Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study.

Objective: Evaluate tolerability and effectiveness of golimumab-IV versus infliximab in patients with rheumatoid arthritis (RA) in a real-world setting.

Methods: AWARE, a prospective, real-world, pragmatic, observational, multicenter, phase 4 study, enrolled RA patients when initiating golimumab-IV or infliximab. Treatment decisions were made by the treating rheumatologist.

Evaluation of Improvement in Skin and Nail Psoriasis in Bio-naïve Patients With Active Psoriatic Arthritis Treated With Golimumab: Results Through Week 52 of the GO-VIBRANT Study.

Objective: To evaluate whether intravenous (IV) golimumab produces improvements in skin and nail symptoms that are concomitant with improvements in quality of life (QoL) and joint symptoms in patients with psoriatic arthritis.

Methods: Patients were randomized to either IV golimumab 2 mg/kg at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo at weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52. Assessments included Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria.

Outcomes of infliximab dose escalation in patients with rheumatoid arthritis.

Introduction: Dose escalation of infliximab in both primary and secondary nonresponders is widely reported; however, the usefulness of dose escalation has been disputed. The objective of this analysis is to evaluate trends in clinical efficacy following multiple infliximab dose escalations in patients with rheumatoid arthritis (RA).

Methods: Patients enrolled in a US RA registry were included if they initiated infliximab at 3 mg/kg every 8 weeks, received ≥ 1 infliximab dose escalation within 12 months of initiation, and had ≥ 1 visit following dose escalation.

Ethnographic Observational Study of the Biologic Initiation Conversation Between Rheumatologists and Biologic-Naive Rheumatoid Arthritis Patients.

Objective: This ethnographic market research study investigated the biologic initiation conversation between rheumatologists and biologic-naive patients with rheumatoid arthritis to assess how therapy options, particularly mode of administration, were discussed.

Methods: Consenting rheumatologists (n = 16) and patients (n = 48) were videotaped during medical visits and interviewed by a trained ethnographer. The content, structure, and timing of conversations regarding biologic initiation were analyzed.

Patient-reported outcome assessment of inflammatory arthritis patient experience with intravenously administered biologic therapy.

Objective: To evaluate patient perspectives regarding utilization of intravenous (IV) therapy for inflammatory arthritis (IA).

Methods: This was a single-center, noninterventional, patient questionnaire-based study of adult IA patients currently receiving IV biologics. At a single visit, patients completed the questionnaire comprising 30 questions centered on their experience receiving an intravenously administered therapy to treat their IA.

One-year outcome of biolimus eluting stent with biodegradable polymer in all comers: the Italian Nobori Stent Prospective Registry.

Objectives: INSPIRE-1 (Italian Nobori Stent ProspectIve REgistry-1) was designed and conducted to assess clinical performance of Nobori biolimus A9-eluting stent (BES) implantation in an unrestricted "real-world" cohort of patients.

Methods: Unrestricted consecutive high-risk patients treated with BES with biodegradable polymer (Nobori, Terumo, Tokyo, Japan) between February 2008 and July 2012 were prospectively enrolled in an independent multicenter registry and divided in two groups: complex and non complex lesions.

Results: 1066 patients (1589 lesions) treated with Nobori BES were analyzed.

Extracorporeal photopheresis (ECP) in patients with steroid-dependent Crohn's disease: an open-label, multicenter, prospective trial.

Background: Extracorporeal photopheresis (ECP) involves ex vivo leukocyte treatment with methoxsalen and UVA light to generate a tolerogenic response. A previous trial demonstrated that ECP permits corticosteroid withdrawal in steroid-dependent Crohn's disease (CD) patients who were in clinical remission. We studied the effect of ECP on steroid withdrawal in steroid-dependent CD.

Progressive improvement in cutaneous and extracutaneous chronic graft-versus-host disease after a 24-week course of extracorporeal photopheresis--results of a crossover randomized study.

In a prior multicenter randomized controlled trial, we found that a 12-week course of extracorporeal photopheresis (ECP) plus standard immunosuppressive therapy resulted in several beneficial outcomes in patients with corticosteroid-refractory/intolerant/dependent chronic graft-versus-host disease (GVHD). Here, we report the results of an open-label crossover ECP study in 29 eligible participants randomized initially to the standard of care non-ECP (control) arm. Eligible for the crossover ECP study were control arm patients who either (1) had progression of cutaneous chronic GVHD (cGVHD), defined as >25% worsening from baseline as measured by the percent change in the total skin score (TSS) at any time, or (2) had less than 15% improvement in the TSS, or had a ≤25% reduction in corticosteroid dose at week 12 of the initial study.

Extracorporeal photopheresis for the treatment of refractory Crohn's disease: results of an open-label pilot study.

Background: Extracorporeal photopheresis (ECP) is effective in immune-mediated disorders. A prospective, uncontrolled pilot study was conducted to evaluate the safety and efficacy of ECP in patients with active Crohn's disease (CD) who were refractory to or intolerant of immunosuppressants and/or anti-TNF therapies.

Methods: Patients with moderate-to-severely active CD (Crohn's Disease Activity Index [CDAI] 220-450 points) underwent 12 weeks of ECP treatment (Weeks 1-4: twice weekly, every week; Weeks 5-12: twice weekly, every other week).

A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease.

