Short-term response in new users of anti-TNF predicts long-term productivity and non-disability: analysis of Czech ATTRA ankylosing spondylitis biologic registry.

Objectives: To assess the role of short-term response to first anti-TNF in long-term prediction of disability.Methods: In nationwide registry ATTRA, we identified ankylosing spondylitis patients starting anti-TNF between 01/2003 and 12/2016. Full disability and work impairment (WI; WPAI questionnaire) were predicted via the Cox- and lagged-parameter mixed-effect regression.Results: 2,274 biologicals-naïve patients newly indicated to anti-TNF were prospectively followed (6,333 patient-years; median follow-up 1.9 years). Reaching BASDAI < 4 (77.4%) and ASDAS-CRP < 2.1 (61.1%) after 3 months of anti-TNF both decreased the risk of future disability by ≈2.5-fold. ASDAS-CRP < 2.1 predicted non-disability better than BASDAI < 4 & CRP < 5 mg/L (p = 0.032). BASDAI < 4 & CRP < 5 mg/L was comparable to BASDAI < 4 (p = 0.941) and to BASDAI change by >50% or by >2 points (p = 0.902). ASDAS-CRP change >1.1 and >2.0 both failed to predict non-disability. Once on anti-TNF therapy, the strongest predictor of WI was Pain (SF36). Yearly increase in indirect costs remains below €3,000 in those reaching ASDAS-CRP < 2.1.Conclusions: Low disease activity measured by ASDAS-CRP ≤ 2.1 should be used to measure the outcome of new anti-TNF therapy. Continuous WI could be decreased through pain management.

Psoriasis treatment with adalimumab in clinical practice: long-term experience in a center for biological therapy in the Czech Republic.

BACKGROUND: Adalimumab therapy has an established record of high efficacy in psoriasis treatment. However, only a limited number of studies have investigated long-term results in clinical practice. OBJECTIVES: To evaluate the effectiveness and safety of adalimumab in a center for biological therapy in the Czech Republic. METHODS: Retrospectively, we analyzed 90 patients with moderate to severe psoriasis who were treated with adalimumab between 2008 and 2016. The proportion of patients achieving PASI75, 90, and 100 after 3, 6, 12, 18, 24, 30, and 36 months was determined. RESULTS: The mean period of treatment was 4.4 years (maximum duration reached was 8.6 years). PASI75 was observed in 85.6% of patients after 3 months, PASI90 in 50%, and PASI100 in 23.3%. Throughout the 3-year analysis, PASI90 was persistent in 91.4% and PASI100 in 51.7%. The majority of patients who reached PASI100 showed a trend to maintain the response in the long-term follow-up. No safety issues were identified. CONCLUSIONS: Adalimumab is effective and safe in the long-term treatment of psoriatic patients in daily clinical practice. Once patients achieved PASI100, they tended to remain stable in treatment.

Mapping Quality of Life (EQ-5D) from DAPsA, Clinical DAPsA and HAQ in Psoriatic Arthritis.

BACKGROUND: Clinical trials and observational studies lacking measures of health-related quality of life (QoL) are often inapplicable when conducting cost-effectiveness analyses using quality-adjusted life-years (QALYs). The only solution is to map QoL ex post from additionally collected clinical outcomes and generic QoL instruments. Nonetheless, mapping studies are absent in psoriatic arthritis (PsA). METHODS: In this 2-year, prospective, multicentre, non-interventional study of PsA patients, EQ-5D and key clinical parameters such as Disease Activity in PsA (DAPsA), clinical DAPsA (cDAPsA; DAPsA without C-reactive protein [CRP]), and Health Assessment Questionnaire disability index (HAQ) were collected. We employed a linear mixed-effect regression model (ME) of the longitudinal dataset to explore the best predictors of QoL. RESULTS: A total of 228 patients were followed over 873 appointments/observations. DAPsA, cDAPsA and HAQ were stable and highly significant predictors of EQ-5D utilities in both cross-sectional and longitudinal analyses. The best prediction was provided using a linear ME with HAQ and cDAPsA or DAPsA. A HAQ increase of 1 point represented a decrease in EQ-5D by -0.204 or -0.203 (p < 0.0001); a one-point increase in cDAPsA or DAPsA dropped EQ-5D equally by -0.005 (p < 0.0001). The ME revealed steeper and more accurate association compared with cross-sectional regressions or non-linear models/transformations. CONCLUSIONS: This is the first mapping study conducted in PsA and we hope that our study will encourage further mapping studies in PsA. The results showed that in cases where CRP is absent, cDAPsA provides similar results to DAPsA in predicting QoL.

