Latest & greatest articles for adalimumab

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Top results for adalimumab

1. 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

2. 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

3. 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

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

Adalimumab (Cyltezo) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, 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, 2017. Reproduction is authorised provided (...) the source is acknowledged. 14 September 2017 EMA/CHMP/750187/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Cyltezo International non-proprietary name: adalimumab Procedure No. EMEA/H/C/004319/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Medicinal product no longer authorised Assessment report EMA/CHMP/750187/2017 Page 2/115 Table of contents 1. Background information on the procedure 7 1.1

2017 European Medicines Agency - EPARs

5. 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

6. Adalimumab for treating moderate to severe hidradenitis suppurativa

Adalimumab for treating moderate to severe hidradenitis suppurativa Adalimumab for treating moder Adalimumab for treating moderate to ate to se sev vere hidr ere hidradenitis suppur adenitis suppurativa ativa T echnology appraisal guidance Published: 22 June 2016 nice.org.uk/guidance/ta392 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance (...) inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Adalimumab for treating moderate to severe hidradenitis suppurativa (TA392) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 43Contents Contents 1 Recommendations 4 2 The technology 5

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

7. 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

8. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy Infliximab, adalimumab and golimumab Infliximab, adalimumab and golimumab for treating moder for treating moderately to se ately to sev verely activ erely active e ulcer ulcerativ ative colitis after the failure of e colitis after the failure of con conv ventional ther entional therap apy y T echnology appraisal guidance Published: 25 February 2015 (...) and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Infliximab, adalimumab

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

9. Adalimumab, etanercept, infliximab and golimumab for the treatment of ankylosing spondylitis and reactive arthritis

Adalimumab, etanercept, infliximab and golimumab for the treatment of ankylosing spondylitis and reactive arthritis Adalimumab, etanercept, infliximab y golimumab para el tratamiento de las espondilitis anquilosante y artritis reactiva [Adalimumab, etanercept, infliximab and golimumab for the treatment of ankylosing spondylitis and reactive arthritis] Adalimumab, etanercept, infliximab y golimumab para el tratamiento de las espondilitis anquilosante y artritis reactiva [Adalimumab, etanercept (...) A, Ciapponi A, Mengarelli C. Adalimumab, etanercept, infliximab y golimumab para el tratamiento de las espondilitis anquilosante y artritis reactiva. [Adalimumab, etanercept, infliximab and golimumab for the treatment of ankylosing spondylitis and reactive arthritis] Buenos Aires: Institute for Clinical Effectiveness and Health Policy (IECS). Informe de Respuesta Rápida N° 294. 2013 Authors' objectives To assess the available evidence on the efficacy, safety and coverage related issues on the use

2014 Health Technology Assessment (HTA) Database.

10. Infliximab versus Methotrexate, Etanercept, Adalimumab, and Ustekinumab for Plaque Psoriasis: A Review of the Comparative Clinical Efficacy, Safety and Cost Effectiveness

Infliximab versus Methotrexate, Etanercept, Adalimumab, and Ustekinumab for Plaque Psoriasis: A Review of the Comparative Clinical Efficacy, Safety and Cost Effectiveness Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic (...) and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. TITLE: Infliximab versus Methotrexate, Etanercept, Adalimumab, and Ustekinumab for Plaque Psoriasis: A Review of the Comparative Clinical Efficacy, Safety and Cost

2012 Canadian Agency for Drugs and Technologies in Health - Rapid Review

11. Adalimumab (Humira) - hidradenitis suppurativa (acne inversa)

Adalimumab (Humira) - hidradenitis suppurativa (acne inversa) Final Appraisal Recommendation Advice No: 1217 – July 2017 Adalimumab (Humira ® ) 40 mg solution for injection (pre-filled pen, pre-filled syringe and vial) Limited submission by AbbVie Ltd In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (reference number 3371), which includes the AWMSG Secretariat Assessment Report (ASAR), the Preliminary Appraisal (...) – 1217: Adalimumab (Humira ® ) 40 mg solution for injection (pre-filled pen, pre-filled syringe and vial). July 2017 Recommendation of AWMSG Adalimumab (Humira ® ) is recommended as an option for use within NHS Wales for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic hidradenitis suppurativa (HS) therapy. This recommendation applies only in circumstances where the approved

2017 All Wales Medicines Strategy Group

12. Adalimumab (Imraldi) - psoriasis, psoriatic arthritis, axial spondyloarthritis, Crohn?s disease, ulcerative colitis

Adalimumab (Imraldi) - psoriasis, psoriatic arthritis, axial spondyloarthritis, Crohn?s disease, ulcerative colitis 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, 2017. Reproduction is authorised provided the source is acknowledged. 22 June 2017 EMA/CHMP/559383/2017 Committee for Medicinal Products (...) for Human Use (CHMP) Assessment report Imraldi International non-proprietary name: adalimumab Procedure No. EMEA/H/C/004279/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/559383/2017 Page 2/111 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 11 2.1. Problem statement 11 2.1.1

2017 European Medicines Agency - EPARs

13. 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 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

2018 Health Technology Assessment (HTA) Database.

14. Adalimumab induces and maintains mucosal healing in patients with Crohn`s disease: data from the EXTEND trial (Abstract)

