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1.
J Eur Acad Dermatol Venereol ; 38(1): 157-166, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37611262

RESUMO

BACKGROUND: The German S2k guideline is the first to include a checklist that captures atopic dermatitis (AD) signs and symptoms as well as the lack of treatment response to identify patients eligible for systemic therapy. OBJECTIVES: Identifying candidates for a start/switch of systemic therapy in adult AD patients in Germany by applying the S2k guideline's checklist. METHODS: In this German multicentre, cross-sectional, non-interventional study (German Clinical Trials Register number: DRKS00023296), adult patients with mild to severe AD were enrolled at dermatological outpatient clinics and offices between April and October 2021. Demographics, clinical characteristics and quality of life were collected using questionnaires during one single visit. Eligibility for a start/switch of systemic AD therapy was evaluated according to the criteria of the German S2k guideline's checklist. RESULTS: Atopic dermatitis patients (575) were included in the analysis. One hundred and sixty-four patients (28.5%) received systemic (SYS) AD therapy and 411 patients (71.5%) did not (TOP). Of the TOP therapy patients, 38.7% were eligible to start systemic AD therapy, and about half of those (49.1%), were scheduled to start systemic AD therapy. The most frequent reason deciding against a systemic therapy was the patient's wish. Although 29.3% of SYS patients were eligible for a switch according to the criteria of the German S2k guideline's checklist, the majority (81.3%) did not switch AD therapy. CONCLUSIONS: This is the first study on the implementation of the German S2k guideline's checklist in everyday care of AD patients in Germany. More than one-third of the TOP patients were identified as eligible for systemic treatment. By applying the guideline's checklist criteria, another one-third of SYS patients may have benefited from a change of current systemic therapy. The use of the German S2k guideline's checklist in routine care represents an important tool to ensure effective patient care and identify inadequately treated patients.


Assuntos
Dermatite Atópica , Adulto , Humanos , Dermatite Atópica/terapia , Lista de Checagem , Estudos Transversais , Qualidade de Vida , Alemanha , Índice de Gravidade de Doença
2.
Artigo em Inglês | MEDLINE | ID: mdl-38572773

RESUMO

BACKGROUND: Brodalumab, a fully human monoclonal immunoglobulin IgG2 antibody that binds the human interleukin 17 receptor subunit A, is available for the treatment of moderate-to-severe plaque psoriasis in Europe since September 2017, but so far there are only a few studies on its use in real-world conditions. OBJECTIVES: To assess the management of moderate-to-severe psoriasis with brodalumab 210 mg in daily practice after 12 and 52 weeks (W). In addition, patient profiles and treatment pathways are described. METHODS: LIBERO is a prospective, multicenter, non-interventional study including adult patients with plaque psoriasis treated with brodalumab 210 mg. RESULTS: In total, 638 patients (65% male, mean age: 49.3 ± 14.4 years) from 148 sites in Germany were enrolled. The majority suffered from severe (51.1%) or very severe (13.1%) psoriasis according to physician global assessment (PGA0-5). When starting with brodalumab, 58.5% were biologic naïve and 41.5% were previously treated with another biologic, mainly adalimumab (18.5%) and secukinumab (17.9%). About 74.0% of patients met the primary endpoint of an absolute PASI ≤3 at ~W12 (n = 618, LOCF). The mean PASI was reduced significantly as of ~W2 from 17.2 (±11.7) to 9.7 (±8.8) and improved further to 3.3 (±6.3) at ~W12 (p < 0.001). At ~W52 85.5% of patients reached a PGA0/1-response (primary endpoint) and 54.1% patients were assessed as completely clear (PGA0) (both n = 399, as observed). Effectiveness of brodalumab was confirmed in relevant subgroup analysis by previous treatment regimen. Most frequently reported adverse events were nasopharyngitis (4.6%), psoriasis (4.6%) and arthralgia (4.1%), new safety signals were not detected. CONCLUSION: This representative, non-interventional study confirms the short- and long-term effectiveness and safety profile of brodalumab in the management of psoriasis in daily practice as well as in relevant treatment pathways.

