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1.
Dermatology ; 239(2): 267-272, 2023.
Article in English | MEDLINE | ID: mdl-36476839

ABSTRACT

BACKGROUND: Health-related quality of life (HRQoL) assessment in patients with acne is recommended by several national guidelines. There are several acne-specific HRQoL instruments. OBJECTIVES: Participants of the European Academy of Dermatology and Venereology (EADV) Task Forces (TFs) on QoL and Patient Oriented Outcomes (PO) and Acne, Rosacea, and Hidradenitis Suppurativa (ARHS) agreed to scrutinize aspects of existing acne-specific HRQoL instruments for their relevance in international study. METHODS: Consensus agreement on items related to QoL was reached after an independent assessment by seven experts from the EADV TFs on QoL and PO, and a list of 97 items was prepared and proposed to a group of acne patients. In order to have data from patients to check if any important topics were overseen, another group of acne patients from participating countries was asked to list how acne influenced different aspects of their lives. RESULTS: Based on results obtained from 601 acne patients from nine countries, most of the items and topics showed low relevance for acne patients especially during the previous month or shorter time periods. Based on percentage of relevance and factor analysis, short (6 items) and long (45 items) lists of the most relevant topics were formed. CONCLUSION: Most of the items and topics from the initial list showed low relevance for acne patients. None of the identified acne-specific HRQoL instruments contain all the items that were deemed most relevant to acne patients. For this reason, participating members of the EADV TFs on QoL and PO, and ARHs are in the process of developing a new acne-specific HRQoL instrument.


Subject(s)
Acne Vulgaris , Hidradenitis Suppurativa , Rosacea , Humans , Quality of Life , Advisory Committees , Surveys and Questionnaires
2.
Health Sci Rep ; 5(2): e487, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35155828

ABSTRACT

BACKGROUND AND AIMS: It has been suggested that professional acne care can be effective not only in reducing clinical signs but also in improving quality of life (QOL). This study aims to reach a better understanding of the association between QOL and professional acne care. The study also investigates other factors that might influence QOL such as age, gender, and acne severity. METHODS: Between 2019 and 2020, a cross-sectional survey-based study was conducted among 362 acne patients. Data were collected by the Cardiff Acne Disability Index (CADI) and a Global QOL scale. Analysis of covariance (ANCOVA) and post hoc comparisons were conducted to analyze the association between professional acne care and health-related QOL. RESULTS: No statistically significant differences were found in QOL measured by CADI among patients visiting the four investigated acne caregivers (mean CADI score: dermatologist, 4.49; GPs, 4.42; dermal therapist, 4.07; beautician, 4.20, P = .24). However, the impact of the treatment on the QOL, which was measured by the level of Global QOL improvement before and after care, demonstrated a statistically significant improvement when attending a dermatologist, compared to the care provided by beauticians (Global QOL improvement: dermatologist, 1.50; GP, 1.01; dermal therapist, 1.10; beautician, 0.54, P = .05). Females experienced a more impaired acne-related QOL than males (P = .05), and increased acne severity was associated with a more impaired QOL (P < .05). CONCLUSIONS: This study delineated factors that influence QOL in acne patients. As the QOL was not associated with the type of caregiver, the greatest QOL improvement before and after care was achieved after medical treatment by the dermatologist. Females and individuals dealing with more severe types of acne experienced a more impaired acne-related QOL. It is recommended to take these factors into account in acne management to optimize professional treatment in line with patient needs.

