scholarly journals Comparative efficacy of tofacitinib and adalimumab in patients with psoriatic arthritis in real clinical practice. Data from the Russian nationwide register of patients with psoriatic arthritis

2021 ◽  
Vol 15 (3) ◽  
pp. 35-42
Author(s):  
E. Yu. Loginova ◽  
T. V. Korotaeva ◽  
E. E. Gubar ◽  
Yu. L. Korsakova ◽  
S. I. Glukhova ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Median Duration ◽  
Comparable Efficacy ◽  
Number Of Patients ◽  
Group 2 ◽  
Low Activity ◽  
Real Clinical Practice ◽  
Group 1

Objective: to compare the clinical efficacy in real clinical practice of the targeted synthetic disease-modifying antirheumatic drug (sDMARD) tofacitinib (TOFA) and the biologic DMARD (bDMARD), an inhibitor of tumor necrosis factor alpha (TNFα), adalimumab (ADA) in patients with psoriatic arthritis (PsA), included in the Russian nationwide register of patients with PsA.Patients and methods. The study included 77 patients with PsA (43 men and 34 women) who met the CASPAR criteria and were observed in the Russian nationwide register. Patients were divided into two groups depending on the treatment. Group 1, in which oral TOFA was prescribed, 5 mg 2 times a day, included 41 patients: 24 (58.5%) men and 17 (41.5%) women, the median age was 41 [34; 50] years, the median duration of PsA was 72 [35; 120] months. Group 2, in which subcutaneous ADA was used, 40 mg every 2 weeks, included 36 patients: 19 (52.8%) men and 17 (47.2%) women, the median age was 44 [34; 51] years, the median duration of PsA was 59 [22; 102] months. Combination therapy, including methotrexate (MT), received 80.5% of patients in the TOFA group and 52.8% of patients in the ADA group. At the beginning of the study and every 6 months further, the activity and efficacy of PsA therapy were assessed in all patients according to DAPSA and criteria for minimal disease activity – MDA (number of painful joints ≤1, number of swollen joints ≤1, PASI ≤1 or BSA ≤3 , pain score ≤15, patient's general assessment of disease activity ≤20 mm on a visual analogue scale, HAQ ≤0.5, enthesitis ≤1), dynamics of BASDAI and BSA were also assessed. The number of patients who achieved remission (DAPSA ≤4) or MDA (5 criteria out of 7) during therapy with TOFA and ADA was determined.Results and discussion. Before the start of the therapy in the 1st group, the median DAPSA was 44.2 [37.8; 55.3]: moderate PsA activity was in 5 (12.2%) patients, high in 36 (87.8%) patients. In group 2, the median DAPSA was 35.8 [21.1; 52]: low activity was detected in 3 (8.6%), moderate – in 11 (31.4%), high – in 21 (60%) patients (data from 35 patients was available). 6 months after the start of treatment in patients of the 1st and the 2nd group, there was a significant decrease in all indicators of PsA activity compared to the baseline. The median DAPSA was 11 [4.3; 17.3] and 9.1 [6; 19.6]; remissions according to DAPSA reached 11 (26.8%) and 6 (20.8%) patients, respectively, low activity – 15 (36.6%) and 13 (44.8%), MDA – 16 (40%) and 9 (30%). The number of patients with dactylitis in the 1st and in the 2nd group significantly decreased: from 22 (53.7%) to 5 (13.2%) and from 13 (36.1%) to 6 (20%), respectively. Median HAQ decreased from 1 [0.625; 1.5] to 0.5 [0; 0.875] and from 0.875 [0.5; 1.38] to 0.5 [0; 0.875]; median BASDAI – from 6 [4.2; 7] to 1.4 [0.6; 3.2] and from 4.4 [1.9; 5.8] to 3 [0.8; 4.5], respectively. In group 1, the number of patients with BSA> 3% decreased from 16 (39%) to 8 (26.7%; p<0.225), and in group 2, due to insufficient data (5 patients), we failed to evaluate BSA dynamics.Conclusion. In real clinical practice TOFA and ADA both had comparable efficacy on all clinical manifestations of PsA: after 6 months of therapy, most patients with PsA achieved MDA, low disease activity and remission according to DAPSA and BASDAI.

