The objective of this study was to contribute long-term safety data for infliximab and other therapies in Crohn's disease (CD).We prospectively evaluated CD patients enrolled the large, observational Therapy, Resource, Evaluation, Assessment Tool registry, established compare with conventional nonbiological medications CD.A total 6,273 were on or before 23 February 2010; 3,420 received (17,712 patient-years; 89.9% ≥ 2 infusions) 2,853 other-treatments-only (13,251 patient-years). Mean length...

IMPORTANCEThe efficacy of treatment for psoriasis must be balanced against potential adverse events.OBJECTIVE To determine the effect on risk serious infections in patients with psoriasis.A multicenter, longitudinal, disease-based registry (Psoriasis Longitudinal Assessment and Registry [PSOLAR]) at dermatology centers.Participants were adult who receiving or eligible to receive conventional systemic biologic agents.The opened June 20, 2007, data included herein collected through August 23,...

Drug survival is a marker for treatment sustainability in chronic diseases such as psoriasis.The aim of these analyses was to assess biologic treatments the PSOriasis Longitudinal Assessment and Registry (PSOLAR).PSOLAR large, prospective, international, disease-based registry patients with psoriasis receiving (or eligible for) systemic therapy real-world setting. defined time from initiation discontinuation (stop/switch) on registry. The number who discontinued each duration were recorded....

We assessed potential associations between malignancy and antitumor necrosis factor therapy in patients with Crohn's disease (CD), as this relationship is currently poorly defined.Utilizing data from the Therapy, Resource, Evaluation, Assessment Tool (TREAT™) Registry, a prospective cohort study examining long-term outcomes of CD treatments community academic settings, influences baseline patient/disease characteristics medications were by survival analysis multivariate models. Standardized...

BackgroundThe effect of systemic therapy on malignancy risk among patients with psoriasis is not fully understood.ObjectiveEvaluate the impact treatment in Psoriasis Longitudinal Assessment and Registry (PSOLAR).MethodsNested case-control analyses were performed no history malignancy. Cases defined as first (other than nonmelanoma skin cancer) Registry, controls matched by age, sex, geographic region, time registry. Study therapies included methotrexate, ustekinumab, tumor necrosis factor-α...

Psoriasis is associated with several comorbidities and behavioural risk factors.

Abstract Background The purpose of this study was to compare the long-term safety infliximab and nonbiologic agents as Crohn’s disease (CD) therapy. Methods Patients with CD were prospectively evaluated in large, observational registry. Results (n = 6273) participated registry from July 1999 through March 2012; 3440 (54.8%) received (20,971 patient-years), 2833 (45.2%) other treatments only (14,806 patient-years). Overall, 59,875 infusions administered (80%, 5 mg/kg); 3006 (89.9%) patients...

Patients with psoriasis are at an increased risk for depression. However, the impact of treatment on this is unclear.Evaluate incidence and depression among patients moderate-to-severe psoriasis.We defined a study population within Psoriasis Longitudinal Assessment Registry measured depressive symptoms (Hospital Anxiety Depression Scale-Depression score ≥8) adverse events (AEs) cohorts receiving biologics, conventional systemic therapies, or phototherapy. were evaluated approximately 6-month...

Prospective data are limited on pregnancy outcomes among women with psoriasis who may be receiving biologic or conventional systemic therapy.To report observed in the Psoriasis Longitudinal Assessment and Registry (PSOLAR).This cohort study used from PSOLAR, a multicenter, disease-based, observational registry evaluating long-term safety clinical for patients eligible to receive treatment biologics and/or therapies. Of 12 090 enrollees, 5456 were (45.1%), 2224 of childbearing age (18-45...

Prospective, open-label, randomized, parallel-group study at 80 centers.To demonstrate there is no clinically important additional risk for deep vein thrombosis with perioperative use of epoetin alfa versus standard care in spine surgery without prophylactic anticoagulation.Trials orthopedic that demonstrated thrombovascular events included pharmacologic anticoagulation.Subjects received 600 U/kg subcutaneously once weekly starting 3 weeks before spinal plus blood conservation, or alone....