3.
J Dermatolog Treat ; 33(4): 2209-2216, 2022 Jun.
Article in English | MEDLINE | ID: mdl-34192987

ABSTRACT

BACKGROUND: Despite the large availability of caregivers, there are no standardized care pathways for patients with acne. This increases the risk of ineffective care and unnecessary medicalizing. To better understand how to provide effective, efficient, and patient-satisfying care, it is necessary to gain insights into the patient journey through acne healthcare services. OBJECTIVE: To explore the patient journeys, assessed by a series of consecutive steps through acne healthcare. METHODS: A cross-sectional survey was conducted among Dutch individuals with acne. RESULTS: A total of 371 respondents completed the questionnaire. Data revealed 58 different pathways through acne healthcare services. Patient with severe acne had a stronger tendency to seek professional care than those with mild acne (p< .05). The highest proportion of clinically relevant improvement was found in patients treated by dermatologists, compared to respondents treated by beauticians, p = .023 and dermal therapists, p = .018. CONCLUSIONS: Mapping the patient journeys contributed to a better understanding of the gap between professional guidelines and the experiences of patients. Identifying these areas of care implies that there is potential to bring acne care services more in line with the patients' needs. Further research is recommended; for example by comparing the clinical treatment outcomes of multiple sequences of caregivers.


Subject(s)
Acne Vulgaris , Acne Vulgaris/drug therapy , Cross-Sectional Studies , Delivery of Health Care , Humans , Surveys and Questionnaires , Treatment Outcome
4.
J Dermatolog Treat ; 33(1): 195-203, 2022 Feb.
Article in English | MEDLINE | ID: mdl-32189533

ABSTRACT

BACKGROUND: Reflectance confocal microscopy (RCM) enables noninvasive Demodex mite detection in rosacea. Objective scoring of rosacea severity is currently lacking. OBJECTIVES: To determine the value of RCM for monitoring Demodex, inflammation and vascular parameters in rosacea during treatment. METHODS: In 20 rosacea patients, clinical and RCM examination were performed before, during, and 12 weeks after a 16-week treatment course with topical ivermectin. Using RCM, number of mites and inflammatory cells, epidermal thickness, and vascular density and diameter were measured. RCM features were correlated with clinical assessment. RESULTS: Treatment resulted in clinical reduction of inflammatory lesions. Mites were detected in 80% of patients at baseline, 30% at week 16, and 63% at week 28. The number of mites reduced significantly during treatment, but no changes in inflammatory cells, epidermal thickness or vascular parameters were observed. Correlation between number of inflammatory lesions and mites was low. None of the RCM variables were significant predictors for clinical success. CONCLUSIONS: RCM enables anti-inflammatory effect monitoring of topical ivermectin by determining mite presence. Quantifying exact mite number, and inflammatory and vascular characteristics is challenging due to device limitations. In its current form, RCM seems of limited value for noninvasive follow-up of rosacea in clinical practice.


Subject(s)
Mites , Rosacea , Animals , Humans , Inflammation , Ivermectin/therapeutic use , Microscopy, Confocal , Rosacea/diagnostic imaging , Rosacea/drug therapy
5.
BMC Health Serv Res ; 21(1): 746, 2021 Jul 27.
Article in English | MEDLINE | ID: mdl-34315450

ABSTRACT

BACKGROUND: A highly promoted opportunity for optimizing healthcare services is to expand the role of non-physician care providers by care reallocation. Reallocating care from physicians to non-physicians can play an important role in solving systemic healthcare problems such as care delays, hospital overcrowding, long waiting lists, high work pressure and expanding healthcare costs. Dermatological healthcare services, such as the acne care provision, are well suited for exploring the opportunities for care reallocation as many different types of care professionals are involved in the care process. In the Netherlands, acne care is mainly delivered by general practitioners and dermatologists. The Dutch healthcare system also recognizes non-physician care providers, among which dermal therapists and beauticians are the most common professions. However, the role and added value of non-physicians is still unclear. The present study aimed to explore the possibilities for reallocating care to non-physicians and identify drivers for and barriers to reallocation. METHODS: A mixed-method design was used collecting quantitative and qualitative data from representatives of the main 4 Dutch professions providing acne care: dermatologists, GP's, Dermal therapists and beauticians. RESULTS: A total of 560 questionnaires were completed and 24 semi-structured interviews were conducted. A broad spectrum of non-physician tasks and responsibilities were delineated. Interviewed physicians considered acne as a low-complexity skin condition which made them willing to explore the possibilities for reallocating. A majority of all interviewees saw a key role for non-physicians in counselling and supporting patients during treatment, which they considered an important role for increasing patients' adherence to proposed treatment regimes, contributing to successful clinical outcome. Also, the amount of time non-physicians spend on patients was experienced as driver for reallocation. Legislation and regulations, uncertainties about the extent of scientific evidence and proper protocols use within the non-physician clinical practice were experienced as barriers influencing the possibilities for reallocation. CONCLUSIONS: Delineated roles and drivers demonstrate there is room and potential for reallocation between physicians and non-physicians within acne healthcare, when barriers are adequately addressed.


