническое иммуновоспалительное заболевание суставов, позвоночника и энтезисов из группы спондилоартритов, которое обычно наблюдается у больных псориазом. В последние годы активно изучается аксиальная форма ПсА (аксПсА). Вместе с тем данных о подходах к диагностике и ведению пациентов с аксПсА в реальной клинической практике недостаточно. В настоящей публикации представлены результаты промежуточного анализа данных неинтервенционного наблюдательного многоцентрового исследования тактики ведения пациентов с аксПсА в условиях реальной клинической практики (NiSaXPA) в российских центрах.Цель исследования – выявление пациентов с аксПсА, их характеристика и описание тактики ведения в условиях реальной клинической практики.Материал и методы. Во время плановых визитов к ревматологу проводилось проспективное наблюдение пациентов с ПсА, соответствовавших критериям включения. Аксиальные рентгенограммы участников были загружены в базу данных для подтверждения наличия или отсутствия аксПсА двумя независимыми экспертами – ревматологом и рентгенологом. Пациенты с подтвержденным диагнозом аксПсА участвовали в дальнейшей фазе сбора данных (визит 2, неделя 24).Результаты и обсуждение. В исследование включено 600 пациентов. На момент проведения анализа с целью выявления аксПсА обследовано 386 (64,3%) из них (209 мужчин и 177 женщин). Диагноз аксПсА подтвержден в 241 (62,4%) случае; эти больные составили популяцию по протоколу (PP, Per Protocol). У 145 (37,6%) пациентов аксПсА не выявлен. Возраст пациентов с аксПсА в популяции РР составил в среднем 46,30±12,6 года, индекс массы тела (ИМТ) – 27,4±5,2 кг/м2 . У 14,9% пациентов длительность псориаза была менее 1–5 лет, у 21,5% – 5–10 лет и у 63,6% – более 10 лет. Давность симптомов ПсА у 31,2% пациентов составляла менее 1–5 лет, у 31,6% – 5–10 лет и у 37,2% – более 10 лет. Низкой активности заболевания (BASDAI ˂ 4) к визиту 1 достигли 33,3% больных аксПсА, к визиту 2 – 64,3%; было отмечено снижение индекса BASDAI в среднем с 4,67±1,95 до 3,31±1,89 балла. В реальной клинической практике пациентам наиболее часто назначали нестероидные противовоспалительные препараты (НПВП) – 88,7% и 71,7% (визиты 1 и 2 соответственно) и синтетические базисные противовоспалительные препараты (сБПВП) – 79,1% и 70,7% соответственно; терапия генно-инженерными биологическими препаратами (ГИБП) была инициирована 40,2% и 60,6% больных соответственно.Заключение. Результаты промежуточной оценки данного наблюдательного исследования показали, что у 87,2% пациентов, отвечавших критериям CASPAR для ПсА, исходно при обследовании по месту жительства были заподозрены аксиальные проявления ПсА. Однако при центральной экспертной оценке диагноз аксПсА был верифицирован только у 62,4% из них, что может свидетельствовать о возможной гипердиагностике аксиального поражения в реальной практике и подчеркивает важность кооперации ревматолога и рентгенолога при анализе результатов визуализационных методов обследования. 33,3% пациентов с аксПсА имели низкую активность заболевания по BASDAI исходно и 64,3% – через 24 нед. Таким образом, несмотря на проводимую терапию, адекватно контролировать заболевание удавалось только в трети случаев, после смены терапии число таких пациентов увеличилось вдвое. В реальной клинической практике пациентам с аксПсА наиболее часто назначают препараты из группы НПВП и сБПВП, частота использования ГИБП варьировалась от 40,2 до 60,6% к концу наблюдения

AB0705 SHORT-TERM OUTCOMES OF COVID-19 IN PATIENTS WITH RHEUMATIC DISEASES WHO ARE TREATED BY BIOLOGICAL AND TARGETED SYNTHETIC DMARDS: OBSERVATIONAL SINGLE-CENTER STUDY