The use of guselkumab in psoriatic arthritis: evidence from real clinical practice

2021 ◽  
Vol 15 (6) ◽  
pp. 91-94
Author(s):  
N. V. Nekrasova ◽  
Yu. E. Borovikov ◽  
T. G. Zadorkina ◽  
P. V. Nekrasova
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Skin Condition ◽  
Chronic Inflammatory Disease ◽  
Mean Value ◽  
Serious Adverse Events ◽  
The Mean ◽  
Interleukin 23 ◽  
Real Clinical Practice

Psoriatic arthritis (PsA) is a chronic inflammatory disease of the joints, spine and enthesis from the group of spondyloarthritis that develops in patients with psoriasis. Guselkumab is a biologic disease-modifying antirheumatic drug, an inhibitor of interleukin 23, which has been shown to be effective in the treatment of plaque psoriasis and PsA.Objective: to evaluate the effectiveness of guselkumab treatment in PsA patients.Patients and methods. The study included 16 patients with PsA. All patients received 100 mg of guselkumab subcutaneously at weeks 0, 4, 12, 20. Disease activity and treatment efficacy were assessed at weeks 0, 12 and 24 using the DAS28, ASDAS, BASDAI, DAPSA activity indices, the index of the extent and severity of psoriasis PASI.Results and discussion. During treatment, patients with PsA showed a pronounced positive dynamics of the indices of disease activity and an improvement in the skin condition. Before the treatment with guselkumab, the mean value of the DAS28 index was 4.26±0.64, DAPSA – 37.94±9.45, ASDAS – 2.7±0.65, and BASDAI – 5.49±1.39, after 12 weeks of treatment these indicators decreased to 3.03±0.49; 17.06±4.58; 1.64±0.33 and 3.48±0.66, respectively, and after 24 weeks (after the 4th injection) – to 2.32±0.18; 11.31±2.18; 1.22±0.27 and 2.62±0.78, respectively (p<0.05 for all cases). Before treatment, the average PASI index reached 30.99±15.43, after 12 weeks – 4.55±4.82, and after 24 weeks – 1.05±1.46 (p<0.05). During treatment, a significant improvement in the main manifestations of the disease was noted: regression of peripheral arthritis, spondylitis, and skin rashes.The treatment was well tolerated during the 24 weeks of the study, and no serious adverse events were reported.Conclusion. The data from real clinical practice indicate that guselkumab is highly effective and safe in the treatment of PsA.

scholarly journals Specific features of axial involvement in psoriatic arthritis: data from real clinical practice

2020 ◽  
Vol 58 (4) ◽  
pp. 401-406
Author(s):  
E. E. Gubar ◽  
E. Yu. Loginova ◽  
Yu. L. Kоrsakova ◽  
T. V. Korotayeva ◽  
S. I. Glukhova ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Activity Index ◽  
Das28 Score ◽  
Tender Joint ◽  
Radiographic Findings ◽  
Group 2 ◽  
Axial Involvement ◽  
Group 1

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.

scholarly journals Nail disease in psoriatic arthritis. Data from the Russian Psoriatic Arthritis Registry

2021 ◽  
Vol 59 (5) ◽  
pp. 563-570
Author(s):  
E. E. Gubar ◽  
Y. L. Korsakova ◽  
E. Yu. Loginova ◽  
T. V. Korotaeva ◽  
E. A. Vasilenko ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Disease Duration ◽  
Response To Therapy ◽  
Peripheral Arthritis ◽  
Nail Psoriasis ◽  
Group 2 ◽  
Nail Involvement ◽  
Group 1

