Latest & greatest articles for adalimumab

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Top results for adalimumab

21. 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 (Abstract)

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

2018 EvidenceUpdates

22. 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 Full Text available with Trip Pro

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

2018 EvidenceUpdates

23. Secukinumab Versus Adalimumab for Psoriatic Arthritis: Comparative Effectiveness up to 48 Weeks Using a Matching-Adjusted Indirect Comparison Full Text available with Trip Pro

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

2018 Rheumatology and therapy Controlled trial quality: uncertain

24. 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 Full Text available with Trip Pro

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

2018 Rheumatology and therapy Controlled trial quality: predicted high

25. 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 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

2018 Health Technology Assessment (HTA) Database.

26. 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.

27. Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response Full Text available with Trip Pro

Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response In SELECT-COMPARE, a randomised double-blind study, upadacitinib 15 mg once daily was superior to placebo or adalimumab on background methotrexate (MTX) for treating rheumatoid arthritis signs and symptoms and inhibited radiographical progression versus placebo at 26 weeks. Here we report 48-week (...) safety and efficacy in patients who continued their original medication or were rescued to the alternative medication for insufficient response.Patients on MTX received upadacitinib 15 mg, placebo or adalimumab for 48 weeks. Rescue without washout, from placebo or adalimumab to upadacitinib or upadacitinib to adalimumab occurred if patients had <20% improvement in tender joint count (TJC) or swollen joint count (SJC) (weeks 14/18/22) or Clinical Disease Activity Index (CDAI) >10 (week 26); remaining

2018 EvidenceUpdates

28. Similar Pharmacokinetics of the Adalimumab (Humira Full Text available with Trip Pro

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

2018 Rheumatology and therapy Controlled trial quality: uncertain

29. Epithelioid myxofibrosarcoma developing at the injection site of Adalimumab therapy for psoriatic synovitis Full Text available with Trip Pro

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

2017 European journal of rheumatology

30. Adalimumab (Humira) - for the treatment of paediatric chronic non-infectious anterior uveitis

Adalimumab (Humira) - for the treatment of paediatric chronic non-infectious anterior uveitis Final Appraisal Recommendation Advice No: 2717 – December 2017 Adalimumab (Humira ® ) 40 mg solution for injection (pre-filled pen, pre-filled syringe and vial) Limited submission by AbbVie Ltd Additional note(s): • Please refer to the Summary of Product Characteristics for the full licensed indication. • The Summary of Product Characteristics recommends that paediatric uveitis patients are treated (...) with adalimumab in combination with methotrexate. In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (reference number 3035), which includes the AWMSG Secretariat Assessment Report (ASAR), the Preliminary Appraisal Recommendation (PAR) and the applicant company’s response to the PAR, clinical expert opinion (where available), the views of patients/patient carers (where available) and the lay member perspective. This recommendation has

2017 All Wales Medicines Strategy Group

31. 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

32. Associating adalimumab with methotrexate decreases uveitis associated with juvenile idiopathic arthritis

Associating adalimumab with methotrexate decreases uveitis associated with juvenile idiopathic arthritis Associating adalimumab with methotrexate decreases uveitis associated with juvenile idiopathic arthritis - Evidencias en pediatría Searching, please wait Show menu Library Management You did not add any article to your library yet. | Search Evidence-Based decision making Evidence-Based decision making Show menu Library Management You did not add any article to your library yet. × User (...) Password Log in × Reset password If you need to reset your password please enter your email and click the Send button. You will receive an email to complete the process. Email Send × Library Management × September 2017. Volume 13. Number 3 Associating adalimumab with methotrexate decreases uveitis associated with juvenile idiopathic arthritis Rating: 0 (0 Votes) Reviewers: , . | Newsletter Free Subscription Regularly recieve most recent articles by e-mail Subscribe × Newsletter subscription: Email

2017 Evidencias en Pediatría

33. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. (Abstract)

Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. Tofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who previously had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs).In this 12-month, double-blind, active-controlled and placebo-controlled, phase 3 trial, we randomly assigned patients in a 2:2:2:1:1 (...) ratio to receive one of the following regimens: tofacitinib at a 5-mg dose taken orally twice daily (107 patients), tofacitinib at a 10-mg dose taken orally twice daily (104), adalimumab at a 40-mg dose administered subcutaneously once every 2 weeks (106), placebo with a blinded switch to the 5-mg tofacitinib dose at 3 months (52), or placebo with a blinded switch to the 10-mg tofacitinib dose at 3 months (53). Placebo groups were pooled for analyses up to month 3. Primary end points were

2017 NEJM Controlled trial quality: predicted high

34. Adalimumab impact on fatigue measured by FACIT-F: a study of rheumatoid arthritis patients in Saudi Arabia Full Text available with Trip Pro

Adalimumab impact on fatigue measured by FACIT-F: a study of rheumatoid arthritis patients in Saudi Arabia The objective of the study was to assess the effectiveness of adalimumab as a treatment for fatigue in patients with rheumatoid arthritis (RA).Fatigue was monitored in patients with RA who were already on an adalimumab treatment regimen. Fatigue, general well-being, comorbidities, and disease activity were measured at baseline and ~8, 16, and 24 weeks, thereafter.Significant reductions (...) in fatigue scores and disease activity were observed from baseline to 6 months after. A predictive regression model of fatigue severity was proposed and was found to be significant, with RA disease activity as the most significant predictor of fatigue severity.This quasi-experimental study is a good starting point for research on the efficacy of adalimumab in treating fatigue in RA patients. The results here suggest that a randomized controlled trial assessing adalimumab as a treatment option for RA

2017 Open access rheumatology : research and reviews Controlled trial quality: uncertain

35. Successful reduction of overexposure in patients with rheumatoid arthritis with high serum adalimumab concentrations: an open-label, non-inferiority, randomised clinical trial Full Text available with Trip Pro

Successful reduction of overexposure in patients with rheumatoid arthritis with high serum adalimumab concentrations: an open-label, non-inferiority, randomised clinical trial High adalimumab serum concentrations do not result in better response in patients with rheumatoid arthritis (RA), suggesting overexposure. We investigated whether patients with adalimumab concentrations >8 µg/mL can prolong their dosing interval by 50% without a clinically relevant change in disease activity.Consecutive (...) patients with RA, treated with adalimumab 40 mg every other week for at least 28 weeks, were approached for this randomised, open-label, non-inferiority trial. Patients with adalimumab trough concentrations >8 µg/mL were randomly (1:1) assigned to dose-interval prolongation of once every 3 weeks or continuation of every other week. Primary outcome was the change in disease activity score of 28 joints (ΔDAS28-ESR) after 28 weeks, with a non-inferiority margin of 0.6 points.In total, 147 patients were

2017 EvidenceUpdates

36. Single-Arm Study of Etanercept in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment Full Text available with Trip Pro

Single-Arm Study of Etanercept in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment To evaluate the efficacy and safety of etanercept treatment in adult patients with moderate to severe rheumatoid arthritis (RA) who failed to respond (primary failure) or lost a satisfactory response (secondary failure) to adalimumab.All patients discontinued prior adalimumab treatment and continued methotrexate with etanercept 50 mg once weekly for 24 weeks. The primary (...) . In planned subgroup analyses, patients with anti-adalimumab antibodies and secondary adalimumab failure had the highest ACR20 response to etanercept at week 12 (11/17 patients; 64.7%). Among the patients with secondary adalimumab failure, those with anti-adalimumab antibodies were fivefold more likely to have an ACR20 response to etanercept than those without anti-adalimumab antibodies (odds ratio 5.2; 95% CI 2.0, 13.5; P < 0.001). Adverse events were reported for 62 (72.9%) patients and were consistent

2017 Rheumatology and therapy

37. 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

38. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study Full Text available with Trip Pro

Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX).In this double-blind phase 3 study, patients were randomised 3:3:2 to placebo (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330 (...) stiffness (MJS), Worst Ttiredness and Worst Joint Pain. The primary study endpoint was at week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables.Compared with placebo and adalimumab, baricitinib showed statistically significant improvements (p≤0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores and WPAI-RA daily activity at week 12. Improvements were maintained for measures

2017 EvidenceUpdates

39. Long-Term Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis: An Observational Analysis from the Corrona Rheumatoid Arthritis Registry Full Text available with Trip Pro

Long-Term Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis: An Observational Analysis from the Corrona Rheumatoid Arthritis Registry Current recommendations for the management of rheumatoid arthritis (RA) focus on a treat-to-target approach with the objective of maximizing long-term health-related quality-of-life in patients with RA. Published studies from randomized clinical trials have reported limited data regarding the long-term efficacy and safety of adalimumab in patients (...) with RA. This study aims to evaluate the long-term (10+ years) persistency and effectiveness of adalimumab in patients with RA in a real-world setting.Included in this study were biologic-naïve adults with RA initiating adalimumab during follow-up enrolled in the Corrona RA registry. More than 10 years of data on persistency of adalimumab and rheumatologist-supplied reasons for discontinuation were examined. Among patients who persisted on adalimumab over the years, clinical [e.g., clinical disease

2017 Rheumatology and therapy

40. 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