A randomized phase 2 trial of pembrolizumab versus pembrolizumab and acalabrutinib in patients with platinum-resistant metastatic urothelial cancer.

Background: Inhibition of the programmed cell death protein 1 (PD-1) pathway has demonstrated clinical benefit in metastatic urothelial cancer (mUC); however, response rates of 15% to 26% highlight the need for more effective therapies. Bruton tyrosine kinase (BTK) inhibition may suppress myeloid-derived suppressor cells (MDSCs) and improve T-cell activation.

Methods: The Randomized Phase 2 Trial of Acalabrutinib and Pembrolizumab Immunotherapy Dual Checkpoint Inhibition in Platinum-Resistant Metastatic Urothelial Carcinoma (RAPID CHECK; also known as ACE-ST-005) was a randomized phase 2 trial evaluating the PD-1 inhibitor pembrolizumab with or without the BTK inhibitor acalabrutinib for patients with platinum-refractory mUC.

A novel electromechanical autoinjector, AutoTouch™, for self-injection of etanercept: real-world use and benefits.

Objectives: We assessed the ability of patients with autoimmune inflammatory diseases to successfully use the investigational AutoTouch™ reusable autoinjector as well as patient preference for AutoTouch™ versus the currently marketed single-use prefilled etanercept SureClick® autoinjector.

Methods: Two multicenter studies were performed: a Home Use Study and a Patient Preference Study. In the Home Use Study, 77 patients with rheumatoid arthritis (RA) or psoriatic arthritis self-administered etanercept once weekly for 5 weeks.

The effect of etanercept on traditional metabolic risk factors for cardiovascular disease in patients with rheumatoid arthritis.

Patients with rheumatoid arthritis (RA) are at an increased risk of cardiovascular disease (CVD). Treatment with tumor necrosis factor inhibitors improves both joint symptoms associated with RA and also CVD risk. This exploratory analysis of a phase 4 study evaluated changes in metabolic risk factors in patients with RA treated with etanercept.

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etanercept in patients with moderately active rheumatoid arthritis despite DMARD therapy.

This study evaluated the efficacy and safety of adding etanercept to disease-modifying antirheumatic drugs (DMARDs) in patients with moderately active rheumatoid arthritis (RA). This randomized, double-blind, placebo-controlled study (ClinicalTrials.gov #NCT01313208) enrolled RA patients with Disease Activity Score using 28 joints with C-reactive protein (DAS28-CRP) >3.

Discontinuation of disease-modifying anti-rheumatic drugs and clinical outcomes in the Rheumatoid Arthritis DMARD Intervention and Utilisation Study 2 (RADIUS 2).

Objectives: The purpose of this analysis was to examine discontinuation and reasons for discontinuation from disease-modifying anti-rheumatic (DMARD) therapies in the RADIUS 2 registry, a long-term, open-label, observational study of patients with moderate to severe rheumatoid arthritis (RA).

Methods: Patients who participated in RADIUS 2 initiated etanercept (ETN) therapy at study entry and were followed for 5 years. In this post hoc analysis, patients who had received ETN continuously from entry to month 4 were categorised by treatment at month 4: ETN monotherapy, ETN+methotrexate (MTX), ETN+MTX+other DMARDs (OTH), or ETN+OTH.

Malignancies in children and young adults on etanercept: summary of cases from clinical trials and post marketing reports.

Background: Malignancy risk may be increased in chronic inflammatory conditions that are mediated by tumor necrosis factor (TNF), such as juvenile idiopathic arthritis (JIA), but the role of TNF in human cancer biology is unclear. In response to a 2011 United States Food & Drug Administration requirement of TNF blocker manufacturers, we evaluated reporting rates of all malignancies in patients =30 years old who received the TNF blocker etanercept.

Methods: All malignancies in etanercept-exposed patients aged =30 years from the Amgen clinical trial database (CTD) and postmarketing global safety database (PMD) were reviewed.

Impact of etanercept on work and activity impairment in employed moderate to severe rheumatoid arthritis patients in the United States.

Objective: To quantify the impact of etanercept on work and activity impairment in employed US patients with moderate to severe rheumatoid arthritis (RA).

Methods: This prospective, observational, longitudinal study recruited RA patients initiating etanercept (50 mg/week) between January 2009 and March 2010. The Work Productivity and Activity Impairment Questionnaire (WPAI) and domestic productivity questionnaire were administered by telephone interviews at baseline and at 1, 2, 3, and 6 months after etanercept initiation.

Predicting low disease activity and remission using early treatment response to antitumour necrosis factor therapy in patients with rheumatoid arthritis: exploratory analyses from the TEMPO trial.

Objective: To derive and validate decision trees to categorise rheumatoid arthritis (RA) patients 12 weeks after starting etanercept with or without methotrexate into three groups: patients predicted to achieve low disease activity (LDA) at 1 year; patients predicted not to achieve LDA at 1 year and patients who needed additional time on therapy to be categorised.

Methods: Data from RA patients enrolled in the TEMPO trial were analysed. Classification and regression trees were used to develop and validate decision tree models with week 12 and earlier assessments that predicted long-term LDA.

Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-rated importance and satisfaction.

Objective: To evaluate changes in function as measured by Health Assessment Questionnaire Disability Index (HAQ-DI) and the meaningfulness of the changes, in importance and satisfaction, in patients with psoriatic arthritis (PsA).

Methods: HAQ-DI was assessed at baseline and at Weeks 4, 12, and 24 in a randomized double-blind study of 205 patients with active PsA receiving etanercept 25 mg twice weekly or placebo. Concurrently, patients rated the importance of and satisfaction with their change in function on a 7-point scale (1 = not at all important/satisfied; 7 = extremely important/satisfied).