Objective of the study – to compare, in real clinical practice, according to the data of the Russian Psoriatic Arthritis Registry, characteristics of two groups of psoriatic arthritis (PsA) patients: with and without nail psoriasis.Material and methods. 588 PsA patients (277 males and 311 females) with PsA according to CASPAR criteria were included in the Russian Psoriatic Arthritis Registry. Patients’ age was 48.6±0.5 years, disease duration – 7.0±0.3 years. Patients underwent standard clinical examination of PsA activity. Disease activity measures evaluated in this study included DAPSA (Disease Activity in Psoriatic Arthritis), BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS-СRP (Ankylosing Spondylitis Disease Activity Score). Enthesitis was measured using LEI (Leeds Enthesitis Index) index. Dactylitis was detected, the number of digits with acute dactylitis was defined. Skin lesion severity was evaluated in terms of BSA (Body Surface Area) affected, and PASI (Psoriasis Area Severity Index); PASI was calculated in case BSA > 3%. The criteria of minimal disease activity (MDA) had been used to assess the treatment efficiency. MDA was achieved if a patient met ≥5 of the 7 following categories: tender joint count (TJC) ≤1, swollen joint count (SJC) ≤1, PASI≤1 or BSA≤3%, patient pain VAS ≤15, patient global activity (PGA) VAS ≤20, Health Assessment Questionnaire Disability Index (HAQ) ≤0.5, and tender entheseal points ≤1. Patients were split into two groups: those with nail psoriasis (group 1), and those without nail psoriasis (group 2).Results. 312 (53.1%) patients had nail psoriasis and 276 (46.9%) did not. Patients’ age in group 1 was 45.7±11.9 years, in group 2 – 48.8±13.2 years (р>0.05). PsA duration in groups 1 and 2 did not differ, it was 7.1±6.6 and 7.0±6.2 years respectively (р>0.05). Higher proportions of patients with nail psoriasis were male, disabled from working and chronic smokers compared to patients without nail psoriasis: 51.9% vs 44.1% (р=0.013), 37.20% vs 26.40% (р<0.01) and 18.9% vs 8.7% (р<0.01) respectively. Patients with nail psoriasis had more severe erosive peripheral arthritis compared to patients without nail psoriasis. Median TJC was 8 [4–15] vs 5 [2–12] (р=0.002), SJC – 5 [1–9] vs 2 [0–7] (р=0.003), and erosive radiographic arthritis of feet was found in 45.0% vs 31.2% of patients (р=0.003) respectively. Group 1 patients had higher disease activity measured by DAPSA – 25 [15–39] vs 20 [12–33] (p=0.001) and ASDAS-CRP – 3.1 [2.2–4.0] vs 2.8 [1.8–3.5] (р=0.004), compared to group 2 patients. Patients with nail psoriasis had higher frequency of heel enthesitis and dactylitis; axial disease was diagnosed more often among them, compared to patients without nail psoriasis. Heel enthesitis was detected in 53 (17.0%) vs 28 (10.1%; р=0.016), dactylitis – in 76 (24.4%) vs 46 (16.7%; р=0.022), spondylitis – in 109 (35.0%) vs 73 (26.4%; р=0.025) patients respectively. Patients in group 1 had worse skin psoriasis than in group 2. Patients with nail psoriasis significantly more often had moderate and severe skin psoriasis according to BSA, compared to patients without nail psoriasis (39.9% vs 26.1% and 14.8 vs 1.1% respectively; р<0.01 for both comparisons); group 2 patients significantly more often had limited skin psoriasis compared to group 1 patients – in 72.8% vs 45.3% of cases respectively (р<0.01). Median PASI index in groups 1 and 2 was 6 [2–14] vs 3 [1–6] respectively (р<0.01). Group 1 patients gave worse assessment of their disease than group 2 patients; median PGA was 50 [40–70] mm vs 50 [30–65] mm VAS respectively (р=0.044). Less patients with nail psoriasis compared to patients without nail psoriasis had achieved MDA throughout the whole study. At the first visit MDA was detected in 3% vs 9% (р=0.006) of patients, at the second – in 12% vs 27% (р<0.001), at the third – in 14% vs 28% (р=0.011), at the fourth – in 17% vs 38% (р<0.001) and at the fifth in 27% vs 52% (р=0.004) of patients respectively. Patients with and without nail psoriasis were given equivalent therapy with diseasemodifying antirheumatic drugs (DMARDs) and biological agents (bDMARDs). DMARDs were given to 78.2% and 80.1% of patients respectively (р>0.05), it was mostly methotrexate (MTX); MTX was used in 66.0% and 64.1% of cases respectively (р>0.05). bDMARDs were prescribed to 22.1% and 28.3% (р>0.05) of patients, including tumour necrosis factor (TNF) inhibitors – in 67% and 63% of cases, interleukin (IL) inhibitors – in 33% and 37% of cases (р>0.05 for both comparisons). Taking into account the similar disease duration and equivalent therapy in both groups, it could be concluded that patients with nail psoriasis achieved MDA less frequently due to greater disease severity.Conclusion. Nail involvement is identified in more than half (53%) of PsA patients of the Russian Psoriatic Arthritis Registry. Nail psoriasis is associated with significantly worse disease status as measured by severe peripheral arthritis, enthesitis, dactylitis, spondylitis and skin lesions; higher frequency of erosive arthritis was detected in this category of patients. Patients with nail psoriasis had achieved MDA less frequently compared to patients without nail psoriasis. Nail involvement is associated with worse response to therapy and patients’ disability. These data emphasize the importance of accurate diagnostics of nail psoriasis and optimization of treatment approach, including “targeted” therapy.

scholarly journals The relationship between obesity, cardiometabolic disorders and disease activity in psoriatic arthritis patients: data from the Russian register

2021 ◽  
Vol 93 (5) ◽  
Author(s):  
Yuliia L. Korsakova ◽  
Tatiana V. Korotaeva ◽  
Elena I. Loginova ◽  
Elena E. Gubar ◽  
Elizaveta A. Vasilenko ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Lower Treatment ◽  
Cardiometabolic Disorders ◽  
High Incidence ◽  
Group 3 ◽  
Group 2 ◽  
Real Practice ◽  
The Relationship ◽  
Group 1