Background:The course of new coronavirus infection in patients with rheumatic diseases (RD) undergoing treatment with biological and targeted drugs is still poorly understood.Objectives:To study outcomes of COVID-19 in patients with RD receiving treatment biological and targeted synthetic DMARDs.Methods:We studied cases of COVID-19 in patients with RD, included in “Moscow regional registry of patients with rheumatic diseases receiving treatment with biological and targeted synthetic drugs” – observational cohort, started in 2018. A total number of patients, included in the registry, is 1048 at December 2020.Results:By January 2021, 44 known cases of COVID-19 were registered among patients included in the registry (4,2%). This group included 29 (65,9%) females, 15 (34,1%) males, with mean age 45,09±12,7 (median 47,0 [34,0; 57,0]) y.o. The vast majority of patients had rheumatoid arthritis (19, 43,2%) and ankylosing spondylitis (19, 43,2%), there were 3 (6,8%) patients with psoriatic arthritis, and one patient each (2,3%) with systemic lupus erythematosus, systemic sclerosis, and ANCA-vasculitis. Before COVID-19, 20 (45,5%) patients received TNF inhibitors (adalimumab, infliximab, etanercept, certolizumab, golimumab), 7 (15,9%) – IL-6 receptor inhibitors (tocilizumab, sarilumab), 7 (15,9%) – rituximab (period between last infusion and COVID-19 was 1-4 months), 5 (11,4%) – sekukinumab, 2 (4,5%) – tofacitinib, and one patient each (2,3%) received abatacept and ustekinumab. Also, 22 (50%) received methotrexate, 4 (9,1%) – leflunomide, 3 (6,8%) - mycophenolate mofetil, 1 (2,3%) – sulfasalazine; 12 (27,3%) took oral steroids. COVID-19 presented as mild disease in 23 (52,3%) patients, and 21 (47,7%) had viral interstitial pneumonia verified by computed tomography. 16 (36,4%) patients were hospitalized, only one patient underwent artificial lung ventilation. We found no significant associations between particular diagnosis and treatment on the one hand, and hospitalization for COVID-19 on the other hand. For treatment of COVID-19, two (4,5%) patients did not receive any medications, and the rest of patients received antiviral and antibacterial therapy according to standardized protocol. In addition, corticosteroids were administered for COVID-19 in 15 (34,1%) patients, mainly (12 cases) in hospital, and two (4,5%) patients in hospital were treated by tocilizumab. The outcome in all cases was favorable, all patients successfully recovered from the new coronavirus infection.Conclusion:In this observational study, we found no association between biologic and targeted therapy for rheumatic diseases and severe course of new coronavirus infection, as well as with the need for hospitalization for COVID-19. The outcome of COVID-19 was favorable in all patients receiving treatment with biological and targeted synthetic drugs for rheumatic diseases.Disclosure of Interests:None declared</jats:sec

Increased hypoxemia in patients with COPD and pulmonary hypertension undergoing bronchoscopy with biopsy

Yoram Neuman,1,3 Matthew Koslow,2,3 Alona Matveychuk,2,3 Avigdor Bar-Sef,1 Alexander Guber,2,3 David Shitrit2,3 1Division of Cardiology, 2Pulmonary Department, Meir Medical Center, Kfar Saba, Israel; 3Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Background and objective: Patients with pulmonary hypertension (PH) are considered to be at risk for complications associated with flexible bronchoscopy (FB), but data concerning the degree of PH are often lacking. We investigated whether COPD patients with PH who undergo bronchoscopy are at greater risk for complications. Methods: This prospective study included 207 consecutive COPD patients undergoing FB. All underwent an echo-Doppler to evaluate pulmonary artery pressure on the day of the bronchoscopy procedure. Pulmonologists were blinded to the echocardiogram results. Results: A total of 167 patients (80.7%) had normal pulmonary pressure. The remaining 40&nbsp;patients (19.3%) had PH: 27 (13.0%) mild, eight (3.9%) moderate, and five (2.4%) severe. Noninvasive hemodynamic parameters between groups before and after FB were similar. Two patients with normal pulmonary pressure developed supraventricular tachycardia. None developed hemodynamically significant dysrhythmia. Bleeding episodes between groups in bronchoalveolar lavage (BAL) and transbronchial biopsy (TBB) did not differ. PH patients who underwent BAL and TBB had decreased O2 saturation during the procedure compared with the non-PH group (23.5% vs 6.9%, P=0.033). No deaths were attributable to FB. Conclusion: PH is common among COPD patients undergoing FB. PH patients undergoing BAL and TBB are at higher risk of decreased O2 saturation than those without PH. Further studies should assess the risk among COPD patients with moderate-to-severe PH. Keywords: bronchoscopy, hypoxemia, pulmonary hypertensio