Subject(s)
Acne Vulgaris , General Practitioners , Acne Vulgaris/therapy , Delivery of Health Care , Health Care Costs , Humans , Netherlands
6.
Ned Tijdschr Geneeskd ; 1652021 11 30.
Article in Dutch | MEDLINE | ID: mdl-35129895

ABSTRACT

BACKGROUND: Tinea corporis is a superficial fungal infection of the limbs, chest or back caused by dermatophytes. Local antifungal treatment is often sufficient to treat tinea corporis. Systemic treatment may be needed in more severe cases, in immunocompromised patients or when treatment failure is documented. Treatment failure is relative common and frequent causes are low compliance, low systemic antifungal drug concentrations, reduced penetration of topical agents or an immunocompromised status. Recently, antifungal resistance has been documented in dermatophytes. CASE DESCRIPTION: We describe a patient with terbinafine treatment failure caused by antifungal drug resistance. CONCLUSION: The frequency of terbinafine resistance in the Netherlands is unknown as no surveillance is performed. Recent reports from both India and European countries indicate that antifungal resistance should be considered in patients with terbinafine treatment failure.


Subject(s)
Tinea , Antifungal Agents/therapeutic use , Drug Resistance, Fungal , Humans , Terbinafine/therapeutic use , Tinea/drug therapy , Tinea/epidemiology , Tinea/microbiology , Treatment Failure
7.
Skin Res Technol ; 27(1): 15-23, 2021 Jan.
Article in English | MEDLINE | ID: mdl-32573826

ABSTRACT

BACKGROUND: Stratum corneum hydration (SCH) and transepidermal water loss (TEWL) provide useful information about skin barrier function. This study aimed to determine the value of GPSkin Pro, a new handheld device determining both SCH and TEWL, to measure skin barrier impairment and to monitor barrier function in rosacea in daily practice. MATERIALS AND METHODS: Two pilots were performed. Pilot 1: in 27 healthy participants, GPSkin SCH and TEWL were compared to Aquaflux® and Epsilon® values at the forearm before and after skin barrier perturbation via tapestripping. Moreover, GPSkin values were measured at both cheeks without intervention. Pilot 2: in 16 rosacea patients, GPSkin measurements were performed at the forearm, and at both cheeks before and during anti-inflammatory treatment. They were compared to clinical symptoms and to GPSkin values from pilot 1. RESULTS: Pilot 1: after merging data from before and after tapestripping, a strong correlation was observed between GPSkin TEWL and Aquaflux® (Rs  = 0.9256), and GPSkin SCH and Epsilon® (Rs  = 0.8798). Pilot 2: SCH was significantly lower at the cheeks of rosacea patients compared to controls, with a normalizing trend during successful treatment. TEWL was comparable among patients and controls and did not change during treatment at all locations. CONCLUSION: The GPSkin determines TEWL and SCH accurately in healthy and impaired skin barrier state and can monitor skin barrier function in rosacea during treatment. The GPSkin device is much more practical compared to previous skin barrier tools when used in clinical practice. Its further validation in other inflammatory skin diseases is recommended.


