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Latest & greatest articles for adalimumab
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Adalimumab (Idacio) - Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease EMA/85985/2019 EMEA/H/C/004475 Idacio (adalimumab) An overview of Idacio and why it is authorised in the EU What is Idacio and what is it used for? Idacio is a medicine that acts on the immune system (the body’s natural defences) and is used to treat the following conditions: • plaque (...) their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments. For more information on the use of Idacio in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist. Idacio contains the active substance adalimumab and is a ‘biosimilar medicine’. This means that Idacio is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine
Adalimumab (Hulio) Hulio | European Medicines Agency Search Search Menu Hulio adalimumab Table of contents Authorised This medicine is authorised for use in the European Union. Overview Hulio is a medicine that acts on the immune system and is used to treat the following conditions: plaque psoriasis (a disease causing red, scaly patches on the skin); psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints); rheumatoid arthritis (a disease causing (...) or pharmacist. Hulio contains the adalimumab and is a ‘ ’. This means that Hulio is highly similar to another (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Hulio is Humira. Expand section Collapse section How is Hulio used? Hulio is available as a solution for injection under the skin in a vial or pre-filled syringe or pen and is usually given every 2 weeks. The dose and frequency of injection depends on the condition to be treated and the dose for a child
Adalimumab (Hadlima / hadlima pushtouch) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012
Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease To evaluate the safety of adalimumab in pediatric patients who participated in clinical trials of juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and pediatric enthesitis-related arthritis), psoriasis, and Crohn's disease.This analysis included data from 7 global, randomized, and open-label AbbVie-sponsored clinical (...) trials of adalimumab and their open-label extensions conducted between September 2002 and December 31, 2015 (cutoff date for ongoing studies). Patients who received ≥1 dose of adalimumab subcutaneously were included. Adverse events that occurred after the first dose of adalimumab and up to 70 days (5 half-lives) after the last dose were reported and events per 100 patient-years were calculated.The analysis included 577 pediatric patients, representing 1440.7 patient-years of adalimumab exposure
A rare case of suicidal ideation related to Adalimumab use Patients undergoing treatment with an anti-tumor necrosis factor-alpha (TNF-α) agent can, as an adverse event, develop anti-TNF-α-induced lupus (ATIL). Neuropsychiatric symptoms such as depression and suicidal ideations are not commonly seen in patients who develop ATIL. We describe a case of a 56-year-old female who developed ATIL and suicidal ideations while on Adalimumab.A 56-year-old female with rheumatoid arthritis (RA (...) ) and no known prior history of systemic lupus erythematosus or depression presented with suicidal ideations, joint pains and a malar rash after a recent change in her Adalimumab dose. She was treated for an acute ATIL episode based on her symptoms and serologies which were positive for anti-double-stranded deoxyribonucleic acid antibody. An inpatient psychiatric consultation determined that the patient's suicidal ideations may be an associated symptom of her current ATIL episode or possibly secondary to her
Adalimumab (Hyrimoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Papulosquamous Skin Diseases, Hidradenitis Suppurativa, Ankylosing Spondylitis, Uveitis 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how (...) to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Hyrimoz 40 mg solution for injection in pre-filled syringe Hyrimoz 40 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hyrimoz 40 mg solution for injection in pre-filled syringe: Each 0.8 ml single-dose pre-filled syringe contains 40 mg of adalimumab. Hyrimoz 40 mg solution for injection in pre-filled pen: Each 0.8 ml single-dose pre-filled pen contains 40 mg of adalimumab. Adalimumab is a recombinant
Adalimumab Top results for adalimumab - Trip Database or use your Google+ account Turning Research Into Practice ALL of these words: Title only Anywhere in the document ANY of these words: Title only Anywhere in the document This EXACT phrase: Title only Anywhere in the document EXCLUDING words: Title only Anywhere in the document Timeframe: to: Combine searches by placing the search numbers in the top search box and pressing the search button. An example search might look like (#1 or #2 (...) ) and (#3 or #4) Loading history... Population: Intervention: Comparison: Outcome: Population: Intervention: Latest & greatest articles for adalimumab The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms
Efficacy and safety of continuing versus withdrawing adalimumab therapy in maintaining remission in patients with non-radiographic axial spondyloarthritis (ABILITY-3): a multicentre, randomised, double-blind study. Success of treatment withdrawal in patients with non-radiographic axial spondyloarthritis who are in remission remains unknown. The ABILITY-3 study explored the ability to withdraw adalimumab treatment in patients with non-radiographic axial spondyloarthritis who achieved sustained (...) -inflammatory drugs. Patients who achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (<1·3) with open-label adalimumab (40 mg subcutaneously every other week for 28 weeks) at weeks 16, 20, 24, and 28 were randomly assigned (1:1) using an interactive voice or web response system to 40-week, double-blind treatment with adalimumab (continuation) or placebo (withdrawal). The primary efficacy endpoint was the proportion of patients who did not experience a flare (defined as ASDAS ≥2
