scholarly journals AB0918 Patient-reported outcomes improvement in the russian cohort of early periferal psoriatic arthritis patients treated according to treat-to-target strategy (OPEN-LABEL REMARCA STUDY)

Author(s):  
E.E. Gubar ◽  
E.Y. Loginova ◽  
S.I. Glukhova ◽  
T.V. Korotaeva ◽  
E.L. Nasonov
2018 ◽  
Vol 90 (5) ◽  
pp. 22-29 ◽  
Author(s):  
T.V. KOROTAEVA ◽  
◽  
E.Yu. LOGINOVA ◽  
T.S. GETIYA ◽  
E.L. NASONOV ◽  
...  

2010 ◽  
Vol 37 (6) ◽  
pp. 1221-1227 ◽  
Author(s):  
PHILIP J. MEASE ◽  
J. MICHAEL WOOLLEY ◽  
AMITABH SINGH ◽  
WAYNE TSUJI ◽  
MELEANA DUNN ◽  
...  

Objective.To evaluate the effects of etanercept treatment on patient-reported outcomes (PRO) in patients with psoriatic arthritis (PsA).Methods.A 24-week double-blind comparison to placebo was followed by a 48-week open-label phase in which all eligible patients received etanercept. PRO were measured using the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), the Medical Outcomes Study Short-Form (SF-36), the EQ-5D visual analog scale (VAS), and the American College of Rheumatology (ACR) patient pain assessment.Results.Beginning at Week 4 and continuing through Week 24 of double-blind treatment, patients treated with etanercept had significantly higher mean percentage improvement in HAQ-DI relative to baseline than patients given placebo (53.6% vs 6.4% at Week 24; p < 0.001). After 48 weeks of open-label treatment with etanercept, the mean percentage change from study baseline was 52.8% for the original etanercept group and 46.9% for the original placebo group, with 41.2% of patients overall achieving a HAQ-DI of 0. Mean changes relative to baseline for SF-36 physical component summary scores, EQ-5D VAS, and ACR pain assessment were also significant in the double-blind period for etanercept compared with placebo (p < 0.001 for all 3 measures). Patients taking placebo achieved similar improvements once they began treatment with etanercept in the open-label period.Conclusion.Patients with PsA treated with etanercept reported significant improvements in physical function that were almost 10 times the improvement seen with placebo and were maintained for up to 2 years. Almost half of patients treated with etanercept reported no disability by the end of the study.


2019 ◽  
Vol 56 (6) ◽  
pp. 739-745
Author(s):  
E. Yu. Loginova ◽  
T. V. Korotaeva ◽  
A. D. Koltakova

The current Treat-to-target (T2T) strategy in the management of patients with psoriatic arthritis (PsA) is based on strict control over the dynamics of a patient's status and timely correction of therapy according to the presence or absence of remission or minimal disease activity (MDA) within 6 months after treatment initiation. The multidimensional RAPID3 questionnaire based on the patient's own opinion of his/her health status, has demonstrated its high effectiveness in assessing remission in patients with rheumatoid arthritis (RA). The possibilities of using the RAPID3 questionnaire in patients with early PsA (ePsA) with T2T strategy have not yet been studied.Objective: to investigate whether the multi-dimensional RAPID3 questionnaire may be used to assess the achievement of remission and MDA in ePsA patients with a T2T (Treat-to-target) strategySubjects and methods. The investigation enrolled 61 patients (29 men and 32 women) with ePsA meeting the 2006 CASPAR criteria; the mean age of the patients was 37±10.6 years; the duration of PsA and psoriasis was 11.3±10.2 and 75.4±80.9 months, respectively. The patients were followed up for 12 months during the open-label REMARCA study performed by the T2T principles. At baseline, all the patients were given methotrexate (MTX; Methoject) subcutaneously at a dose of 10 mg/week, with escalation by 5 mg every 2 weeks up to 20–25 mg/week. If there was no low disease activity (LDA), DAS28/DAS remission, or MDA after 3 months, the patients received combined therapy with MTX 20–25 mg/week and adalimumab (ADA) or ustekinumab (UST) at standard doses. All the patients underwent standard rheumatologic examination before therapy and every 3 months. The investigators calculated tender joint count (TJC) among 78 joints; swollen joint count (SJC) among 76 joints, the Ritchie articular index, and the number of entheses by the Leeds Enthesitis index (LEI). Joint pain measurement, patient (PGA) and physician (PhGA) global assessment on visual analog scale (VAS) was performed, the serum level of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were evaluated. DAS and DAS28, HAQ and RAPID3 functional index were estimated. The number of patients achieving LDA, DAS/DAS28 remission, and MDA were determined. Results and discussion. At 1 year of therapy, 36 (59%) out of the 61 patients and 25 (41%) out of the 61 patients were treated with MTX and this drug in combination with ADA or UST, respectively. After 1 year of treatment, the whole group displayed a significant improvement of all PsA activity parameters as compared with baseline values: DAS, 3.93 [3.20; 4.58] / 1.36 [0.82; 2.25], SJC, 7 [5; 11] / 1 [0; 3], TJC, 8 [6; 1] / 1 [0; 3], PhGA, 56 [48; 69] / 10 [5; 20] and VAS pain, 54 [48; 68] / 11 [1; 20], PGA, 55 [49; 68] / 14 [7; 24], HAQ, 0.75 [0.50; 1] / 0 [0; 0.63], respectively. There was a significant correlation of RAPID3 with PsA activity and CRP. MDA was seen in 43 (70.5%) out of the 61 patients. Among the patients who had achieved MDA, the RAPID3 values corresponded to remission, but were significantly higher in the patients who had not attained MDA: 2.5 [1.3; 5.3] and 8.1 [6.0; 15.1], respectively. RAPID3 demonstrated high sensitivity in assessing the achievement of remission, LDA, and MDA in patients with ePsA.Conclusion. RAPID3 based on a patient's personal opinion of his/her disease is a simple and reliable tool to assess the disease activity in patients with ePsA and to monitor the efficiency of therapy with a T2T strategy and may be really useful in practice.


2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110123
Author(s):  
Sergej M. Ostojic ◽  
Aleksandra Milovancev ◽  
Patrik Drid ◽  
Alexandros Nikolaidis

In this open-label case series trial, we evaluated the effects of a nitrate-based nutritional formula on oxygen saturation (SpO2) and patient-reported outcomes in individuals with coronavirus disease 2019 (COVID-19). Five adult patients (three men and two women, age 39.6 ± 6.9 years) with a positive COVID-19 test result, breathing difficulties, and SpO2 ≤95%, who were free from other pulmonary and cardiovascular conditions, were recruited for this study. Participants were assigned to receive a multi-component nutritional formula (containing 1200 mg of potassium nitrate, 200 mg of magnesium, 50 mg of zinc, and 1000 mg of citric acid) every 4 hours during the 48-hour monitoring period. In all participants, SpO2 improved immediately after administration of the nutritional formula, from 1 to 7 percentage points (mean increase 3.6 ± 2.7 points; 95% confidence interval 0.3 to 7.0). SpO2 remained above baseline values throughout the monitoring interval, with values persisting over threshold values (>92%) for all patients and at each time point during the 48 hours. No patients reported any side effects of the intervention. These promising and rather unexpected results call for immediate, well-sampled, mechanistic randomized controlled trials to validate our findings.


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