Cost Effectiveness of Tofacitinib for the Treatment of Active Ankylosing Spondylitis in Greece.

BACKGROUND AND OBJECTIVE: Ankylosing spondylitis is a chronic, progressive, inflammatory, multidimensional, musculoskeletal disease primarily involving the axial skeleton. In addition, ankylosing spondylitis is associated with increased morbidity and mortality, significantly affecting productivity and overall quality of life. The aim of the present study was to evaluate the cost effectiveness of tofacitinib compared to currently marketed biologic treatment in patients with active ankylosing spondylitis who have responded inadequately to conventional therapy (biologic-naïve population) or previous biologic therapy (biologic-experienced population) in Greece. METHODS: A published model comprising a decision tree and a three-state Markov model was adapted from a public payer perspective over a lifetime horizon. Adalimumab and secukinumab, having the highest market shares among biologics for the treatment of ankylosing spondylitis in Greece (standard practice), were selected as comparators in the analysis. Clinical parameters captured treatment response defined per Assessment of Spondyloarthritis International Society 20 response, short-term and long-term changes in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores, long-term biologic treatment discontinuation, and adverse events. Efficacy, safety data, and utility values were elicited from the published literature. Direct costs pertaining to drug acquisition, monitoring, adverse events, and disease management costs were considered in the analysis (€2022). Model outcomes were patients' quality-adjusted life-years, total costs, and incremental cost-effectiveness ratios. All future outcomes were discounted at 3.5% per annum. A probabilistic sensitivity analysis was conducted to account for model uncertainty. RESULTS: In a biologic-naïve population, compared with adalimumab, tofacitinib produced an estimated 0.06 additional quality-adjusted life-years [QALYs] (10.67 vs 10.73), at additional costs of €2403 (€147,096 vs €149,500) resulting in an incremental cost-effectiveness ratio of €41,378 per QALY gained. In a biologic-experienced population, the total cost per patient for tofacitinib and secukinumab was estimated to be €151,371 and €145,757, respectively. In terms of health outcomes, tofacitinib was associated with a 0.13 increment in QALYs compared with secukinumab resulting in an incremental cost-effectiveness ratio of €42,784 per QALY gained. The probabilistic sensitivity analysis confirmed the deterministic results for both populations. CONCLUSIONS: Tofacitinib was estimated to be a cost-effective option for the treatment of active ankylosing spondylitis in Greece for both biologic-naive and biologic-experienced patients.

Antithyroid drug induced syndrome that lies in between ANCA vasculitis and lupus-like syndrome in a 40-year-old female with Graves' disease under methimazole therapy: A Case report.

We report the case of a 40-year-old Greek female with symptoms of polyarthritis, pruritic rash and positive p-ANCA antibodies, undergoing treatment with Methimazole therapy for Graves' disease. The rash and the arthritis symptoms promptly disappeared after withdrawal of methimazole, but p-ANCA antibodies remained positive for 6 weeks. By the time that p-ANCA became negative, anti-dsDNA antibodies presented and remained at high titers for 3 months, with no clinical or specific organ disease symptoms. The patient was under close monitoring for the case of potentially life-threating vasculitis of the lung or the kidney and was treated with methylprednisolone. We diagnosed the patient with Antithyroid drug Syndrome, which in our patient presented with arthritis symptoms and had serological features which are commonly found to Antithyroid drug pANCA vasculitis and Antithyroid drug lupus-like syndrome. Physician's awareness is essential for the diagnosis and treatment of this syndrome in clinical practice, taking into consideration the high frequency of the use of antithyroid agents.

Five-year prospective multi-center cohort study of patients with giant cell arteritis in Greece.

Giant cell arteritis (GCA) is the most common systemic vasculitis in the aged population associated with significant morbidity due to the long term administration of corticosteroids and the presence of various comorbidities. Data regarding its current treatment modalities, comorbidities, morbidity and mortality in Greece are limited. In this multi-center, prospective study that begun at the end of 2015 patients with newly diagnosed GCA according to the modified 1990 ACR criteria, as well as individuals with established or relapsing disease have been included. During the 1st phase of the study that is still ongoing, data are being collected concerning demographic and clinical characteristics of the patients, treatment at the onset of the disease and at relapses, relapses, adverse events of therapy, comorbidities, hospitalizations and deaths. During the 2nd and 3rd phase of the study patients will be reevaluated 2 and 5 years after their 1st evaluation. The study is expected to provide valuable data regarding the current clinical characteristics, comorbidities, therapeutic regimens used, relapse rate, morbidity and mortality of patients with GCA.