A randomized, double-blind, placebo-controlled, multicenter trial (EPO-2, N = 1,302) in anemic critically ill patients demonstrated a 29-day survival benefit the trauma subgroup receiving epoetin alfa (mortality 8.9% vs. 4.1%). second similarly designed (EPO-3, 1,460) confirmed this alfa-treated cohort 6.7% 3.5%). This analysis presents data from both trials for evaluation of impact baseline factors including trauma-specific variables on outcomes.Patients received 40,000 U or placebo weekly,...

We described pregnancy outcomes in Crohn's disease (CD) patients enrolled the TREAT Registry who received infliximab before, or during and those not treated with any biologic agent.In (1999-2012), were analyzed from maternal paternal exposed to ≤365 days (gestational exposure), >365 (pre-gestational exposure) of outcome without exposure (non-biologic exposed). "Healthy infants" defined as no congenital abnormalities, neonatal complications (e.g., jaundice, prematurity, heart murmur, cortical...

Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many PsA TNFi inadequate responders (TNF-IR; either efficacy or intolerance), treatments utilizing alternative mechanisms of action needed. In phase 3 studies, fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in active PsA, including TNFi-IR. Efficacy generally consistent between TNFi-naïve and TNFi-experienced cohorts;...

Patients with psoriatic arthritis (PsA) have increased risk of adverse events, including serious infections (SI), compared psoriasis patients.Patients eligible for, or receiving conventional systemic and biologic agents for were followed prospectively using PSOLAR. Cohorts included: ustekinumab, tumor necrosis factor (TNF) inhibitors; infliximab; etanercept; adalimumab; non-biologic/methotrexate (MTX) (reference group); non-biologic/non-MTX. Multivariate analyses Cox hazard regression used...

The effects of systemic therapy on mortality risk among patients with psoriasis are not fully understood.To evaluate the impact treatment in enrolled Psoriasis Longitudinal Assessment and Registry.Nested case-control analyses were performed to estimate risk. Cases defined as who died while participating Registry. matched (1:4) controls by age, race, sex, geographic region. Evaluated treatments included methotrexate, ustekinumab, tumor necrosis factor α inhibitors. Exposure was at least 1...

Abstract Background After successful induction, a subset of patients with Crohn’s disease (CD) experience secondary loss response (LoR) to ustekinumab (UST) maintenance therapy. Dose intensification may assist in regaining response. The phase 3b randomised, double-blind, multicentre POWER study evaluated efficacy and safety single intravenous (IV) re-induction UST dose vs continued subcutaneous (SC) treatment CD LoR standard every 8 weeks (q8w) Methods Adults moderately–severely active who...

Our objective was to compare therapeutic response among patients with early-onset psoriasis (EOP) and late-onset (LOP) receiving adalimumab, etanercept, infliximab, ustekinumab, or methotrexate in the Psoriasis Longitudinal Assessment Registry (PSOLAR). Patients were grouped by age of onset: EOP (age ≤ 40 years) LOP > years). Repeated-measures analysis logistic regression used calculate adjusted odds ratio (AOR; for baseline characteristics) achieving a Physician's Global score...

Background: AWARE is a real-world evidence-based (RWE) study evaluating the safety and efficacy of IV golimumab (GLM) infliximab (IFX) in adults with RA. Objectives: Evaluate GLM IFX elderly participants. Methods: AWARE, prospective non-interventional (88 US sites), enrolled patients (pts) initiating either or IFX. Pt management was at discretion treating rheumatologists. In post hoc analysis, pts were grouped by age (<65/≥65/≥75 yrs). Adverse events (AEs) collected through Week (W) 52...

Purpose: To describe the risk of herpes zoster (HZ) in patients with psoriasis and its relation to non-biologic systemic therapies or biologic treatment. Materials methods: Psoriasis Longitudinal Assessment Registry (PSOLAR) is an international, prospective, registry that follows adult eligible receive therapies. Mutually exclusive therapy cohorts were defined. HZ incident rates calculated for each cohort between compared using hazard ratios (HR) adjusted potential confounders, new users...