Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial.

OBJECTIVES: To compare the benefits of a tight-control/treat-to-target strategy (TC/T2T) in axial spondyloarthritis (axSpA) with those of usual care (UC). METHODS: Pragmatic, prospective, cluster-randomised, controlled, open, 1-year trial (NCT03043846). 18 centres were randomised (1:1). Patients met Axial Spondylo Arthritis International Society (ASAS) criteria for axSpA, had an Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥2.1, received non-optimal treatment by non-steroidal anti-inflammatory drugs and were biologic-naive. INTERVENTIONS: (1) TC/T2T: visits every 4 weeks and prespecified strategy based on treatment intensification until achieving target (ie, ASDAS <2.1); (2) UC: visits every 12 weeks and treatment at the rheumatologist's discretion. MAIN OUTCOME: Percentage of patients with a ≥30% improvement on the ASAS-Health Index (ASAS-HI). Other efficacy outcomes and adverse events were recorded. A health economic evaluation was performed. STATISTICAL ANALYSIS: Two-level mixed models were used to estimate efficacy outcomes. Cost-effectiveness was assessed by the incremental cost per quality-adjusted life-year (QALY) gained for TC/T2T versus UC. RESULTS: 160 patients were included (80/group). Mean (SD) age was 37.9 (11.0) years and disease duration was 3.7 (6.2) years; 51.2% were men. ASDAS at inclusion was 3.0 (0.7), and ASAS-HI was 8.6 (3.7). ASAS-HI improved by ≥30% in 47.3% of the TC/T2T arm and in 36.1% of those receiving UC (non-significant). All secondary efficacy outcomes were more frequent in the TC/T2T arm, although not all statistically significant. Safety was similar in both arms. From a societal perspective, TC/T2T resulted in an additional 0.04 QALY, and saved €472 compared with UC. CONCLUSION: TC/T2T was not significantly superior to UC for the primary outcome, while many secondary efficacy outcomes favoured it, had a similar safety profile and was favourable from a societal health economic perspective. TRIAL REGISTRATION NUMBER: NCT03043846.

Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial.

BACKGROUND: Axial spondyloarthritis (AxSpA) is a chronic disease which results in fatigue, pain, and reduced quality of life (QoL). Traditional Chinese medicine (TCM), especially acupuncture, has shown promise in managing pain. Although a TCM collaborative model of care (TCMCMC) has been studied in cancer, there are no randomized controlled trials investigating TCM in AxSpA. Therefore, we will conduct a pragmatic trial to determine the clinical effectiveness, safety, and cost-effectiveness of TCMCMC for patients with AxSpA. We define TCMCMC as standard TCM history taking and physical examination, acupuncture, and TCM non-pharmacological advice and communications with rheumatologists in addition to usual rheumatologic care. The purpose of this paper is to describe the rationale for and methodology of this trial. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 160 patients who are diagnosed with AxSpA and have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Simple randomization to usual rheumatologic care or the intervention (TCMCMC) with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the TCMCMC arm. All participants will continue to receive usual rheumatologic care. The primary endpoint - spinal pain - will be evaluated at week 6. Secondary endpoints include clinical, quality of life, and economic outcome measures. Patients will be followed up for up to 52 weeks, and adverse events will be documented. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of a TCMCMC for patients with AxSpA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03420404 . Registered on 14 February 2018.

Counting Costs under Severe Financial Constraints: A Cost-of-Illness Analysis of Spondyloarthropathies in a Tertiary Hospital in Greece.

OBJECTIVE: To investigate the total annual direct cost of patients with spondyloarthritis (SpA) in Greece. METHODS: Retrospective study with 156 patients diagnosed and followed up in the rheumatology clinic of the University Hospital of Ioannina. Sixty-four had ankylosing spondylitis (AS) and 92 had psoriatic arthritis (PsA). Health resource use for each patient was elicited through a retrospective chart review that documented the use of monitoring visits, medications, laboratory/diagnostic tests, and inpatient stays for the previous year from the date that the review took place. Costs were calculated from a third-party payer perspective and are reported in 2014 euros. RESULTS: The mean ± SD annual direct cost for the patients with SpA reached €8680 ± 6627. For the patients with PsA and AS, the cost was estimated to be €8097 ± 6802 and €9531 ± 6322, respectively. The major cost was medication, which represented 88.9%, 88.2%, and 89.3% of the mean total direct cost for SpA, AS, and PsA, respectively. The annual amount of the scheduled tests for all patients corresponded to 7.5%, and for those performed on an emergency basis, 1.1%. Further, the cost for scheduled and emergency hospitalization, as well as the cost of scheduled visits to an outpatient clinic, corresponded to 2.5% of the mean total annual direct cost for the patients with SpA. CONCLUSION: SpA carries substantial financial cost, especially in the era of new treatment options. Adequate access and treatment for patients with SpA remains a necessity, even in times of fiscal constraint. Thus, the recommendations of the international scientific organizations should be considered when administering high-cost drugs such as biological treatments.

[Analisis of the budget impact of adalimumab and etanercept in rheumatoid arthritis and spondyloarthropathies]. / Análisis del impacto presupuestario de adalimumab y etanercept en artritis reumatoide y espondiloartropatías.

