Original articleCost-Effectiveness Analysis of Adalimumab for the Treatment of Uveitis Associated with Juvenile Idiopathic Arthritis
Section snippets
SYCAMORE Trial Data
The SYCAMORE trial was a multicenter, double-blind, randomized, placebo-controlled trial to assess the clinical effectiveness of adalimumab in refractory uveitis associated with JIA.9, 15 The trial recruited children and adolescents 2 to 18 years of age with active JIA-associated uveitis, despite stable methotrexate treatment for at least 12 weeks, from 14 United Kingdom centers. Ninety participants between 2 and 18 years of age who were taking methotrexate without improvement in uveitis were
Utilities and Quality-Adjusted Life-Years
Baseline utility scores were 0.83 (95% CI, 0.76–0.89) and 0.87 (95% CI, 0.78–0.96) for the adalimumab and placebo groups, respectively. Based on a complete case analysis of 25 participants (42%) randomized to adalimumab and 3 participants (10%) randomized to placebo, the number of QALYs over the 18-month trial period was 1.40 (95% CR, 1.35–1.45) and 1.45 (95% CR, 1.41–1.50), respectively. After imputation, the mean QALY scores were numerically higher for adalimumab at 1.35 (95% CI, 1.30–1.41)
Principal Findings
This analysis suggested that adalimumab in combination with methotrexate for JIA-associated uveitis is associated with appreciably higher healthcare costs than methotrexate alone and exceeds the threshold for cost-effectiveness operated by the NHS in the United Kingdom by a significant margin. The results are robust to changes in parameter estimates and some alternative modeling assumptions (although we had limited scope for assessing structural uncertainty) and are consistent with the
Acknowledgments
The authors thank the trial participants, members of the Medicine for Children Research Network young person’s advisory group, Drs. Colin Ridyard and Lorna Tuersley for their contributions to the economic evaluation, and Dr. Megan Cann for help in collating data from the Bristol Regional Tertiary Paediatric Uveitis clinic that contributed to the analysis.
References (31)
- et al.
Occurrence of uveitis in recently diagnosed juvenile chronic arthritis: a prospective study
Ophthalmology
(2001) - et al.
Methotrexate for resistant chronic uveitis in children with juvenile rheumatoid arthritis
J Pediatr
(1998) - et al.
EQ-5D for the assessment of health-related quality of life and resource allocation in children: a systematic methodological review
Value Health
(2011) - et al.
Prevalence, risk factors, and outcome of uveitis in juvenile idiopathic arthritis: a long-term followup study
Arthritis Rheum
(2007) - et al.
Non-infectious pediatric uveitis: an update on immunomodulatory management
Paediatr Drugs
(2009) - et al.
Methotrexate is an effective treatment for chronic uveitis associated with juvenile idiopathic arthritis
J Rheumatol
(2005) - et al.
Outcomes of treatment with immunomodulatory therapy in patients with corticosteroid-resistant juvenile idiopathic arthritis-associated chronic iridocyclitis
Ocul Immunol Inflamm
(2005) - et al.
Adalimumab with or without methotrexate in juvenile rheumatoid arthritis
N Engl J Med
(2008) Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
NICE Technology appraisal guidance 373
(2015)- et al.
Adalimumab plus methotrexate for uveitis in juvenile idiopathic arthritis
N Engl J Med
(2017)
A systematic review and economic evaluation of adalimumab and dexamethasone for treating non-infectious intermediate uveitis, posterior uveitis or panuveitis in adults
Health Technol Assess
Financial Disclosure(s): The author(s) have made the following disclosure(s): A.D.D.: Consultant – AbbVie (UK).
A.P.J.: Drug supply – AbbVie (UK).
A.M.: Drug supply – AbbVie (UK).
P.R.W.: Drug supply – AbbVie (UK).
S.C.L.: Drug supply – AbbVie (UK).
B.H.: Drug supply – AbbVie (UK).
H.H.: Drug supply – AbbVie (UK).
P.W.: Drug supply – AbbVie (UK).
A.V.R.: Consultant – UCB (USA); Eli Lilly (USA); Lecturer – SOBI (UK), AbbVie (UK).
Supported by the National Institute for Health Research Health Technology Assessment Programme (project no.: 09/51/01); and Arthritis Research United Kingdom (grant no.: 19612). The University Hospitals Bristol NHS Foundation Trust, as sponsor of study, has a data sharing agreement with AbbVie in support of regulatory purposes. AbbVie had no role in the funding, trial management, or data analysis or writing of the manuscript but have licensed use of the data resulting from the study for regulatory purposes. AbbVie was given the opportunity to review the final draft of the manuscript, but the authors maintained complete control over the content of the article.
HUMAN SUBJECTS: Human subjects were included in this study. The SYCAMORE trial was approved by the NHS National Research Ethics Service Committee (Hampstead, London) 11/LO/0425, and written, informed consent was given by a parent or guardian of each trial participant. The study was conducted according to the principles of the World Medical Association Declaration of Helsinki and its amendments since 1964. All participants provided informed consent.
No animal subjects were included in this study.
Author Contributions:
Conception and design: Hughes, Culeddu, Plumpton, Wood, Dick, Beresford, Ramanan
Analysis and interpretation: Hughes, Culeddu, Plumpton, Wood, Dick, Jones, McKay, Williamson, Compeyrot Lacassagne, Hardwick, Hickey, Woo, Beresford, Ramanan
Data collection: Hughes, Culeddu, Plumpton, Wood, Dick, Jones, McKay, Williamson, Compeyrot Lacassagne, Hardwick, Hickey, Woo, Beresford, Ramanan
Obtained funding: Ramanan, Beresford, Jones, Hughes, Woo, Hickey, Dick
Overall responsibility: Hughes, Culeddu, Plumpton, Wood, Dick, Beresford, Ramanan
- ∗
Both authors contributed equally.