Immunosuppressive Drug Discontinuation in Noninfectious Uveitis From Real-Life Clinical Practice: A Survival Analysis

Abásolo, Lydia; Rosales, Zulema; Díaz-Valle, D.; Gómez-Gómez, Alejandro; Peña-Blanco, R; Prieto-García, Ángela; Benítez-del-Castillo, J.M.; Pato, Esperanza; García‐Feijoó, Julián; Fernández‐Gutiérrez, Benjamín; Rodríguez‐Rodríguez, Luis

doi:10.1016/j.ajo.2016.06.007

Cited by 14 publications

(6 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Inadequate clinical response is cited as the most frequent cause for discontinuation of therapy, followed by inefficacy (no clinical drug effect noted), then adverse drug reactions (EL 2A). 78 Cost and desire for fertility are also considerations, and all of these factors can be used to guide withdrawal decisions. 79 Although the data on sustained remission after withdrawal of biologic therapy are limited, there are some supportive data in juvenile idiopathic arthritis and even more limited data from Behçet's disease (EL 3A).…”

Section: Resultsmentioning

confidence: 99%

Guidance on Noncorticosteroid Systemic Immunomodulatory Therapy in Noninfectious Uveitis

et al. 2018

View full text Add to dashboard Cite

show abstract

Section: Resultsmentioning

confidence: 99%

Guidance on Noncorticosteroid Systemic Immunomodulatory Therapy in Noninfectious Uveitis

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Goldberg et al 50 reported in patients with multifocal choroidopathies initially treated with MMF that at 24 months follow-up, 21% required the addition of a second IMD to control inflammation. Data from Abasolo et al 51 showed that among patients initially receiving IMDs in monotherapy, 46.2% required a modification in their initial treatment (27.4% of patients added a second IMD due to inefficacy and 18.9% switched to a new IMD).…”

Section: Imdsmentioning

confidence: 99%

Non-infectious non-anterior uveitis: Pharmacological management

Rodríguez‐Rodríguez¹

2021

JIMIDS

Self Cite

View full text Add to dashboard Cite

“…In a second trial,23 randomising 200 patients, the percentage of subjects achieving a similar outcome was 67% and 57% for MTX and MMF, respectively (p>0.05), with similar tolerability. Regarding safety, adverse events (AEs) are generally mild and discontinuations due to serious adverse events (SAEs) are less common than for most ISDs,24 25 translating it in higher retention rates 26 27…”

Section: Introductionmentioning

confidence: 99%

Efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis: a protocol for a multicentre, randomised, parallel three arms, active-controlled, phase III open label with blinded outcome assessment study

et al. 2022

Self Cite

View full text Add to dashboard Cite

IntroductionNon-infectious uveitis include a heterogeneous group of sight-threatening and incapacitating conditions. Their correct management sometimes requires the use of immunosuppressive drugs (ISDs), prescribed in monotherapy or in combination. Several observational studies showed that the use of ISDs in combination could be more effective than and as safe as their use in monotherapy. However, a direct comparison between these two treatment strategies has not been carried out yet.Methods and analysisThe Combination THerapy with mEthotrexate and adalImumAb for uveitis (CoTHEIA) study is a phase III, multicentre, prospective, randomised, single-blinded with masked outcome assessment, parallel three arms with 1:1:1 allocation, active-controlled, superiority study design, comparing the efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis. We aim to recruit 192 subjects. The duration of the treatment and follow-up will last up to 52 weeks, plus 70 days follow-up with no treatment. The complete and maintained resolution of the ocular inflammation will be assessed by masked evaluators (primary outcome). In addition to other secondary measurements of efficacy (quality of life, visual acuity and costs) and safety, we will identify subjects’ subgroups with different treatment responses by developing prediction models based on machine learning techniques using genetic and proteomic biomarkers.Ethics and disseminationThe protocol, annexes and informed consent forms were approved by the Reference Clinical Research Ethic Committee at the Hospital Clínico San Carlos (Madrid, Spain) and the Spanish Agency for Medicines and Health Products. We will elaborate a dissemination plan including production of materials adapted to several formats to communicate the clinical trial progress and findings to a broad group of stakeholders. The promoter will be the only access to the participant-level data, although it can be shared within the legal situation.Trial registration number2020-000130-18; NCT04798755.

show abstract

Immunosuppressive Drug Discontinuation in Noninfectious Uveitis From Real-Life Clinical Practice: A Survival Analysis

Cited by 14 publications

References 21 publications

Guidance on Noncorticosteroid Systemic Immunomodulatory Therapy in Noninfectious Uveitis

Guidance on Noncorticosteroid Systemic Immunomodulatory Therapy in Noninfectious Uveitis

Non-infectious non-anterior uveitis: Pharmacological management

Efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis: a protocol for a multicentre, randomised, parallel three arms, active-controlled, phase III open label with blinded outcome assessment study

Contact Info

Product

Resources

About