title: 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.
authors.affiliation: Institute of Rheumatology and Clinic of Rheumatology, Charles University, Na Slupi 4, 12850, Prague 2, Czech Republic. pavelka@revma.cz
authors.forename: Karel
authors.initials: K
authors.lastname: Pavelka
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Szekanecz
authors.forename: Nemanja
authors.initials: N
authors.lastname: Damjanov
authors.forename: Maria
authors.initials: M
authors.lastname: Majdan
authors.forename: Evgeny
authors.initials: E
authors.lastname: Nasonov
authors.forename: Vadim
authors.initials: V
authors.lastname: Mazurov
authors.forename: Tibor
authors.initials: T
authors.lastname: Fabo
authors.forename: Eustratios
authors.initials: E
authors.lastname: Bananis
authors.forename: Heather
authors.initials: H
authors.lastname: Jones
authors.forename: Annette
authors.initials: A
authors.lastname: Szumski
authors.forename: Boxiong
authors.initials: B
authors.lastname: Tang
authors.forename: Sameer
authors.initials: S
authors.lastname: Kotak
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Koenig
authors.forename: Radu
authors.initials: R
authors.lastname: Vasilescu
mesh_terms: D000203:Activities of Daily Living; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001799:Blood Sedimentation; D004334:Drug Administration Schedule; D000068800:Etanercept; D005061:Europe, Eastern; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D012074:Remission Induction; D012890:Sleep; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate