Adalimumab in Patients with Active Noninfectious Uveitis

Jaffe, Glenn J.; Dick, Andrew D.; Brézin, Antoine P.; Nguyen, Quan Dong; Thorne, Jennifer E.; Kestelyn, Philippe; Barisani-Asenbauer, Talin; Franco, Pablo; Heiligenhaus, Arnd; Scales, David K.; Chu, David; Camez, Anne; Kwatra, Nisha V.; Song, Alexandra P.; Kron, Martina; Tari, Samir; Suhler, Eric B.

doi:10.1056/nejmoa1509852

Cited by 484 publications

(453 citation statements)

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“…23 Most recently, the main study data from VISUAL I and VISUAL II studies also demonstrated the efficacy and safety of adalimumab (anti-TNFα) to treat uveitis. 13,14 Low adalimumab immunogenicity was observed in both VISUAL I and VISUAL II studies and was in the range of rates observed in other disease states. 13,14 The safety profile of adalimumab was similar to the established safety profile for approved adalimumab indications, 24 and the rates of AEs were similar compared with placebo.…”

Section: Discussionmentioning

confidence: 88%

“…13,14 Low adalimumab immunogenicity was observed in both VISUAL I and VISUAL II studies and was in the range of rates observed in other disease states. 13,14 The safety profile of adalimumab was similar to the established safety profile for approved adalimumab indications, 24 and the rates of AEs were similar compared with placebo. In participants with active uveitis (VISUAL I), the overall rates of adalimumab-associated AEs were higher than the placebo group, as were serious AEs and AEs leading to discontinuation.…”

Section: Discussionmentioning

confidence: 88%

“…In participants with inactive uveitis (VISUAL II), injection-site reactions were the most frequently reported AEs with adalimumab, consistent with other reports.- 21,25 The strengths and the limitations of the VISUAL I and VISUAL II studies have been described and published. 13,14 Additionally, in the Japan substudies, the sample sizes of 16 participants (VISUAL I) and 32 participants (VISUAL II) were very low and no clear differences were expected. Furthermore, to receive 60 mg of prednisone per the VISUAL I protocol, participants needed to be hospitalized, which was one of the reasons for low enrollment in the VISUAL I study in Japan.…”

Section: Discussionmentioning

confidence: 98%

“…The VISUAL I and VISUAL II studies were randomized, doublemasked, placebo-controlled clinical trials designed to assess the efficacy and safety of adalimumab in inducing quiescence along with CS and maintaining the achieved quiescence in participants with active uveitis (VISUAL I) and as a steroid-sparing agent preventing relapse in participants dependent on CS to maintain inactivity (VISUAL II). The VISUAL program demonstrated adalimumab's ability to lower the risk of uveitic recurrence and visual acuity loss in participants with active (VISUAL I) and an inactive disease state (VISUAL II) uveitis.- 13,14 The VISUAL program is the first successful program where the treatment effect of a non-CS medication could be demonstrated in two separate randomized controlled trials in non-infectious uveitis populations.…”

mentioning

confidence: 99%

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Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials

Gotô

Zako²,

Namba

et al. 2018

Ocular Immunology and Inflammation

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Section: Discussionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 98%

mentioning

confidence: 99%

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Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials

Gotô

Zako²,

Namba

et al. 2018

Ocular Immunology and Inflammation

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“…Patients with bilateral uveitis but no active systemic disease could be treated using either a local or a systemic approach. Although the inclusion criteria for the clinical trials of these drugs [46][47][48] were not limited by these factors, our clinical experts suggest that clinicians may have selected patients for the trials accordingly.…”

Section: Place Of the Interventions In The Treatment Pathwaymentioning

confidence: 99%

A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults

Squires

Poku

Bermejo

et al. 2017

Health Technol Assess

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Declared competing interests of authors: Fahd Quhill has received personal fees from Allergan for participation in medical education and training, and has participated in advisory boards given his clinical expertise in the role of steroids in diabetic macular oedema. He has also received support from Allergan to attend international conferences.Published November 2017 DOI: 10.3310/hta21680 This report should be referenced as follows: This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: journals.library@nihr.ac.ukThe full HTA archive is freely available to view online at www.journalslibrary.nihr.ac.uk/hta. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Health Technology Assessment journalReports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for the HTA programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors.Reviews in Health Technology Assessment are termed 'systematic' when the account of the search appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. HTA programmeThe HTA programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.The journal is indexed in NHS Evidence via its abstracts included in MEDLINE and its Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions.For more information about the HTA programme please visit the website: http://www.nets.nihr.ac.uk/programmes/hta This reportThe research reported in this issue of the journal was commissioned and funded by the HTA programme on behalf of NICE as project number 15/64/07. The protocol was agreed in June 2016. The assessment report began editorial review in December 2016 and was accepted for publication in May 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expre...

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Effect of Corticosteroid-Sparing Treatment With Mycophenolate Mofetil vs Methotrexate on Inflammation in Patients With Uveitis

Rathinam

Gonzales

Thundikandy

et al. 2019

JAMA

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; for the FAST Research Group IMPORTANCE Methotrexate and mycophenolate mofetil are commonly used immunomodulatory therapies for achieving corticosteroid-sparing control of noninfectious uveitis, but there is uncertainty about which drug is more effective. OBJECTIVE To compare the effect of methotrexate and mycophenolate for achieving corticosteroid-sparing control of noninfectious intermediate uveitis, posterior uveitis, and panuveitis. DESIGN, SETTING, AND PARTICIPANTS The First-line Antimetabolites as Steroid-sparing Treatment (FAST) uveitis trial screened 265 adults with noninfectious uveitis requiring corticosteroid-sparing immunosuppressive therapy from 9 referral eye centers in India, the

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Adalimumab in Patients with Active Noninfectious Uveitis

Abstract: In our trial, adalimumab was found to be associated with a lower risk of uveitic flare or visual impairment and with more adverse events and serious adverse events than was placebo. (Funded by AbbVie; VISUAL I ClinicalTrials.gov number, NCT01138657 .).

Cited by 484 publications

References 23 publications

Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials

Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials

A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults

Effect of Corticosteroid-Sparing Treatment With Mycophenolate Mofetil vs Methotrexate on Inflammation in Patients With Uveitis

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