Aim. To study the relationship between obesity, cardiometabolic disorders and disease activity in patients with psoriatic arthritis (PsA) in real practice. Materials and methods. The Russian register included 614 PsA patients [female 331 (54%)/283 (46%)]. Average age 45.20.52 years, PsA duration 5.70.27 years, psoriasis 15.710.56 years. Patients underwent examination, body mass index (BMI), PsA activity according to DAPSA, cDAPSA, analysis of concomitant diseases were assessed. The patients were divided into 3 groups depending on BMI (kg/m2): normal 25 (group 1), increased 2530 (group 2), obesity 30 (group 3). Results. The average BMI was 27.70.23 kg/m2, normal BMI in 213 (34.7%), increased in 214 (34.8%) and obesity in 187 (30.5%). Concomitant diseases in 297 (48%). In group 3, arterial hypertension was observed significantly more often than in groups 1 and 2 (p0.0001); more often than in group 2 diabetes mellitus (p0.0001), metabolic syndrome (p0.0001); more often than in group 1 ischemic heart disease (p=0.026). PsA activity at Baseline, after 6/12 months was significantly higher in group 3 (p0.031). In obese patients, the chance of a decrease in disease activity to a moderate/low level and remission during therapy for 6/12 months is 2.484 times lower than in group 1, and 2.346 times lower than in group 2: odds ratio 2.346 (95% сonfidence interval 1.075.143) and 2.484 (95% сonfidence interval 1.1355.439), respectively. Conclusion. In the majority (65.3%) of PsA patients, BMI exceeded the norm. Obesity is associated with a high incidence of cardiometabolic disorders, with higher PsA activity and lower treatment efficacy.

scholarly journals Results of direct comparison of the clinical efficacy of ixekizumab and adalimumab: data from the SPIRIT H2H study

2020 ◽  
Vol 14 (3) ◽  
pp. 50-56
Author(s):  
T. V. Korotaeva
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Relative Number ◽  
Response Rates ◽  
Comparable Efficacy ◽  
Controlled Study ◽  
Inadequate Response ◽  
Serious Adverse Events ◽  
Low Disease Activity ◽  
Number Of Patients

Objective: to analyze the data available in the literature on the efficacy and safety of ixekizumab (IXE) and adalimumab (ADA) via their direct comparisons in the treatment of psoriatic arthritis (PsA).Patients and methods. The results of the SPIRIT H2H study were analyzed, the aim of which was to investigate the potential superiority of IXE to ADA for arthritis and skin manifestations in a group of patients with active PsA, stable plaque psoriasis with an inadequate response to synthetic disease-modifying antirheumatic drugs (sDMARDs) who had not previously received biological agents (BAs).Design: a 52-week multicenter, randomized, parallel-group study. The patients were randomized 1:1 to open IXE or ADA administration groups for 52 weeks. This review presents the data obtained at 24-week follow-up.Of the 684 screened patients, 566 (82.7%) were included in the study; moreover, the distribution of the patients was equal between the ADA (n=283) and IXE (n=283) groups. At 6 months, 269 (95%) patients in the ADA group and 262 (93%) in the IXE one continued to participate in the study. Efficacy analysis was made based on the achievement of the primary endpoint that was considered to be related to the relative number of patients, who had simultaneously achieved improvements in the joints and skin according to the ACR50 and PASI100 criteria.Results and discussion. At 24 weeks, the proportion of patients who had simultaneously achieved ACR50 and PASI100 responses was significantly higher in the IXE group (36%) than in the ADA one (28%) (p=0.036). It was found that the IXE group was not inferior to the ADA one in terms of ACR50 response rates (in 51% (IXE) and 47% (ADA) patients) and was superior in achieving PASI100 response rates (in 60% (IXE) and 47% (ADA) patients) (p=0.001). The IXE group was recorded to have a higher response than the ADA group and in terms of other manifestations of the disease: the severity of skin and nail psoriasis, enthesitis, remission achievement, minimal and very low disease activity, and improved quality of life. Comparable effectiveness was noted for the effect of the drugs on dactylitis, as well as for the simultaneous achievement of remission and low disease activity in psoriatic arthritis according DAPSA. Serious adverse events (SAEs) were recorded in 8.5% (ADA) and 3.5% (IXE) patients.The safety and tolerability of both BAs corresponded to their previously presented safety profile. The findings were also confirmed at 52-week follow-up, presented at the Meetings of the American College of Rheumatology in November 2019 and the European League Against Rheumatism in June 2020, and published in the leading journals of rheumatology.Conclusion. The first randomized placebo-controlled study (SPIRIT H2H) directly comparing the two BAs with different mechanisms of action demonstrated the advantage of IXE over ADA in simultaneously reducing the activity of arthritis and psoriasis and showed their comparable efficacy comparable efficacy regarding joint symptoms. The use of IXE versus ADA was accompanied by the more frequent achievement of a combined endpoint related to the signs of joint and skin damages in patients with PSA, as well as by the quantitatively lower frequency of SAEs in patients with active PSA who had failed previous sDMARD therapy. The findings are of great importance for clinical practice from the point of view of the reasonable choice of a treatment strategy in these patients.

