Induction of response with etanercept–methotrexate therapy in patients with moderately active rheumatoid arthritis in Central and Eastern Europe in the PRESERVE study

Abstract

Biologics have mainly been assessed in patients with severe rheumatoid arthritis (RA) globally. Less attention has been paid to moderately active disease, especially in Central and Eastern Europe (CEE). Access to biologics and the disease features of RA patients may differ in CEE, relative to other regions. We assessed the clinical and patient-reported outcomes (PROs) of treatment from CEE patients in the multinational PRESERVE study ( NCT00565409 ). Patients with moderate RA 28-joint disease activity score ((DAS28) erythrocyte sedimentation rate (ESR) >3.2 and ≤5.1) despite methotrexate (MTX) treatment received open-label etanercept (ETN) 50 mg QW + MTX for 36 weeks. Low disease activity (DAS28 low disease activity (LDA) ≤3.2) and remission (DAS28 ESR <2.6) were assessed. PROs included Health Assessment Questionnaire Disability Index (HAQ-DI), patient global assessment (PGA), EuroQol-5 Dimension (EQ-5D), pain visual analogue scale (VAS), Medical Outcomes Study sleep questionnaire (MOS Sleep), Functional Assessment of Chronic Illness Therapy (FACIT), and Work Productivity and Activity Impairment for RA (WPAI-RA). Descriptive summary statistics were employed. Of the 834 enrolled patients, 302 were from CEE. At baseline, CEE patients had similar disease states versus the overall population. By week 36, LDA was achieved by 87 %, remission by 67 %, and normal HAQ-DI (≤0.5) by 53 % of patients. Mean scores (SDs) for PROs significantly improved by week 36 as follows: HAQ-DI total by -0.6 (0.5); PGA by -2.4 (2.1); EQ-5D total index by 0.2 (0.2). Pain VAS, MOS Sleep, FACIT, and WPAI-RA also showed significant improvements. In conclusion, induction therapy with ETN + MTX led to DAS28 LDA, remission, and improvements in PROs in most CEE patients with moderately active RA despite treatment with MTX. These results are similar to the overall study population in the PRESERVE trial.

A structured literature review of the burden of illness and unmet needs in patients with rheumatoid arthritis: a current perspective

“…Moreover, current evidence suggested that available therapies often fail to improve HAQ scores by clinically important margins, with patients frequently experiencing an unacceptable level of physical disability despite ongoing treatment [ 18 , 19 ]. Furthermore, approximately 47 % of patients failed to achieve HAQ levels indicative of minimal residual disease activity (a secondary goal of treatment for patients unlikely to achieve remission) [ 20 , 21 ].…”

Rheumatoid arthritis and work: The impact of rheumatoid arthritis on absenteeism and presenteeism

“…Even though the description of absenteeism seems relatively straightforward, a number of different definitions were used to define the number of days absent from work in these studies. A few studies used validated questionnaires to estimate the number of days absent including the Work Productivity Survey for Rheumatoid Arthritis (WPS-RA) [23,25], Health Labour Questionnaire (HLQ) [29] and Work Productivity and Activity Impairment questionnaire (WPAI-RA) [31,40]. In two studies, Short Form (SF)36 or Health Assessment Questionnaire (HAQ) scores were mapped onto existing measures of presenteeism (i.e., WPAI and Work Limitation Questionnaire (WLQ)) using regression techniques to estimate the inability to work [21] and the number of days missed due to absenteeism/presenteeism [24], whereas a zero-inflated Poisson (ZIP) model, which accounts for excessive zero values in absenteeism, was used in another study [19].…”

Autoimmune Rheumatic Diseases: Results and Prospects for Researches

“…Аутоиммунные противовоспалительных препаратов) [14], часть между-народного исследования PRESERVE [15,16], а также пе-гилированных моноклональных антител к ФНОα -ЦЗП [17] и АДА [18] при РА. Результаты, полученные в этих и других исследованиях, свидетельствуют о высокой эф-фективности ГИБП у больных РА, резистентных к тера-пии «стандартными» базисными противовоспалительны-ми препаратами (БПВП) [19].…”