3.
J Eur Acad Dermatol Venereol ; 36(10): 1796-1804, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35696305

RESUMO

BACKGROUND: Randomized controlled trials of secukinumab have shown sustained efficacy and a favourable safety profile in multiple manifestations of psoriatic disease. OBJECTIVES: To assess the long-term, real-world retention, effectiveness and safety of secukinumab in routine clinical practice for the treatment of moderate-to-severe plaque-type psoriasis (PsO). METHODS: SERENA (CAIN457A3403) is a large, ongoing, longitudinal, observational study conducted at 438 sites and 19 countries for an expected duration of up to 5 years in adult patients with moderate-to-severe PsO, psoriatic arthritis and ankylosing spondylitis. Patients received ≥16 weeks of secukinumab treatment before enrolment. This interim analysis presents data from PsO patients, who were enrolled in the study between October-2016 and October-2018 and were observed for ≥2 years. RESULTS: In total, 1756 patients (67.3% male) with a mean age of 48.4 years and body mass index of 28.8 kg/m2 were included in the analysis. The secukinumab treatment retention rates after 1, 2 and 3 years in the study were 88.0%, 76.4% and 60.5%, respectively. Of the 648 patients who discontinued the study, the most common reasons included lack of efficacy (42.6%), adverse event (17.4%), physician decision (12.2%) and subject decision (11.6%). Mean ± SD absolute PASI was 21.0 ± 13.0 at the start of treatment (n = 1,564). At baseline, the mean ± SD PASI score reduced to 2.6 ± 4.8 and remained low at Year 1 (2.3 ± 4.3), Year 2 (1.9 ± 3.6) and Year 3 (1.9 ± 3.5). The safety profile of secukinumab during the SERENA study was consistent with its known safety profile, with no new safety signals reported. Particularly, low rates of inflammatory bowel disease (0.3%; Incidence Rate [IR]:0.15), candida infections (3.1%; IR:1.43) and MACE (0.9%; IR:0.37) were observed. CONCLUSIONS: Secukinumab showed high treatment persistence, sustained effectiveness and a favourable safety profile up to 3 years of follow-up in the real-world population of PsO patients observed in SERENA.


Assuntos
Anticorpos Monoclonais , Psoríase , Adulto , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/induzido quimicamente , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Resultado do Tratamento
4.
J Eur Acad Dermatol Venereol ; 36(3): 413-421, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34743344

RESUMO

BACKGROUND: Atopic dermatitis (AD) is a chronic inflammatory skin disease with a multifactorial genesis including genetic predispositions and environmental risk and trigger factors. One of the latter possibly is smoking, indicated by an increased prevalence of AD in adults and children that are actively or passively exposed to cigarette smoke. OBJECTIVES: In this study, AD characteristics and its atopic comorbidities are compared in smoking and non-smoking AD patients. METHODS: TREATgermany is a non-interventional clinical registry which includes patients with moderate to severe AD in Germany. Baseline data of patients included in TREATgermany from inception in June 2016 to April 2020 in 39 sites across Germany was analysed comparing AD disease characteristics and comorbidities in smokers vs. non-smokers. RESULTS: Of 921 patients, 908 (male: 58.7%) with a mean age of 41.9 ± 14.4 reported their smoking status. The objective Scoring of Atopic Dermatitis (oSCORAD) did not differ between smokers (n = 352; 38.8%) and non-smokers, however, lesions' intensity of oozing/crusts and excoriations as well as patient global assessment scores (PGA) of AD severity were higher in smoking as opposed to non-smoking patients. Smokers reported a lower number of weeks with well-controlled AD and more severe pruritus than non-smokers. Total IgE levels were more elevated in smokers and they displayed a younger age at the initial diagnosis of bronchial asthma. After adjustment for potential confounders, the increased intensity of oozing/crusts, the reduced number of weeks with well-controlled AD and the greater pruritus remained different in smokers compared to non-smokers. In addition, smoking patients with adult-onset AD showed a 2.5 times higher chance of involvement of the feet. CONCLUSIONS: German registry data indicate that AD patients who smoke have a higher disease burden with a different distribution pattern of lesions in adult-onset AD.