Characteristics and risk profile of psoriasis patients included in the Czech national registry BIOREP and a comparison with other registries.

BACKGROUND: BIOREP is a Czech registry of psoriatic patients on biological treatment in a clinical setting. We describe the characteristics of patients with psoriasis at the time of enrollment and present comparisons with published data from other national registries. METHODS: We analyzed the cohort of patients treated with biologics between May 2005 and May 2015. Demographic data, previous therapies, comorbidities, and severity of psoriasis were compared with data from other registries - DERMBIO, BIOBADADERM, BADBIR, and PSOBEST. RESULTS: A total of 1412 psoriatic patients initiating biological treatment were included with a predominance of males (63.4%). The mean patient age was 50.2 years, and approximately 70.5% of patients were either overweight or obese. The mean baseline Psoriasis Area and Severity Index was 19.8, and the Dermatology Life Quality Index was 16.6. More than one-third of patients (41.0%) reported a history of psoriatic arthritis, and a high proportion of patients (49.5%) with cardiovascular risk factors (hypertension [35.2%], hyperlipidemia [27.7%], diabetes mellitus [11.4%], coronary heart disease [4.9%], and obesity [15.2%]) were observed. Most of the patients had been previously treated with phototherapy (85.4%), acitretin (74.0%), methotrexate (65.7%), or cyclosporine (53.1%). CONCLUSION: BIOREP is one of the first registries of patients with psoriasis treated with biologics in Central and Eastern Europe. Our results found a similar or higher prevalence of comorbidities, long disease duration, and high impact on the quality of life among patients included in Western European registries.

Cost-of-illness analysis and regression modeling in cystic fibrosis: a retrospective prevalence-based study.

BACKGROUND: Economic data pertaining to cystic fibrosis (CF), is limited in Europe generally, and completely lacking in Central and Eastern Europe. We performed an analysis of all direct costs associated with CF relative to key disease features and laboratory examinations. METHODS: A retrospective prevalence-based cost-of-illness (COI) study was performed in a representative cohort of 242 CF patients in the Czech Republic, which represents about 65 % of all Czech CF patients. Medical records and invoices to health insurance companies for reference year 2010 were analyzed. RESULTS: The mean total health care costs were €14,486 per patient, with the majority of the costs going towards medicinal products and devices (€10,321). Medical procedures (€2676) and inpatient care (€1829) represented a much smaller percentage of costs. A generalized linear model showed that the strongest cost drivers, for all cost categories, were associated with patient age and lung disease severity (assessed using the FEV1 spirometric parameter), when compounded by chronic Pseudomonas aeruginosa airway infections. Specifically, maximum total costs are around the age 16 years; a FEV1 increase of 1 % point represented a cost decrease of: 0.9 % (medicinal products), 1.7 % (total costs), 2.8 % (procedures) and 7.0 % (inpatient care). CONCLUSIONS: COI analysis and regression modeling using the most recent data available can provide a better understanding of the overall economic CF burden. A comparison of our results with other methodologically similar studies demonstrates that although overall costs may differ, FEV1 can nonetheless be utilized as a generally transferrable indicator of the relative economic impact of CF.

Mapping the relationship between clinical and quality-of-life outcomes in patients with ankylosing spondylitis.

AIM: To map health-related quality of life (Qol) with clinical parameters BASFI and ASDAS-CRP measure, and other covariates. METHODS: Our prospective multicenter non-interventional observation study of ankylosing spondylitis (AS) collected data about QoL and clinical outcomes on the initial and four subsequent visits. We employed simple linear regression analysis of a cross-sectional dataset, and fixed effect, random effect and pooled linear regression of a longitudinal dataset. RESULTS: We showed that BASFI and ASDAS-CRP are very strong, robust predictors of EQ-5D utilities in all regression specifications together with sex (female), invalidity, and activity impairment. Additionally, the longitudinal regression analysis showed that a fixed effect model may be a viable alternative to the most commonly used random effect model or pooled linear regression due to the nature of our dataset. CONCLUSION: This is one of the first studies using a fixed effect model in longitudinal patient-level data, although, this method has been widely used in economics.