Real-World Treatment Patterns, Resource Use and Costs in Adult Patients With Atopic Dermatitis Receiving Systemic Treatment: Derma-Atopic Study in Spain.

BACKGROUND: Moderate-severe atopic dermatitis (AD) has a significant impact on patients' lives, with many requiring systemic treatment to manage symptoms (e.g., pruritus). Several drugs are used off-label to treat AD. This study describes sociodemographic/clinical characteristics, treatment patterns, health resource use (HRU) and costs in adults with AD who initiated systemic treatment or phototherapy in routine practice. METHODS: This retrospective observational study of electronic medical records in the BIG-PAC database identified adults with prior diagnosis of AD (ICD-9: 691.8 or 692.9) starting oral corticosteroids, immunosuppressants, biologics or phototherapy between 01/01/2012 and 31/12/2016. Patients were followed for 3 years from treatment initiation, up to 31/12/2019. Data on patient characteristics, treatment patterns, HRU and costs were analyzed descriptively. RESULTS: Patients (N=1995) had a mean age of 60 years, 64% were female, with a mean time of 23 years since diagnosis (84% were ≥18 years at AD onset). Main comorbidities were anxiety (38%), arterial hypertension (36%) and dyslipidemia (35%). Most patients used oral corticosteroids as first systemic (84%; median duration 29 days) and immunosuppressants in 13% of patients (median duration 117 days, 5% cyclosporine and 4% methotrexate). Half of patients required a second line systemic and 12% a third line. The use of immunosuppressants and biologics increased with treatment lines. About 13% of patients received systemic treatments continuously over the 3-year follow-up. The average 3-year per patient cost was 3835 euros, with an average annual cost of 1278 euros. CONCLUSIONS: Results suggest a high comorbidity and economic burden in this real-world adult population with AD, and the need for systemic treatments indicated for use in AD.

Real-World Treatment Patterns, Resource Use and Costs in Adult Patients With Atopic Dermatitis Receiving Systemic Treatment: Derma-Atopic Study in Spain. / [Artículo traducido] Características de los pacientes, patrones de tratamiento, uso de recursos y costes en adultos con dermatitis atópica moderada-grave en la práctica habitual en España: Estudio Derma-Atopic.

BACKGROUND: Moderate-severe atopic dermatitis (AD) has a significant impact on patients' lives, with many requiring systemic treatment to manage symptoms (e.g., pruritus). Several drugs are used off-label to treat AD. This study describes sociodemographic/clinical characteristics, treatment patterns, health resource use (HRU) and costs in adults with AD who initiated systemic treatment or phototherapy in routine practice. METHODS: This retrospective observational study of electronic medical records in the BIG-PAC database identified adults with prior diagnosis of AD (ICD-9: 691.8 or 692.9) starting oral corticosteroids, immunosuppressants, biologics or phototherapy between 01/01/2012 and 31/12/2016. Patients were followed for 3 years from treatment initiation, up to 31/12/2019. Data on patient characteristics, treatment patterns, HRU and costs were analyzed descriptively. RESULTS: Patients (N = 1995) had a mean age of 60 years, 64% were female, with a mean time of 23 years since diagnosis (84% were ≥18 years at AD onset). Main comorbidities were anxiety (38%), arterial hypertension (36%) and dyslipidemia (35%). Most patients used oral corticosteroids as first systemic (84%; median duration 29 days) and immunosuppressants in 13% of patients (median duration 117 days, 5% cyclosporine and 4% methotrexate). Half of patients required a second line systemic and 12% a third line. The use of immunosuppressants and biologics increased with treatment lines. About 13% of patients received systemic treatments continuously over the 3-year follow-up. The average 3-year per patient cost was 3835 euros, with an average annual cost of 1278 euros. CONCLUSIONS: Results suggest a high comorbidity and economic burden in this real-world adult population with AD, and the need for systemic treatments indicated for use in AD.

Patient-Reported Outcome Measures in Real-World Atopic Dermatitis Studies in Spain: A Systematic Review. / Medidas de los resultados percibidos por el paciente en estudios de vida real en dermatitis atópica en España: revisión sistemática de la literatura.