Assuntos
Dermatite Atópica , Eczema , Adulto , Criança , Dermatite Atópica/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Prurido , Sistema de Registros , Índice de Gravidade de Doença
5.
Hautarzt ; 73(1): 27-39, 2022 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-34821976

RESUMO

BACKGROUND: Psoriasis (Pso) and atopic dermatitis (AD) are chronic skin diseases that result in significant physical and psychological impairment, financial burden, and loss of quality of life. According to previous data, there are regional differences in healthcare. OBJECTIVES: The aim was to analyse the epidemiology as well as the treatment of insured people with Pso and AD in Germany in a regional comparison. METHODS: Data of the insurance company Techniker Krankenkasse for the year 2019 regarding treatment prevalences as well as drug prescriptions on the regional level for all physicians were examined. RESULTS: In 2019 the overall prevalence of Pso was 2.5% (about 2 million insured people in Germany) and AD was 4.2% (about 3.6 million insured people). In Pso, new guideline-compliant drugs were frequently utilised, yet systemic glucocorticosteroids (GCS) were still disproportionally prescribed. Regionally, there were pronounced disparities with higher prescription rates of the new drugs in the north and east. Insured people with AD most frequently received topical GCS (approx. 88%), of which most were class III (66%), and significantly less frequently calcineurin inhibitors (< 10%), which also conform to guidelines. Systemically, GCS were by far most commonly used (about 25% of all insured people with drug prescriptions). Dupilumab, the only long-term drug approved in 2019, was very rarely prescribed, accounting for less than 1%. Again, large regional differences similar to Pso were found. CONCLUSION: Pso and AD show relevant disparities and gaps in drug care in the regional comparison despite uniform national guidelines and patient needs. The barriers to appropriate modern pharmaceuticals need to be clarified and mitigated.


Assuntos
Dermatite Atópica , Eczema , Psoríase , Atenção à Saúde , Dermatite Atópica/diagnóstico , Dermatite Atópica/tratamento farmacológico , Dermatite Atópica/epidemiologia , Alemanha/epidemiologia , Humanos , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Psoríase/epidemiologia , Qualidade de Vida
6.
J Eur Acad Dermatol Venereol ; 35(7): 1536-1542, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33714231

RESUMO

BACKGROUND: In the study series PsoHealth first data from 2004/05 showed a poor quality of health care for psoriasis in Germany. Most patients lacked sufficient care and only a minor proportion received systemic drugs. Since 2007, a national psoriasis programme has been conducted. OBJECTIVES: (1) To analyse the quality of health care for psoriasis in the most recent PsoHealth4 survey 2016/17, (2) to compare health care quality indicators with prior assessments since 2004/05. MATERIALS AND METHODS: The recent cross-sectional PsoHealth4 survey was conducted 2016/17, and three preceding studies were performed in 2004/05, 2007 and 2013/14, each including at least 1500 patients. The common set of quality indicators included disease severity (PASI and proportion of patients with PASI > 20, indicating high severity), quality of life (DLQI and proportion of patients with DLQI > 10, indicating strong impairments in quality of life), systemic therapy and inpatient treatment of the last five years. RESULTS: Between December 2015 and December 2017, n = 1827 patients from 93 dermatological centres were included in the most recent survey (mean age: 50.8 ± 14.6 years, 45.2% female). 7.3% showed a PASI > 20, compared to 17.8% in 2004/05. 21.4% reported a DLQI > 10, compared to 34.0% in 2004/05. 57.6% of all participants stated to have received a systemic therapy at least once within the last five years, compared to 32.9% in 2004/05. 18.0% received inpatient hospital treatment at least once within the last five years, compared to 26.9% in 2004/05. CONCLUSION: A remarkable improvement in the health care quality for psoriasis patients in Germany within the past 12 years can be assumed. Major determinants could be the innovation shift which included programmes such as the S3 guideline, a consensus on treatment goals, national health care goals for psoriasis and higher utilisation of innovative drugs.