scholarly journals Thrombolytic Therapy in Treatment in Patients with Pulmonary Embolism not High-risk: SIRENA Registry Data

2021 ◽  
Vol 17 (3) ◽  
pp. 401-407
Author(s):  
N. A. Cherepanova ◽  
I. S. Mullova ◽  
T. V. Pavlova ◽  
A. D. Erlikh ◽  
O. L. Barbarash ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Clinical Practice ◽  
High Risk ◽  
Thrombolytic Therapy ◽  
Blood Clot ◽  
Clinical Factors ◽  
Risk Patients ◽  
Group 2 ◽  
Real Clinical Practice ◽  
Group 1

Aim. To study the features of the use of thrombolytic therapy (TLT) in normotensive patients with pulmonary embolism (PE) in real clinical practice in Russian hospitals.Material and Methods. From 04/1 5/2018 to 04/15/2019 patients hospitalized with a diagnosis of PE consistently were included in the Russian multicenter observational prospective register "SIRENA” (RusSIan REgistry of pulmoNAry embolism).Results. For 12 months in the registry was included 609 patients with a lifetime confirmed diagnosis of PE. TLT was performed in 152 patients with PE (25.0%), of which only 51 (33.8%) were indicated as "high risk" (shock or hypotension). In 101 not high risk patients, the indications for TLT were: severe shortness of breath/respiratory failure - 19 (18.8%), massive venous thrombosis - 7 (6.9%), signs of massive/submassive PE - 10 (9.9%), intermediate-high risk - 14 (13.9%), suspicion of acute coronary syndrome with ST segment elevation - 3 (2.9%), high pulmonary hypertension -2 (2.0%). The other 46 (45.5%) non-high-risk patients had no clear indication of the reasons for TLT in their medical history. To study the features of management of patients with not high-risk PE who received TLT (group 1), a selection of pairs of patients from the "SIRENA” registry, comparable in gender and age, in a ratio of 1:1 of patients with not high-risk PE who did not perform TLT (group 2). Hospital mortality was 4 (4%) patients in the TLT group and 6 (5.9%) patients in group 2 (р=0,748). Logistic regression analysis showed that floating blood clot in the veins of the lower extremities, syncopes in the debut of PE, respiratory rate over 22 per minute were independent clinical factors that significantly influence the doctor's decision to perform thrombolysis, and probability of completion TLT decreased in the presence of a history of bleeding, chronic kidney disease, surgery in the previous 12 months, increase in the size of the right atrium on EchoCG (statistical significance of the model x2=51.574; p<0.001). The development of bleeding during hospitalization was recorded only in 10 (9.9%) patients of group 1, including severe (3 stage on the BARC scale) in 2 patients. Patients without TLT more often developed an acute heart failure (25.9% vs. 8.5%, p=0.043).Conclusion. In real clinical practice, there is a high frequency of TLT in patients with not high-risk PE. Floating blood clot in the veins of the lower extremities, syncope in the debut of PE, respiratory rate over 22 per minute were independent clinical factors that significantly influence the doctor's decision to perform thrombolysis.

scholarly journals The efficacy and safety of apremilast in patients with psoriatic arthritis concurrent with comorbidity in clinical practice

2019 ◽  
Vol 57 (3) ◽  
pp. 299-306
Author(s):  
E. Yu. Loginova ◽  
Yu. L. Korsakova ◽  
A. D. Koltakova ◽  
E. E. Gubar ◽  
P. L. Karpova ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Skin Lesions ◽  
Tender Joint Count ◽  
Psoriatic Skin ◽  
Efficacy And Safety ◽  
Tender Joint ◽  
Number Of Patients ◽  
Conventional Dmards ◽  
Low Activity

