Latest & greatest articles for adalimumab

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Top results for adalimumab

1. Adalimumab (Amsparity)

Adalimumab (Amsparity) Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EMA/682333/2019 EMEA/H/C/004879 Amsparity (adalimumab) An overview of Amsparity and why it is authorised (...) (collections of pus) and scarring on the skin; • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball). Amsparity is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments. For more information on the use of Amsparity in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist. Amsparity contains the active substance adalimumab

2020 European Medicines Agency - EPARs

2. Adalimumab for moderate to severe hidradenitis suppurativa

Adalimumab for moderate to severe hidradenitis suppurativa '); } else { document.write(' '); } ACE | Adalimumab for treating active moderate to severe hidradenitis suppurativa Search > > Adalimumab for treating active moderate to severe hidradenitis suppurativa - Adalimumab for treating active moderate to severe hidradenitis suppurativa Published on 2 May 2019 Guidance Recommendations The Ministry of Health's Drug Advisory Committee has recommended: Adalimumab 40 mg/0.8 ml solution (...) for injection (prefilled syringe and pen) for treating active moderate to severe hidradenitis suppurativa (acne inversa), defined by Hurley stage II or III disease in patients with an inadequate response to conventional systemic therapy. Prescribing clinicians should assess the patient's initial response to adalimumab after 12 weeks of treatment, and only continue if there is clear evidence of Hidradenitis Suppurativa Clinical Response (HiSCR), defined as: A reduction of 50% or more from baseline in total

2019 Appropriate Care Guides, Agency for Care Effectiveness (Singapore)

3. 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 Full Text available with Trip Pro

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

2019 EvidenceUpdates

4. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. (Abstract)

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

2019 NEJM

5. 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 (Abstract)

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

2019 EvidenceUpdates

6. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. (Abstract)

Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Psoriasis is an autoimmune disease that affects approximately 100 million people worldwide, and is a disease that can be ameliorated by anti-cytokine treatment. We aimed to compare the efficacy and safety of risankizumab with adalimumab in patients with moderate-to-severe plaque psoriasis.IMMvent was a phase 3, randomised (...) , double-blind, active-comparator-controlled trial completed at 66 clinics in 11 countries. Eligible patients were aged 18 years or older with moderate-to-severe chronic plaque psoriasis. Patients were randomly assigned 1:1 using interactive response technology to receive 150 mg risankizumab subcutaneously at weeks 0 and 4 or 80 mg adalimumab subcutaneously at randomisation, then 40 mg at weeks 1, 3, 5, and every other week thereafter during a 16-week double-blind treatment period (part A). For weeks

2019 Lancet Controlled trial quality: predicted high

7. Adalimumab (Idacio) - Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease

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

2019 European Medicines Agency - EPARs

8. Switching and alternating infliximab, etanercept and adalimumab biologics and their biosimilars in patients with rheumatoid arthritis: a systematic review and meta-analysis

Switching and alternating infliximab, etanercept and adalimumab biologics and their biosimilars in patients with rheumatoid arthritis: a systematic review and meta-analysis Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability

2019 PROSPERO

9. Equivalence or non-inferiority of infliximab, etanercept and adalimumab biosimilars in patients with rheumatoid arthritis: systematic review and meta-analysis

Equivalence or non-inferiority of infliximab, etanercept and adalimumab biosimilars in patients with rheumatoid arthritis: systematic review and meta-analysis Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content

2019 PROSPERO

10. Adalimumab (Hulio)

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

2018 European Medicines Agency - EPARs

11. Adalimumab (Hadlima / hadlima pushtouch)

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

2018 Health Canada - Drug and Health Product Register

12. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease Full Text available with Trip Pro

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

2018 EvidenceUpdates

13. A rare case of suicidal ideation related to Adalimumab use Full Text available with Trip Pro

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

2018 Open access rheumatology : research and reviews

14. Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 31 May 2018 (...) EMA/CHMP/519681/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Halimatoz International non-proprietary name: adalimumab Procedure No. EMEA/H/C/004866/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/519681/2018 Page 2/128 Table of contents 1 Background information on the procedure 8 1.1 Submission of the dossier 8 1.2 Steps taken for the assessment of the product 10 2

2018 European Medicines Agency - EPARs

15. Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 31 May 2018 EMA/CHMP/520007/2018 Committee for Medicinal (...) Products for Human Use (CHMP) Assessment report Hefiya International non-proprietary name: adalimumab Procedure No. EMEA/H/C/004865/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/520007/2018 Page 2/128 Table of contents 1 Background information on the procedure 8 1.1 Submission of the dossier 8 1.2 Steps taken for the assessment of the product 10 2 Scientific discussion 12 2.1 Problem statement 12 2.1.1

2018 European Medicines Agency - EPARs

16. Adalimumab (Hyrimoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Papulosquamous Skin Diseases, Hidradenitis Suppurativa, Ankylosing Spondylitis, Uveitis

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

2018 European Medicines Agency - EPARs

17. Adalimumab

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

2018 Trip Latest and Greatest

18. 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. (Abstract)

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

2018 Lancet Controlled trial quality: predicted high

19. Whole-body Magnetic Resonance Imaging in Axial Spondyloarthritis: Reduction of Sacroiliac, Spinal, and Entheseal Inflammation in a Placebo-controlled Trial of Adalimumab (Abstract)

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

2018 EvidenceUpdates

20. Impact of the Adalimumab Patient Support Program on Clinical Outcomes in Ankylosing Spondylitis: Results from the COMPANION Study Full Text available with Trip Pro

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

2018 Rheumatology and therapy