Assuntos
Psoríase , Qualidade de Vida , Adulto , Idoso , Estudos Transversais , Atenção à Saúde , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/tratamento farmacológico , Psoríase/epidemiologia , Índice de Gravidade de Doença
7.
J Eur Acad Dermatol Venereol ; 34(2): 310-318, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31541554

RESUMO

BACKGROUND: Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate-to-severe psoriasis. Trial protocols specify transition periods and prohibit concomitant psoriasis medication. Data are therefore needed on secukinumab effectiveness and safety in routine clinical practice. OBJECTIVES: The PROSPECT study assesses prior and concomitant psoriasis treatments and transition periods in subjects receiving secukinumab. Here, we report interim effectiveness and safety data for secukinumab in the context of prior and concomitant treatments. METHODS: PROSPECT is an ongoing 24-week, single-cohort, non-interventional study. Subjects with moderate-to-severe psoriasis with a decision to receive secukinumab 300 mg were included. RESULTS: Of 1988 subjects, 1238/1988 (62.4%) were male, and mean age was 48.1 ± 13.7 years. Mean baseline Psoriasis Area and Severity Index (PASI) score was 17.7 ± 12.5. 90.9% of subjects had prior systemic treatment. Concomitant treatment was recorded in 44.3% of subjects. Median duration of transition period was 14.0, 30.0 and 44.5 days from prior topical, conventional systemic and biologic treatments. At Week 24, PASI75/90/100 was reached by 86.1%, 68.5% and 39.7% of subjects who started secukinumab treatment at baseline. No unexpected safety signals were observed. CONCLUSION: PROSPECT provides a large prospective real-world analysis of secukinumab treatment and includes prior and concomitant use of psoriasis treatments in subjects receiving secukinumab in a real-world setting. Secukinumab effectiveness and safety were comparable to that seen in the phase 2/3 secukinumab clinical trial programme.


Assuntos
Anticorpos Monoclonais Humanizados , Psoríase , Adulto , Anticorpos Monoclonais Humanizados/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Psoríase/tratamento farmacológico , Índice de Gravidade de Doença , Resultado do Tratamento
8.
J Eur Acad Dermatol Venereol ; 34(6): 1263-1272, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31721316

RESUMO

BACKGROUND: The Atopic Dermatitis (AD) TREATgermany registry was initiated by the German Society for Dermatology (DDG) in 2011 to evaluate the 'real-life' situation of health care for patients with AD. OBJECTIVES: Interim data analysis on baseline characteristics as well as current and prescribed systemic treatments of the TREATgermany registry patients. METHODS: Patients (≥18 years) with moderate-to-severe AD [objective (o)SCORAD > 20], or with current or previous anti-inflammatory systemic treatment for AD within 24 months, were included and are followed up over at least 24 months. To assess clinical signs, the eczema area severity index (EASI, 0-72), the oSCORAD (0-83) and the Investigator Global Assessment (IGA; 6-point scale) were used. The disease severity was globally scored by the patients [Patient Global Assessment (PGA); six-step Likert scale]. Disease symptoms were assessed by the patient-oriented eczema measure (POEM, 0-28) and numeric rating scales (NRS, 0-10). Health-related quality of life was measured using the dermatological life quality index (DLQI, 0-30). RESULTS: A total of 612 patients were recruited across 32 sites between 06/2016 and 01/2019 (mean age: 42.6 ± 14.2 years; mean oSCORAD: 40.8 ± 16.3). The mean POEM score was 16.3 ± 7.5. Pruritus was rated highest among subjective symptoms (NRS: 5.4 ± 2.7). The mean DLQI value was 11.3 ± 7.5. The frequency of arterial hypertension was lower (20.8%) compared with the general population, whilst this was higher for depression (10%). More than 60% of the patients had received systemic glucocorticosteroids, and 36.8% had received cyclosporine A prior to inclusion. Dupilumab was the leading substance documented as either 'current' (12.1%) or 'prescribed' (31.4%) at baseline. CONCLUSIONS: These 'real-life' data clearly demonstrate the substantial disease burden. Most of TREATgermany patients were already treated with or prescribed dupilumab at baseline. Moreover, current findings indicate the urgent need for further alternative agents in order to achieve a perceptible improvement of quality of life of patients with moderate-to-severe AD.