Objective: to evaluate the clinical efficacy and safety of the targeted synthetic disease-modifying antirheumatic drug (DMARD) apremilast (AP; Otesla®) in patients with active psoriatic arthritis (PsA) at 14 and 26 weeks after starting the treatment and to identify the place of AP in the combination therapy of patients with PsA, by taking into consideration a comorbidity.Subjects and methods. Examinations were made in 20 patients (11 women and 9 men) with active PsA who had comorbidity, lack of efficiency of or intolerance to previous therapy with synthetic DMARDs or biologic agents, and contraindications to its use. The median baseline Disease Activity in Psoriatic Arthritis (DAPSA) score was 35.6 [24.8; 55.6]; those of DAS and DAS28 were 3.8 [3.2; 5.0] and 4.4 [4.0; 5.2], respectively. AP (Otesla®) was administered in tablets with a starting dose of 10 mg/day with a daily dose escalation of 10 mg to the therapeutic dose of 60 mg/day for 26 weeks. At baseline, 14 and 26 weeks, the disease activity and efficiency of AP were evaluated using DAPSA, DAS, and DAS28, as well as minimal disease activity (MDA) criteria (tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or BSA ≤3%; a patient’s assessment of pain ≤15 mm; patient’s global assessment ≤ 20 mm; Health Assessment Questionnaire (HAQ) ≤ 0.5; enthesitis ≤1). The investigators estimated the number of patients who had achieved remission (DAPSA≤4; DAS<1.6; DAS28<2.6), low activity (5≤DAPSA≤14; 1.6≤DAS<2.4; 2.6≤DAS28<3.2) or MDA (5 of the 7 criteria) during AP therapy at 26-week follow-up. The safety of therapy was evaluated, by analyzing the adverse events (AE): the frequency, severity, and time of their occurrence were studied.Results and discussion. At 26 weeks after AP therapy initiation, there was a significant decrease of all PsA activity scores as compared to the baseline ones to the following median values: DAPSA 25.9 [11.3; 35.2]; DAS 3.3 [1.8; 3.9], and DAS28 3.4 [2.3; 4.8]. The median BASDAI and ASDAS scores also significantly declined from 5.1 [2.5; 7.3] and 3.35 [2.3; 4.2] to 3.45 [2.15; 6.15] and 2.7 [1.8; 3.35], respectively. The median area of psoriatic skin lesions (body surface area (BSA)) significantly reduced from 2 [0.35; 6] to 1 [0.2; 2]. At 26 weeks after starting AP therapy, the low activity/remission according to DAPSA, DAS, and DAS28 was achieved by 20/10%, 20/15%, and 10/35% of patients, respectively. Three (15%) patients achieved MDA. Fifteen (75%) of the 20 patients completed an AP therapy course. In the period of 14 to 26 weeks, four patients dropped out of the study due to ineffective therapy and one because of a severe AE (pneumonia at 14 weeks of treatment); at 26 weeks, another patient was withdrawn due to lack of effect. At 14 weeks, ten patients had a moderate AE that did not required treatment discontinuation. The most common AE were diarrhea in 5 (25%) patients, headache in 4 (20%), nausea in 3 (15%), and insomnia in 3 (15%).Conclusion. AP is a safe and effective drug for the treatment of PsA patients with moderate and high inflammatory activity and various comorbidities that do not allow the use of conventional DMARDs.

ANALYSIS OF THE RESULTS OF TOFACITINIB THERAPY IN REAL CLINICAL PRACTICE ACCORDING TO THE ALL-RUSSIAN ARTHRITIS REGISTRY (OREL)

2020 ◽  
Vol 58 (3) ◽  
pp. 262-267
Author(s):  
A. S. Avdeeva ◽  
A. S. Misiyuk ◽  
A. M. Satybaldyev ◽  
G. V. Lukina ◽  
V. N. Sorotskaya ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Age At Onset ◽  
Similar Efficacy ◽  
Moderate Activity ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Number Of Patients ◽  
Low Activity ◽  
Necrosis Factor ◽  
Real Clinical Practice

Objective: to analyze the results of tofacitinib (TOFA) therapy in real clinical practice according to the All-Russian Arthritis Registry (OREL). Subjects and methods. The OREL Registry included 347 patients (286 (82%) women and 61 (18%) men) with rheumatoid arthritis (RA) who initiated TOFA therapy. The male:female ratio was 1:4.7. The patients’ median age at onset of the disease was 42 years; its duration was 8 years. Most of the patients included in the registry had extended- (n=171 (52%)) or late- (n=148 (45%)) stage of RA. Results and discussion. Prior to initiation of TOFA therapy, RA activity according to DAS28 was high and moderate in 91 (64.5%) and 40 (28.4%) patients, respectively; the median DAS28 value was 5.5 [4.6; 6.2]; SDAI – 30.5 [21.4; 42.9], and CDAI – 28.2 [20.0; 37.1]. The use of TOFA was accompanied by significant decrease of disease activity. After 12 weeks, high RA activity was persistent in 32 (22.7%) patients; the number of patients with moderate activity increased to 77 (54.6%), that of those with low activity rose to 15 (10.6%); remission was observed in 17 (12.1%) patients. 216 (62.6%) and 76 (22%) patients received TOFA as first- and second-line therapy, respectively. TOFA was most frequently prescribed when tumor necrosis factor-á inhibitors (19.6%), rituximab (7.8%), tocilizumab (4.3%), and abatacept (5.2%) were insufficiently effective or poorly tolerated. Conclusion. The results of using TOFA in real clinical practice may suggest that the drug has high efficacy in patients with RA. TOFA can be used at a dose of 5 or 10 mg twice daily as both alone and in combination with disease-modifying anti-rheumatic drugs. TOFA showed similar efficacy in patients who had earlier taken biological agents and in those who had not.