PURPOSE: To assess the economic impact derived from the widening of the administration intervals of adalimumab (ADA) and etanercept (ETN) for the treatment of rheumatoid arthritis (RA) and spondyloarthropathies (SAP) at our working environment. MATERIAL AND METHODS: A budget impact model (BIM) was developed to estimate the economic impact that would have widening the usual administration intervals of ADA, 40 mg every 2 weeks and ETN, 50 mg weekly (scenario A), to ADA, 40 mg every 3 weeks, and ETN, 50 mg every 2 weeks (scenario B) according to the guidelines and recommendations applied to these studies, specifying the target population, the study perspective, the temporal horizon, and analysing the study robustness by a threshold univariate sensitivity analysis. RESULTS: 71 patients were included in the study. The application of the BIM showed yearly savings for ADA and ETN of 19.784 ??and 38.271 ?, respectively. The net cost, that is to say the saving that this would imply within the temporal horizon considered (2 years), was 116.110 ?. The sensitivity analysis showed that the estimated BIM for the study period was very robust since the net result in the different scenarios varied very little, being negative in the new scenarios. CONCLUSIONS: widening the administration intervals of ADA and ETN to every 3 weeks and 2 weeks respectively, would be a strategy that would allow generating savings in the hospital budget close to 116.110 ??for the temporal horizon considered, achieving this way optimization of the treatment with these two drugs.

Objetivo: Evaluar el impacto económico derivado de la ampliación de los intervalos de administración de adalimumab (ADA) y etanercept (ETN), en el tratamiento de la artritis reumatoide (AR) y espondiloartropatias (EAP) en nuestro ámbito de trabajo. Material y método: Se desarrolló un modelo de impacto presupuestario (MIP) para estimar la repercusión económica que tendría la ampliación en los intervalos habituales de administración de ADA 40 mg cada dos semanas y ETN 50 mg semanal (escenario A), por ADA 40 mg cada tres semanas y ETN 50 mg cada dos semanas (escenario B) de acuerdo a las guías y recomendaciones que se aplican a estos estudios, especificando la población diana, la perspectiva del estudio, el horizonte temporal y analizando la robustez del estudio a través de un análisis de sensibilidad univariante de tipo umbral. Resultados: Se incluyeron un total de 71 pacientes en el estudio. La aplicación del MIP mostró unos ahorros anuales para ADA y ETN de 19.784??y 38.271 ??respectivamente. El coste neto, es decir, el ahorro que esto supuso en el horizonte temporal considerado (dos años) ascendió a 116.110 ?. El análisis de sensibilidad realizado mostró que el MIP estimado para el periodo de estudio fue muy robusto ya que el resultado neto en diferentes escenarios apenas variaba, manteniéndose negativo en los nuevos escenarios. Conclusiones: La ampliación de los intervalos de administración de ADA y ETN cada tres semanas y dos semanas respectivamente, sería una estrategia que permitiría generar ahorros en el presupuesto hospitalario cercanos a los 116.110 ??en el horizonte temporal considerado, consiguiendo así una optimización del tratamiento con estos fármacos.

Etanercept in spondyloarthopathies. Part II: safety and pharmacoeconomic issues.

Etanercept (ETN) and other anti-TNF-α agents have revolutionised the management of spondyloarthropathies (SpA). With the increasingly widespread and prolonged use of these drugs an assessment of their long-term safety is extremely important. An additional concern regarding biological agents is their higher costs compared with conventional drugs. We examined safety data regarding ETN from clinical reports, clinical trials, review articles, databases and registries. In addition, evidence was reviewed about the cost effectiveness of ETN in the treatment of patients with SpA. Our review suggests that ETN is well tolerated as long-term, continuous treatment of SpA with a favourable risk-benefit ratio maintained from 4 to 5 years. Diversity in structure and mode of action could explain some differences in the safety profile of ETN with respect to the other anti-TNF agents. In particular, ETN is less immunogenic and is less likely to induce tuberculosis re-activation than the other TNF-α antagonists. Although ETN is considerably more expensive than conventional therapy, it reduces direct and indirect costs associated to SpA by improving disease activity and quality of life. Recent pharmacoeconomic studies have demonstrated its cost-effectiveness in the treatment of SpA.

[The influence of rheumatoid and degenerative disease on hospital resources in the operative treatment of cervical spine instability]. / Einfluss einer rheumatischen oder degenerativen Grunderkrankung auf perioperative Aufwendungen in der Therapie der Halswirbelsäuleninstabilität.

The aim of this study was to compare perioperative diagnostic and therapeutic measures in the treatment of cervical spine instability in patients with rheumatoid arthritis or degenerative disease. Twenty patients (ten in each group) were evaluated and compared with regard to age, sex, surgery time, total operating room time, intensive care time, extent of physical therapy, nursing requirements, costs of medication and radiography. Rheumatoid arthritis patients required more resources with regard to surgery, nursing and rehabilitation than the patients with degenerative disease. Significant differences existed with regard to patient age (P=0.0005), surgery time (P=0.0021), total operating room time (P=0.0001), duration of intensive care (P=0.0005), nursing requirements (P=0.0000), costs of medication (P=0.0000), costs of radiography (P=0.0015) and the duration of hospitalisation (P=0.0115). The data suggest that it is necessary to distinguish patients with rheumatoid or degenerative cervical spine instability from an economic point of view, as the treatment of the rheumatoid cervical spine requires more resources.