Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: a RCT
| Autor: | Ramanan, Athimalaipet V, Dick, Andrew D, Jones, Ashley P, Hughes, Dyfrig A, McKay, Andrew, Rosala-Halas, Anna, Williamson, Paul R, Hardwick, Ben, Hickey, Helen, Rainford, Naomi, Hickey, Graeme, Kolamunnage-Dona, Ruwan, Culeddu, Giovanna, Plumpton, Catrin, Wood, Eifiund, Compeyrot-Lacassagne, Sandrine, Woo, Patricia, Eaelsten, Clive, Beresford, Michael W, Grp, SYCAMORE Study |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Cost-Benefit Analysis law.invention 0302 clinical medicine Randomized controlled trial law Outcome Assessment Health Care 030212 general & internal medicine JUVENILE IDIOPATHIC ARTHRITIS Child skin and connective tissue diseases RHEUMATOLOGY Health Policy Incidence (epidemiology) METHOTREXATE lcsh:R855-855.5 SAFETY Antirheumatic Agents Child Preschool Drug Therapy Combination Female PAEDIATRIC Research Article medicine.drug musculoskeletal diseases medicine.medical_specialty lcsh:Medical technology UVEITIS Adolescent Placebo Uveitis 03 medical and health sciences Double-Blind Method Internal medicine OPHTHALMOLOGY Adalimumab medicine Humans Adverse effect 030203 arthritis & rheumatology business.industry Arthritis Juvenile United Kingdom Confidence interval Rheumatology Clinical trial Methotrexate RANDOMISED CONTROLLED TRIAL business ADALIMUMAB |
| Zdroj: | HEALTH TECHNOLOGY ASSESSMENT Ramanan, A V, Dick, A D, Jones, A P, Hughes, D A, McKay, A, Rosala-Hallas, A, Williamson, P R, Hardwick, B, Hickey, H, Rainford, N, Hickey, G, Kolamunnage-Dona, R, Culeddu, G, Plumpton, C, Wood, E, Compeyrot-Lacassagne, S, Woo, P, Edelsten, C & Beresford, M W 2019, ' Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis : a RCT ', Health Technology Assessment, vol. 23, no. 15, pp. 1-140 . https://doi.org/10.3310/hta23150 Health Technology Assessment, Vol 23, Iss 15 (2019) |
| Popis: | Background Children with juvenile idiopathic arthritis (JIA) are at risk of uveitis. The role of adalimumab (Humira®; AbbVie Inc., Ludwigshafen, Germany) in the management of uveitis in children needs to be determined. Objective To compare the efficacy, safety and cost-effectiveness of adalimumab in combination with methotrexate (MTX) versus placebo with MTX alone, with regard to controlling disease activity in refractory uveitis associated with JIA. Design This was a randomised (applying a ratio of 2 : 1 in favour of adalimumab), double-blind, placebo-controlled, multicentre parallel-group trial with an integrated economic evaluation. A central web-based system used computer-generated tables to allocate treatments. A cost–utility analysis based on visual acuity was conducted and a 10-year extrapolation by Markov modelling was also carried out. Setting The setting was tertiary care centres throughout the UK. Participants Patients aged 2–18 years inclusive, with persistently active JIA-associated uveitis (despite optimised MTX treatment for at least 12 weeks). Interventions All participants received a stable dose of MTX and either adalimumab (20 mg/0.8 ml for patients weighing Main outcome measures Primary outcome – time to treatment failure [multicomponent score as defined by set criteria based on the Standardisation of Uveitis Nomenclature (SUN) criteria]. Economic outcome – incremental cost per quality-adjusted life-year (QALY) gained from the perspective of the NHS in England and Personal Social Services providers. Full details of secondary outcomes are provided in the study protocol. Results A total of 90 participants were randomised (adalimumab, n = 60; placebo, n = 30). There were 14 (23%) treatment failures in the adalimumab group and 17 (57%) in the placebo group. The analysis of the data from the double-blind phase of the trial showed that the hazard risk (HR) of treatment failure was significantly reduced, by 75%, for participants in the adalimumab group (HR 0.25, 95% confidence interval 0.12 to 0.51; p Conclusions Adalimumab in combination with MTX is safe and effective in the management of JIA-associated uveitis. However, the likelihood of cost-effectiveness is Future work A clinical trial is required to define the most effective time to stop therapy. Prognostic biomarkers of early and complete response should also be identified. Trial registration Current Controlled Trials ISRCTN10065623 and European Clinical Trials Database number 2010-021141-41. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 15. See the NIHR Journals Library website for further project information. This trial was also funded by Arthritis Research UK (grant reference number 19612). Two strengths of adalimumab (20 mg/0.8 ml and 40 mg/0.8 ml) and a matching placebo were manufactured by AbbVie Inc. (the Marketing Authorisation holder) and supplied in bulk to the contracted distributor (Sharp Clinical Services, Crickhowell, UK) for distribution to trial centres. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|