Subject(s)
Rosacea , Water Loss, Insensible , Body Water , Epidermis/metabolism , Humans , Rosacea/drug therapy , Skin/metabolism , Water/metabolism
8.
Skin Res Technol ; 26(6): 804-812, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32537843

ABSTRACT

BACKGROUND: Facial erythema is a common symptom in rosacea. To overcome subjectivity in scoring erythema severity, objective redness quantification is desirable. This study evaluated an image-based erythema quantification tool to monitor facial erythema in rosacea patients during treatment and compared these values to clinical scores. MATERIALS AND METHODS: Twenty-one rosacea patients were treated with topical ivermectin for 16 weeks. Clinical erythema scores and clinical photographs were taken at week 0, 6, 16 and 28. Using ImageJ, RGB images were split into red, green and blue channels to measure the green/red ratio of lesional skin compared with a green sticker. With CIELAB colour space, a* (indicating colour from green to red) of a lesional and non-lesional facial site was measured, calculating ∆a*. Interobserver concordance and correlation between quantitative and clinical erythema values were determined. RESULTS: Treatment resulted in reduction of clinical erythema scores. No significant changes in red/green ratios were measured. Lesional a* and ∆a* significantly decreased from baseline to week 16 and 28 (P < .05). A weak correlation existed between clinical scores and lesional a* (Rs  = 0.37), and between clinical scores and ∆a* (Rs  = 0.30), with a clear trend towards higher a* and ∆a* for higher clinical scores. Interobserver correlation was high (R2  = 0.82). CONCLUSION: ImageJ is a simple, rapid, objective and reproducible tool to monitor erythema in rosacea patients during treatment. The photographs allow retrospective analysis, evaluation of large and small lesions, and discrimination of subtle redness differences. We recommend using lesional a* to monitor erythema of inflammatory dermatoses in clinical practice.


Subject(s)
Erythema , Ivermectin/therapeutic use , Rosacea , Administration, Cutaneous , Erythema/diagnosis , Erythema/drug therapy , Humans , Photography , Retrospective Studies , Rosacea/diagnosis , Rosacea/drug therapy , Severity of Illness Index , Skin Cream , Treatment Outcome
9.
J Am Acad Dermatol ; 83(4): 1088-1097, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32360760

ABSTRACT

BACKGROUND: Flushing and erythema are frequent skin symptoms in rosacea. Because their adequate treatment remains a clinical challenge, new treatment options are explored, such as oral ß-blockers. OBJECTIVES: To evaluate the efficacy of oral ß-blockers for rosacea-associated facial flushing and erythema. METHODS: PubMed, Embase, Web of Science, and Cochrane Library were systematically searched, including studies providing original data on the efficacy of oral ß-blockers in rosacea patients with facial flushing and/or persistent erythema. Risk of bias was assessed using the Cochrane Risk of Bias tool, Newcastle-Ottawa scale, and Quality in Prognosis Studies tool. RESULTS: Nine studies evaluating the use of carvedilol, propranolol, nadolol, and ß-blockers in general were included. Articles studying carvedilol and propranolol showed a large reduction of erythema and flushing during treatment with a rapid onset of symptom control. Bradycardia and hypotension were the most commonly described adverse events. LIMITATIONS: Most studies had a retrospective design with a small sample size, and outcome measurement was often subjective. CONCLUSIONS: Oral ß-blockers could be an effective treatment option for patients with rosacea with facial erythema and flushing that does not respond to conventional therapy. Larger prospective trials with objective outcome assessment are needed to validate the promising results of these studies.


Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Dermatologic Agents/therapeutic use , Erythema/drug therapy , Facial Dermatoses/drug therapy , Flushing/drug therapy , Rosacea/drug therapy , Administration, Oral , Adrenergic beta-Antagonists/administration & dosage , Adrenergic beta-Antagonists/adverse effects , Bradycardia/chemically induced , Carvedilol/therapeutic use , Dermatologic Agents/administration & dosage , Dermatologic Agents/adverse effects , Drug Evaluation , Erythema/physiopathology , Facial Dermatoses/physiopathology , Flushing/etiology , Flushing/physiopathology , Humans , Hypotension/chemically induced , Nadolol/therapeutic use , Propranolol/therapeutic use , Retrospective Studies , Rosacea/complications , Rosacea/physiopathology , Treatment Outcome
10.
Ann Dermatol ; 32(3): 247-250, 2020 Jun.
Article in English | MEDLINE | ID: mdl-33911746

