database including approximately 6.7 million insured anonymities originating from 63 statutory health insurances. Analyses were performed by the InGef institute. A sample with approximately 4 million insured persons was drawn and stratified by age and gender according to the official demographic structure of the German statutory health insured population (DeStatis, Dec 31st, 2013). Patient data from 2012 -2016 were included if they met the following conditions: Main diagnosis of PsO (ICD-10 code L40.-), and start / maintenance / switch of treatment with PsO approved biological agent(s) (at least for three months). The study evaluated hospital admission, change in medication and direct medical costs (drug, outpatient care, hospitalization). Results: Leading biological agents for 1st line treatment of PsO are adalimumab and apremilast, however, at a low level of share of prescriptions. Adalimumab and etanercept are administered mostly to patients already on treatment (in 2015 adalimumab 40.4 % vs. etanercept 26.6 %). The total costs of the included 2'041 patients add up to € 36'874'827 in 2015. The total number of patients, the number of hospital admissions and the total treatment costs including all individual cost items grew yearly on average between 1. 7% and 14.5 % (2012 -2015). Hospitalization per patient declined slightly from 0.8 to 0.7. ConClusions: Adalimumab, apremilast and etanercept are those biological agents mainly used for treating PsO. All cost items grew steadily over the last 4 years. Total costs in 2015 were € 36.9 million (on average € 18'067 per patient).
Background The Public Health System in our Autonomous Community has established a protocol for biological treatments (BTs) in rheumatoid arthritis (RA), spondyloarthropathies (SAPs) and juvenile idiopathic arthritis (JIA). Purpose To evaluate the implementation of the BTs protocol and to analyse the use of these treatments. Materials and MethodsWe analysed patients who had started treatment with BT or been switched from a previous biological treatment, since the implementation of the protocol (12/05/2011 to 29/02/2012). This document has different levels of decision based on both disease status and treatment effectiveness; RA: 1st level: infliximab or subcutaneous tumour necrosis factor inhibitor (anti-TNF) (etanercept or adalimumab); 2nd: tocilizumab or abatacept or rituximab; 3rd: golimumab or certolizumab pegol. SAPs: 1st level: infliximab or etanercept or adalimumab; 2nd: golimumab; 3rd: infliximab. JIA: 1st level: etanercept; 2nd: adalimumab or abatacept. Data collected: age, sex, diagnosis, drug used after protocol implementation, previous treatments and reasons for changing. Data Source: medical records, pharmacy database. Statistical analysis: SPSS 15.0. Results Of 455 patients receiving BT, 73 met the inclusion criteria: 53.4% were beginning their treatment, 46.6% were treatment changes. Median age: 51.1 (±11.5) years, 76.7% were women. The percentages by pathology and gender were: RA 56.9% (women: 95.1%), SAPs 43.1% (women: 51.6%) (p < 0.05). Patients starting treatment: RA: 52.7%, SAPs 47.3%. Administration routes and drugs used: RA: subcutaneous (95.0%) and etanercept (90.0%); SAPs: subcutaneous (94.5%) and etanercept (66.7%). Changes in treatment: RA 61.8%, SAPs 38.2%, drug used after switching: RA (adalimumab 33.3%, etanercept 28.6%, tocilizumab 14.3%, rituximab 9.5%), SAPs (golimumab 61.5%, adalimumab 30.8%, etanercept 7.7%). The reasons for switching were ineffectiveness (91.2%) and intolerance (8.8%). Conclusions The overall level of compliance with the protocol was high. The most widely prescribed drug in treatment-naive patients was etanercept. Adalimumab was the most prescribed in patients who switched treatment. Lack of effectiveness was the main reason for changing treatment. No conflict of interest.