scholarly journals AB0542 EVALUATION OF APREMILAST USE IN THE ROUTINE CLINICAL PRACTICE IN PATIENTS WITH PSORIATIC ARTHRITIS NAÏVE TO BIOLOGICAL TREATMENTS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1303.2-1304
Author(s):  
J. Gratacos-Masmitja ◽  
J. L. Álvarez Vega ◽  
E. Beltrán ◽  
A. Urruticoechea-Arana ◽  
C. Fito-Manteca ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Routine Clinical Practice ◽  
Wilcoxon Test ◽  
Psychiatric Disease ◽  
Biological Therapies ◽  
Research Support ◽  
Disease Evolution ◽  
Biological Treatments

Background:Apremilast is a non-biologic systemic agent approved for the treatment of plaque psoriasis, oral ulcers of Behcet’s disease and PsA with proven efficacy in clinical trials [1,2]. However, more real-world evidence of apremilast use and effectiveness is needed to identify the patient profile most likely to benefit from this treatment [3].Objectives:To evaluate the persistence of apremilast treatment in patients with PsA naïve to biological treatments in routine clinical practice and assess its effectiveness. Baseline clinical characteristics on patients who started apremilast were also evaluated.Methods:Observational, prospective, multicenter (20 centers) study including consecutive adult patients with PsA naïve to biological therapies who had started treatment with apremilast during the previous 5 to 7 months and were followed-up during 12 months. Variables recorded were persistence of treatment with apremilast at 6 months (6mo) and number of swelling joints, presence of enthesitis and dactylitis, and disease activity, measured by the Disease Activity in Psoriatic Arthritis (DAPSA) score and Physician Global Assessment (PGA) of psoriasis, collected at baseline (BL) (i.e., apremilast treatment start) and 6mo; comorbidities were retrospectively collected at BL. Categorical and quantitative variables were compared using McNemar’s and Wilcoxon test, respectively. Data sets analyzed included all assessable patients.Results:Of the 60 patients recruited at the time of this interim analysis, 54 (90.0%) [mean (SD) age 53.4 (13.9) years] were assessable; 41 (75.9%) of these continued treatment with apremilast at 6mo. At BL, 34 (63.0%) patients had at least one comorbidity, the most frequent being cardiovascular disease (n=15, 27.8%), including hypertension (n=8, 14.8%), metabolic/endocrine disease (n=18, 33.3%), including obesity (n=8, 14.8%) and dyslipidemia (n=10, 18.5%). Psychiatric disease (i.e., depression) (n=5, 9.3%) and neoplasia (n=8, 14.8%) were also observed. The number of swelling joints decreased from median (Q1, Q3) 4.0 (2.0, 7.0) at BL to 1.5 (0.0, 4.0) at 6mo (p=0.0012). Patients with dactylitis and enthesitis decreased from 19 (35.2%) and 16 (29.6%) at BL to 10 (18.5%) and 9 (16.7%) at 6mo (p=0.0225 and p=0.0391), respectively. The distribution of patients in the different disease activity categories according to DAPSA scale changed between BL and 6mo, indicating a favorable disease evolution (Figure 1 next page). According to PGA, at BL (n=53), disease activity was categorized as mild in 18.0%, as moderate in 72.0%, and as severe in 10% of patients and, at 6mo (n=54), as mild in 70.6%, as moderate in 25.5%, and as severe in 3.9% of patients. Fifteen (27.8%) patients interrupted treatment permanently (n=13, 24.1%) or temporarily (n=2, 3.7%), due to no/partial response (n=8, 14.8%), tolerability issues leading to adverse events (n=3, 5.6%), patient decision (n=2, 3.7%), and other reasons (n=2, 3.7%) after a mean (SD) treatment of 3.05 (2.20) months.Conclusion:Forty-one (75.9%) patients with PsA naïve to biological therapies were treated with apremilast during ≥6 months. After treatment, the number of swelling joints, and dactylitis and enthesitis decreased and changes in disease activity according to DAPSA and PGA pointed to a favorable disease evolution. Apremilast treatment provides a clinical benefit to patients with PsA treated in clinical practice.References:[1]Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Feb 10;75(3):499 LP-510[2]Torres T and Puig L. Apremilast: A novel oral treatment for psoriasis and psoriatic arthritis. Am J clin Dermatol. 2018 Feb;19(1):23-32[3]Coates LC, Kavanaugh A, Mease PJ et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015. Treatment Recommendations for Psoriatic Arthritis. Arthritis Rheumatol. 2016;68(5):1060– 71.Disclosure of Interests:Jordi Gratacos-Masmitja Speakers bureau: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., Consultant of: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., José Luis Álvarez Vega Speakers bureau: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Consultant of: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Grant/research support from: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Emma Beltrán Speakers bureau: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, ANA URRUTICOECHEA-ARANA: None declared., C. Fito-Manteca: None declared., Francisco Maceiras: None declared., Joaquin Maria Belzunegui Otano Speakers bureau: Lilly, Amgen, Novartis, Abbvie, Janssen., J. Fernández-Melón Speakers bureau: Amgen SL, Eugenio Chamizo Carmona: None declared., Abad Hernández Speakers bureau: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Consultant of: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Grant/research support from: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Inmaculada Ros Consultant of: Amgen, Grant/research support from: MSD, Roche, Novartis, lilly, Pfizer, Amgen, Eva Pascual Shareholder of: Amgen, Employee of: Amgen, Juan Carlos Torre Speakers bureau: Amgen, Lilly, Novartis, Janssen, Pfizer, Consultant of: Amgen, Lilly, Novartis, Janssen, Pfizer, Grant/research support from: Amgen, Lilly, Novartis, Janssen, Pfizer.