ABSTRACT

Rosacea is a chronic inflammatory skin disease of unknown etiology. We noticed a series of patients who were diagnosed with rosacea as well as obstructive sleep apnea syndrome (OSAS), for which they used a continuous positive airway pressure (CPAP) mask. This case series aims to give insight in the possible relationship between rosacea and the use of a CPAP mask for OSAS. We present five patients with OSAS who developed or worsened rosacea symptoms after use of a CPAP mask covering nose and mouth. Two patients showed centrofacial symptoms consistent with the shape of the CPAP mask; three patients had nasal cutaneous symptoms. It is postulated that the occlusive effect of the CPAP mask, increasing skin humidity and temperature, can induce primary symptoms in patients with an underlying sensibility for rosacea. This could have implications for choice of CPAP mask type and topical therapeutic options for rosacea.

11.
Eur J Dermatol ; 28(5): 575-596, 2018 Oct 01.
Article in English | MEDLINE | ID: mdl-30378544

ABSTRACT

Clinical diagnosis of inflammatory skin disorders (ISD), including hair and nail disorders, is not always straightforward. Not uncommonly, a punch biopsy may be required. Dermoscopy and videodermoscopy (VD) are non-invasive techniques that are used for in vivo examination of the skin, hair, and nails. Both techniques can contribute to determining the accurate diagnosis of common ISD and can be useful for assessing treatment effects. However, the value of VD over conventional dermoscopy for ISD is undetermined. We systematically searched and reviewed the current published literature on ISD evaluated by VD and dermoscopy in the electronic databases, PubMed, Embase, the Cochrane Library, and Web of Science. All studies were assessed for quality using the Strengthening the Reporting of Observational studies in Epidemiology and Cochrane checklist. Finally, 82 studies were eligible for inclusion. An overview is presented of the (video)dermoscopic features for common ISD diagnoses, with details regarding the level of accuracy and features that should be monitored during treatment. Although both techniques are promising, studies of high methodological quality are necessary to determine the value of VD over conventional dermoscopy for common ISD.


Subject(s)
Dermatitis/diagnosis , Dermoscopy/methods , Hair Diseases/diagnosis , Nail Diseases/diagnosis , Video Recording , Alopecia/diagnosis , Dermatitis/pathology , Female , Hair Diseases/pathology , Humans , Lichen Planus/diagnosis , Male , Nail Diseases/pathology , Psoriasis/diagnosis , Scleroderma, Systemic/diagnosis , Sensitivity and Specificity
12.
J Med Internet Res ; 20(9): e10135, 2018 09 24.
Article in English | MEDLINE | ID: mdl-30249584