Atopic dermatitis (AD) is a chronic inflammatory skin disease with symptoms such as pruritus that can be a major burden for patients. Patient-reported outcomes (PRO) complement clinician-reported outcomes in AD. This systematic review aims to identify and describe patient-reported outcome measures (PROM) used in observational studies of AD over the last decade in Spain. Eighteen PROM were identified to measure 13 different PRO that assess multiple aspects of the disease, including symptoms and disease severity, impact on daily activities and on work productivity/functioning, psychosocial impact, patient empowerment, and health-related quality of life (HRQoL). HRQoL, symptoms (particularly pruritus), and anxiety/depression were the most frequently assessed PRO, and the Dermatology Quality of Life Index, the Visual Analogue Pruritus Scale, and the Hospital Anxiety and Depression Scale were the most frequently used PROM, respectively. The growing number of observational studies on AD including PROM in Spain suggests that PRO are becoming increasingly important in the management of AD.

Evaluating the Impact of a Training Program in Shared Decision-Making for Neurologists Treating People with Migraine.

INTRODUCTION: Migraine symptoms vary significantly between patients and within the same patient. Currently, an increasing number of therapeutic options are available for symptomatic and preventive treatment. Guidelines encourage physicians to use shared decision-making (SDM) in their practice, listening to patients' treatment preferences in order to select the most suitable and effective therapy. Although training for healthcare professionals could increase their awareness of SDM, results concerning its effectiveness are inconclusive. This study aimed to analyze the impact of a training activity to promote SDM in the context of migraine care. This was addressed by evaluating the impact on patients' decisional conflict (main objective), patient-physician relationship, neurologists' perceptions of the training and patient's perception of SDM. METHODS: A multicenter observational study was conducted in four highly specialized headache units. The participating neurologists received SDM training targeting people with migraine in clinical practice to provide techniques and tools to optimize physician-patient interactions and encourage patient involvement in SDM. The study was set up in three consecutive phases: control phase, in which neurologists were blind to the training activity and performed the consultation with the control group under routine clinical practice; training phase, when the same neurologists participated in the SDM training; and SDM phase, in which these neurologists performed the consultation with the intervention group after the training. Patients in both groups with a change of treatment assessment during the visit completed the Decisional conflict scale (DCS) after the consultation to measure the patient's decisional conflict. Also, patients answered the patient-doctor relationship questionnaire (CREM-P) and the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). The mean ± SD scores obtained from the study questionnaires were calculated for both groups and compared to determine whether there were significant differences (p < 0.05). RESULTS: A total of 180 migraine patients (86.7% female, mean age of 38.5 ± 12.3 years) were included, of which 128 required a migraine treatment change assessment during the consultation (control group, n = 68; intervention group, n = 60). A low decisional conflict was found without significant differences between the intervention (25.6 ± 23.4) and control group (22.1 ± 17.9; p = 0.5597). No significant differences in the CREM-P and SDM-Q-9 scores were observed between groups. Physicians were satisfied with the training and showed greater agreement with the clarity, quality and selection of the contents. Moreover, physicians felt confident communicating with patients after the training, and they applied the techniques and SDM strategies learned. CONCLUSION: SDM is a model currently being actively used in clinical practice for headache consultation, with high patient involvement in the process. This SDM training, while useful from the physician's perspective, may be more effective at other levels of care where there is still room for optimization of patient involvement in decision-making.

[Development of conjunctival hyperemia with the use of a fixed combination of latanoprost/timolol: systematic review and meta-analysis of clinical trials]. / Desarrollo de hiperemia conjuntival tras el empleo de la combinación fija de latanoprost/timolol: revisión sistemática y metaanálisis de ensayos clínicos publicados.