Assuntos
Dermatite Atópica , Eczema , Adulto , Dermatite Atópica/tratamento farmacológico , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , Sistema de Registros , Índice de Gravidade de Doença
9.
J Eur Acad Dermatol Venereol ; 33(11): 2202-2208, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31087405

RESUMO

BACKGROUND: Even today, a substantial number of individuals with visible skin diseases still suffer from incomprehension and stigmatization. About 10 million people are affected by such diseases in Germany. The WHO strongly urges member states to take measures against stigmatization in skin diseases. OBJECTIVES: Objectives are the development of an action programme to raise awareness and address stigmatization. Therefore, conception, development and testing of interventions for the destigmatization of persons with skin diseases in Germany will be carried out. METHODS: A series of actions addressing decision makers, politicians and the Federal Ministry of Health were initiated, all based on the World Health Assembly (WHA). Argumentation was largely based on data from health services research. Supported by the Federal Ministry of Health, a concept against stigmatization was developed by an expert consortium of researchers, dermatologists and patients. Specific strategies of structured destigmatization between those affected and those not will be developed and scientifically evaluated. RESULTS: The activities addressed to politics were - to a large extent - successfully and financially supported by a 3-year programme (2018-2020), designed to develop interventions against stigma. It was funded by the Federal Ministry of Health. The project includes conception and development, intervention and evaluation, data analyses and development of a long-term concept. CONCLUSIONS: The WHO's call against stigmatization in psoriasis (resolution WHA67.9 and global report on psoriasis 2016) was taken into account and developed into a destigmatization programme supported by the German government and German politicians. This has been achieved by successful collaborations between dermatologists, researchers, patients and policymakers. Next step will be the testing of interventions in situations and surroundings, where stigmatization usually occurs. The data will be used for the implementation of a long-term concept that can be used to continue destigmatization in Germany far beyond the project's initial phase.


Assuntos
Dermatopatias , Estereotipagem , Organização Mundial da Saúde , Doença Crônica , Alemanha , Humanos , Desenvolvimento de Programas , Psoríase
10.
J Eur Acad Dermatol Venereol ; 33(4): 700-708, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30388318

RESUMO

BACKGROUND: Though patient needs are key drivers of treatment decisions, they are rarely systematically investigated in routine care. OBJECTIVE: This study aimed at analysing needs and expectations from the patient perspective in the German and Swiss psoriasis registries PsoBest and Swiss Dermatology Network of Targeted Therapies (SDNTT) with respect to treatment choice, age and gender. METHODS: The German and Swiss psoriasis registries observe patients recruited at first-time use of systemic drugs. Within 10 years, clinical [Psoriasis Area Severity Index (PASI), Body Surface Area (BSA)] and patient-reported outcomes are documented, including the Dermatology Quality of Life Index (DLQI) and the Patient Benefit Index (PBI), characterizing patient needs for treatment. The analysis data set includes n = 4894 patients from PsoBest and n = 449 from SDNTT with mean follow-up time of 7.5 months. RESULTS: A total of 5343 patients registered between 2008 and 2016 were included in the analyses (at baseline: 59.6% male, mean age 47.6 years ± 14.5, PASI 14.2 ± 9.7, BSA 22.7 ± 19.7, DLQI 11.3 ± 7.2). The most important patient needs were to 'get better skin quickly' and to 'be healed of all skin defects'. Subgroup analyses by age revealed significant differences in needs, especially higher needs regarding social impairments in patients younger than 65 years. Patients 65 years or older attributed more importance to sleep quality, less dependency on medical visits, fewer side-effects and confidence in the therapy. Out of 25 items reflecting patient needs, 20 items were rated significantly more important by women than men, with the greatest differences regarding feeling of depression, sleep quality and everyday productivity. Divided by treatment, needs were rated differently, recommending individualized and targeted choice of therapy. CONCLUSION: Age and gender stratify patient needs. Women showed higher expectations and rated specific needs in psoriasis treatment higher than men. Analysing the patient needs on an individual level will facilitate shared decisions by patient and physician in finding the optimal personalized treatment.


Assuntos
Fármacos Dermatológicos/uso terapêutico , Necessidades e Demandas de Serviços de Saúde , Planejamento de Assistência ao Paciente , Preferência do Paciente , Psoríase/tratamento farmacológico , Adulto , Fatores Etários , Depressão/etiologia , Fármacos Dermatológicos/efeitos adversos , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação das Necessidades , Psoríase/psicologia , Sistema de Registros , Fatores Sexuais , Sono , Participação Social , Suíça
11.
Br J Dermatol ; 179(6): 1385-1391, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30334253