ABSTRACT

BACKGROUND: Most electronic health (eHealth) interventions offered to patients serve a single purpose and lack integration with other tools or systems. This is problematic because the majority of patients experience comorbidity and chronic disease, see multiple specialists, and therefore have different needs regarding access to patient data, communication with peers or providers, and self-monitoring of vital signs. A multicomponent digital health cloud service that integrates data sharing, collection, and communication could facilitate patient-centered care in combination with a hospital patient portal and care professionals. OBJECTIVE: This study aimed to assess the feasibility and functionality of a new cloud-based and multicomponent outpatient clinic, the "Virtual Outpatient Clinic" (VOC). METHODS: The VOC consists of 6 digital tools that facilitate self-monitoring (blood pressure, weight, and pain) and communication with peers and providers (chat and videoconferencing) connected to a cloud-based platform and the hospital patient portal to facilitate access to (self-collected) medical data. In this proof-of-concept study, 10 patients from both Departments of Internal Medicine and Dermatology (N=20) used all options of the VOC for 6 weeks. An eNurse offered support to participants during the study. We assessed the feasibility, usage statistics, content, adherence, and identified technical issues. Moreover, we conducted qualitative interviews with all participants by following a standard interview guide to identify user experiences, including barriers, facilitators, and potential effects. RESULTS: Most participants successfully used all options of the VOC and were positive about different tools and apps and the integral availability of their information. The adherence was 37% (7/19) for weight scale, 58% (11/19) for blood pressure monitor, and 70% (14/20) and 85% (17/20) for pain score and daily questions, respectively. The adherence for personal health record was 65% (13/20) and 60% (12/20) for the patient portal system. Qualitative data showed that performance and effort expectancy scored high among participants, indicating that using the VOC is convenient, easy, and time-saving. CONCLUSIONS: The VOC is a promising integrated Web-based technology that combines self-management, data sharing, and communication between patients and professionals. The system can be personalized by connecting various numbers of components, which could make it a relevant tool for other patient groups. Before a system, such as the VOC, can be implemented in daily practice, prospective studies focused on evaluating outcomes, costs, and patient-centeredness are needed.


Subject(s)
Ambulatory Care Facilities , Cloud Computing , Electronic Health Records , Patient Education as Topic , Patient-Centered Care , Adolescent , Adult , Aged , Chronic Disease , Communication , Female , Hospitals , Humans , Male , Middle Aged , Netherlands , Proof of Concept Study , Prospective Studies , Young Adult
15.
Acta Derm Venereol ; 96(4): 453-8, 2016 May.
Article in English | MEDLINE | ID: mdl-26537336

ABSTRACT

The efficacy of biologic or conventional systemic therapies for psoriasis has been shown in randomized controlled trials. Effectiveness, however, has been studied in daily practice cohorts, and no aggregation of effectiveness data is available. This systematic review searched PubMed and EMBASE and summarized the real-world evidence on effectiveness of biologics (adalimumab, etanercept, infliximab and ustekinumab) and conventional systemic therapies (acitretin, cyclosporine, fumarates and methotrexate) for the treatment of plaque psoriasis in adults. Thirty-two studies were included. Few data were available on infliximab, ustekinumab and conventional systemics. Results show that biologics and conventional systemics were effective in real-life treatment of psoriasis, with large ranges in the percentage of patients reaching 75% improvement in psoriasis area and severity index score compared with baseline, especially for etanercept and adalimumab treatment. Combination therapies of biologics with conventional systemics, and dose adjustments of biologics were frequently applied strategies and may explain the large range in improvements between cohorts.


Subject(s)
Biological Products/therapeutic use , Immunosuppressive Agents/therapeutic use , Psoriasis/drug therapy , Adult , Biological Products/adverse effects , Chronic Disease , Drug Therapy, Combination , Humans , Immunosuppressive Agents/adverse effects , Psoriasis/diagnosis , Psoriasis/immunology , Remission Induction , Time Factors , Treatment Outcome
16.
J Am Acad Dermatol ; 68(1): 57-63, 2013 Jan.
Article in English | MEDLINE | ID: mdl-22846689