Whole-body Magnetic Resonance Imaging in Axial Spondyloarthritis: Reduction of Sacroiliac, Spinal, and Entheseal Inflammation in a Placebo-controlled Trial of Adalimumab To investigate whether adalimumab (ADA) reduces whole-body (WB-) magnetic resonance imaging (MRI) indices for inflammation in the entheses, peripheral joints, sacroiliac joints, spine, and the entire body in patients with axial spondyloarthritis (axSpA).An investigator-initiated, randomized, placebo-controlled, double-blinded
Impact of the Adalimumab Patient Support Program on Clinical Outcomes in Ankylosing Spondylitis: Results from the COMPANION Study Adalimumab (ADA) is a tumor necrosis factor (TNF)-alpha inhibitor indicated for the treatment of inflammatory autoimmune diseases, including ankylosing spondylitis (AS). Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care™ patient support program (AC-PSP), which provides personalized services, including care coach calls (CCCs). We estimated
Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naive patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study This randomised, double-blind, parallel-group, phase 3 study compared monotherapy with sirukumab, an anti-interleukin-6 cytokine monoclonal antibody, with adalimumab monotherapy in patients with rheumatoid arthritis (RA).Biologic-naïve patients with active (...) RA who were inadequate responders or were intolerant to, or inappropriate for, methotrexate were randomised to subcutaneous sirukumab 100 mg every 2 weeks (n=187), sirukumab 50 mg every 4 weeks (n=186) or adalimumab 40 mg every 2 weeks (n=186). Primary endpoints at week 24 were change from baseline in Disease Activity Score in 28 joints (DAS28) using erythrocyte sedimentation rate (ESR) and proportion of patients achieving an American College of Rheumatology (ACR) 50 response; these endpoints
Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study To demonstrate clinical equivalence of adalimumab biosimilar candidate BI 695501 with Humira.Patients with active rheumatoid arthritis on stable methotrexate were randomised to BI 695501 or Humira in a double-blind, parallel-group, equivalence study
Secukinumab Versus Adalimumab for Psoriatic Arthritis: Comparative Effectiveness up to 48 Weeks Using a Matching-Adjusted Indirect Comparison Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). In the absence of direct randomized controlled trial (RCT) data, matching-adjusted indirect comparison can estimate the comparative effectiveness in anti-tumor necrosis factor (TNF)-naïve populations.Individual patient data from the FUTURE 2 RCT (secukinumab vs (...) . placebo; N = 299) were adjusted to match baseline characteristics of the ADEPT RCT (adalimumab vs. placebo; N = 313). Logistic regression determined adjustment weights for age, body weight, sex, race, methotrexate use, psoriasis affecting ≥ 3% of body surface area, Psoriasis Area and Severity Index score, Health Assessment Questionnaire Disability Index score, presence of dactylitis and enthesitis, and previous anti-TNF therapy. Recalculated secukinumab outcomes were compared with adalimumab outcomes
Similar Improvements in Patient-Reported Outcomes Among Rheumatoid Arthritis Patients Treated with Two Different Doses of Methotrexate in Combination with Adalimumab: Results From the MUSICA Trial In patients with rheumatoid arthritis (RA), combination treatment with methotrexate (MTX) and adalimumab is more effective than MTX monotherapy. From the patients' perspective, the impact of reduced MTX doses upon initiating adalimumab is not known. The objective was to evaluate the effects of low (...) and high MTX doses in combination with adalimumab initiation on patient-reported outcomes (PROs), in MTX-inadequate responders (MTX-IR) with moderate-to-severe RA.MUSICA was a randomized, double-blind, controlled trial evaluating the efficacy of 7.5 or 20 mg/week MTX, in combination with adalimumab for 24 weeks in MTX-IR RA patients receiving prior MTX ≥ 15 mg/week for ≥ 12 weeks. PROs were recorded at each visit, including physical function, health-related quality-of-life, work productivity, quality
Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Duarte A, Mebrahtu T, Goncalves P S, Harden M, Murphy R, Palmer S, Woolacott (...) N, Rodgers M & Rothery C. Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Duarte A, Mebrahtu T, Goncalves P S, Harden M, Murphy R, Palmer S, Woolacott N, Rodgers M & Rothery C.. Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation. Health Technology
A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis (...) in adults Squires H, Poku E, Bermejo I, Cooper K, Stevens J, Hamilton J, Wong R, Denniston A, Pearce I & Quhill F. Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Squires H, Poku E, Bermejo I, Cooper K, Stevens J, Hamilton J, Wong R, Denniston A, Pearce I & Quhill F.. A systematic review and economic evaluation of adalimumab and dexamethasone
Similar Pharmacokinetics of the Adalimumab (Humira BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira®. We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS).Both trials were randomized, open-label, parallel-group studies undertaken in subjects aged ≥ 18-65 years. VOLTAIRE®-AI (NCT02606903) recruited healthy, Caucasian, male, non
Epithelioid myxofibrosarcoma developing at the injection site of Adalimumab therapy for psoriatic synovitis The interplay between inflammation and cancer is the subject of intense interest. The recent approval of a number of checkpoint inhibitors has opened novel therapeutic pathways for several cancers. Conversely, biologic suppressors of inflammation, such as Tumor Necrosis Factor (TNF) inhibitors, have been utilized over the past two decades for the management of chronic inflammatory (...) autoimmune diseases. While the overall rates of malignancy in patients using anti TNF therapies are not elevated, increased risk has been established for cutaneous malignancy, particularly carcinoma. In subsets of patients, such as those with rheumatoid arthritis, a modestly increased incidence of melanoma is also documented. Herewith, we present the first reported instance of a sarcoma of the dermis and superficial subcutaneous tissue at the injection site of Adalimumab in a woman being treated