Adalimumab induces and maintains mucosal healing in patients with Crohn`s disease: data from the EXTEND trial We investigated the efficacy of adalimumab for inducing and maintaining mucosal healing in patients with Crohn's disease (CD).A randomized, double-blind, placebo-controlled trial (extend the safety and efficacy of adalimumab through endoscopic healing [EXTEND]) evaluated adalimumab for induction and maintenance of mucosal healing in 135 adults with moderate to severe ileocolonic CD (...) . The baseline degree of mucosal ulceration was documented by ileocolonoscopy. All patients received induction therapy (subcutaneous adalimumab 160/80 mg at weeks 0/2). At week 4, patients were randomly assigned to groups given 40 mg adalimumab or placebo every other week through week 52. Open-label adalimumab was given to patients with flares or no response, starting at week 8. Mucosal healing was reassessed by ileocolonoscopy at weeks 12 and 52.Twenty-seven percent of patients receiving adalimumab had

2012 EvidenceUpdates Controlled trial quality: predicted high

15. VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis or psoriasis treated in clinical practice in New Zealand. (Abstract)

VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis or psoriasis treated in clinical practice in New Zealand. Objective: VITALITY, a 6-month, multicenter, prospective, observational study, assessed the effects of originator adalimumab (HUMIRA) on health and disability outcomes in patients with Crohn's disease (CD), rheumatoid arthritis (RA), or psoriasis treated in routine clinical practice in New Zealand (NZ). Methods (...) : Biologic-naïve adults initiating adalimumab in accordance with NZ funding requirements were recruited. The primary endpoint was 6-month change from baseline in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 score in all participants completing the study (full analysis set). Secondary endpoints included 6-month change in other patient-reported outcomes (PROs) of work activity and wellbeing (Work Productivity and Activity Impairment Questionnaire: General Health, Kessler

2019 Current medical research and opinion

16. Long-term outcomes of patients with Crohn's disease who received infliximab or adalimumab as the first-line biologics. (Abstract)

Long-term outcomes of patients with Crohn's disease who received infliximab or adalimumab as the first-line biologics. Although previous studies compared the efficacy of infliximab (IFX) versus adalimumab (ADA) as the first-line biologics for Crohn's disease (CD), the difference in long-term prognosis based on which biologic was used first has scarcely been reported. In particular, the clinical courses after loss of response (LOR) of the first-line biologics are largely unknown.A multicenter

2019 Journal of gastroenterology and hepatology

17. Concerns and side effects of azathioprine during adalimumab induction and maintenance therapy for Japanese patients with Crohn's disease: a sub-analysis of a prospective randomized clinical trial (DIAMOND study). (Abstract)

Concerns and side effects of azathioprine during adalimumab induction and maintenance therapy for Japanese patients with Crohn's disease: a sub-analysis of a prospective randomized clinical trial (DIAMOND study). Combining a thiopurine with the human anti-tumor necrosis factor- monoclonal antibody adalimumab for Crohn's disease (CD) treatment is controversial with regard to efficacy and safety. By conducting a sub-analysis of a multicenter, randomized, prospective, open-label trial (...) in the monotherapy group, whereas it was adverse effects in the combination group (Fisher's exact test, p < 0.001). Kaplan-Meier analyses revealed significantly earlier dropout in the combination group (log-rank test, p = 0.001). Multivariable analysis revealed low body weight to be a risk for dropout due to adverse effects in the combination group.Combination of azathioprine with adalimumab resulted in dropout in the early stage of the study due to side effects of azathioprine, in comparison with late dropout

2019 Journal of Crohn's & colitis Controlled trial quality: uncertain

18. Switch to adalimumab in patients with Crohn`s disease controlled by maintenance infliximab: prospective randomised SWITCH trial (Abstract)

Switch to adalimumab in patients with Crohn`s disease controlled by maintenance infliximab: prospective randomised SWITCH trial Elective switching between anti-tumour necrosis factor (TNF) agents not necessarily dictated by efficacy or tolerability occurs in clinical practice. A study was undertaken to evaluate prospectively the impact of elective switching of patients with Crohn's disease well controlled with intravenous infliximab to subcutaneous adalimumab in a controlled trial.An open-label (...) randomised single-centre trial recruited 73 patients with ongoing response to at least 6 months of scheduled maintenance infliximab. Patients were randomised to continue intravenous 5 mg/kg infliximab or to switch to subcutaneous adalimumab 80 mg at baseline followed by 40 mg every other week for 1 year. Dose optimisation was allowed for intermittent flares, and patients with loss of response or intolerance could cross over to the alternative treatment group. Tolerability, patient preference and efficacy

2012 EvidenceUpdates Controlled trial quality: uncertain

19. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. Full Text available with Trip Pro

Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. Baricitinib is an oral, reversible inhibitor of the Janus kinases JAK1 and JAK2 that may have therapeutic value in patients with rheumatoid arthritis.We conducted a 52-week, phase 3, double-blind, placebo- and active-controlled trial in which 1307 patients with active rheumatoid arthritis who were receiving background therapy with methotrexate were randomly assigned to one of three regimens in a 3:3:2 ratio: placebo (switched (...) to baricitinib after 24 weeks), 4 mg of baricitinib once daily, or 40 mg of adalimumab (an anti-tumor necrosis factor α monoclonal antibody) every other week. End-point measures evaluated after adjustment for multiplicity included 20% improvement according to the criteria of the American College of Rheumatology (ACR20 response) (the primary end point), the Disease Activity Score for 28 joints (DAS28), the Health Assessment Questionnaire-Disability Index, and the Simplified Disease Activity Index at week 12

2017 NEJM Controlled trial quality: predicted high

20. Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis

Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis Abatacept, adalimumab, etanercept and Abatacept, adalimumab, etanercept and tocilizumab for treating juv tocilizumab for treating juvenile enile idiopathic arthritis idiopathic arthritis T echnology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y (...) to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis (TA373) © NICE 2019. All rights reserved. Subject to Notice of rights (https

2016 National Institute for Health and Clinical Excellence - Technology Appraisals