How to Read a Study Record. Purpose. Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice. Patients will be enrolled in this PMOS if they fulfill all of the below criteria:. Patients were evaluated monthly for safety and effectiveness.
To evaluate the long-term safety and effectiveness of ADA in clinical practice settings over 5 years in patients who completed ReAct, the REgistry of HUMIRA in RA: a Long-Term Investigation of Safety and Efficacy (ReAlise) observational follow-up study was conducted (NCT00234884). The combined data from ReAct and ReAlise include more than 6,600 RA patients and provide one of the largest well-monitored evaluations of the long-term safety and effectiveness of a single TNF antagonist in routine clinical practice settings. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s disease. In clinical practice patients who have not responded to one TNF antagonist may respond to another TNF antagonist. Recently established registries will yield additional data on the effectiveness and long-term safety of adalimumab. How can adalimumab (Humira) be used to treat rheumatoid arthritis? Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis. ESPRIT is an ongoing, 10-year, observational registry, evaluating long-term safety and effectiveness of adalimumab treatment in routine clinical practice for patients with moderate to severe, chronic plaque psoriasis. In all-treated, rate (events per 100 patient-years of total adalimumab exposure E/100PY ) of serious treatment-emergent adverse events (inside or outside of the registry) was 4.
Purpose: Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice. This page is no longer being updated. Please use our search for current trials or visit ClinicalTrials. Research regarding the safety, efficacy, and patient-reported outcomes support a favorable risk-benefit profile for adalimumab. Humira (adalimumab): adequacy of patient exposure and safety assessments.
Safety And Effectiveness Of Adalimumab In Patients With Rheumatoid Arthritis Over 5 Years Of Therapy In A Phase 3b And Subsequent Postmarketing Observational Study
Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice CompletedRheumatoid ArthritisAbbVie (prior sponsor, Abbott); IndustryMale, Female18 Years – N/AN/AObservational: Observational Model: Case-Only, Time Perspective: ProspectiveObservation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period. Documentation of Humira in Psoriasis Patients in Routine Clinical Practice Active, not recruitingModerate to Severe Plaque PsoriasisAbbVie (prior sponsor, Abbott); IndustryMale, Female18 Years – 99 YearsN/AObservational: Observational Model: Case-Only, Time Perspective: ProspectiveSafety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice. To evaluate the effectiveness and safety of adalimumab in patients with active psoriatic arthritis (PsA) and an inadequate response to prior therapy. Data from the Canadian population are still lacking regarding the effectiveness of adalimumab used to treat PsA in a routine clinical practice setting. Patients with active skin disease other than psoriasis that would interfere with the assessment of a target lesion were excluded from the study. Study of Adalimumab (HUMIRA) in Patients With Moderate to Severe Psoriasis in Spain (PROMISE) clinicaltrials:NCT01076192 Goto Sponge NotDistinct Permalink. Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities. The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain. This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis. However, in clinical practice, complicating the treatment regimen with more than one topical product may reduce the likelihood of consistent adherence to the treatment regimen. In addition, head-to-head trials included in the systematic review supported the superiority of infliximab and adalimumab over methotrexate therapy and the superiority of ustekinumab over etanercept therapy. Immune function, requiring routine laboratory monitoring because of the increased hepatic and renal toxicity, hematologic conditions and myelosuppresion. Adalimumab for PsA has also been effective as shown in a post hoc analysis from ADEPT (Adalimumab Effectiveness in Psoriatic Arthritis Trial) of 152 placebo-treated and 144 adalimumab-treated patients who had evaluable radiographs at baseline and 24 weeks. In a new study, Mease et al28 assessed this efficacy and safety data at 96 weeks with 400 mg certolizumab pegol and 200 mg certolizumab pegol dosing regimens in PsA patients with and without prior anti-TNF exposure. Placebo patients switching to certolizumab pegol displayed rapid clinical improvements that were maintained to week 96.
Documentation Of Humira In Psoriasis Patients In Routine Clinical Practice
Summary and information for: Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities. Moderate to severe Plaque Psoriasis patients with at last one co-morbid disease and/or symptom such as hypertension, Psoriasis Arthritis confirmed by a rheumatologist, obesity, diabetes, metabolic syndrome or depression. Safety Issue? Aetna considers adalimumab (Humira) medically necessary for the following indications where the member has a documented negative TB test (which can include a tuberculosis skin test (PPD), an interferon-release assay (IGRA), or a chest x-ray) within 6 months of initiating therapy for persons who are naiive to biologics, and repeated yearly for members with risk factors for TB that are continuing therapy with biologics:. Treatment of adults with moderate to severe chronic plaque psoriasis according to the criteria set forth in CPB 0658 – Psoriasis and Psoriatic Arthritis: Biological Therapies; or. Sieper et al (2013) evaluated the safety and effectiveness of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA). (2013) compared the efficacy of the 3 anti-TNFs for CD in clinical practice. Use the information in the Patient Instructions for Use in your HUMIRA box. Be sure to practice injecting HUMIRA with your doctor or nurse so that you are not startled by this click when you start giving yourself the injection at home. Background: Psoriatic arthritis often affects patients with psoriasis. Impact of Adalimumab on Symptoms of Psoriatic Arthritis in Patients with Moderate to Severe Psoriasis: A Pooled Analysis of Randomized Clinical Trials.
The emergence of biologic agents has provided effective therapeutic options for patients with inadequate response to conventional DMARDs. Patients with RA are at increased risk for several disorders, including cancer, infection and cardiovascular disease (CVD). (i.e. infliximab, etanercept, adalimumab, certolizumab and golimumab), anakinra, tocilizumab, abatacept and rituximab. The safety profile of tocilizumab in an open-label clinical practice study was similar to that noted in randomized controlled trials 69.