ABSTRACT

BACKGROUND: A problem encountered when analyzing long-term efficacy is that the number of patients in follow-up decreases with time for different reasons. The method used to account for missing observations for the therapy under analysis has a great influence on the inference of efficacy. OBJECTIVE: To describe the long-term efficacy of etanercept for psoriasis in daily practice using 3 analytical approaches. METHODS: Prospective data from a cohort of patients with psoriasis treated with etanercept for at least 24 weeks were analyzed using 3 analytical approaches: as treated analysis, intention-to-treat analysis (ITT) with last observation carried forward (LOCF) and intention-to-treat analysis with modified nonresponder imputation (modified NRI). RESULTS: One hundred thirty-one patients were treated with etanercept during 134 treatment episodes with a mean treatment duration of 2.7 years. The maximum follow-up was 6.0 years. The methodological approach chosen had a great influence. Psoriasis Area and Severity Index (PASI) 75 response rates varied from 60% in the as-treated approach to 34% in LOCF and to 29% in modified NRI at week 264. LIMITATIONS: All analytical methods applied have limitations. Other outcome measures could be used to overcome the bias introduced by each method of analysis, such as drug survival. CONCLUSIONS: The methodological approach chosen to analyze long-term efficacy data has a great influence on the inferences that may be drawn regarding the degree of efficacy. Therefore we support the use of different methods to present long-term efficacy data.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Immunoglobulin G/therapeutic use , Psoriasis/drug therapy , Receptors, Tumor Necrosis Factor/therapeutic use , Statistics as Topic/methods , Adult , Aged , Etanercept , Female , Follow-Up Studies , Humans , Intention to Treat Analysis , Male , Middle Aged , Patient Dropouts/statistics & numerical data , Prospective Studies , Registries , Severity of Illness Index , Time Factors , Treatment Outcome , Young Adult
17.
Br J Clin Pharmacol ; 71(1): 7-19, 2011 Jan.
Article in English | MEDLINE | ID: mdl-21143496

ABSTRACT

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: Infliximab is an effective treatment for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease (both adult and paediatric), ulcerative colitis, psoriatic arthritis and plaque psoriasis and national and international guidelines have been developed for each indication. WHAT THIS STUDY ADDS: This study is the first study which compared current international, national and local guidelines from the medical specialties involved in the treatment with infliximab on the following topics: indication, dosage, synergy and monitoring of vital signs. AIMS: Infliximab, an anti-TNF biologic agent, is currently indicated and reimbursed for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease (both adult and paediatric), ulcerative colitis, psoriatic arthritis and plaque psoriasis. Development of national and international guidelines for rheumatology, gastroenterology and dermatology, was mostly based on clinical studies and expert opinion. The aim of this study was to compare available guidelines and local protocols for rheumatology, dermatology and gastroenterology, regarding dosage of infliximab, synergy of infliximab with concomitant medication and monitoring of vital signs during infliximab administration, for achieving optimal care. METHODS: Current international, national and local guidelines on the use of infliximab were reviewed and compared, differences and shortcomings were identified, and optimal treatment schedules discussed during a meeting (July 2008) of clinical experts and researchers from three departments of a Dutch university hospital. RESULTS: Recommended dosages of infliximab are not equal for different indications. Loss of response to infliximab is a common problem encountered within the three medical specialties, but indications for adjustments in treatment schedules are lacking in all of the guidelines. Monitoring of vital signs (blood pressure, pulse, temperature) during infusion with infliximab is common practice and recommended by some guidelines. Routine measurement of vital signs is not of any value in predicting or recognizing acute infusion reactions, in our experience, and this is confirmed by literature on inflammatory bowel disease. CONCLUSION: Different indications encompass different dosing schedules. National and internal guidelines do not provide advice regarding loss of response. Routine measurement of vital signs during infusion is not valuable in detecting acute infusion reactions and should only be performed in case of an acute infusion reaction. These topics need to be studied in future studies and covered in future guidelines.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal/administration & dosage , Arthritis/drug therapy , Inflammatory Bowel Diseases/drug therapy , Skin Diseases/drug therapy , Vital Signs/drug effects , Adult , Child , Drug Monitoring , Humans , Infliximab , International Cooperation , Treatment Outcome
18.
Arch Dermatol ; 146(2): 127-32, 2010 Feb.
Article in English | MEDLINE | ID: mdl-20157022