RESUMO

BACKGROUND: Assessment of disease severity is an essential component of psoriasis management. Moderate-to-severe disease qualifies for systemic treatment but different definitions are used. OBJECTIVES: To analyse the impact of different severity definitions for psoriasis in real-world healthcare. METHODS: Cross-sectional data on 3274 patients with psoriasis from more than 200 dermatology offices and clinics across Germany were analysed for disease severity based on Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). The proportions of patients having moderate-to-severe disease were determined accordingly. RESULTS: The proportion of patients meeting the European consensus criteria for moderate-to-severe psoriasis (PASI AND DLQI > 10) was 14·0%, although 45·3% attained at least PASI OR DLQI > 10. Consideration of all patients on systemic drugs as being 'moderate-to-severe' increased these proportions to 56·9% and 75·2%, respectively. When only PASI > 10 was used, moderate-to-severe disease affected 35·3% and 69·3%, respectively. CONCLUSIONS: The proportion of patients with psoriasis under dermatological care considered to have moderate-to-severe disease varies considerably according to how the latter is defined, resulting in uncertainty and inequity of access to systemic therapy. We propose an international standardisation in this for the sake of more reliable treatment and healthcare planning.


Assuntos
Fármacos Dermatológicos/uso terapêutico , Assistência de Longa Duração/normas , Guias de Prática Clínica como Assunto , Psoríase/diagnóstico , Índice de Gravidade de Doença , Adulto , Idoso , Tomada de Decisão Clínica/métodos , Consenso , Estudos Transversais , Dermatologia/normas , Feminino , Alemanha , Humanos , Assistência de Longa Duração/métodos , Masculino , Pessoa de Meia-Idade , Psoríase/tratamento farmacológico , Qualidade de Vida
12.
J Eur Acad Dermatol Venereol ; 32(3): 411-419, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28960469

RESUMO

BACKGROUND: Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe psoriasis. However, as per study protocols, transition periods from prior psoriasis treatments of a defined minimal length were required and use of concomitant psoriasis medication was prohibited. There is therefore a lack of data on the effect of shorter transition periods and concomitant psoriasis treatment with other pharmacologically active substances on the effectiveness and safety of secukinumab in routine clinical practice. OBJECTIVES: The PROSPECT study was designed to assess prior and concomitant use of psoriasis treatments in subjects receiving secukinumab and the duration of transition periods from prior treatments to secukinumab. Here, we report the baseline characteristics and the duration of transition period in an interim analysis of the first 805 subjects. METHODS: PROSPECT is an ongoing 24-week, single-cohort, non-interventional study. Subjects with moderate to severe psoriasis with a decision to receive secukinumab were included. RESULTS: The majority of subjects were male (491/796, 61.7%), with a mean age of 47.7 years (SD 13.7). The baseline Psoriasis Area and Severity Index (PASI) was available for 92.4% (744/805) of subjects, and mean baseline PASI was 17.5 (SD 13.1); 93.4% (752/805) of subjects had signs of high disease severity. Use of concomitant treatment increased with the number of signs. Within the last 12 months prior to inclusion, 10%, 40%, and 28% of subjects had received topical, conventional systemic, or biologic treatments as their last prior psoriasis therapy, respectively, and 22% of subjects had not received any psoriasis therapy. Discontinuation of prior treatment due to adverse events was high in subjects with conventional systemic treatment (93/413, 22.5%) compared to biologic treatment (5/210, 2.4%). The median duration of the transition period was 14.0, 30.5, and 38.0 days for prior topical, conventional systemic, and biologic treatments, respectively. CONCLUSION: PROSPECT is the first study to investigate prior and concomitant use of psoriasis treatments in subjects receiving secukinumab in a real-world setting. The majority of the subjects had a high disease burden and use of concomitant treatment increased with disease severity. The duration of the transition period depended on prior treatment.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Psoríase/tratamento farmacológico , Adulto , Anticorpos Monoclonais Humanizados , Quimioterapia Combinada , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Psoríase/fisiopatologia , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento , Suspensão de Tratamento
13.
Hautarzt ; 69(10): 815-824, 2018 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-30191254