Chronic graft-versus-host disease (cGVHD) is a major limitation of successful hematopoietic cell transplantation. The safety and efficacy of extracorporeal photopheresis (ECP) for 12 to 24 weeks together with standard therapy was compared with standard therapy alone in patients with cutaneous manifestations of cGVHD that could not be adequately controlled by corticosteroid treatment. The primary efficacy end point was a blinded quantitative comparison of percent change from baseline in Total Skin Score (TSS) of 10 body regions at week 12.

Retrospective analysis of transient elevations in alanine aminotransferase during long-term treatment with acetaminophen in osteoarthritis clinical trials.

Background: In two recent osteoarthritis trials, alanine aminotransferase (ALT) elevations were observed more frequently in patients receiving acetaminophen 3.9 g daily than in patients receiving placebo, and the rates were higher than aminotransferase values observed in some previous osteoarthritis studies with acetaminophen.

Objective: To retrospectively analyze ALT data from McNeil osteoarthritis clinical studies involving acetaminophen in order to assess the frequency and magnitude of ALT elevations and rate of ALT resolution while patients remained on acetaminophen treatment.

"Do least harm" philosophy may suffice for percutaneous coronary intervention in octogenarians.

Background: Octogenarians represent one of the most rapidly expanding segments of the population and an ever growing number are undergoing percutaneous coronary intervention (PCI). A simplified approach with incomplete or "culprit-lesion" only PCI may be an option even in multivessel disease, to minimize periprocedural complications while still allowing a meaningful clinical recovery in patients with inherent functional limitations related to age itself. We tried to determine the effects of either complete or partial PCI on procedural and long-term outcome in a consecutive series of octogenarians.

Evidence for a "gender paradox" in diabetic patients undergoing percutaneous coronary intervention: adverse preprocedural risk but favorable long-term clinical outcome in women.

Background: The aim of this study was to assess the impact of gender on procedural and late clinical outcome in a large cohort of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in a single center.

Methods: The study included a cohort of 542 consecutive diabetic patients (414 men, 128 women), undergoing PCI for stable and unstable angina. Clinical events were assessed every 6 months for a mean follow-up period of 24 months.

Different quantitative apoptotic traits in coronary atherosclerotic plaques from patients with stable angina pectoris and acute coronary syndromes.

Background: Apoptosis in human atherosclerotic coronary plaques possibly causes plaque destabilization by contributing to the weakening and breaking down of the fibrous cap. We tested the hypothesis that apoptosis is quantitatively increased in unstable atherosclerotic plaques.

Methods And Results: We analyzed the expression of apoptotic genes such as BAX, CASP1, FAS, FAS L, FOS, MDM2, NFkB2, P53, PCNA, TERT, and XRCC1 in coronary plaques collected with directional coronary atherectomy from 15 patients with stable angina and 15 with acute coronary syndromes without ST elevation (ACS).

Immediate and late results of coronary angioplasty in patients with severe left ventricular dysfunction.

Background: Severe coronary artery disease in patients with a markedly depressed left ventricular function is associated with a poor prognosis. Even though coronary angioplasty (PTCA) has been offered as an alternative to bypass surgery, the role of PTCA in the treatment of patients with severe left ventricular dysfunction has not been well defined. The aim of the present study was to evaluate the immediate and long-term results in patients with severe left ventricular dysfunction < or = 35% who underwent PTCA.

A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee.

Objective: To assess prospectively the efficacy and tolerability of hylan G-F 20 (HG-F 20; Synvisc) and intraarticular triamcinolone hexacetonide (TH; Aristospan) for treatment of osteoarthritis (OA) knee pain in a 26 week, randomized, multicenter, evaluator-blind study.

Methods: Patients with OA were treated with typical regimens of HG-F 20 (n = 113) and TH (n = 102). Primary assessments were the WOMAC question A1 (pain walking on a flat surface), and a 100 mm visual analog scale (VAS) for patient and investigator overall assessments.

Intracoronary beta-radiation for the treatment of patients at very high risk for recurrence of in-stent restenosis: a single center experience.

Background: Intracoronary brachytherapy has significantly reduced the recurrence of in-stent restenosis. The aim of this study was to evaluate the feasibility, safety and efficacy of intracoronary beta-radiation in patients at very high risk for recurrence of in-stent restenosis.

Methods: We analyzed 42 patients with 50 lesions submitted to catheter-based beta-radiation (Beta-Cath System, Novoste Corporation, Norcross, GA, USA) for in-stent restenosis.

Clinical characteristics and treatment outcome of early Lyme disease in patients with microbiologically confirmed erythema migrans.

Background: Lyme disease has a wide spectrum of clinical manifestations. Diagnosis is usually based on the clinical and serologic picture rather than on microbiological confirmation.

Objective: To examine the clinical presentation and treatment outcome of early Lyme disease in patients with microbiologically confirmed erythema migrans.

Magnitude and quality of antibody response to a combination hepatitis A and hepatitis B vaccine.

Interference between antibodies generated by a combination hepatitis A and B vaccine was investigated by evaluating the quantity and quality of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies generated by Twinrix (Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine). The magnitude of the immune response was determined by a retrospective analysis of eight clinical trials, completed during stepwise development of Twinrix. The functionality of anti-HAV was evaluated by comparison of routine ELISA results with neutralization assays and was further characterized by defining the epitope-specificity of binding.