PURPOSE: To asses the association of conjunctival hyperemia with the use of a fixed combination of latanoprost/timolol, through a systematic review and meta-analysis of clinical trials in patients with glaucoma. METHODS: A systematic review of published clinical trials of latanoprost/timolol and other competitors was conducted in Medline, Embasse and Cochrane Controlled Clinical Trials Register, between 2000 and 2007. Statistical analysis included calculation of the odds ratio (OR) with its 95% confidence interval (CI) using the fixed effects model of Mantel-Haenszel and the random effects model of Der Simonian and Laird. To assess the heterogeneity between trials the Cochrane Q test and the I(2) rate were calculated. The conjunctival hyperemia rates obtained were compared with the Chi-square test. RESULTS: A total of 8 clinical trials comparing latanoprost/timolol fixed combination with different therapeutic options were found. As trial heterogeneity was moderate (Q: 14.64; df=7; p=0.041; I(2)= 52.2%) a random effects model was used. The final OR was 0.47 (CI 95%: 0.24-0.90); p = 0.024. The total conjunctival hyperemia incidence was 2.9% in the latanoprost/timolol group and 7.0% for the competitors (p<0.0001). CONCLUSIONS: The use of a fixed combination of latanoprost/timolol is associated with a significant reduction (53%; CI 95%: 10%-76%) in the development of conjunctival hyperemia against the other compared options for the treatment of glaucoma.

[Budget impact of growth hormone treatment during the transition phase between childhood and adulthood]. / Impacto presupuestario de la utilización de hormona de crecimiento de la edad pediátrica a la adulta.

OBJECTIVE: To estimate the budget impact of somatrophin (Genotonorm) use in growth hormone deficiency (GHD) patients during the transition between childhood and adulthood. METHOD: A budget impact model was designed under the Spanish National Health System with a 5-year time horizon. Calculations of susceptible patients were based on disease prevalence (0.02%) applied to Spanish population. From total GHD cases, 60% was considered persistent and treatment candidates. An expert panel assumed that 20% of candidates would reject the treatment and 8% would withdraw therapy annually. Considered costs included: therapy costs, diagnosis (test and medical visit) and follow-up cost. RESULTS: There would be 49, 93, 132, 186 and 199 patients undergoing treatment each year (2010-2014). The total impact of Genotonorm use during the transition phase would be €367,691, €655,430, €1044,874, €1334,059, and €1594,670 for years 1 to 5. The average annual cost per patient would be €7506, €7059, €7903, €7960, €7995. CONCLUSIONS: GHD treatment during the transition phase in Spain poses an annual average layout of €7684/patient.

Cost-effectiveness evaluation of sunitinib as first-line targeted therapy for metastatic renal cell carcinoma in Spain.

INTRODUCTION Sunitinib, an oral, multitargeted receptor tyrosine kinase inhibitor, delays disease progression, with a median overall survival (OS) of more than 2 years, improves quality of life and is becoming the first-line standard of care for metastatic renal carcinoma (mRCC). PURPOSE To assess the economic value of sunitinib as fi rst-line therapy in mRCC within the Spanish healthcare system. METHODS An adapted Markov model with a 10-year time horizon was used to analyse the cost effectiveness of sunitinib vs. sorafenib (SFN) and bevacizumab/interferon-α (BEV/IFN) as first-line mRCC therapy from the Spanish third-party payer perspective. Progression-free survival (PFS) and OS data from sunitinib, SFN and BEV/IFN pivotal trials were extrapolated to project survival and costs in 6-week cycles. Results, in progression-free life-years (PFLY), life years (LY) and quality-adjusted life-years (QALY) gained, expressed as incremental cost-effectiveness ratios (ICER) with costs and benefits discounted annually at 3%, were obtained using deterministic and probabilistic analyses. RESULTS Sunitinib was more effective and less costly than both SFN (gains of 0.52 PFLY, 0.16 LY, 0.17 QALY) and BEV/IFN (gains of 0.19 PFLY, 0.23 LY, 0.16 QALY) with average cost savings/patients of €1,124 and €23,218, respectively. Using a willingness-to-pay (WTP) threshold of €50,000/QALY, sunitinib achieved an incremental net benefit (INB) of €9,717 and €31,211 compared with SFN and BEV/IFN, respectively. At this WTP, the probability of sunitinib providing the highest INB was 75%. CONCLUSION Our analysis suggests that sunitinib is a costeffective alternative to other targeted therapies as first-line mRCC therapy in the Spanish healthcare setting.