Background Fampridine (4-aminopyridine) improves motor function in people with Multiple Sclerosis (MS). It is a new drug in Spain indicated for symptomatic improvement of walking in adults with several variations of the disease. Purpose To assess the effectiveness, recorded adverse events and adherence to fampridine in patients with MS. Materials and methods Retrospective study. Patients with MS and disability score (EDSS) between 4–7, treated with fampridine 10 mg/12 h from April 2012 to September 2013. Effectiveness assessment: timed 25-foot walk (T25FW) and 12-item multiple sclerosis walking scale (MSWS-12) at baseline, 15 days, 3,6,9 and 12 months, responder patient: T25FW decrease ≥20% and/or MSWS-12 ≥ 4–6 points from baseline. Safety assessment: adverse events recorded, visits to emergency services and hospitalisations. Adherence was assessed by the pharmacy dispensing ratio. Results 19 patients. Average age: 61.9 years, 68.4% women. 26.3% Relapsing Remitting MS, 31.6% Primary Progressive MS and 42.1% Secondary Progressive MS. EDSS, TW25F and MSWS average baseline values: 5.92, 21.06 and 47.89 respectively. 3 patients discontinued treatment: 2 after 15 days and 1 after 9 months due to intolerance/ineffectiveness. At 15th day, (n = 17 (89%)), TW25F was 13.18 (average reduction 34.26%, 88.2% ≥ 20%) and MSWS-12 was 37.41 (70.6% ≥ 4–6 points reduction). 3 months later, (n = 17 (89%)), TW25F was 14.86 (average reduction 33.78%, 78.9% ≥ 20%) and MSWS-12 was 36.65 (82.4% ≥ 4 points reduction and 70.6% ≥ 6). After 1 year of treatment, (n = 16 (84%)), TW25F was 14.56 (average reduction 32.0%, 87.5% ≥ 20%) and MSWS-12 was 40.0 (62.5% ≥ 4–6 points reduction). Global average time reduction at 15 days, 3 and 12 months was 14.2 (average reduction 32.6%). After 1 year EDSS was 5.93. According to the recorded adverse events, 41.1% (7/17) of those who continued treatment after 15 days were hospitalised or visited emergency services, 23.5% (4/17) due to urinary tract infection and 23.5% because of dizziness falls (relationship drug/events not evaluated). Treatment adherence was 98.7% Conclusions Fampridine produces a clinical hold-in-time improvement in walking ability and mobility. After 1 year, from the whole patients, in 47% there was a reduction >20% in TW25F, together with a reduction in MSWS-12 >6. Fampridine was well tolerated. In our patients there was a global average of T25FW reduction of 14.2 sec (as a reduction of 32.6% of time), which means 47.2% faster. In the pivotal clinical trials (PCT) there was a 25% reduction.1,2 Our data are referred to a year of treatment and the two PCT just analysed 14 and 9 months respectively. Additional studies are warranted to assess possible explanations for these discrepancies. References Goodman AD, et al. Lancet 2009;373:732-738 Goodman AD, et al. Ann Neurology 2010;68:494-502 No conflict of interest.
Background Anaemia is a common complication of chronic kidney disease (CKD), and its correction with erythropoiesis-stimulating agents (ESAs) is associated with improved patient outcomes and quality of life. Purpose To evaluate the demographic and clinical characteristics of outpatients with CKD and anaemia, treated with epoetin alfa (EPO) or darbepoetin alfa (DARB). To compare the use of ESAs in predialysis patients. Materials and methods Descriptive observational study, including patients with CKD and treated with ESAs, recorded in our pharmacy outpatient database and treated with ESAs, from March to July 2011. Data collected: age, gender, GRF, cause of CKD, ESA prescribed, dosage of ESA; during the period the latest data of haemoglobin (Hb), serum ferritin level and transferrin saturation were recorded. Use of ESAs was assessed in the group of predialysis patients (stage 3 and 4 of CKD) with Hb levels between 10 and 12 g/dl (the current FDA and EMA targets). Results 476 patients were recorded (51.5% men, average age 69.4±15.6 years). 376 patients received EPO and 100 DARB. Hb levels: 10 to 12 g/dl (45.2%), < 10 g/dl (10.9%) and > 12 g/dl (43.9%). 18.4% of patients had Hb level >13 g/dl. CKD stages: stage 3 (30.6%), 4 (45.7%) and 5 (home dialysed patients) (19.2%). Subgroup of predialysis patients with Hb level between 10-12 g/dl: 155 patients (average age 70±16.4 years, 51% men), 77% with EPO and 23% DARB. Significant differences in EPO versus DARB patients were found in: average age (71.2 vs 65.0, p=0.04), men (55.5% vs 36.0%, p=0.04), the use of extended dosing (≥q 2 wk) (24.4% vs 66.7%, p<0.001). Mean weekly doses in each: 4986 IU (EPO) versus 25.88 mcg (DARB). Conclusions A high number of patients were above the safe limit (12 g/dl); action must be taken to improve the quality of pharmacotherapy. The dose ratio within EPO and DARB was 192:1.
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