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Latest & greatest articles for adalimumab
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Adalimumab (Idacio) - Arthritis 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 will be updated
Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naive to biological disease-modifying antirheumatic drug: final results by week 52 Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52 - PubMed (...) Actions Cite Share Permalink Copy Page navigation Ann Rheum Dis Actions . 2020 Jul 13;annrheumdis-2020-217372. doi: 10.1136/annrheumdis-2020-217372. Online ahead of print. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52 , , , , , , , , , , , , , , Affiliations Expand Affiliations 1 Division of Rheumatology
Adalimumab use in paediatric and adolescent rheumatology 1 Adalimumab use in paediatric and adolescent rheumatology Information for health professionals Name of drug: Adalimumab Brief overview of mechanism: Adalimumab is a fully human monoclonal antibody which binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion (...) molecules responsible for leukocyte migration. Originator/brands/biosimilar: Humira (originator) available in 20mg, 40mg and 80mg dose sizes. Biosimilars include: Amgevita, Hulio, Hyrimoz, Imraldi. Not all products are available in all dose sizes. Different products may have different excipients, volume size and types of pen. To ensure patients receive the same branded product for each dose of adalimumab, prescriptions should clearly state the brand name and the presentation e.g. pen or prefilled
Adalimumab for maintenance of remission in Crohn's disease. Conventional medications for Crohn's disease (CD) include anti-inflammatory drugs, immunosuppressants and corticosteroids. If an individual does not respond, or loses response to first-line treatments, then biologic therapies such as tumour necrosis factor-alpha (TNF-α) antagonists such as adalimumab are considered for treating CD. Maintenance of remission of CD is a clinically important goal, as disease relapse can negatively affect (...) quality of life.To assess the efficacy and safety of adalimumab for maintenance of remission in people with quiescent CD.We searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, and clinicaltrials.gov from inception to April 2019.We considered for inclusion randomized controlled trials (RCTs) comparing adalimumab to placebo or to an active comparator.We analyzed data on an intention-to-treat basis. We calculated risk ratios (RRs) and corresponding 95% confidence intervals (95
Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College (...) of Rheumatology (ACR) 20 response.This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg
Risk of Tuberculosis in Patients With Inflammatory Bowel Disease on Infliximab or Adalimumab Is Dependent on the Local Disease Burden of Tuberculosis: A Systematic Review and Meta-Analysis. Infliximab (IFX) or adalimumab (ADA) use in patients with inflammatory bowel disease (IBD) leads to increased risk of tuberculosis (TB). This meta-analysis evaluated the factors which determine this risk, with special focus on local TB incidence.All studies until January 31, 2019, which reported
Adalimumab for induction of remission in Crohn's disease. Adalimumab is an IgG1 monoclonal antibody that targets and blocks tumor necrosis factor-alpha, a pro-inflammatory cytokine involved in the pathogenesis of Crohn's disease (CD). A significant proportion of people with CD fail conventional therapy or therapy with biologics or develop significant adverse events. Adalimumab may be an effective alternative for these individuals.The objectives of this review were to assess the efficacy (...) and safety of adalimumab for the induction of remission in CD.We searched MEDLINE, Embase, CENTRAL, the Cochrane IBD Group Specialized Register, ClinicalTrials.Gov and the World Health Organization trial registry (ICTRP) from inception to 16 April 2019. References and conference abstracts were searched to identify additional studies.Randomized controlled trials (RCTs) comparing any dose of adalimumab to placebo or an active comparator in participants with active CD were included.Two authors independently
Indirect comparison of vedolizumab and adalimumab for biologic-naive patients with ulcerative colitis. Indirect comparison of efficacy and safety of vedolizumab with adalimumab in biologic-naïve patients with moderate to severe ulcerative colitis (UC).Vedolizumab is a gut-selective medication for moderate to severe UC. Since no comparative trials are available for direct comparison of vedolizumab vs adalimumab in UC, a systematic review of literature databases was conducted to identify (...) randomized, placebo-controlled trials of the two drugs in patients with moderate to severe UC after failure of conventional treatment. Studies were screened for eligibility by two reviewers based on predefined inclusion criteria. Bucher's adjusted indirect comparison was used to compare vedolizumab and adalimumab indirectly through placebo as common comparator.One vedolizumab study (GEMINI 1) and three adalimumab studies (ULTRA 1, ULTRA 2 and M10-447) met the eligibility criteria. Baseline