scholarly journals AB0564 RHEUMATOLOGISTS’ VIEWS AND EXPERIENCES IN MANAGING PsA PATIENTS BASED ON TREATING TO TARGET STRATEGY: A CROSS-SECTIONAL STUDY IN CHINA

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1318.2-1319
Author(s):  
L. Xu ◽  
Z. Wang ◽  
J. Xue ◽  
M. Bai ◽  
H. Zhong ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Western Medicine ◽  
Work Experience ◽  
Tertiary Hospital ◽  
Treat To Target ◽  
Cross Sectional ◽  
Activity Assessment ◽  
High Level

Background:Psoriatic arthritis (PsA) is a chronic inflammatory arthritis with progressive, erosive destruction associated with functional impairment. Principles of treat-to-target (T2T) have been widely used in rheumatoid arthritis, which has powerfully improved patient outcomes. In 2017, the concept of T2T has proposed to apply in PsA patients. However, the awareness and implementation of evidence-based T2T treatment guidelines varies across different geographical regions of China, hospital grades, professional status and specialities.Objectives:The study aimed to investigate Rheumatologists’ views and experiences in managing PsA patients with T2T strategy in china.Methods:A cross-sectional questionnaire survey of Rheumatologists in China from 5 August to 15 August 2020 was conducted for this study. Rheumatologists were contacted by WeChat (a Chinese cell/web app) and asked to complete a web-based questionnaire anonymously. The electronic questionnaire was sent out by the internet platform of WenJuanXing via WeChat (https://www.wjx.cn/). The questionnaire was designed to collect: (a) demographic information; (b) patient management in clinical practice for Rheumatologists; (c) familiarity and application of T2T strategy in Rheumatologists. P values ≤0.05 were considered significant.Results:(1) A total of 823 rheumatologists (69.87% female, 30.13% male) provided valid answers to the questionnaire. 71.09% of the participants major in Modern Western Medicine, 28.91% major in traditional chinese medicine. A total of 75.94% worked in Grade-A Tertiary Hospital. A total of 52.73% had more than 10 years of work experience and 63.55% had High-level title. (2) More than half of the patients were followed up by 69% Rheumatologists in their daily practice. The proportion of follow-up patients increased powerfully in the group of Rheumatologists who major in Modern Western Medicine (P=0.014), work in Grade-A Tertiary Hospital (P<0.001), have more than 10 years of work experience (P<0.001) and High-level title (P<0.001). (3) 36.45% Rheumatologist thought the frequency for patient disease activity assessment was every 1 month and 53.1% was every 3 months. And 41.7% Rheumatologist prefer to use PASDAS for disease activity criteria, and only 3.6% choose MDA. (4) A total of 62.43% thought they were familiar with T2T strategy, and 83.6% Rheumatologists applied T2T strategy in clinical practice. Among 135 Rheumatologists who did not apply T2T strategy, 62.2% of Rheumatologists thought that the main barrier to T2T application was that they did not fully understand the strategy. The frequency of application of T2T strategy in clinical practice was significantly different between Rheumatologists who major in Modern Western Medicine (60.75%) and traditional chinese medicine (22.84%) (P=0.023).Conclusion:In china, the management of PsA patients need to be standardized to improve patient outcomes. And the promotion of T2T strategy in PsA need to be further strengthened.References:[1]Smolen JS, Schöls M, Braun J,et al. Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force. Ann Rheum Dis. 2018 Jan;77(1):3-17.[2]Tucker LJ, Ye W, Coates LC. Novel Concepts in Psoriatic Arthritis Management: Can We Treat to Target? Curr Rheumatol Rep. 2018 Sep 18;20(11):71.[3]Coates LC, Helliwell PS. Treating to target in psoriatic arthritis: how to implement in clinical practice. Ann Rheum Dis. 2016;75(4):640-643.Figure 1A. Rheumatologist priority of frequency for patient follow-up in different disease status. B. Rheumatologist priority of frequency for patient disease activity assessment in clinical practice. C. Rheumatologist priority of disease activity criteria for PsA patients.Disclosure of Interests:None declared.

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