Objective. To evaluate the efficacy and safety of intraarticular sprifermin (recombinant human fibroblast growth factor 18) in the treatment of symptomatic knee osteoarthritis (OA).Methods. The study was a randomized, doubleblind, placebo-controlled, proof-of-concept trial. Intraarticular sprifermin was evaluated at doses of 10 g, 30 g, and 100 g. The primary efficacy end point was change in central medial femorotibial compartment cartilage thickness at 6 months and 12 months as determined using quantitative magnetic resonance imaging (qMRI). The primary safety end points were nature, incidence, and severity of local and systemic treatment-emergent adverse events (AEs) and acute inflammatory reactions, as well as results of laboratory assessments. Secondary end points included changes in total and compartment femorotibial cartilage thickness and volume as assessed by qMRI, changes in joint space width (JSW) seen on radiographs, and pain scores on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results. One hundred ninety-two patients were randomized and evaluated for safety, 180 completed the trial, and 168 were evaluated for the primary efficacy end point. We found no statistically significant dose response in change in central medial femorotibial compartment cartilage thickness. Sprifermin was associated with statistically significant, dose-dependent reductions in loss of total and lateral femorotibial cartilage thickness and volume and in JSW narrowing in the lateral femorotibial compartment. All groups had improved WOMAC pain scores, with statistically significantly less improvement at 12 months in patients receiving the 100-g dose of sprifermin as compared with those receiving placebo. There was no significant difference in serious AEs, treatment-emergent AEs, or acute inflammatory reactions between sprifermin and placebo groups. Conclusion. No statistically significant relation-ClinicalTrials.gov identifier: NCT01033994.

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Objective: To evaluate the effectiveness and tolerability of lacosamide added to one or two antiepileptic drugs (AEDs) in the treatment of patients with brain tumor-related epilepsy (BTRE), and to evaluate patients' global impression of change and quality of life (QoL). Methods: This was a prospective, multicenter, single-arm, noninterventional study with a 6-month observation period (EP0045; NCT02276053). Eligible patients (≥16 years old) had active BTRE secondary to low-grade glioma (World Health Organization grade 1 and 2) and were receiving treatment with one or two AEDs at baseline. Lacosamide was initiated by the treating physician in the course of routine clinical practice. Primary outcomes were 50% responders (≥50% reduction in focal seizure frequency from baseline) and Patient's Global Impression of Change (PGIC) at month 6. Secondary outcomes included seizure-free status and Clinical Global Impression of Change (CGIC) at month 6, change in QoL (5-Level EuroQol-5 Dimension Quality of Life Assessment) and symptom outcomes (MD Anderson Symptom Inventory-Brain Tumor) from baseline to month 6, and Kaplan-Meier estimated 6-month retention on lacosamide. Safety variables included adverse drug reactions (ADRs). Results: Patients were recruited from 24 sites in Europe. Ninety-three patients received lacosamide (mean [standard deviation] age = 44.5 [14.7] years; 50 [53.8%] male; median baseline focal seizure frequency = five seizures/28 days [range = 1-280]), of whom 79 (84.9%) completed the study. At 6 months, 66 of 86 (76.7%) patients were 50% responders and 30 of 86 (34.9%) were seizure-free. Improvements on PGIC were reported by 49 of 76 (64.5%) patients. Based on CGIC, 52 of 81 (64.2%) patients improved. QoL and symptoms outcome measures remained stable. 648 | RUDÀ et al.

Background: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Objectives: To assess patients' ability to self-inject bimekizumab subcutaneously using a 1 mL safety syringe or auto-injector. Methods: DV0002 and DV0006 were sub-studies of BE BRIGHT, a multicenter, phase 3 open-label extension study. Patients with moderate to severe plaque psoriasis received bimekizumab 320 mg (2x160 mg injections) every 4 or 8 weeks and were randomized 1:1 to the safety syringe or the auto-injector. The ability of patients to safely and effectively self-inject bimekizumab was assessed at 8 weeks (primary endpoint) and immediately after self-injection training at Baseline (secondary endpoint). Patient experience was evaluated using the pain visual analog scale (VAS; 0-100 mm; 100 being worst pain), and the Self-Injection Assessment Questionnaire (SIAQ; 0-10; 10 being most positive experience). Results: All evaluable patients in DV0002 (n=125) and DV0006 (n=86) safely and effectively self-injected bimekizumab at Week 8. All evaluable patients in DV0002 who used the safety syringe (n=64) and 97.1% (n=66/68) who used the auto-injector, as well as all evaluable DV0006 patients (n=88) also self-injected bimekizumab safely and effectively at Baseline. Median VAS scores were low (range: 7.0-20.0), and median pre-injection and post-injection SIAQ scores were high (range: 5.

Given the increasing interest in treatment satisfaction research and the lack of a specific questionnaire in osteoarthritis (OA), we developed and explored the psychometric properties of the osteoARthritis Treatment Satisfaction (ARTS) questionnaire. The ARTS questionnaire which consists of 18 items was developed in French following the analysis of semi-structured interviews performed among 20 OA participants, five rheumatologists and five general practitioners. Psychometric properties were assessed in France on a cross-sectional sample of 797 OA participants and test-retest reliability was evaluated in an independent sample of 111 clinically stable OA participants who filled-in the questionnaire within a 7.7 (+/- 3.1) day interval. Using principal component analysis, four scales were identified: Treatment advantages (seven items), Treatment convenience (three items), Treatment confidence (two items) and Satisfaction with physician (six items). Item convergent and item discriminant validity were satisfactory. Internal consistency provided evidence of reliability and lack of redundancy (Cronbach's alphas ranged from 0.66 to 0.86). Test-retest reliability was acceptable for two out of four scales (intraclass correlations coefficients (ICC) ranged from 0.61 to 0.75). Significant between groups differences were found on the ARTS scales, demonstrating the known groups validity of the ARTS questionnaire. The responsiveness of the ARTS is still to be documented.