Meta-Analyses of Clinical Efficacy of Risankizumab and Adalimumab in Chronic Plaque Psoriasis: Supporting Evidence of Risankizumab Superiority. Risankizumab, an anti-interleukin-23 monoclonal antibody, achieved significantly (P < 0.001) greater Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA) clear or almost clear (0/1) responses than adalimumab in a phase III trial in patients with moderate-to-severe psoriasis. Meta-analyses of the PASI 50, PASI 75, PASI (...) 90, PASI 100, and sPGA0/1 responses after 16 weeks of treatment from eight (three for risankizumab and five for adalimumab) randomized, placebo-controlled trials were conducted to estimate the efficacy difference between risankizumab and adalimumab. For PASI 75, PASI 90, PASI 100, and sPGA0/1 responses, the estimated effect differences (95% confidence interval) between risankizumab and adalimumab were 15.2% (10.1%, 20.4%), 23.7% (15.7%, 31.2%), 20.8% (13.0%, 28.7%), and 20.1% (13.7%, 26.1
Adalimumab for treating inflammatory conditions ACE Technology Guidances Adults with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis, ulcerative colitis, Crohn’s disease or hidradenitis suppurativa;Adults with non-infectious intermediate, posterior and panuveitis;Children aged 2 years or older with chronic non-infectious anterior uveitis or polyarticular juvenile idiopathic arthritis;Children aged 4 years or older (...) with severe chronic plaque psoriasis;Children aged 6 years or older with moderately to severely active Crohn’s disease or enthesitis-related arthritis; andChildren aged 12 years or older with moderate to severe hidradenitis suppurativa; The removal of adalimumab reference biologic (Humira) 40 mg/0.8 ml prefilled autoinjector from the Medication Assistance Fund (MAF) for all indications; and> Not to list new formulations of Humira (20 mg/0.2 ml or 40 mg/0.4 ml prefilled syringe and pen) on SDL or MAF
Relationship between Serum Adalimumab Levels and Clinical Outcome in the Treatment of Inflammatory Bowel Disease. Adalimumab (ADA) is an anti-tumor necrosis factor agent that has been shown to be effective in inducing and maintaining remission in adult patients with inflammatory bowel disease. The relationship between the ADA trough levels and clinical efficacy has been demonstrated, but there is variability in the definition of the most suitable range for its clinical applicability.A review
An update on clinical safety of adalimumab in treating psoriasis: A systematic review and meta-analysis based on 20 randomized controlled trials. The current meta-analysis was conducted to better evaluate the role of adalimumab for patients with psoriasis in terms of its safety profile on the basis of eligible randomized controlled trials (RCTs).The following electronic databases such as Cochrane, PubMed, and Embase database involving the index words were screened and identified for qualified (...) studies updated to December 2018. Associated publications and sources were hand-searched for more related details. To further analyze the main outcomes, the odds ratio (OR) and mean difference (MD) with its 95% confidence interval (95% CI) were utilized.There were a total of 20 RCTs involving respective 3795 and 3266 patients in the adalimumab and control group that met our inclusion criteria. According to the aggregated results, the adalimumab group was highly associated with significant improvement
A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naive patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial To compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug
Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. Biologic therapies are widely used in patients with ulcerative colitis. Head-to-head trials of these therapies in patients with inflammatory bowel disease are lacking.In a phase 3b, double-blind, double-dummy, randomized trial conducted at 245 centers in 34 countries, we compared vedolizumab with adalimumab in adults with moderately to severely active ulcerative colitis to determine whether vedolizumab was superior (...) . Previous exposure to a tumor necrosis factor inhibitor other than adalimumab was allowed in up to 25% of patients. The patients were assigned to receive infusions of 300 mg of vedolizumab on day 1 and at weeks 2, 6, 14, 22, 30, 38, and 46 (plus injections of placebo) or subcutaneous injections of 40 mg of adalimumab, with a total dose of 160 mg at week 1, 80 mg at week 2, and 40 mg every 2 weeks thereafter until week 50 (plus infusions of placebo). Dose escalation was not permitted in either group
Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial To evaluate the efficacy, including capacity for inhibition of radiographic progression, and safety of upadacitinib, a JAK1-selective inhibitor, as compared to placebo or adalimumab in patients with rheumatoid arthritis (RA) who have experienced an inadequate response to methotrexate (MTX).In total, 1,629 RA (...) patients with an inadequate response to MTX were randomized (2:2:1) to receive upadacitinib (15 mg once daily), placebo, or adalimumab (40 mg every other week) while continuing to take a stable background dose of MTX. The primary end points were achievement of an American College of Rheumatology 20% (ACR20) improvement response and a Disease Activity Score in 28 joints using C-reactive protein level (DAS28-CRP) of <2.6 in the upadacitinib group compared to the placebo group at week 12; inhibition