ABSTRACT

OBJECTIVES: To investigate the extent antibodies to adalimumab are formed in patients with plaque psoriasis and whether these antibodies have clinical consequences. Also, to examine the relationship between antibodies to adalimumab and adalimumab trough titers. DESIGN: Prospective observational cohort study. SETTING: Two Dutch dermatology departments in university hospitals. PATIENTS: All consecutive patients starting a regimen of adalimumab for chronic plaque psoriasis. Patients were screened and fulfilled the Dutch reimbursement criteria for adalimumab to treat psoriasis. INTERVENTION: Adalimumab treatment (per label). MAIN OUTCOME MEASURES: The titer of antibodies to adalimumab, the adalimumab trough concentration, and the Psoriasis Area and Severity Index at weeks 12 and 24. RESULTS: Antibodies to adalimumab were detected in 13 of 29 patients (45%) during 24 weeks of treatment. Differences in response rates among patients with low, high, and no titers of antibodies to adalimumab were significant at weeks 12 and 24 (P = .04 and P < .001, respectively). The median adalimumab trough concentrations varied significantly among patients with low, high, and no titers of antibodies to adalimumab (1.30 [range, 0.01-5.50], 0.0 [range, 0.0-0.0], and 9.6 [range, 0.0-22.6] mg/L, respectively; P < .001). At week 24, the median adalimumab trough concentrations also differed significantly among good responders, moderate responders, and nonresponders (9.7 [range, 0.0-22.6], 8.9 [range, 3.2-12.6], and 0.0 [range, 0.0-13.3] mg/L, respectively; P = .01). CONCLUSION: Antibodies to adalimumab are associated with lower serum adalimumab trough concentrations and with nonresponse or loss of response to adalimumab in patients with plaque psoriasis.


Subject(s)
Anti-Inflammatory Agents/blood , Anti-Inflammatory Agents/immunology , Antibodies, Monoclonal/immunology , Immunoglobulin G/blood , Psoriasis/blood , Psoriasis/immunology , Adalimumab , Adult , Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal/blood , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , Antibody Formation , Cohort Studies , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Psoriasis/drug therapy , Risk Factors , Severity of Illness Index , Treatment Failure
19.
Rheumatology (Oxford) ; 49(3): 588-91, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20040525

ABSTRACT

OBJECTIVES: To get the approval for reimbursement of biological therapies for PsA, patients need to fulfil specific criteria in many countries. The aim of this study was to evaluate the 4-year Dutch reimbursement application data, including the diagnostic, disease activity and response criteria that were applied for treatment of PsA with biologics. METHODS: All initial and follow-up applications for approval of treatment with biologics were included for investigation. Data were analysed descriptively with regard to application characteristics, patient characteristics and response to therapy. RESULTS: In the period studied, 3723 application forms of 1991 patients were received. This concerned 2118 initial treatment applications and 1605 follow-up applications. Of all initial treatment applications, 2003 (94.6%) were approved. The major part of all applications concerned requests for etanercept (59.1%), followed by adalimumab (38.2%). Patients were suffering from polyarthritis in most cases (63.1%). MTX was used by nearly all patients, but only 55.8% had used the required dosage of 25 mg/week. Approximately 79.4% of all patients met the response criteria after 3 months of treatment. The mean number of affected joints declined from 7.7 at first application to 1.4 at follow-up. The initial visual analogue scale (VAS) score indicated by patients decreased from 71.2 to 24.1 at follow-up. The VAS score indicated by physicians decreased from 66.0 to 18.4. CONCLUSIONS: Biologics are expensive, but highly effective in the treatment of PsA. Careful compilation of treatment and reimbursement criteria is important for patients as well as for physicians and health insurance companies.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Psoriatic/drug therapy , Biological Products/therapeutic use , Adalimumab , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal/economics , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , Antirheumatic Agents/economics , Arthritis, Psoriatic/economics , Biological Products/economics , Child , Drug Utilization/statistics & numerical data , Etanercept , Female , Follow-Up Studies , Humans , Immunoglobulin G/economics , Immunoglobulin G/therapeutic use , Male , Methotrexate/therapeutic use , Middle Aged , Netherlands , Receptors, Tumor Necrosis Factor/therapeutic use , Reimbursement Mechanisms/statistics & numerical data , Treatment Outcome , Young Adult
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