RESUMO

BACKGROUND: Clinical registries may provide high-quality evidence on the use and effectiveness of therapeutic interventions under real-life conditions. Adults with moderate-to-severe atopic eczema (atopic dermatitis [AD]) are enrolled into TREATgermany and prospectively followed over at least 2 years. This paper analyses the association between dermatological quality of life and work limitations. MATERIALS AND METHODS: Treatment modalities and a broad set of physician- and patient-reported outcome measures are documented using validated instruments to assess clinical disease severity (EASI [Eczema Area and Severity Index], objective SCORAD [objective-SCORing Atopic Dermatitis]), quality of life (DLQI [Dermatology Life Quality Index]), symptoms (POEM [Patient-oriented Eczema Measure]), global disease severity, as well as patient satisfaction and work limitations including presenteeism (WLQ [Work Limitation Questionnaire]). From 06/2016 until 12/2017, 241 individuals (mean age 43 ± 15 years, 38.6% female) were enrolled at 19 recruitment centers; 69% of the patients were employed. RESULTS: Employed persons had DLQI and WLQ scores of 10.6 ± 6.9 points and 17.7 ± 18.1%, respectively. Mean presenteeism was substantial accounting for 9.2%. With coefficients of 0.39 and 0.33 WLQ and presenteeism scores significantly correlate with DLQI (p < 0.000). Bootstrapped regression models showed that the limitations in coping with work requirements increase by 1.7% as DLQI increases by one point. Lower quality of life due to AD is most strongly associated with limitations in the area of physical and performance requirements in general. Presenteeism increases by 0.5% as DLQI increases by one point. CONCLUSION: Moderate-to-severe AD has substantial adverse economic impact with mean productivity loss of patients of almost 10%. Future analyses from TREATgermany will address the impact of innovative treatment modalities on quality of life and work productivity of patients with moderate-to-severe AD.


Assuntos
Competência Clínica , Dermatite Atópica , Eczema , Sistema de Registros , Adulto , Dermatite Atópica/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Índice de Gravidade de Doença
18.
Arch Dermatol Res ; 308(6): 389-400, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27048503

RESUMO

In 2005, the first national psoriasis survey in Germany revealed large deficits in health care particularly in patients with moderate to severe disease. The consecutive goal was to improve health care for psoriasis countrywide. For this, a large-scale national program was initiated starting with a comprehensive analysis of structures and processes of care for psoriasis. Patient burden, economic impact and barriers to care were systematically analyzed. In order to optimize routine care, a S3 guideline, a set of outcomes measures and treatment goals, were developed. Implementation was enforced by the German Psoriasis Networks (PsoNet) connecting the most dedicated dermatologists. The annual National Conference on Health Care in Psoriasis established in 2009 consented National Health Care Goals in Psoriasis 2010-2015 and defined a set of quality indicators, which are monitored on a regular basis. Currently 28 regional networks including more than 800 dermatologists are active. Between 2005 and 2014 7 out of 8 quality indicators have markedly improved, and regional disparities were resolved. e.g., mean PASI (Psoriasis Area Severity Index) dropped from 11.4 to 8.1 and DLQI (Dermatology Life Quality Index) from 8.6 to 5.9. A decade of experience indicates that a coordinated nationwide psoriasis program based on goal orientation can contribute to better quality of care and optimized outcomes.


Assuntos
Programas Nacionais de Saúde , Psoríase/epidemiologia , Indicadores de Qualidade em Assistência à Saúde , Alemanha/epidemiologia , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Guias de Prática Clínica como Assunto , Avaliação de Programas e Projetos de Saúde , Psoríase/terapia , Melhoria de Qualidade
19.
Dig Dis Sci ; 46(5): 939-44, 2001 May.
Artigo em Inglês | MEDLINE | ID: mdl-11341662

RESUMO

Regulation of gallbladder motility is complex. Mechanisms via which cisapride may interact with gallbladder function are being reviewed. These are multiple and include direct effects on gallbladder and the sphincter of oddi, as well as indirect effects involving gastro-intestinal hormone levels, gastric emptying, gallbladder refilling, interdigestive migrating motor cycle (IMMC) and small intestinal transit. Effects, moreover, may vary according to dose, route and duration of cisapride administration, which may explain conflicting data so far with cisapride.


Assuntos
Cisaprida/farmacologia , Vesícula Biliar/efeitos dos fármacos , Vesícula Biliar/fisiologia , Fármacos Gastrointestinais/farmacologia , Esvaziamento Gástrico/fisiologia , Hormônios Gastrointestinais/fisiologia , Humanos
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